An Open-Label, Phase 1b Study of SL-172154 (SIRPα-Fc-CD40L) Administered With Either Pegylated Liposomal Doxorubicin or Mirvetuximab Soravtansine in Subjects With Platinum-Resistant Ovarian Cancers
Phase: PHASE1
Conditions: Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Epithelial Ovarian Cancer, Ovarian Cancer, Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Primary Peritoneal Carcinoma
Sponsor: Shattuck Labs, Inc.

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SL03-OHD-105 
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Version no:3.0 
 
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Protocol Title: An Open-Label, Phase 1b Study of SL-172154 (SIRPα-Fc-CD40L) 
Administered with Either Pegylated Liposomal Doxorubicin or Mirvetuximab 
Soravtansine in Subjects with Platinum-Resistant Ovarian Cancers  
 
Short Title: Phase 1b Study of SL-172154 Administered with Combination Agent(s) in Subjects 
with Ovarian Cancers  
Protocol Identifying Number: SL03-OHD-105 
Version Number: 3.0 
Study Phase: Phase 1b 
Investigational New Drug (IND) Sponsor: Shattuck Labs 
Legal Registered Address: 
Shattuck Labs, Inc. 
21 Alexandria Way, Suite, 200 
Durham, North Carolina 27709 
Regulatory Agency Identifier Number(s) 
IND: 142568 
EudraCT: 2022-000698-17 
Approval Date:   25 Jun 2024 
 
 
 
 
 
 
 
 
 
This document is the confidential property of Shattuck Labs. It contains proprietary information and is 
submitted to the clinical trial site for the sole purpose of reviewing and conduct of the named clinical trial. 
Reproduction, disclosure, or use of the submission or information contained therein in whole or part 
otherwise than for this purpose is prohibited unless Shattuck Labs provides prior written authorization for 
such reproduction, disclosure or use. 
 

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TABLE OF CONTENTS 
TABLE OF CONTENTS ................................................................................................................ 2 
LIST OF TABLES .......................................................................................................................... 8 
LIST OF FIGURES ........................................................................................................................ 8 
LIST OF ABBREVIATIONS ......................................................................................................... 9 
STATEMENT OF COMPLIANCE .............................................................................................. 14 
KEY TRIAL CONTACTS ........................................................................................................... 15 
STUDY SCHEMA........................................................................................................................ 16 
PROTOCOL SYNOPSIS ............................................................................................................. 17 
1. 
BACKGROUND AND STUDY RATIONALE ................................................................... 32 
1.1 
Bridging Innate and Adaptive Immunity via Concurrent Targeting of CD47 and CD40
 32 
1.2 
Ovarian Cancer ............................................................................................................... 33 
1.3 
CD47 and CD40 Targeting in Ovarian Cancer ............................................................... 33 
1.4 
SL-172154 ...................................................................................................................... 34 
1.4.1 
Mechanism of Action ............................................................................................... 34 
1.4.2 
Summary of Nonclinical Data ................................................................................. 35 
1.4.3 
In Vitro Pharmacology Studies ................................................................................ 35 
1.4.4 
In Vivo Pharmacology .............................................................................................. 36 
1.4.5 
Toxicology Studies in Non-Human Primates .......................................................... 36 
1.4.6 
Toxicokinetic Studies............................................................................................... 37 
1.4.7 
Summary of Clinical Data for SL-172154 ............................................................... 37 
1.5 
Rationale for Combination Therapies ............................................................................. 38 
1.5.1 
Rationale for SL-172154 Administered with Pegylated Liposomal Doxorubicin 
(PLD) ....................................................................................................................... 39 
1.5.2 
Rationale for SL-172154 Administered with Mirvetuximab Soravtansine (MIRV) 40 
1.6 
Dose and Schedule Rationale ......................................................................................... 41 
1.6.1 
Pegylated Liposomal Doxorubicin (PLD) ............................................................... 41 
1.6.2 
Mirvetuximab Soravtansine (MIRV) ....................................................................... 41 
1.6.3 
SL-172154................................................................................................................ 41 
1.7 
Potential Risks and Benefits of SL-172154 .................................................................... 42 
1.7.1 
Potential Risks ......................................................................................................... 42 
1.7.2 
Potential Benefits ..................................................................................................... 46 
1.8 
Study Rationale ............................................................................................................... 47 
2. 
STUDY OBJECTIVES AND OUTCOME MEASURES ..................................................... 48 
3. 
STUDY DESIGN .................................................................................................................. 49 
3.1 
Description of Study Design ........................................................................................... 49 
3.1.1 
Sample Size .............................................................................................................. 50 

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3.2 
Dose Escalation .............................................................................................................. 51 
3.2.1 
SL-172154 Administered with Pegylated Liposomal Doxorubicin (PLD) ............. 51 
3.2.2 
SL-172154 Administered with Mirvetuximab Soravtansine (MIRV) ..................... 52 
3.3 
Dose Expansion .............................................................................................................. 53 
3.3.1 
SL-172154 Administered with PLD ........................................................................ 53 
3.3.2 
SL-172154 Administered with MIRV ..................................................................... 54 
3.4 
Selection of Recommended Phase 2 Dose ...................................................................... 54 
3.5 
Definition of Dose-Limiting Toxicity ............................................................................ 54 
3.6 
Concomitant Medications, Treatments, and Procedures ................................................ 55 
3.6.1 
Prohibited Medications or Treatments ..................................................................... 56 
3.6.2 
Medications to be used with Caution ....................................................................... 57 
3.7 
Toxicity Management Guidelines ................................................................................... 58 
3.7.1 
Toxicity Management Guidelines for SL-172154 ................................................... 58 
3.7.1.1 
Management of Infusion-Related Reactions [SL-172154] .............................. 60 
3.7.1.2 
Management of Cytokine Release Syndrome ................................................. 63 
3.7.1.3 
Management of Hepatotoxicity ....................................................................... 68 
3.7.1.4 
Management of Hematologic AEs .................................................................. 69 
3.7.1.5 
Management of Other AEs Not Specified ....................................................... 71 
3.7.2 
Toxicity Management Guidelines for PLD.............................................................. 72 
3.7.2.1 
Management of Hematologic Toxicity [PLD Cohort] .................................... 72 
3.7.2.2 
Management of Infusion-Related Reaction [PLD Cohort] .............................. 72 
3.7.2.3 
Management of Mucocutaneous Toxicity [PLD Cohort] ................................ 73 
3.7.2.4 
Management of Left Ventricular Ejection Fraction Decreased [PLD Cohort] 73 
3.7.3 
Toxicity Management Guidelines for MIRV ........................................................... 74 
3.7.3.1 
MIRV Treatment Criteria ................................................................................ 74 
3.7.3.2 
Dose Modifications for MIRV-Related Adverse Events ................................. 74 
3.7.3.3 
Monitoring and Management of Nausea and Vomiting [MIRV Cohort] ........ 76 
3.7.3.4 
Monitoring and Management of Diarrhea [MIRV Cohort] ............................. 76 
3.7.3.5 
Ocular Disorders [MIRV Cohort] .................................................................... 76 
3.7.3.6 
Monitoring of Noninfectious Pneumonitis [MIRV Cohort] ............................ 80 
3.7.3.7 
Management of Electrolyte Imbalance [MIRV Cohort] .................................. 81 
3.7.3.8 
Potential Infusion-Related Reactions [MIRV Cohort] .................................... 81 
3.8 
Subject Withdrawal of Consent ...................................................................................... 82 
3.9 
Lost to Follow-Up ........................................................................................................... 83 
3.10 Premature Termination or Suspension of Study ............................................................. 83 
3.11 Study Treatment Discontinuation Criteria ...................................................................... 84 
3.12 Duration of Follow-Up ................................................................................................... 84 
3.13 End-of-Study Definition ................................................................................................. 85 

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4. 
STUDY POPULATION ........................................................................................................ 85 
4.1 
Inclusion Criteria ............................................................................................................ 85 
4.2 
Exclusion Criteria ........................................................................................................... 87 
4.3 
Screen Failures ................................................................................................................ 90 
5. 
PHARMACEUTICAL PRODUCT INFORMATION .......................................................... 90 
5.1 
SL-172154 ...................................................................................................................... 90 
5.1.1 
Investigational Product Description ......................................................................... 90 
5.1.2 
Preparation, Handling, Administration, and Storage of SL-172154 ........................ 91 
5.1.2.1 
Preparation ....................................................................................................... 91 
5.1.2.2 
Handling .......................................................................................................... 91 
5.1.2.3 
Administration ................................................................................................. 91 
5.1.2.4 
Storage ............................................................................................................. 92 
5.1.3 
Dosing and Change in Weight ................................................................................. 92 
5.1.4 
Monitoring Dose Administration ............................................................................. 92 
5.1.5 
SL-172154 Accountability and Treatment Compliance .......................................... 93 
5.1.6 
Treatment of SL-172154 Overdose ......................................................................... 93 
5.2 
Pegylated Liposomal Doxorubicin (PLD) ...................................................................... 94 
5.3 
Mirvetuximab Soravtansine (MIRV) .............................................................................. 94 
5.3.1 
MIRV Product and Packaging Description.............................................................. 94 
5.3.2 
Preparation and Administration of MIRV ............................................................... 95 
5.3.2.1 
Premedication for MIRV Treatment ................................................................ 95 
5.3.2.2 
Prophylactic Use of Eye Drops ....................................................................... 95 
5.3.2.3 
Calculation for Adjusted Ideal Body Weight .................................................. 95 
5.3.2.4 
Preparation of MIRV ....................................................................................... 95 
5.3.3 
MIRV Accountability .............................................................................................. 96 
5.3.4 
MIRV Study Treatment Compliance ....................................................................... 96 
5.3.5 
MIRV Overdose and Medication Error ................................................................... 97 
6. 
STUDY ASSESSMENTS AND PROCEDURES ................................................................ 97 
6.1 
Schedule of Assessments: SL-172154 + PLD Cohorts (Dose Escalation and Dose 
Expansion) ...................................................................................................................... 98 
6.1.1 
PK, ADA, Cytokines and Receptor Occupancy (SL-172154 + PLD Dose Escalation 
and Dose Expansion Cohorts) ................................................................................ 102 
6.2 
Schedule of Assessments: SL-172154 + MIRV Cohorts (Dose Escalation and Dose 
Expansion) .................................................................................................................... 103 
6.2.1 
PK, ADA, Cytokines and Receptor Occupancy (SL-172154 + MIRV Dose 
Escalation and Dose Expansion Cohorts) .............................................................. 107 
6.3 
Demographics, Medical History and Screening Assessments ...................................... 109 
6.3.1 
Informed Consent................................................................................................... 109 
6.3.2 
Eligibility Criteria .................................................................................................. 109 

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6.3.3 
Subject Demographics ........................................................................................... 109 
6.3.4 
Medical History ..................................................................................................... 109 
6.3.5 
Concomitant Medications and Procedures............................................................. 109 
6.4 
Evaluation of FRα Expression in Tumor Tissue [MIRV Cohort] ................................ 109 
6.5 
Safety Evaluations ........................................................................................................ 110 
6.5.1 
Physical Examination............................................................................................. 110 
6.5.2 
ECOG Performance Status .................................................................................... 110 
6.5.3 
Pulse Oximetry....................................................................................................... 110 
6.5.4 
Vital Signs .............................................................................................................. 110 
6.5.5 
Electrocardiogram - ECG ...................................................................................... 111 
6.5.6 
Echocardiogram (ECHO)/Multigated Acquisition Scan (MUGA)........................ 111 
6.5.7 
Ocular Symptom Assessment [MIRV Cohort Only] ............................................. 111 
6.5.8 
Ophthalmic Examination [MIRV Cohort Only] .................................................... 111 
6.5.9 
Local and Central Clinical Laboratory Assessments ............................................. 112 
6.5.9.1 
Ad Hoc Labs for IRR or CRS AEs ................................................................ 113 
6.5.9.2 
Pregnancy Testing ......................................................................................... 113 
6.5.9.3 
CA-125 .......................................................................................................... 113 
6.5.9.4 
Blood type and Screen (ABO/Rh) and DAT ................................................. 114 
6.6 
Pharmacokinetics .......................................................................................................... 114 
6.7 
Anti-Drug Antibody and Neutralizing Antibody Assessments .................................... 114 
6.8 
Cytokine Analysis ......................................................................................................... 114 
6.9 
Receptor Occupancy Analysis ...................................................................................... 114 
6.10 Tumor Biopsy ............................................................................................................... 115 
6.10.1 Baseline and On-Treatment Fresh Tumor Biopsies [MIRV cohort only] ............. 115 
6.11 Assessment of Anti-Tumor Activity ............................................................................. 116 
6.12 Unscheduled Visit ......................................................................................................... 116 
7. 
SAFETY ASSESSMENTS ................................................................................................. 116 
7.1 
Definitions for Safety Parameters ................................................................................. 117 
7.1.1 
Events not Qualifying as AEs/SAEs ...................................................................... 118 
7.2 
Classification of an Adverse Event ............................................................................... 119 
7.2.1 
Assessment of Severity .......................................................................................... 119 
7.2.2 
Assessment of Causality ........................................................................................ 119 
7.2.3 
Expectedness .......................................................................................................... 120 
7.3 
Timing for Event Assessment and Follow-Up ............................................................. 120 
7.4 
Procedures for Recording and Reporting of Adverse Events ....................................... 120 
7.5 
Reporting of Pregnancy ................................................................................................ 121 
7.6 
Reporting of Events to Sponsor .................................................................................... 122 
7.7 
Study Halting Rules ...................................................................................................... 122 

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7.8 
Safety Oversight ........................................................................................................... 122 
8. 
ANTI-TUMOR ACTIVITY ASSESSMENTS ................................................................... 122 
8.1 
Disease Assessment ...................................................................................................... 123 
8.1.1 
Assessment of Response ........................................................................................ 123 
8.2 
Criteria for Treatment Beyond Initial Progression ....................................................... 123 
9. 
STATISTICAL CONSIDERATIONS AND DATA ANALYSIS ...................................... 124 
9.1 
Study Design and Sample Size Determinations ........................................................... 124 
9.1.1 
Dose Escalation ...................................................................................................... 124 
9.1.2 
Dose Expansion ..................................................................................................... 125 
9.1.3 
Safety Monitoring During Dose Expansion ........................................................... 125 
9.1.3.1 
Safety Monitoring in the SL-172154 + PLD Dose Expansion Cohort .......... 126 
9.1.3.2 
Safety Monitoring in the SL-172154 + MIRV Dose Expansion Cohort ....... 126 
9.1.4 
Sample Size Determination.................................................................................... 127 
9.2 
Statistical Analysis ........................................................................................................ 127 
9.2.1 
Analysis Populations .............................................................................................. 127 
9.2.2 
Data Analysis During Dose Escalation .................................................................. 128 
9.2.3 
General Data Analysis Consideration .................................................................... 128 
9.2.4 
Safety Analyses ...................................................................................................... 128 
9.2.5 
Efficacy Analyses .................................................................................................. 129 
9.2.6 
Pharmacokinetic Analysis ...................................................................................... 129 
9.2.6.1 
Immunogenicity Analysis .............................................................................. 130 
9.2.7 
Pharmacodynamics Analysis ................................................................................. 130 
10. CLINICAL MONITORING ................................................................................................ 131 
11. SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA AND DOCUMENTS ... 131 
11.1 Source Data ................................................................................................................... 131 
11.2 Access to Data .............................................................................................................. 131 
11.3 Data Recording and Record Keeping ........................................................................... 131 
12. QUALITY ASSURANCE PROCEDURES ........................................................................ 132 
13. ETHICS/PROTECTION OF HUMAN SUBJECTS ........................................................... 132 
13.1 Ethical Standard ............................................................................................................ 132 
13.2 Institutional Review Board/Independent Ethics Committee ........................................ 132 
13.3 Informed Consent Process ............................................................................................ 132 
13.3.1 Consent/Assent and Other Informational Documents Provided to Subjects ......... 132 
13.3.2 Consent Procedures and Documentation ............................................................... 133 
13.4 Subject and Data Confidentiality .................................................................................. 133 
13.4.1 Research Use of Stored Human Samples, Specimens, or Specimen Data ............. 134 
14. DATA HANDLING AND RECORD KEEPING ............................................................... 134 
14.1 Communication and Data Dissemination Plan ............................................................. 134 

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14.2 Data Collection and Management Responsibilities ...................................................... 135 
14.3 Study Records Retention .............................................................................................. 135 
14.4 Protocol Deviations ...................................................................................................... 136 
14.5 Publications and Data Sharing Policy ........................................................................... 136 
15. LITERATURE REFERENCES .......................................................................................... 137 
16. APPENDICES ..................................................................................................................... 143 
16.1 ECOG Performance Status Criteria .............................................................................. 143 
16.2 Contraception Requirements ........................................................................................ 144 
16.2.1 Pregnancy Status .................................................................................................... 145 
16.3 Cockcroft-Gault Formula for Creatinine Clearance ..................................................... 146 
16.4 Adjusted Ideal Body Weight Calculation ..................................................................... 147 
16.5 RECIST 1.1 Criteria ..................................................................................................... 148 
16.5.1 Evaluation of Response.......................................................................................... 149 
16.6 Grading of Ocular AEs [MIRV Cohort Only] .............................................................. 151 
16.7 Summary of Changes from Version 0.0 to 1.0 ............................................................. 155 
16.8 Summary of Changes from Version 1.0 to 2.0 ............................................................. 159 
16.9 Summary of Changes from Version 2.0 to 3.0 ............................................................. 165 
 
 
 

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LIST OF TABLES 
Table 1 
SL-172154 Dose Escalation Plan When Administered with PLD .............................. 51 
Table 2 
SL-172154 Dose Escalation Plan When Administered with MIRV ........................... 53 
Table 3 
SL-172154 Dose Levels for Dose Reductions ............................................................ 59 
Table 4 
ASTCT Consensus Grading Criteria for CRS [Lee, 2019] ......................................... 63 
Table 5 
PLD Dose Reduction for Management of Toxicities ................................................. 72 
Table 6 
MIRV Dose Reduction Dose Levels........................................................................... 74 
Table 7  
Dose Modifications for MIRV-Related Adverse Events ............................................ 74 
Table 8 
Management of Corneal Adverse Reactions (Keratitis/Keratopathy) ........................ 78 
Table 9 
Management of Ocular Disorders ............................................................................... 79 
Table 10 Management of Noninfectious Pneumonitis ............................................................... 80 
Table 11 Management Guidelines for Potential Infusion-Related Reaction [MIRV Cohort] ... 82 
Table 12 SL-172154 Dose Escalation Decision Rules for Each Dose Level Based on mTPI-2
................................................................................................................................... 124 
Table 13 Response Rate 90% CI Out of 20 Subjects ............................................................... 125 
Table 14  Serum SL-172154 PK Parameters ........................................................................... 130 
Table 15 Grading for Ocular Symptoms .................................................................................. 151 
Table 16 Grading for Other Ocular Events .............................................................................. 151 
 
LIST OF FIGURES 
Figure 1.  Study Schema.............................................................................................................. 16 
Figure 2.  SIRPα-Fc-CD40L (SL-172154) Mechanism of Action .............................................. 35 
 
 

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LIST OF ABBREVIATIONS 
Ab 
Antibody 
ADA 
Anti-drug antibodies 
ADC 
Antibody drug conjugate 
ADL 
Activities of daily living 
AE 
Adverse event 
AIBW 
Adjusted ideal body weight 
ALT 
Alanine aminotransferase 
AML 
Acute myeloid leukemia 
ANA 
Anti-nuclear antibody 
ANC 
Absolute neutrophil count 
APC 
Antigen-presenting cell 
aPTT 
Activated partial thromboplastin time 
AR 
Adverse reaction 
ARC 
Agonist redirected checkpoint 
ASCO 
American Society of Clinical Oncology 
AST 
Aspartate aminotransferase 
ASTCT 
American Society for Transplantation and Cellular Therapy 
AUC 
Area under the serum concentration time curve 
AUClast 
Area under the serum concentration time curve, time 0 to the last quantifiable concentration 
AUC0-inf 
Area under the serum concentration time curve from time 0 extrapolated to infinity 
AUC0-t 
Area under the serum concentration time curve, time 0 to time = t 
%AUCext 
Percentage of AUC0-inf due to extrapolation from Tlast to infinity 
AUCtau 
The area under the serum concentration time curve, over the dosing interval 
BCVA 
Best corrected visual acuity 
β-hCG 
Beta-human chorionic gonadotropin 
BID 
Twice a day 
BP 
Blood pressure 
BRCA 
Breast cancer gene 
C 
Cycle 
CBC 
Complete blood count 
CBR 
Clinical benefit rate 
CD 
Cluster of differentiation 
C1D1 
Cycle 1 Day 1 
CFR 
Code of Federal Regulations 
cGAS/STING 
Cyclic guanine monophosphate – adenosine monophosphate synthase/stimulator of interferon 
genes 
CI 
Confidence Interval 
CL 
Clearance 
Cmax 
Maximum observed concentration 

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Cmin 
Minimum observed concentration 
CMP 
Clinical monitoring plan 
CNS 
Central nervous system 
CPAP 
Continuous positive airway pressure 
CR 
Complete response 
CrCl 
Creatinine clearance 
CRO 
Clinical research organization 
CRS 
Cytokine release syndrome 
CRT 
Calreticulin 
CT 
Computed tomography 
CTCAE 
Common terminology criteria for adverse event 
CTLA-4 
Cytotoxic T cell lymphocyte-associated antigen 4 
CYP 
Cytochrome P 
D 
Day 
DAT 
Direct antiglobulin test 
DC 
Dendritic cells 
DL 
Dose level 
DLT(s) 
Dose-limiting toxicity(ies) 
DNA 
Deoxyribonucleic acid 
DoR 
Duration of response 
ECD 
Extracellular domain 
ECG 
Electrocardiogram 
ECHO 
Echocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EIOP 
Elevated intraocular pressure 
EMA 
European Medicines Agency 
EOC 
Epithelial ovarian cancer 
EOI 
End of infusion 
EPO 
Erythropoietin 
ESMO 
European Society for Medical Oncology 
ETFE 
Ethylene tetrafluoroethylene 
FCBP 
Female of childbearing potential 
FDA 
Food and Drug Administration 
FFPE 
Formalin-fixed paraffin-embedded 
FOLR1 
Folate receptor 1 
FRα 
Folate receptor alpha 
FSH 
Follicle stimulating hormone 
GCP 
Good Clinical Practice 

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GCSF 
Granulocyte colony stimulating factor 
GLP 
Good Laboratory Practice 
H1/H2 
Histamine 1/ Histamine 2 
HBcAb 
Hepatitis B core antibody 
HBsAg 
Hepatitis B surface antigen 
HBV 
Hepatitis B virus 
HCV 
Hepatitis C virus 
Hgb 
Hemoglobin 
HIV 
Human immunodeficiency virus 
HR 
Heart rate 
HRD 
Homologous recombination deficiency 
HSR(s) 
Hypersensitivity reaction(s) 
IB 
Investigator’s brochure 
IBW 
Ideal body weight 
IC 
Investigator’s choice 
ICF 
Informed consent 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IFNγ 
Interferon gamma 
IHC 
Immunohistochemistry 
IL 
Interleukin 
ILD 
Interstitial lung disease 
IM 
Intramuscular 
IND 
Investigational new drug 
INR 
International normalized ratio 
IOP 
Intra-ocular pressure 
IP 
Investigational product 
irAE 
Immune-related adverse event 
IRB 
Institutional Review Board 
IRR(s) 
Infusion-related reaction(s) 
ITT 
Intent-to-treat 
IV 
Intravenous 
IVIG 
IV immunoglobulin 
KD 
Receptor off-rate constant 
LLOQ 
Lower limit of quantification 
LVEF 
Left ventricular ejection fraction 
mAb(s) 
Monoclonal antibody(ies) 
MAD 
Maximum administered dose  
MDS 
Myelodysplastic syndrome 
MedDRA 
Medical Dictionary for Regulatory Activities 

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MIRV 
Mirvetuximab soravtansine 
MMF 
Mycophenolate mofetil 
MRI 
Magnetic resonance imaging  
MTD 
Maximum tolerated dose  
mTPI-2 
Modified toxicity probability interval  
MUGA 
Multigated acquisition scan 
NCI 
National Cancer Institute 
NHL 
non-Hodgkin’s lymphoma 
ORR 
Objective response rate 
OS 
Overall survival 
PARP 
Poly ADP-ribose polymerase 
PBMC 
Peripheral blood mononuclear cells 
PCR 
Polymerase chain reaction 
PD 
Pharmacodynamic(s) 
PET 
Positron Emission Tomography 
PFS 
Progression-free survival 
P-gp 
P-glycoprotein 
PK 
Pharmacokinetic(s) 
PLD 
Pegylated liposomal doxorubicin 
PLT 
Platelet 
PO 
Orally 
PR 
Partial response 
PRN 
As needed 
PROC 
Platinum-resistant ovarian cancer 
PS2+ 
Scoring method based on membrane stain intensity level of 2 or greater 
PT 
Prothrombin time 
PTV 
Post-treatment visit 
q 
Every 
Q3W 
Every 3 weeks 
RANKL 
Receptor activator of nuclear factor kappa B ligand 
RBC 
Red blood cell 
RECIST 
Response evaluation criteria in solid tumors 
RNA 
Ribonucleic acid 
RO 
Receptor Occupancy 
RP2D 
Recommended Phase 2 dose 
RR 
Respiratory rate 
RSI 
Reference safety information 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SAR 
Serious adverse reaction 

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SD 
Stable disease 
SFU 
Survival follow-up 
SIRPα 
Signal regulatory protein alpha 
SL-172154  
SIRPα-Fc-CD40L 
SLM 
Study Lab Manual 
SMC 
Safety Monitoring Committee 
SmPC 
Summary of product characteristics 
SOA 
Schedule of Assessments 
SPM 
Study Pharmacy Manual 
SQ 
Subcutaneous 
SUSAR 
Suspected unexpected serious adverse reaction 
T 
Temperature 
t½ 
Terminal elimination half-life 
TAM 
Tumor-associated macrophages 
TEAE 
Treatment-emergent adverse event 
Tlast 
Time of last observed quantifiable concentration 
Tmax 
Time of maximum observed concentration 
TME 
Tumor microenvironment 
TNF 
Tumor necrosis factor 
TRAF 
Tumor necrosis factor receptor-associated factor 
TSH 
Thyroid stimulating hormone 
TTR 
Time to response 
ULN 
Upper limit of normal 
USPI 
United States Prescribing Information 
Vz  
Volume of distribution 
WBC 
White blood cell 
λz 
Terminal elimination rate constant 
 
 
Trademark Information 
Trademarks of Shattuck Labs, Inc. 
Trademarks not owned by Shattuck Labs, Inc. 
Agonist Redirected Checkpoint (ARC™) 
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STATEMENT OF COMPLIANCE 
 
 
The trial will be conducted in accordance with the protocol and the International Council for 
Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, and applicable Federal 
Regulations on the Protection of Human Subjects, and consistent with the consensus ethical 
principles derived from international guidelines including the Declaration of Helsinki and Council 
for International Organizations of Medical Sciences International Ethical Guidelines. The 
Principal Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement from the Sponsor and documented approval from the Institutional Review 
Board (IRB)/Independent Ethics Committee (IEC), except where necessary to eliminate an 
immediate hazard(s) to the trial subjects. All personnel involved in the conduct of this study have 
completed Human Subjects Protection Training. 
 
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments. 
 
Principal Investigator: 
 
 
 
 
Print/Type Name 
 
Signature 
 
 
Date: ______________ 
 
 
 

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STUDY SCHEMA 
Figure 1.  
Study Schema 
 
 
Abbreviations: AIBW = adjusted ideal body weight; D = day; DL = dose level; FOLR1 = folate receptor 1; FRα = folate receptor alpha; IV = intravenous; MIRV = mirvetuximab 
soravtansine; PLD = pegylated liposomal doxorubicin 
Doses explored in SL03-OHD-105 will not exceed the highest dose determined to be safe and tolerable in the monotherapy dose escalation study SL03-OHD-101. 
Positive FRα expression is defined as ≥ 25% of tumor cells positive for FRα by Ventana FOLR1 assay by central testing. 

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PROTOCOL SYNOPSIS 
Sponsor 
Shattuck Labs 
Product Name 
SL-172154 
Other Names 
SIRPα-Fc-CD40L recombinant fusion glycoprotein 
Protocol Title 
An Open-Label, Phase 1b Study of SL-172154 
(SIRPα-Fc-CD40L) Administered with Either Pegylated 
Liposomal Doxorubicin or Mirvetuximab Soravtansine 
in Subjects with Platinum-Resistant Ovarian Cancers 
Protocol Number 
SL03-OHD-105 
Clinical Phase 
Phase 1b 
Planned Sample Size 
Approximately 102 subjects 
Planned Number of Sites and Countries 
Approximately 30 to 40 clinical sites 
United States, Canada, United Kingdom, Spain 
Recruitment Duration: 
14 months 
Study Duration 
25 months 
Background and Rationale 
The investigational product, SL-172154, is a novel fusion protein consisting of human signal 
regulatory protein alpha (SIRPα) and CD40L (SIRPα-Fc-CD40L) linked via a human Fc. Fusion of the 
extracellular domains of SIRPα, a type 1 membrane protein, with CD40L, a type 2 membrane protein, 
generated a single molecule with dual specificity that retained individual target avidity. SL-172154 not 
only inhibits the cluster of differentiation (CD)47/SIRPα axis but it also augments cross presentation of 
antigens by antigen-presenting cells (APC) to T cells through the costimulatory role of CD40L, thus 
bridging innate and adaptive immunity. In vitro, SL-172154 was shown to bind to its cognate targets, 
CD47 and CD40, both individually and simultaneously. High binding affinity for CD47 and CD40 was 
noted (KD values of 0.628 nM and 4.74 nM, respectively) as well as a slow off rate, indicating a longer 
on target resident time. This longer resident time could be of benefit in the tumor microenvironment 
(TME) where CD47 is known to be expressed. CD40-mediated activity by SL-172154 was 
demonstrated in a NFkB reporter system in which CD40-dependent signaling was stimulated in the 
absence of Fc receptor cross-linking, and in cultured human peripheral blood mononuclear cells 
(PBMCs) in which dose-dependent proliferation, an increase in the number of interleukin (IL)-2 
secreting PBMCs, and the secretion of multiple cytokines were observed.  
Ovarian, fallopian tube, and primary peritoneal cancers, collectively known as epithelial ovarian cancer 
(EOC), are the most lethal gynecological cancer. The current standard-of-care front-line treatment for 
advanced EOC patients consists of combination carboplatin and paclitaxel chemotherapy before or 
after debulking surgery and results in high response rates. Further progress has recently been made by 
incorporating molecularly targeted agents into treatment paradigms. The use of PARP (poly 
ADP-ribose polymerase) inhibitors into front-line maintenance and recurrent, platinum-sensitive 
settings, as well as bevacizumab in all lines of therapy, have improved patient outcomes [Liu, 2014] 
[Herzog, 2017]. Unfortunately, most patients eventually relapse with disease that is platinum-resistant 
which is defined by relapse between 0 to 6 months after the last platinum dose. Outcomes for patients 
with platinum-resistant EOC remain particularly poor, with low response rates to non-platinum 
chemotherapy (e.g., 11.8% in the AURELIA trial; [Pujade-Lauraine, 2014]), median progression-free 

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survival (PFS) of 3 to 4 months, and median overall survival less than 1 year [Davis, 2014]. 
Furthermore, subsequent lines of systemic therapy are often associated with cumulative toxicities and 
limited tolerability in patients. For these reasons, the development of novel therapies for use in the 
platinum-resistant setting is critical. 
Ovarian and related cancers were selected for investigation in both the Phase 1a first-in-human dose 
escalation study of SL-172154 monotherapy (SL03-OHD-101) and for this Phase 1b study of 
SL-172154 (SL03-OHD-105) due to the fact that these histologies have a high percentage of tumors 
with detectable CD47 expression (TCGA data; [Wang, 2015; Brightwell, 2016]). A tissue microarray 
of 265 tissues from patients with ovarian, primary peritoneal, and fallopian tube cancers were analyzed 
by immunohistochemical analysis for CD47 expression; expression was detected in 210 of 265 cases 
(79%). Furthermore, CD47 is a tumor associated antigen with higher levels of expression in epithelial 
ovarian cancer cells compared with normal ovarian cells [Li, 2017]. Finally, ovarian cancer is 
characterized by peritoneal metastasis which is facilitated by a crosstalk between tumor cells and other 
cells in the TME, including a high percentage of tumor associated macrophages. This rationale is 
supported by the results of a Phase 1 study of an anti-CD47 antibody, Hu5F9-G4 (magrolimab), in 
which monotherapy activity was reported in 2 (partial responses) out of 13 patients with ovarian cancer 
[Sikic, 2019]. Given that the APC is hypothesized to be the primary target of SL-172154, the unique 
immune contexture of ovarian and related cancers in conjunction with their high tumor CD47 
expression makes these histologies particularly suitable for clinical investigation. 
It is likely that a combinatorial approach to overcoming immune suppression will be required to 
provide benefit from immune-targeting agents in EOCs [Leary, 2021]. SL-172154 potentiates 
macrophage phagocytosis when combined with agents that induce immunogenic tumor cell death 
(see SL-172154 investigator’s brochure [IB]). Initiation of these cell death pathways makes tumor cells 
more visible to APCs, such as macrophages and dendritic cells, resulting in enhanced phagocytotic 
activity. We hypothesize that combining SL-172154 with cytotoxic agents may concurrently 1) inhibit 
the CD47/SIRPα checkpoint; 2) enhance stimulation of phagocytosis by induction of prophagocytic 
proteins on tumor cells, and 3) augment antigen presentation by APCs to T cells via costimulation of 
the CD40L/CD40 pathway.  
Preclinical data have demonstrated that pegylated liposomal doxorubicin (PLD) induces immunogenic 
cell death as evidenced by increased extracellular ATP levels, secreted HMGB1, induction of 
calreticulin (CRT) and CRT translocation to the plasma membrane [Solari, 2020] thus increasing 
infiltration of active T cells. Similarly, doxorubicin has also been shown to further promote immune 
priming by enhancing antigen presentation [Zitvogel, 2013] and modifying the suppressive 
microenvironment by increasing the infiltration of active T cells [Hao, 2018]. In preclinical murine 
studies using subcutaneous CT26 colorectal carcinoma tumors, mSIRPα-Fc-CD40L (intraperitoneal) in 
combination with doxorubicin (intravenous) resulted in greater tumor growth inhibition in comparison 
to either monotherapy treatment. This synergistic activity may be due to chemotherapy-induced tumor 
cell death resulting in increased tumor visibility to APCs (e.g., macrophages and dendritic cells) and 
subsequent enhanced phagocytosis activity mediated by mSIRPα-Fc-CD40L.  
There are no highly effective therapies in the platinum-resistant EOC population, although 
non-platinum agents have demonstrated modest antitumor efficacy in a subset of these patients. PLD is 
commonly used in clinical practice for the treatment of platinum-resistant ovarian cancer (PROC; 
[Davis, 2014]). Single-agent PLD has been extensively studied in this patient population, 
demonstrating an objective response rate (ORR) of 10 to 20%, median PFS of 2.1 to 3.7 months, and 
overall survival (OS) ranging from 8.4 to16.8 months [Gordon, 2001; Lawrie, 2013; Pujade-Lauraine, 
2021]. Taken together, these observations suggest that combination of anthracyclines with SL-172154 
may provide added clinical benefit relative to either agent alone. 

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Folate receptor alpha (FRα) is a glycosylphosphatidylinositol-anchored cell surface protein encoded by 
the folate receptor 1 (FOLR1) gene. FRα internalizes folate, which is an essential cofactor for one-
carbon transfer reactions that are required for deoxyribonucleic acid (DNA) and ribonucleic acid 
(RNA) synthesis, cell growth, and proliferation. Published studies have demonstrated FRα 
overexpression by immunohistochemistry (IHC) in various epithelial tumors, particularly the serous 
and endometrioid histologic subtypes of ovarian and endometrial cancers [Garin-Chesa, 1993; Allard, 
2007; Dainty, 2007; Brown Jones, 2008; Kalli, 2008; Scorer, 2010; Crane, 2012; Ab, 2015]. Because 
of its tumor-specific expression and capacity to internalize small and large molecule ligands, FRα has 
emerged as a biologically rational target for antibody drug conjugate (ADC) therapy. ADCs combine 
the specificity of a monoclonal antibody (mAb) to tumor antigens with the extraordinary cytotoxicity 
of maytansine derivatives, which are potent anti-microtubule agents that target proliferating cells. 
Mirvetuximab soravtansine (MIRV) consists of the chimeric anti-FRα mAb M9346A attached via a 
cleavable linker to the cytotoxic maytansinoid, DM4. 
The internalization of MIRV leads to the apoptosis of target ovarian tumor cells that overexpress FRα. 
The hypothesis that combining MIRV with SL-172154 may increase the macrophage-mediated 
phagocytosis of these apoptotic cells is supported by in vitro phagocytosis assays using human 
monocyte-derived macrophages and human ovarian cancer cell lines. These assays demonstrated that 
SL-172154 or MIRV stimulated macrophage-mediated phagocytosis of KB, IGROV1, and OV90 
ovarian cancer cells, and the combination of the two agents further enhanced phagocytic activity. 
Interestingly, in MESOV ovarian cancer cells (which express low levels of FRα and high levels of 
CD47 and calreticulin), SL-172154 alone stimulated phagocytosis whereas MIRV alone did not and 
combining the two agents enhanced phagocytosis above that seen with SL-172154 alone. These data 
suggest that SL-172154 may broaden the activity of MIRV to tumor cells expressing low FRα levels. 
Single-agent MIRV has recently been studied in a randomized, open-label Phase 3 trial comparing 
MIRV and investigator’s choice (IC) chemotherapy in patients with platinum-resistant EOC who had 
received 1 to 3 prior lines of therapy and whose tumors were positive for FRα. While the primary 
endpoint, PFS, did not reach statistical significance in either the intent-to-treat (ITT) or the FRα high 
population, superior outcomes for MIRV over chemotherapy were observed in all secondary endpoints 
in the FRα high population, including improved ORR (24% versus 10%), CA-125 responses, and 
patient-reported outcomes. Importantly, confirmed responses were seen across FRα levels, with a 
confirmed ORR in the ITT population being higher for MIRV than for IC chemotherapy (22% versus 
12%, P= 0.015) and correlated with improved CA-125 responses (51% versus 27%, P < 0.001). These 
data suggest that MIRV is generating a cytotoxic signal even in ovarian tumors expressing medium and 
low levels of FRα expression. It is hypothesized that this pro-phagocytic signal from MIRV could 
synergize with SL-172154 in platinum-resistant ovarian cancer patients whose tumors express low, 
medium or high levels of FRα expression and potentially result in clinically meaningful durable 
responses that are greater than observed with either monotherapy treatment.  
Taken together, these data suggest that both PLD and MIRV are appropriate to combine with 
SL-172154 in this phase 1b trial in patients with platinum-resistant EOC, a population with high unmet 
need. 
SL03-OHD-105 is designed as a Phase 1b open-label trial to evaluate the safety, pharmacokinetic (PK), 
pharmacodynamic (PD), and preliminary efficacy of SL-172154 administered as add-on therapy to 
background treatment with either PLD or MIRV in subjects with ovarian and related cancers. PLD is 
commonly used in clinical practice in this patient population, with well-described safety, PK and PD 
profiles. MIRV is being investigated for the treatment of PROC patients with efficacy, safety and PK 
profiles reported. Each component is anticipated to have activity on distinct targets, and PLD or MIRV 
combined with SL-172154 has the potential to further bridge innate and adaptive immunity, thus 

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potentially improving treatment outcomes without increasing toxicity. Anticipated overlapping 
toxicities are minimal when combining SL-172154 with PLD (infusion-related reactions [IRRs], 
fatigue, nausea, constipation, diarrhea and cytopenias) or with MIRV (IRR, low grade fatigue, nausea, 
diarrhea and cytopenias). 
Upon identification of the SL-172154 dose in each of the combination regimens during dose escalation, 
a dose expansion cohort will enroll additional subjects to receive either PLD or MIRV with the selected 
SL-172154 dose. 
Study Objectives 
Primary Objective(s) 
Outcome Measures 
To evaluate the safety and tolerability of SL-
172154 administered with pegylated 
liposomal doxorubicin (PLD) or 
mirvetuximab soravtansine (MIRV) in 
subjects with platinum-resistant ovarian, 
primary peritoneal, or fallopian tube cancer 
• 
Incidence and severity of adverse events (AE) per 
National Cancer Institute Common Terminology 
Criteria for Adverse Events (NCI-CTCAE), version 
5.0  
• 
Change from baseline in laboratory values per 
NCI-CTCAE, version 5.0 
• 
AEs leading to discontinuation  
• 
Maximum tolerated dose (MTD) of SL-172154 in 
each combination regimen based on the rate of 
dose-limiting toxicities (DLTs), or the Maximum 
Administered Dose (MAD) of SL-172154 
To select the recommended Phase 2 dose 
(RP2D) for SL-172154 administered with 
PLD or MIRV in subjects with platinum-
resistant ovarian, primary peritoneal, or 
fallopian tube cancer 
• 
Number and occurrence of DLTs as defined in the 
protocol 
• 
Available pharmacokinetic (PK) parameters 
• 
Available pharmacodynamic (PD) effects 
• 
Safety 
• 
Anti-tumor activity 
Secondary Objectives 
Outcome Measures 
To assess preliminary evidence of anti-tumor 
activity of SL-172154 when administered 
with PLD or MIRV (overall as well as 
subgroups with high (PS2+ ≥ 75%), medium 
(PS2+ ≥ 50% and < 75%), or low (PS2+ ≥ 
25% and < 50%) tumor FRα expression) in 
subjects with platinum-resistant ovarian, 
primary peritoneal, or fallopian tube cancer. 
• 
ORR based on investigator assessment by 
Response Evaluation Criteria in Solid Tumors 
(RECIST v1.1) 
• 
Clinical benefit rate (CBR)  
• 
Time to response (TTR) 
• 
Duration of response (DoR) 
• 
PFS based on investigator assessment 
To evaluate immunogenicity to SL-172154 
or MIRV during and after treatment of  
SL-172154 administered with PLD or MIRV 
in subjects with platinum-resistant ovarian, 
primary peritoneal, or fallopian tube cancer 
• 
Number/proportion of subjects with positive or 
negative anti-drug antibody (ADA) titer 
• 
Number/proportion of subjects with neutralizing 
anti-drug antibodies 
• 
ADA duration  
• 
Transient vs. persistent ADA 
To assess the pharmacokinetic profile of 
SL-172154 when administered with PLD or 
MIRV in subjects with platinum-resistant 
• 
Maximum observed concentration (Cmax), time at 
which the maximum concentration is observed 
(Tmax), and minimum observed concentration (Cmin) 
following single and multiple doses of SL-172154 

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ovarian, primary peritoneal, or fallopian tube 
cancer 
• 
Area under the serum concentration-time curve 
(AUC) 
• 
Terminal elimination half-life (t½), Clearance (CL) 
and Volume of Distribution (Vz), as data permit 
To assess the pharmacokinetic profile of 
MIRV when administered with SL-172154 
in subjects with platinum-resistant ovarian, 
primary peritoneal, or fallopian tube cancer 
• 
PK exposure evaluation of MIRV, total antibody, 
and payload (DM4 and S-methyl DM4) 
Exploratory Objectives 
Outcome Measures 
To identify and assess pharmacodynamic 
biomarkers associated with ovarian cancer or 
the mechanism of action of SL-172154, 
PLD, or MIRV following treatment with SL-
172154 administered with PLD or MIRV in 
subjects with platinum-resistant ovarian, 
primary peritoneal, or fallopian tube cancer 
• 
Changes from baseline in select cytokines  
• 
Changes in immune cell subsets 
• 
CD47 and CD40 expression 
• 
Target-associated regulatory networks 
• 
Genomic alterations which may correlate with drug 
safety or efficacy 
To explore the association of 
biological/clinical endpoints with PK 
parameters of SL-172154 administered with 
PLD or MIRV in subjects with platinum-
resistant ovarian cancer, primary peritoneal, 
or fallopian tube cancer 
• 
To assess the relationship between SL-172154 PK 
parameters and the anti-tumor activity and safety of 
SL-172154, if feasible  
Estimate overall survival (OS) 
• 
OS: time from first dose to death 
Study Design 
Study SL03-OHD-105 is an open-label, multicenter, Phase 1b trial designed to evaluate the safety, PK, 
PD effects, and preliminary anti-tumor activity of SL-172154 administered as add-on therapy to 
background treatment with either PLD or MIRV in subjects with platinum-resistant ovarian, primary 
peritoneal, or fallopian tube cancers. The study will consist of dose escalation followed by dose 
expansion.  
Subjects with histologically confirmed epithelial ovarian cancer or primary peritoneal or fallopian tube 
cancer of high-grade histology who are platinum-resistant are eligible. For the SL-172154 + MIRV 
cohort, the subject’s tumor must be positive for FRα expression as defined by central testing using the 
Ventana FOLR1 Assay. 
All subjects (dose escalation and dose expansion) will receive SL-172154 administered with PLD or 
with MIRV until documented disease progression, unacceptable toxicity or intolerance, withdrawal of 
consent, investigator’s decision to discontinue treatment, or lost to follow-up. 
Study SL03-OHD-105 will initially enroll subjects to one of two dose escalation cohorts: SL-172154 + 
PLD or SL-172154 + MIRV. The SL-172154 starting dose of 3.0 mg/kg is supported by safety data 
from the SL03-OHD-101 study in which 4 subjects receiving 1.0 mg/kg and 6 subjects receiving 
3.0 mg/kg of SL-172154 once-weekly have cleared the DLT evaluation period with no DLTs reported. 
Five subjects were enrolled at 10 mg/kg dose level and 1 DLT has been reported in this group.  
The initial SL-172154 dose escalation cohorts in Study SL03-OHD-105 are:  

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• 
SL-172154 (3.0 mg/kg, intravenous(ly) (IV); Days 8 and 15 of each 28-day cycle) 
administered with PLD (40 mg/m2, IV, Day 1 of each 28-day cycle) 
• 
 SL-172154 (3.0 mg/kg, IV; Days 8 and 15 of each 21-day cycle) administered with MIRV 
(6.0 mg/kg adjusted ideal body weight [AIBW], IV; Day 1 of each 21-day cycle) 
During dose escalation, subjects will be enrolled in sequential cohorts of approximately 3 subjects and 
evaluated for DLT during the first cycle of therapy (i.e., DLT evaluation period). Treatment will be 
administered in 28-day (PLD cohorts) or 21-day (MIRV cohorts) cycles until disease progression, 
unacceptable toxicity, or withdrawal of consent. Dose escalation of SL-172154 with each of the 
combination regimens will continue until a safe dose of SL-172154 when administered with the 
assigned combination agent (e.g., PLD or MIRV) is identified. The dose escalation cohorts will utilize 
the modified Toxicity Probability Interval (mTPI-2) design [Guo, 2017] with target DLT rate of 30% 
for the maximum tolerated dose (MTD). 
In selecting the dose of SL-172154 to be evaluated in the respective combination regimen dose 
expansion cohort, the totality of the data from the dose escalation phase including the safety of the 
combination and PD activity will be considered. Upon identification of the selected SL-172154 dose 
administered with PLD, a dose expansion cohort will enroll approximately 20 subjects (including 
subjects from dose escalation at the same dose level) to further evaluate the safety and efficacy of the 
study treatment. The same patient population will be enrolled in both the dose escalation and dose 
expansion portion of the study.  
Upon identification of the selected SL-172154 dose administered with MIRV, a dose expansion cohort 
will enroll approximately 70 subjects whose tumor is FRα-positive (including subjects from dose 
escalation at the same dose level) to further evaluate the safety and efficacy of the study treatment. All 
subjects with FRα-positive tumors will be enrolled and retrospectively binned by FRα expression 
subgroups (high, medium, or low) in the study analysis. The same patient population will be enrolled in 
both the dose escalation and dose expansion portion of the study. 
The planned sample size is approximately 102 subjects, depending on the number of dose levels 
evaluated in dose escalation for each of the combination. Approximately 24 subjects will be enrolled in 
dose escalation cohorts (12 subjects in PLD cohorts and 12 subjects in MIRV cohorts) and 
approximately 78 subjects will be enrolled in the dose expansion cohorts (an additional 14 subjects at 
the selected dose in PLD cohort and additional 64 subjects at the selected dose in MIRV cohort).  
NOTE: The planned sample sizes may be revised if additional dose levels are evaluated or if more 
subjects (i.e., subjects available for dosing beyond the number required in a cohort) are enrolled than 
anticipated. The actual number of subjects to be enrolled for each combination dose escalation will 
depend upon the number of dose levels evaluated and the number of DLTs observed for each dose level 
and related dose escalation/stay/de-escalation decision. 
Treatment Schedules 
All subjects will receive the assigned study treatment until disease progression, unacceptable toxicity, 
withdrawal of consent, investigator’s decision to discontinue treatment, or lost to follow-up. 
For all subjects in all cohorts, premedication as prophylaxis for IRR with dexamethasone (8 mg IV), an 
antipyretic and antihistamines should be administered at least 30 minutes prior to each SL-172154 
administration. For subjects enrolled to receive MIRV, premedication with antipyretic, antihistamine, 
and dexamethasone will be administered at least 30 minutes prior to each MIRV administration. The 
infusion rate of SL-172154 may change based on final drug volume needed for administration, safety, 
and tolerability of the infusion for the subject and/or observed safety findings during the study or 

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SL-172154 development program. Additional doses and/or schedules or intermediate doses may be 
explored based on emerging safety, PK and PD data. 
DOSE ESCALATION: SL-172154 + PLD 
Dose 
Levela 
SL-172154 Doseb 
[D8 and 15 in each 28d cycle] 
SL-172154 Infusionc  
Pegylated liposomal 
doxorubicin (PLD) 
-1d 
1.0 mg/kg 
60 min ± 10 min 
PLD (40 mg/m2) IV administered 
on Day 1 of each 28-day cycle 
 
Administer first dose on study 
(C1D1) as 1 mg/min IV infusion; 
after Cycle 1, if tolerated, PLD 
can be delivered as a 1-hour 
infusion. 
1 
(Starting 
Dose) 
3.0 mg/kg 
120 min ± 15 min 
2 
6.0 mg/kg 
180 min ± 15 min 
Abbreviations: AIBW = adjusted ideal body weight; C1D1 = Cycle 1 Day 1; D = day; IV = intravenously; mTPI-2 = modified 
toxicity probability interval; PLD = pegylated liposomal doxorubicin  
a. 
Doses explored in SL03-OHD-105 will not exceed the highest dose determined to be safe and tolerable in the 
monotherapy dose escalation study SL03-OHD-101.  
b. 
The actual body weight in kilograms (kg) will be used for SL-172154 dose calculation in all subjects whose body 
weight is ≤ 100 kg. For subjects with body weight > 100 kg, the dose to be administered should be the same as that 
calculated for a subject weighing 100 kg. 
c. 
Infusion time may change based on final drug volume needed for administration, safety and tolerability of the infusion 
for the subject and/or observed safety findings during the study. Please refer to the Study Pharmacy Manual (SPM) for 
details. 
d. 
SL-172154 dose level -1 at 1.0 mg/kg will be evaluated if 3.0 mg/kg is not safe per mTPI-2. 
 
DOSE ESCALATION: SL-172154 + MIRV 
Dose 
Levela 
SL-172154 Doseb 
[D8 and 15 in each 21d cycle] 
SL-172154 
Infusionc  
Mirvetuximab (MIRV)e 
-1d 
1.0 mg/kg 
60 min ± 10 min 
6.0 mg/kg AIBW, IV administered on 
Day 1 of each 21-day cycle 
 
Administer first dose on study (C1D1) 
at rate of 1 mg/min; after 30 min 
increase rate to 3.0 mg/min if well 
tolerated. If well-tolerated after 30 min 
at 3.0 mg/min, infusion rate may be 
increased to 5.0 mg/min. Subsequent 
infusions should be delivered at the 
tolerated rate. 
1 
(Starting 
Dose) 
3.0 mg/kg 
120 min ± 15 min 
2 
6.0 mg/kg 
180 min ± 15 min 
Abbreviations: AIBW = adjusted ideal body weight; C1D1 = Cycle 1 Day 1; D = day; IV = intravenously; MIRV = 
mirvetuximab soravtansine; mTPI-2 = modified toxicity probability interval 
a. 
Doses explored in SL03-OHD-105 will not exceed the highest dose determined to be safe and tolerable in the 
monotherapy dose escalation study SL03-OHD-101.  
b. 
The actual body weight in kilograms (kg) will be used for SL-172154 dose calculation in all subjects whose body 
weight is ≤ 100 kg. For subjects with body weight > 100 kg, the dose to be administered should be the same as that 
calculated for a subject weighing 100 kg. 

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c. 
Infusion time may change based on final drug volume needed for administration, safety, and tolerability of the infusion 
for the subject and/or observed safety findings during the study. Please refer to the Study Pharmacy Manual (SPM) 
for details. 
d. 
SL-172154 dose level -1 at 1.0 mg/kg will be evaluated if 3.0 mg/kg is not safe per mTPI-2. 
e. 
Administer premedication at least 30 min prior to the start of MIRV infusion. 
The SL-172154 dose in combination with either PLD or MIRV that is selected in dose escalation will 
be used in the respective dose expansion cohort. The same schedule and infusion duration for 
SL-172154 as well as for the combination agent (either PLD or MIRV) that was utilized during dose 
escalation will be used in dose expansion. 
Definition of Dose-Limiting Toxicity  
Protocol-defined DLT criteria are applicable to the dose escalation portion of the study. The 
determinant period for DLT is the first cycle of treatment (i.e., 28 days for PLD cohorts, 21 days for 
MIRV cohorts); however, there is provision in the criteria below for AEs that occur beyond this period 
to be considered in the determination of the RP2D. All toxicities except for cytokine release syndrome 
(CRS) and ocular AEs will be graded as per NCI CTCAE v5. CRS will be graded per the American 
Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Criteria for CRS; 
ocular AEs for the MIRV cohort will be graded per the tables provided in the Appendix. AEs clearly 
related to the underlying disease, disease progression, intercurrent illness, or concomitant medications 
are not considered DLTs. AEs that are clearly related to PLD or MIRV only do not have to be 
considered DLTs, unless the investigator considers the AE to be exacerbated by SL-172154. DLT is 
defined as an event considered related or possibly related to SL-172154 and meets one of the following 
criteria: 
• 
Any death not clearly related to underlying disease or intercurrent illness 
• 
Elevations in liver transaminases (aspartate aminotransferase [AST], alanine aminotransferase 
[ALT]) or total bilirubin: 
o In subjects who enroll with AST/ALT/total bilirubin ≤ upper limit of normal (ULN), AST 
or ALT elevation of > 8x ULN or total bilirubin > 5x ULN. 
o In subjects who enroll with AST/ALT/total bilirubin > ULN, AST or ALT elevation of 
> 8x baseline or total bilirubin > 5x baseline. 
o Evidence of Hy’s Law (AST or ALT > 3x ULN [or baseline*] with concurrent increase in 
total bilirubin > 2x ULN [or baseline*] without evidence of cholestasis or alternative 
explanation such as disease progression or viral hepatitis. 
*ULN or baseline dependent on value at enrollment as described above. 
• 
Any AE that requires permanent discontinuation of SL-172154  
• 
Any Grade 3 or greater AE except for those listed below: 
o Grade 3 fatigue lasting ≤ 7 days 
o Grade 3 anemia 
o Grade 3 or 4 neutropenia not associated with fever (temperature > 38.5°C) that improves to 
Grade 2 within 7 days  
o Grade 3 or 4 lymphopenia 

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o Grade 3 thrombocytopenia not associated with clinically significant bleeding and does not 
require medical intervention 
o Grade 3 anorexia, nausea, vomiting or diarrhea provided that it does not require tube 
feeding, total parenteral nutrition, or require or prolong hospitalization 
o Grade 3 laboratory abnormalities which resolve to Grade 1 or baseline within 72 hours 
with or without intervention 
o Grade 3 hypertension that can be controlled (i.e., systolic BP < 140 mmHg and diastolic 
BP < 90 mmHg) with medical therapy 
o Grade 3 or 4 amylase and/or lipase abnormalities that are not associated with clinical 
signs/symptoms or finding on imaging consistent with pancreatitis 
o Grade 3 endocrine disorder (thyroid, pituitary, hyperglycemia and/or adrenal insufficiency) 
that is managed with treatment with resolution of symptoms within 14 days after treatment 
onset 
o Vitiligo or alopecia of any grade 
Other toxicities may be considered a DLT as determined by the investigator in conjunction with the 
Safety Monitoring Committee (SMC). 
Eligibility Criteria 
Patients may be considered for enrollment in the study if they meet all the eligibility criteria. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted 
Inclusion Criteria 
Subjects must meet all of the following criteria: 
1. Subject has voluntarily agreed to participate by giving written informed consent in accordance 
with ICH/GCP guidelines and applicable local regulations. 
2. Age ≥ 18 years. 
3. [PLD Cohort] Subject has a histologically confirmed diagnosis of high grade EOC (including 
primary peritoneal cancer or fallopian tube cancer).  
NOTE: Non-epithelial tumors and ovarian tumors with low malignant potential are excluded.  
4. [PLD Cohort] Subject must have platinum-resistant disease, defined as radiologic disease 
progression within 180 days (6 months) following the last administered dose of platinum 
therapy.  
NOTE: Progression should be calculated from the date of the last administered dose of 
platinum therapy to the date of the radiographic imaging showing progression. 
NOTE: Subjects who are primary platinum refractory, defined by progressing during or within 
1 month of upfront platinum therapy, are excluded. 
5. [PLD Cohort] Subjects may have received any number of prior lines of therapy for EOC; 
however, they may not have received more than 1 prior line of systemic anticancer therapy for 
platinum-resistant disease.  
Lines of therapy are defined in this study as: 

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• 
Adjuvant ± neoadjuvant is considered 1 line of therapy. 
• 
Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered part of the 
preceding line of therapy (i.e., not counted independently). 
• 
Therapy changed due to toxicity in the absence of progression will be considered part of 
the same line (i.e., not counted independently). 
• 
Hormonal therapy will be counted as a separate line of therapy unless it was given as 
maintenance. 
6. [MIRV Cohort] Subject has a histologically confirmed diagnosis of high grade serous EOC 
including primary peritoneal cancer or fallopian tube cancer).  
NOTE: non-epithelial tumors and ovarian tumors with low malignant potential are excluded. 
7. [MIRV Cohort] Subject must have platinum-resistant disease as defined by: 
• 
Subjects who have only had 1 line of platinum-based therapy must have received at least 
4 cycles of platinum, must have had a response (complete response/remission [CR] or 
partial response/remission [PR]) and then progressed between > 3 months and ≤ 6 months 
after the date of the last dose of platinum. 
• 
Subjects who have received 2 or 3 lines of platinum therapy must have progressed on or 
within 6 months after the date of the last dose of platinum. 
NOTE: Progression should be calculated from the date of the last administered dose of 
platinum therapy to the date of the radiographic imaging showing progression. 
NOTE: Subjects who are platinum refractory during front-line treatment are excluded [primary 
platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has 
progressed within 3 months of the last dose of first-line platinum-containing chemotherapy]. 
8. [MIRV Cohort] Subjects must have received at least 1 but no more than 3 prior systemic lines 
of anticancer therapy.  
Lines of therapy are defined in this study as: 
• 
Adjuvant ± neoadjuvant is considered 1 line of therapy. 
• 
Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered part of the 
preceding line of therapy (i.e., not counted independently). 
• 
Therapy changed due to toxicity in the absence of progression will be considered part of 
the same line (i.e., not counted independently). 
• 
Hormonal therapy will be counted as a separate line of therapy unless it was given as 
maintenance. 
9. [MIRV Cohort] Willing to provide an archival tumor tissue block or slides or undergo 
procedure to obtain new biopsy using a low-risk, medically routine procedure for IHC 
confirmation of FRα positivity. 
10. [MIRV Cohort] Subject’s tumor must be positive for FRα expression defined as PS2+ ≥ 25% 
by the Ventana FOLR1 Assay.  
11. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 
12. Measurable disease by RECIST v1.1 using radiologic assessment. 

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Prior severe hypersensitivity to monoclonal antibodies [MIRV Cohort only] or liposomal 
preparations [PLD Cohort only]. 
12. Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction 
within 4 weeks prior to study entry. 
13. Clinically significant or uncontrolled cardiovascular disease including any of the following: 
• 
Myocarditis 
• 
Unstable angina within 6 months from first dose of study treatment 
• 
Acute myocardial infarction within 6 months from first dose of study treatment 
• 
Uncontrolled hypertension 
• 
NYHA Class III or IV congestive heart failure 
• 
Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular 
tachycardia, second- or third- degree atrioventricular block without a pacemaker, 
circulatory collapse requiring vasopressor or inotropic support, or arrhythmia requiring 
therapy) 
• 
History of hemorrhagic or ischemic stroke within 6 months prior to enrollment 
• 
Prior anthracycline-related cardiotoxicity or prior anthracycline exposure approaching the 
lifetime limit [PLD cohort only] 
14. [MIRV Cohort] History of cirrhotic liver disease (Child-Pugh Class B or C) 
15. [MIRV Cohort] Active or chronic corneal disorders, history of corneal transplantation, or 
active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled 
glaucoma, wet age-related macular degeneration requiring intravitreal injections, active 
diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, 
and/or monocular vision. 
16. Previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including 
noninfectious pneumonia. 
17. Untreated central nervous system (CNS) or leptomeningeal metastases. Subjects with treated 
CNS metastases must have completed definitive treatment (radiotherapy and/or surgery) 
> 2 weeks prior to first dose of study treatment and no longer require steroids. 
18. Women who are pregnant or breast feeding, or who plan to become pregnant or breast feed while 
receiving study treatment. 
19. Psychiatric illness/social circumstances that would limit compliance with study requirements 
and substantially increase the risk of AEs or compromised ability to provide written informed 
consent. 
20. Another malignancy that requires active therapy and that, in the opinion of the investigator and 
Sponsor, would interfere with monitoring of radiologic assessments of response to the study 
treatment.  
21. Has undergone allogeneic stem cell transplantation or organ transplantation. 
22. Known history or positive test for human immunodeficiency virus (HIV), or positive test for 
hepatitis B (positive for hepatitis B surface antigen [HBsAg]) or hepatitis C virus ([HCV]; if 
HCV antibody (Ab) test is positive check for HCV RNA).  

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NOTE: Hepatitis B virus (HBV): Subjects who are hepatitis B core antibody [HBcAb] positive, 
but HBsAg negative are eligible for enrollment. HCV: Subjects who are HCV Ab positive, but 
HCV RNA negative are eligible for enrollment. 
Safety Oversight 
Study progress and safety will be reviewed throughout the conduct of the study. During the study while 
subjects are receiving treatment with SL-172154, SMC meetings will be held to review relevant data 
with the investigators or designees during both dose escalation and dose expansion. These meetings 
will be held once a month (or more frequently if required) during dose escalation to share safety data 
and communicate results of ongoing analyses provided subjects have been enrolled and data are 
available to be reviewed. All available safety, PK, PD, and clinical outcome data for all subjects at the 
time of the scheduled SMC Meeting will be reviewed and summarized. Attendees of SMC meetings 
will include, but not limited to, clinical investigators (or designees), the Sponsor Medical Monitor and 
Statistician. The SMC will operate in accordance with the SMC charter which will define roles and 
accountabilities and the process for safety review. As dose escalation proceeds, the SMC will take into 
account data from Study SL03-OHD-105 as well as other knowledge obtained for SL-172154, 
including data from the monotherapy SL-172154 dose escalation in Study SL03-OHD-101. Safety and 
PK data from Study SL03-OHD-101 will be shared with the SMC for SL03-OHD-105. Doses explored 
in SL03-OHD-105 will not exceed the highest dose cleared for safety in SL03-OHD-101. All dose 
escalation or safety decisions made by the SMC will be documented in writing with copies maintained 
at each site and in the Trial Master File at the Contract Research Organization. 
Statistics 
The safety evaluation for each combination regimen will be based on the All-Treated Population 
defined as all subjects who received at least one dose of study treatment. Frequency tables by dose 
levels will be used to describe safety and tolerability parameters such as: AEs, SAEs, fatal AEs, and 
AEs leading to discontinuation of SL-172154, PLD or MIRV. Changes in toxicity grade for laboratory 
parameters will also be summarized. AEs will be mapped to a Medical Dictionary for Regulatory 
Activities (MedDRA) preferred term and system organ classification. All AEs except CRS and ocular 
AEs will be graded according to the NCI CTCAE v5.0. CRS will be graded per the ASTCT Consensus 
Grading Criteria for CRS; ocular AEs for the MIRV cohort will be graded per the tables provided in 
the Appendix. The DLT evaluation will be based on the DLT-evaluable population. The DLT-
evaluable population for SL-172154 + PLD and SL-172154 + MIRV is defined as all subjects enrolled 
in the dose escalation cohorts who receive at least 50% scheduled doses of SL-172154 and one dose of 
PLD or MIRV and complete the post-treatment visit (PTV) through the DLT evaluation period or 
experience any DLT during the DLT evaluation period. DLTs will be summarized by dose level for 
each of the combination dose escalation cohorts. The MTD will be estimated using isotonic regression. 
Continuous toxicity monitoring based on the Pocock-type stopping boundary [Ivanova, 2005] will be 
used for the rate of AEs leading to treatment discontinuation within each of the dose expansion cohorts. 
Anti-tumor activity data will be summarized by dose level and for all subjects for each combination 
regimen, respectively, in the All Treated population and Response-Evaluable population (defined as 
Subjects in the All Treated Population who have a baseline disease assessment and have at least one 
post-baseline disease assessment or have progressed or died before the first post-baseline disease 
assessment). The ORR and CBR based on investigator-assessed response per RECIST v1.1 will be 
estimated along with a 95% confidence interval using the exact probability method. Duration of 
response and time to response will be evaluated, using the Kaplan-Meier method, for the subgroup of 

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subjects with a confirmed response. The Kaplan-Meier method will be used to estimate the PFS/OS 
curve and PFS/OS rate at timepoints of interest. 
SL-172154 PK parameters will be summarized and analyzed using appropriate statistical methods. The 
relationship between PK exposure parameters and ADA, safety, efficacy, and PD endpoints may be 
explored, as data permit, using appropriate graphical and statistical methods. PD biomarkers values 
will be summarized descriptively by dose level for each combination regimen. The effect of ADA and 
neutralization capacity on the PK, PD, safety and efficacy will be explored, as data permit, using 
appropriate graphical and statistical methods. 
Plasma concentrations for MIRV will also be summarized. All concentration data will be determined 
using validated assays. The immunogenic potential of MIRV will also be assessed.  
 
 

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1. 
BACKGROUND AND STUDY RATIONALE 
1.1 
Bridging Innate and Adaptive Immunity via Concurrent Targeting of CD47 and 
CD40 
Cluster of differentiation (CD)47 is expressed by many somatic and hematopoietic tissues and is 
an important protective mechanism to prevent red blood cell (RBC) and platelet destruction by 
macrophages and splenic CD4+ dendritic cells [Oldenborg, 2000; Blazar, 2001; Yamao, 2002; 
Olsson, 2005; Yi, 2015]. The anti-phagocytic activity of CD47/signal regulatory protein α 
(SIRPα) led to the description of this axis as the macrophage ‘do not eat me’ signal. The ‘eat me’ 
signal which ultimately leads to RBC destruction by splenic dendritic cells (DCs) is dependent 
upon a second activating signal, including CD18 containing integrins [Yi, 2015]. Uncoupling of 
the ‘do not eat me’ and ‘eat me’ signals likely increased the fitness of the host by providing 
improved regulation for erythrocyte homeostasis and should be considered in the therapeutic 
application of CD47/SIRPα inhibitors. 
Abundant expression of CD47 in many solid and hematogenous tumors led to investigation of 
whether tumor cells had co-opted this pathway as a protective mechanism against immune 
mediated destruction. Early studies hypothesized that the role of CD47 as a ‘do not eat me’ 
signal by macrophages for erythrocyte homeostasis would also explain the observed anti-tumor 
benefit in preclinical studies with CD47 blocking antibodies or SIRPα-Fc fusion proteins [Chao, 
2012; Willingham, 2012; Weiskopf, 2013]. More recent studies, however, have clarified that 
DCs are also an important target of CD47/SIRPα inhibition in the context of tumor 
immunotherapy [K. Liu, 2015]. Specifically, inhibition of SIRPα signaling in CD8α+ DCs has 
been shown to enhance sensing of phagocytosed tumor mitochondrial deoxyribonucleic acid 
(DNA), which initiates a cyclic guanine monophosphate – adenosine monophosphate 
synthase/stimulator of interferon genes (cGAS/STING) mediated type I interferon response that 
facilitates cross-presentation of tumor antigens to CD8+ T cells [K. Liu, 2015; Xu, 2018]. 
Increased antigen priming of CD8α+ DC in the presence of CD47/SIRPα inhibition dramatically 
enhances tumor rejection in multiple preclinical tumor models, demonstrating that the 
CD47/SIRPα axis is capable of bridging innate and adaptive immunity.  
CD8α+ DCs expressing the transcription factor batf3 have previously been reported to be 
essential for anti-tumor immunity [Hildner, 2008]. The essential role of CD8α+ DCs in anti-
tumor immunity is due to the specialized ability of these antigen-presenting cells (APCs) to 
cross-present exogenous tumor antigens. Following phagocytosis, these tumor antigens gain 
entry to the DC cytosol and then are cross presented to CD8+ T cells. CD40 ligation by CD40L, 
expressed by resting CD8α+ (but not CD8α negative) DCs, is an important signal for enhancing 
the antigen cross-presenting activity of exogenous antigen by DCs to CD8+ T cells [Bennett, 
1998; Schoenberger, 1998; O'Connell, 2000; Delamarre, 2003; Yasumi, 2004]. Interestingly, 
activation of tumor necrosis factor receptor-associated factor (TRAF) signaling downstream of 
CD40 ligation has also been shown to facilitate a type I interferon response via STING 
activation, but STING activation does not appear to be essential for the anti-tumor immune 
response to CD40 stimulation [Byrne, 2016; Yao, 2016]. Despite the potentially context-
dependent role of a type I interferon response, anti-tumor immunity to CD40 agonists remained 
dependent upon batf3 positive DCs and CD8+ T cells [Byrne, 2016]. These data indicate that, 
like CD47/SIRPα, the CD40/CD40L axis appears capable of bridging innate and adaptive 

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immunity; however, the two pathways appear to have distinct dependence upon a type I 
interferon response. 
1.2 
Ovarian Cancer 
Ovarian, fallopian tube, and primary peritoneal cancers, collectively known as epithelial ovarian 
cancer (EOC), are the most lethal gynecological cancer with greater than 185,000 yearly deaths 
worldwide. EOCs are the fifth most common cause of cancer mortality in women [Bray, 2018]. 
Patients are initially considered to have platinum-sensitive disease if they respond to first-line 
platinum and taxane based chemotherapy and experience a relapse-free period of greater than 
6 months following the last dose of platinum therapy. The current standard-of-care frontline 
treatment for advanced EOC patients consists of combination carboplatin and paclitaxel 
chemotherapy before or after debulking surgery and results in high response rates. Further 
progress has recently been made by incorporating molecularly targeted agents into treatment 
paradigms. The use of PARP (poly ADP-ribose polymerase) inhibitors into front-line 
maintenance and recurrent, platinum-sensitive settings, as well as bevacizumab in all lines of 
therapy, have improved patient outcomes [J. Liu, 2014; Herzog, 2017]. However, most patients 
eventually relapse with disease that is platinum-resistant, which is defined by relapse between 
0 to 6 months after the last platinum dose. Outcomes for patients with platinum-resistant EOC 
remain particularly poor, with low response rates to non-platinum chemotherapy (e.g., 11.8% in 
the AURELIA trial; [Pujade-Lauraine, 2014]), median progression-free survival (PFS) of 3 to 
4 months, and median overall survival less than 1 year [Davis, 2014]. Furthermore, subsequent 
lines of systemic therapy are often associated with cumulative toxicities and limited tolerability 
in patients. For these reasons, the development of novel therapies for use in the platinum-
resistant setting is critical. 
1.3 
CD47 and CD40 Targeting in Ovarian Cancer 
Ovarian and related cancers were selected for investigation in the Phase 1a first-in-human dose 
escalation study of SL-172154 (SL03-OHD-101) and this Phase 1b study of SL-172154 
(SL03-OHD-105) due to the fact that these histologies have a high percentage of tumors with 
detectable CD47 expression (TCGA data; [Wang, 2015; Brightwell, 2016]). A tissue microarray 
of 265 tissues from patients with ovarian, primary peritoneal, and fallopian tube cancers were 
analyzed by immunohistochemical analysis for CD47 expression and expression was detected in 
210 of 265 cases (79%). Furthermore, CD47 is a tumor-associated antigen with higher levels of 
expression in epithelial ovarian cancer cells compared with normal ovarian cells [Li, 2017]. High 
CD47 expression is associated with poor response to primary therapy in ovarian cancer 
[Brightwell, 2016]. Finally, ovarian cancer is characterized by peritoneal metastasis which is 
facilitated by crosstalk between tumor cells and other cells in the tumor microenvironment 
(TME). Tumor-associated macrophages (TAMs) constitute over 50% of cells within the 
peritoneal TME and malignant ascites and are potential targets for therapy [Gupta, 2018]. This 
rationale is supported by the results of a Phase 1 study of an anti-CD47 antibody, Hu5F9-G4, in 
which monotherapy activity was reported in 2 (partial responses) out of 13 patients with ovarian 
cancer [Sikic, 2019]. Given that the APC is hypothesized to be the primary target of SL-172154, 
the unique immune contexture of ovarian and related cancers in conjunction with their high 
tumor CD47 expression makes these histologies particularly suitable for clinical investigation. 

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1.4 
SL-172154 
1.4.1 Mechanism of Action 
The apparently non-overlapping roles of CD47/SIRPα and CD40/CD40L in bridging innate and 
adaptive cancer immunotherapy suggests that the two pathways could be complimentary or 
synergistic in combination and have the potential to improve survival in patients with ovarian 
and related cancers. In an attempt to improve upon current paradigms, Shattuck Labs has 
developed a bifunctional fusion protein platform, capable of simultaneously blocking 
‘checkpoints’ while activating tumor necrosis factor (TNF) receptor superfamily co-stimulators. 
Shattuck’s Agonist Redirected Checkpoint (ARC) platform adjoins the extracellular domain 
(ECD) of a select type 1 membrane protein to the ECD of a select type 2 membrane protein, via a 
central Fc domain. Using this approach, combination immunotherapy can be achieved by a 
single fusion protein. Superior preclinical activity compared to the separate administration of two 
individual antibodies against identical targets were reported [de Silva, 2020]. As a result, 
Shattuck sought to develop a SIRPα-Fc-CD40L ARCTM fusion protein as a means to target these 
pathways with a single compound. Tumor-expressed CD47 can provide a “do not eat me” signal 
to APCs, including macrophages and DCs, through the binding of SIRPα [Figure 2A]. 
SIRPα-Fc-CD40L (SL-172154) can relieve this inhibitory signal through blockade of CD47 with 
the SIRPα domain of the ARC, while simultaneously providing a co-stimulatory signal via CD40 
[Figure 2B]. This enhances tumor phagocytosis, APC activation, increased antigen 
processing/presentation, and induction of an antitumor antigen-specific CD8+ T cell response. 
The preclinical data supporting the translational study of SL-172154 in human subjects with 
cancer is described in detail in the Investigator’s Brochure (IB). The mechanism of action, 
in vitro and in vivo pharmacology, toxicokinetics, summary of clinical data, and the rationale for 
investigation are briefly summarized below.  

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Figure 2.  
SIRPα-Fc-CD40L (SL-172154) Mechanism of Action 
 
 
A. Tumor expressed CD47 can bind SIRPα and suppress APCs (i.e., macrophages and DCs) 
B. SIRPα-Fc-CD40L directly induces APC activation through CD40 stimulating an antigen-specific CD8 T cell response.  
1.4.2 Summary of Nonclinical Data 
A brief summary of the nonclinical data is provided in the following section. SIRPα-Fc-CD40L 
has demonstrated functional activity both in vitro and in vivo [de Silva, 2020]. Detailed 
information is presented in the SL-172154 IB. 
1.4.3 In Vitro Pharmacology Studies 
In vitro, SL-172154 was shown to bind to its cognate targets, CD47 and CD40, both individually 
and simultaneously. High binding affinity for CD47 and CD40 was noted (KD values of 
0.628 nM and 4.74 nM, respectively) as well as a slow off rate, indicating a longer on target 
resident time. This longer resident time could be of benefit in the TME where CD47 is known to 
be expressed. CD40-mediated activity by SL-172154 was demonstrated in a NFkB reporter 
system in which CD40-dependent signaling was stimulated in the absence of Fc receptor 
cross-linking, and in cultured human peripheral blood mononuclear cells (PBMCs) in which 
dose-dependent proliferation, an increase in the number of interleukin (IL)-2 secreting PBMCs, 
and the secretion of multiple cytokines were observed. 
Tumor-macrophage engulfment assays were performed to determine if SL-172154 similarly 
potentiates phagocytosis of tumor cells by macrophages in combination with ADCC-competent 
antibodies including rituximab, cetuximab, trastuzumab, an anti-CD38 antibody, an 
anti-SLAM-F7 antibody, and an anti-BCMA antibody. Generally, across the antibodies and 
tumor cell lines, macrophage mediated phagocytosis was enhanced with the Sl-172154/antibody 
combination in comparison to Sl172154 alone or antibody alone.  
In other tumor-macrophage engulfment assays, both calreticulin and Fc receptor engagement was 
demonstrated to be required for efficient phagocytosis of CD20+ B-cell lymphoma cells by the 
combination of Sl-172154 and rituximab. Addition of a calreticulin-blocking peptide confirmed 
the importance of Fc interactions for Fc-competent targeting antibodies and provided evidence 
that the initiation of phagocytosis by Sl-172154 was driven by the SIRPα domain [de Silva, 
2020]. 

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1.4.4 In Vivo Pharmacology 
It has been previously reported that CD47 blockade in vivo leads to rapid upregulation of CD86 
and MHC-II on splenic CD8α+ DCs [Yi, 2015]. In mice given a single intravenous (IV) injection 
of the murine surrogate of SL-172154 (mSIRPα-Fc-CD40L), rapid and durable activation and 
proliferation of both CD4+ and CD8+ splenic DCs was observed, which matched the duration of 
activation observed with murine CD40 antibodies [de Silva, 2020]. Furthermore, CD40 
stimulation had a more prolonged effect on the same DC populations.  
In preclinical murine studies using subcutaneous CT26 colorectal carcinoma tumors, 
mSIRPα-Fc-CD40L given via intraperitoneal injection enhanced tumor control and rejection of 
both primary and re challenge tumors. These data suggest that mSIRPα-Fc-CD40L elicits an 
antitumor response and programs a durable immunological memory response. The decrease in 
tumor size associated with mSIRPα-Fc-CD40L was statistically significant compared to vehicle, 
murine anti-CD40, murine anti-CD47, and anti-CD47/anti-CD40 in combination. Approximately 
63% of mSIRPα-Fc-CD40L treated mice rejecting the initial tumor and 60% rejected the 
subsequent tumor re-challenge. In comparison, in the anti-CD40/anti-CD47 combination group, 
33% rejected the primary tumor, and neither of the 2 animals available for assessment rejected 
the secondary tumor. Additionally, in CT26 tumor-bearing mice, immune profiling for 
antigen-specific CD8+ T cells by flow cytometry demonstrated that anti-tumor activity of 
mSIRPα-Fc-CD40L was accompanied by an expansion of antigen-specific CD8+ T cells. To 
characterize the mediators of the antitumor response, mice were depleted of CD8+ cells, 
CD4+ cells or both, followed by mSIRPα-Fc-CD40L treatment. The tumor growth inhibition of 
mSIRPα-Fc-CD40L was most significantly impacted by depletion of CD8+ T cells suggesting 
that the in vivo antitumor activity of mSIRPα-Fc-CD40L is heavily dependent on CD8+ T cells. 
1.4.5 Toxicology Studies in Non-Human Primates 
Two repeat IV dose studies in cynomolgus monkeys, utilizing once-weekly administration, of up 
to 5 weeks in duration evaluated SL-172154 doses of 0 (vehicle), 0.1, 1, 10, and 40 mg/kg. 
Dose-dependent receptor occupancy was observed with up to > 90% CD40 receptor occupancy 
on PBMCs and up to ~80% CD47 receptor occupancy on erythrocytes. Following IV 
administration of SL-172154, transient and reversible decreases in platelets (minimal to 
moderate) and lymphocytes (mild) were observed. Additionally, the increased splenic weight and 
lymphoid cellularity observed in the Good Laboratory Practice (GLP) study are consistent with a 
pharmacological effect; these findings were reversed following the 4-week off-dose period.  
While SL-172154 was shown to bind to CD47 receptors on monkey erythrocytes in vivo, clinical 
hematology (erythrocyte count, hemoglobin, and hematocrit) and serum chemistry (lactate 
dehydrogenase and total bilirubin) evaluations at multiple timepoints in the study showed no 
evidence of hemolysis or anemia. Additionally, the in vitro incubation of SL-172154 with human 
whole blood did not result in any detectable hemolysis. SL-172154’s lack of hemolysis of 
erythrocytes is likely because it does not engage effector Fc gamma receptors unlike CD47 
targeting antibodies such as Hu5F9-G4 (magrolimab) [Sikic, 2019]. 
The principal SL-172154-related toxicity finding in the GLP toxicology study was the 
occurrence of dose-dependent infusion-related reactions (IRRs) at 10 mg/kg (2 of 6 animals) and 
40 mg/kg (6 of 10 animals) during the third or fourth doses of SL-172154. These IRRs were 
coincident with the emergence of anti-drug antibodies (ADA) and complement activation. ADA 

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was present in all SL-172154-treated monkeys by Day 15 (Dose 3) and complement activation is 
commonly associated with the presence of ADA. Emergence of ADA in the non-human primate 
studies was expected given that SL-172154 is based on human amino acid sequences which have 
82% identity to the corresponding cynomolgus sequences.  
In the GLP toxicity study in cynomolgus monkeys, there were no findings in the safety 
pharmacology endpoints assessing the central and peripheral nervous systems, respiratory 
system, or cardiovascular system. 
1.4.6 Toxicokinetic Studies 
In two studies in cynomolgus monkeys, systemic exposure, as evaluated by Cmax and AUC, 
increased in a greater than dose-proportional manner on Day 1. Clearance of SL-172154 from 
serum decreased as the dose increased, suggesting a saturable clearance mechanism. In the GLP 
Study, the mean terminal elimination half-life (t½) on Day 1 was approximately 0.4 hours 
following a 1.0 mg/kg dose, and approximately 1 hour after the 10 and 40 mg/kg doses. Potential 
explanations for rapid drug clearance include an antigen sink due to the ubiquitous expression of 
CD47 on peripheral blood cells (i.e., RBC, platelets, and PBMCs), target-mediated uptake at 
early time points with trafficking of cells (e.g., PBMCs), and binding of drug to peripheral 
tissues. In both studies, compared to Day 1, systemic exposure to SL-172154 following multiple 
once-weekly IV infusions was reduced on Day 29, with the decrease appearing more marked in 
the GLP toxicity study compared to the dose-range finding study. As all monkeys were positive 
for ADA by Day 15 (Dose 3) in both studies, the production of ADA to SL-172154 was likely 
the primary factor contributing to the lower serum SL-172154 concentrations observed on 
Day 29 compared to Day 1. 
1.4.7 Summary of Clinical Data for SL-172154 
A brief summary of the clinical data is provided for Study SL03-OHD-101. Detailed information 
is presented in the current SL-172154 IB. As of the data cut-off of 12 September 2022, 
SL-172154 has been administered IV as monotherapy to 26 subjects with ovarian cancer. 
Study SL03-OHD-101 is a Phase 1, first-in-human, open-label, multicenter, dose escalation 
study to investigate the safety, pharmacokinetic (PK), pharmacodynamic (PD), and clinical 
activity of SL-172154 administered to subjects with platinum-ineligible ovarian, fallopian tube, 
or primary peritoneal cancers. SL-172154 was administered on two schedules. In dosing 
Schedule 1, SL-172154 was administered on Days 1, 8 and 15 of a 28-day cycle and then every 
2 weeks (Days 1 and 15) in 28-day cycles starting at Cycle 2. In dosing Schedule 2, SL-172154 
was administered weekly (i.e., Days 1, 8, 15 and 22 in 28-day cycles). Twenty-six subjects were 
enrolled into 6 dose cohorts where SL-172154 was administered as a 30, 60 or 120-minute 
infusion in ascending doses of 0.1 mg/kg (n=3, Schedule 1), 0.3 mg/kg (n=3, Schedule 1), 
3.0 mg/kg (n=2, Schedule 1), 0.3 mg/kg (n=3, Schedule 2), 1.0 mg/kg (n=4, Schedule 2), 
3.0 mg/kg (n=6, Schedule 2), and 10 mg/kg (n=5, Schedule 2). Subjects treated with IV 
SL-172154 from 0.1mg/kg through 3.0 mg/kg cleared the 28-day dose-limiting toxicity (DLT) 
evaluation period with no DLTs. 1 DLT (Grade 3 alanine aminotransferase [ALT] increased) has 
been reported in the 10 mg/kg cohort.  
Most subjects (96%) reported adverse events (AEs) with the most frequently (> 20% of subjects) 
reported AEs being IRR (17 subjects, 65%), fatigue (11 subjects, 42%), nausea (9 subjects, 
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SL-172154 per investigator assessment were reported in 23 subjects (89%), with the most 
common (> 15% of subjects) being IRR, fatigue, nausea and decreased appetite. IRRs are further 
described in Section 1.7.1. Eleven subjects (42%) reported at least one Grade 3/4 AE. Of the 
Grade 3/4 AEs, anemia, aspartate aminotransferase (AST) increased, ALT increased, back pain, 
thrombocytopenia, IRR, muscular weakness (all in 1 subject), and lymphopenia (2 subjects) were 
considered to be related to SL-172154. There were 6 subjects with serious adverse events (SAEs), 
none of which were considered drug-related. No Grade 5 AEs have been reported and no AEs led 
to permanent discontinuation of SL-172154.  
The PK parameters for SL-172154 have been estimated in 23 subjects receiving 0.1 mg/kg (n=3), 
0.3 mg/kg (n=6), 1.0 mg/kg (n=4), 3.0 mg/kg (n=5) and 10 mg/kg (n=5) in Study 
SL03-OHD-101. For doses > 0.1 mg/kg that have been evaluated, serum SL-172154 
concentrations were above the lower limit of quantification (LLOQ) for 2 to 25 hours after the 
start-of-infusion. Following a dose of ≥ 1.0 mg/kg, concentrations appear to decline in a weakly 
biphasic manner. In general, serum SL-172154 Cmax and AUClast values increased with increasing 
dose, with evidence of non-linearity noted by a positive relationship between dose-normalized 
exposure versus the administered dose. Additionally, marked variability in Cmax and AUC values 
at dose levels ≥ 1.0 mg/kg was noted, which is most likely due to dosing interruption secondary 
to infusion-related reactions. Clearance and volume of distribution decreased as a function of 
dose between 1.0 mg/kg and 3.0 mg/kg. For doses ≥ 0.3 mg/kg, geometric mean values indicated 
a short serum half-life (less than 1 hour). Preliminary evidence of decreasing clearance with 
increasing dose may be due to target mediated drug disposition. In general, subject serum 
concentrations and exposure (i.e., Cmax, AUC) were within the same magnitude on Cycle 1, Days 
1 and 15 and Cycle 2, Day 1, indicating no accumulation and no time-dependence on SL-172154 
PK. Also, serum SL-172154 Cmax and AUClast values increased with increasing dose in a greater 
than dose proportional manner. Clearance was similar between Cycle 1, Day 15 and Cycle 2, 
Day 1. The volume of distribution after repeat dosing was lower than that following a single 
dose.  
In summary, SL-172154 has demonstrated an AE profile that has been manageable and 
acceptable in the context of benefit-risk. As of the data cut-off, no clinically significant findings 
were identified from the two ongoing clinical trials. One DLT at the 10 mg/kg dose has been 
observed and no AE led to permanent drug discontinuation as of the data cut-off date for the 
SL03-OHD-101 study.  
Hematologic toxicities have been reported with Fc-active CD47 antibodies or SIRPα-Fc fusion 
proteins, while hepatotoxicity and cytokine release syndrome (CRS) have been reported with 
CD40 agonist antibodies. Of note, no event of CRS has been noted in the clinical trial as of 
23 April 2022. Treatment-related Grade 3 ALT/AST elevations were reported in one subject 
treated at 10 mg/kg. The ALT/AST elevations normalized with withholding of treatment. 
Overall, the benefit-risk profile of SL-172154 supports the continued investigation of SL-172154 
in subjects with advanced cancer.  
1.5 
Rationale for Combination Therapies 
SL-172154 is a novel Fc-fusion protein consisting of human SIRPα and CD40L 
(SIRPα−Fc-CD40L). SL-172154 not only inhibits CD47/SIRPα axis but it also augments cross 
presentation of antigens by APC to T cells through the costimulatory role of CD40L, thus 
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combined with agents that induce immunogenic tumor cell death [SL-172154 IB]. It is likely that 
a combinatorial approach to overcoming immune suppression will be required to provide benefit 
from immune-targeting agents in EOCs [Leary, 2021]. Cytotoxic agents initiate a cascade of 
events by initiating tumor cell apoptosis, thus providing an ‘eat me’ signal and exposing 
neighboring macrophages to tumor antigens. In this context, SL-172154 blocks the SIRPα/CD47 
‘do not eat me’ axis and simultaneously provides a co-stimulatory signal to the macrophages 
within the tumor microenvironment, enhancing their ability to process tumor antigens and 
present them to CD8+ T cells. In preclinical studies, the combination of these ‘eat me’ and ‘do 
not eat me blocking’ signals synergize and further increase macrophage mediated phagocytosis 
of tumor cells. 
1.5.1 Rationale for SL-172154 Administered with Pegylated Liposomal Doxorubicin 
(PLD) 
Preclinical data has demonstrated that pegylated liposomal doxorubicin (PLD) induces 
immunogenic cell death as evidenced by increased extracellular ATP levels, secreted HMGB1, 
induction of calreticulin (CRT) and CRT translocation to the plasma membrane [Bezu, 2015; 
Solari, 2020]. Similarly, doxorubicin has been shown to further promote immune priming by 
enhancing antigen presentation [Zitvogel, 2013] and modifying the suppressive 
microenvironment by increasing infiltration of active T cells [Hao, 2018]. Thus, combining 
SL-172154 with PLD may concurrently 1) enhance stimulation of phagocytosis by induction of 
prophagocytic proteins and inhibition of the CD47/SIRPα checkpoint along with 2) 
augmentation of antigen presentation by APC to T cells via costimulation of the CD40L/CD40 
pathway.  
In preclinical murine studies using subcutaneous CT26 colorectal carcinoma tumors, 
mSIRPα-Fc-CD40L (intraperitoneal) in combination with intravenous doxorubicin resulted in 
enhanced antitumor response. Combination therapy of mSIRPα-Fc-CD40L with paclitaxel or 
doxorubicin both resulted in greater tumor growth inhibition in comparison to either 
monotherapy control. At Day 18, the mean tumor size was smaller in each combination therapy 
group with statistical significance achieved for the combination with doxorubicin (p=0.0195). 
While 25% of mSIRPα-Fc-CD40L + doxorubicin treated animals completely rejected the tumor 
implants, there were no complete rejections noted in the mSIRPα-Fc-CD40L + paclitaxel group. 
This synergistic activity may be due to chemotherapy-induced tumor cell death resulting in 
increased tumor visibility to APCs (e.g., macrophages and dendritic cells) and subsequent 
enhanced phagocytosis activity mediated by mSIRPα-Fc-CD40L. 
There are no highly effective therapies in the platinum-resistant/refractory population, although 
non-platinum agents have demonstrated modest antitumor efficacy in a subset of these patients. 
PLD is a standard of care option for the treatment of platinum-resistant ovarian cancer (PROC; 
[Davis, 2014]) and is therefore appropriate to combine with SL-172154 in this Phase 1b trial. 
Single-agent PLD has been extensively studied in this patient population, demonstrating an 
objective response rate (ORR) of 10 to 20%, median PFS of 2.1 to 3.7 months, and overall 
survival (OS) ranging from 8.4 to 16.8 months [Gordon, 2001; Lawrie, 2013; Pujade-Lauraine, 
2021]. Based on the proposed mechanism of action, we hypothesize that that combination of 
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1.5.2 Rationale for SL-172154 Administered with Mirvetuximab Soravtansine (MIRV) 
Folate receptor alpha (FRα) is a glycosylphosphatidylinositol-anchored cell surface protein 
encoded by the folate receptor 1 (FOLR1) gene. FRα internalizes folate, which is an essential 
cofactor for one-carbon transfer reactions that are required for DNA and ribonucleic acid (RNA) 
synthesis, cell growth, and proliferation. Published studies have demonstrated FRα 
overexpression by immunohistochemistry (IHC) in various epithelial tumors, particularly the 
serous and endometrioid histologic subtypes of ovarian and endometrial cancers [Garin-Chesa, 
1993; Allard, 2007; Dainty, 2007; Brown Jones, 2008; Kalli, 2008; Scorer, 2010; Crane, 2012; 
Ab, 2015]. Several additional studies have validated FRα as a target in serous EOC. First, 
quantitative polymerase chain reaction studies show ubiquitous FRα mRNA expression in serous 
EOC [Hoskins, 1998; Hough, 2001; Hanker, 2012] and high levels of FRα mRNA correlate with 
poor response to chemotherapy and decreased disease-free survival [Chen, 2012]. Second, it has 
been demonstrated that recurrent tumors retain FRα expression comparably to primary tumors as 
shown by serial biopsy sampling and IHC [Kalli, 2008; Crane, 2012]. Third, studies with FRα-
specific imaging agents have demonstrated real-time FRα expression at primary and metastatic 
tumor sites [Garin-Chesa, 1993; Fisher, 2008; van Dam, 2011; Garcia, 2013; Gaillard, 2018]. 
Because of its tumor-specific expression and capacity to internalize small and large molecule 
ligands, FRα has emerged as a biologically rational target for antibody drug conjugate (ADC) 
therapy. ADCs combine the specificity of monoclonal antibody (mAb) to tumor antigens with 
the extraordinary cytotoxicity of maytansine derivatives, which are potent antimicrotubule agents 
that target proliferating cells. MIRV consists of the chimeric anti-FRα mAb M9346A attached 
via a cleavable linker to the cytotoxic maytansinoid, DM4. 
The internalization of MIRV leads to the apoptosis of target ovarian tumor cells that overexpress 
FRα. The hypothesis that SL-172154, by blocking the SIRPα/CD47 axis, would increase the 
macrophage-mediated phagocytosis of these apoptotic cells is supported by in vitro phagocytosis 
assays using human monocyte-derived macrophages and human ovarian cancer cell lines. These 
assays demonstrated that individually, SL-172154 and MIRV stimulated macrophage-mediated 
phagocytosis of KB, IGROV1, and OV90 ovarian cancer cells, and the combination of the two 
agents further enhanced the phagocytic activity. 
Interestingly, in MESOV ovarian cancer cells (which express low levels of FRα and high levels 
of CD47 and calreticulin), SL-172154 alone stimulated phagocytosis whereas MIRV alone did 
not; combining the two agents enhanced phagocytosis above that seen with SL-172154 alone. 
These data suggest that SL-172154 may broaden the activity of MIRV to tumor cells expressing 
low FRα levels.  
Single-agent MIRV has recently been studied in a randomized, open-label Phase 3 comparing 
MIRV and investigator’s choice (IC) chemotherapy in patients with platinum-resistant EOC who 
had received 1 to 3 prior lines of therapy and whose tumors were positive for FRα. While the 
primary endpoint, PFS, did not reach statistical significance in either the intent-to-treat (ITT) or 
the FRα high population, superior outcomes for MIRV over chemotherapy were observed in all 
secondary endpoints in the FRα high population including improved ORR (24% versus 10%), 
CA-125 responses, and patient-reported outcomes. Importantly, confirmed responses were seen 
across FRα levels, with a confirmed ORR in the ITT population being higher for MIRV than for 
IC chemotherapy (22% versus 12%, P=0.015) and correlated with improved CA-125 responses 
(51% versus 27%, P< 0.001). These data indicate that MIRV was generating a cytotoxic signal 
even in ovarian tumors expressing medium and low levels of FRα expression. The in vitro 

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phagocytosis data demonstrates that SL-172154 can synergize with this cytotoxic signal. Thus, 
by increasing tumor phagocytosis and programming a durable immunologic memory response, 
SL-172154 may enhance MIRV anticancer effects, including in tumors expressing lower FRα 
levels. MIRV demonstrated a more manageable safety profile than chemotherapy with fewer 
treatment-related Grade ≥ 3 AEs, and fewer events leading to dose reduction and treatment 
discontinuation in comparison with chemotherapy [Moore, 2021]. Two additional phase 3 
studies for MIRV in PROC are ongoing (IMGN853-0416 and IMGN853-0417). Taken together, 
these data suggest that both PLD and MIRV are appropriate to combine with SL-172154 in this 
Phase 1b trial in patients with platinum-resistant EOC, a population with high unmet need. 
1.6 
Dose and Schedule Rationale 
1.6.1 Pegylated Liposomal Doxorubicin (PLD) 
The approved dose of PLD in the US, Canada, and Europe is 50 mg/m2 administered IV every 
4 weeks; however, 40 mg/m2 every 4 weeks is commonly used in clinical practice and in clinical 
trials [Gordon, 2001]. This latter dose is associated with significantly reduced frequencies of 
AEs, particularly hand-foot syndrome, and a lower frequency of dose reductions with a similar 
ORR [Markman, 2000]. The dose of 40 mg/m2 was used in the AURELIA study which formed 
the basis of approval of bevacizumab in platinum-resistant ovarian cancer [Pujade-Lauraine, 
2014]. In Study SL03-OHD-105, the PLD dose will be 40 mg/m2 administered every 4 weeks. 
1.6.2 Mirvetuximab Soravtansine (MIRV) 
The selection of the Phase 2 dose of 6.0 mg/kg adjusted ideal body weight (AIBW) IV every 
3 weeks (Q3W) was based on data obtained from Study IMGN853-0401, a first-time-in-human 
study designed to establish the maximum tolerated dose (MTD) and determine the recommended 
Phase 2 dose (RP2D) of MIRV when administered IV as a single-agent in adult patients with 
FRα-positive solid tumors who have relapsed or are refractory to standard therapies. This dose 
and schedule were deemed well tolerated in patients with PROC, based on the results from 
243 patients who received MIRV in Study IMGN853-0403. In addition, this full dose and 
schedule of MIRV was able to be combined with full doses of each of the combination agents in 
Study IMGN853-0402. Therefore, 6.0 mg/kg AIBW IV Q3W was chosen for evaluation in Study 
SL03-OHD-105 of subjects with platinum-resistant ovarian cancer. For more information, please 
see the MIRV IB. 
1.6.3 SL-172154 
In Study SL03-OHD-101, SL-172154 monotherapy was administered on two schedules. In 
dosing Schedule 1, SL-172154 was administered on Days 1, 8 and 15 of a 28-day cycle and then 
every 2 weeks (Days 1 and 15) in 28-day cycles starting at Cycle 2. In dosing Schedule 2, 
SL-172154 was administered weekly (i.e., Days 1, 8, 15 and 22 in 28-day cycles). As of 
12 September 2022, 26 subjects have been enrolled into 6 dose cohorts where SL-172154 was 
administered as a 30, 60 or 120-minute infusion in ascending doses of 0.1 mg/kg (n=3, 
Schedule 1), 0.3 mg/kg (n=3, Schedule 1), 3.0 mg/kg (n=2, Schedule 1), 0.3 mg/kg (n=3, 
Schedule 2), 1.0 mg/kg (n=4, Schedule 2), 3.0 mg/kg (n=6, Schedule 2), or 10 mg/kg (n=5, 
Schedule 2). Across these dose levels, SL-172154 has been well tolerated on both schedules with 
one DLT noted in the 10 mg/kg cohort.  

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The starting dose of 3.0 mg/kg in SL03-OHD-105 is supported by safety data from the Study 
SL03-OHD-101 study (Section 1.4.7) in which 4 subjects receiving 1.0 mg/kg and 6 subjects 
receiving 3.0 mg/kg of SL-172154 once-weekly have cleared the DLT evaluation period with no 
DLTs reported. 1 DLT (Grade 3 ALT increased) was reported in 1 of the 5 DLT-evaluable 
subjects in the 10 mg/kg cohort.  
For Study SL03-OHD-105, a less intense schedule of SL-172154 administration will be explored 
with each of the combination agents. SL-172154 will be administered by IV infusion on Days 8 
and 15 in combination with PLD (40 mg/m2, IV, Day 1 of each 28-day cycle) or MIRV 
(6.0 mg/kg AIBW, IV, Day 1 of each 21-day cycle). This dosing schedule was empirically 
selected. PLD or MIRV dosing will be staggered with SL-172154, with the assumption that peak 
tumor concentrations and maximal cytotoxicity for PLD or MIRV occur within 3 to 7 days 
postinfusion [Northfelt, 1996; Harrington, 2001; Gabizon, 2002; Charrois, 2003] [Al-Saden, 
2018; Brand, 2018; Heo, 2019]. Therefore, SL-172154 is provided on Days 8 and 15 of each 
cycle at a point when peak concentrations of the cytotoxic agent are beginning to wane and 
immune cells have infiltrated the tumor microenvironment in the setting of tumor cell destruction 
and phagocytosis of cell debris [Heath, 2021]. It is hypothesized that during this window, tumor 
cell phagocytosis, antigen processing and presentation by APCs can be maximized by 
SL-172154. Another important consideration is that concurrent dosing of MIRV or PLD with 
SL-172154 may ablate macrophages and immune effector populations by exposing them to high 
concentrations of the cytotoxic agent [Takayama, 2020]. 
1.7 
Potential Risks and Benefits of SL-172154 
1.7.1 Potential Risks 
Potential risks to subjects in the study are addressed by vigilant monitoring and safety guidelines 
as outlined below. The risks (evaluation of safety and tolerability) and potential benefits 
(evaluation of anti-tumor activity) of SL-172154 monotherapy administered IV are being 
assessed in the Phase 1 first-in-human clinical trial, SL03-OHD-101, in subjects with relapsed, 
refractory ovarian cancer and provide relevant safety information for this study. Therefore, the 
assessment of potential safety concerns is based on (1) the published safety profiles of other 
CD40 agonists and CD47-SIRPα targeting agents; (2) preclinical toxicology data from 
cynomolgus monkeys; and (3) emerging safety data from the SL03-OHD-101 study 
(Section 1.4.7). 
Adverse events reported with other CD47-SIRPα targeting agents and CD40 agonists: 
Anti-CD47 monoclonal antibodies and SIRPα-Fc fusion proteins have been evaluated in patients 
with hematologic malignancies and solid tumors. AEs that have been observed include anemia, 
hemagglutination, hyperbilirubinemia, lymphopenia, thrombocytopenia, neutropenia, elevation 
of hepatic transaminases, fatigue, headache, fever, and IRRs [Chao, 2019; Sikic, 2019; Eladl, 
2020]. A common AE reported with CD40 agonist monoclonal antibodies was transient IRRs 
characterized by fever, rigors, chills, and other symptoms such as headache and back pain. Rare 
events of CRS were noted. Other AEs include fatigue, rash, elevation of hepatic transaminases, 
lymphopenia, anemia, thrombocytopenia, neutropenia, thromboembolism, and inflammatory eye 
disorders (conjunctivitis and ocular hyperemia). Immune mediated events, including dermatitis, 
colitis, hypophysitis and thyroiditis, have not been seen with CD47-targeted agents or CD40 

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antibodies but remain a potential concern [Vonderheide, 2001; Vonderheide, 2007; Vonderheide, 
2013a; Vonderheide, 2013b; Nowak, 2015; Chao, 2019; Sanborn, 2019; Eladl, 2020]. 
Toxicities observed with SL-172154 in preclinical toxicology studies in cynomolgus 
monkeys: The underlying etiology of the SL-172154-related effects observed in cynomolgus 
monkeys is most likely due to a combination of both the pharmacologic activity of the molecule 
and immunologic reactions to SL-172154 administration. The following are potential 
contributory factors to the dose-dependent IRRs observed in monkeys during or following the 
third to the fifth dose of SL-172154: (1) development of ADA and downstream complement 
activation; (2) elevations in serum cytokines; and (3) postdose changes in peripheral blood 
lymphocyte counts. Emergence of ADA in cynomolgus monkeys was expected given that 
SL-172154 is based on human amino acid sequences which have 82% identity to the 
corresponding cynomolgus sequences. SL-172154 has > 99% identity to the corresponding 
human proteins and hence SL-172154 is considered to have a low risk of immunogenicity in 
humans. 
Safety profile of SL-172154 in the context of PLD: The combination of SL-172154 and PLD 
has not previously been studied in humans. The most common AE (> 20%) reported with PLD in 
patients with ovarian cancer includes asthenia, fatigue, fever, anorexia, nausea, vomiting, 
stomatitis, diarrhea, constipation, hand-foot syndrome, rash, neutropenia, thrombocytopenia, and 
anemia [DOXIL USPI, 2019]. Serious, life-threatening, and fatal IRRs can occur with PLD. 
Across multiple studies of PLD monotherapy in various solid tumors, 11% of patients had IRRs 
with the majority of infusion-related events occurred during the first infusion. Doxorubicin 
hydrochloride can cause myocardial damage, including acute left ventricular failure. The risk of 
cardiotoxicity is 11% when the lifetime cumulative anthracycline dose (not limited to PLD) 
approaches 450 to 550 mg/m2. Complete information for PLD to be used in Study 
SL03-OHD-105 may be found in the current PLD prescribing information (i.e., Doxil USPI, 
Caelyx product monograph, or Caelyx SmPC).  
Fatigue and IRRs have been reported following administration with CD47-SIRPα targeting 
agents as well as with CD40 agonist monoclonal antibodies. In addition, IRRs, fatigue, nausea, 
constipation and diarrhea are the most frequently reported AEs associated with IV SL-172154 
monotherapy in the SL03-OHD-101 study (Section 1.4.7). Thus, potential overlapping toxicities 
between SL-172154 and PLD include IRRs, fatigue, nausea, constipation, diarrhea and 
cytopenias. It is not expected that SL-172154 would exacerbate any other toxicities commonly 
observed with PLD in this patient population. 
Safety profile of SL-172154 in the context of MIRV: The combination of SL-172154 and 
MIRV has not previously been studied in humans. Safety information for MIRV is summarized 
in the reference safety information (RSI) provided in the MIRV IB. Single-agent MIRV safety 
data are available for 599 patients, which includes 137 patients treated with single-agent 
6.0 mg/kg MIRV in the expansion phase of Study IMGN853-0401, 243 patients treated with 
single-agent 6.0 mg/kg MIRV in the pivotal stage of Study IMGN853-0403, 112 patients treated 
with single-agent 6.0 mg/kg MIRV in Study IMGN853-0416, and 106 patients treated with 
single-agent 6.0 mg/kg MIRV in Study IMGN853-0417. All-causality, treatment-emergent 
adverse events (TEAEs) by preferred term observed in > 10% of patients treated with 
monotherapy MIRV in Study IMGN853-0401 (expansion phase) were diarrhea, vision blurred, 
AST increased, nausea, vomiting, headache, dry eye, keratopathy, decreased appetite, ALT 
increased, and peripheral neuropathy. The majority of TEAEs were Grade ≤ 2. The nature, 

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frequency, and severity of TEAEs were consistent with the safety profile of MIRV, and there 
were no clinically significant differences between the EOC and endometrial cohorts. The most 
common Grade ≥ 3 TEAEs were vomiting and abdominal pain (8 patients each, 5.8%) and 
fatigue and dehydration (7 patients each, 5.1%). There was no clinically significant difference in 
either the nature or severity of Grade ≥ 3 TEAEs experienced by patients in the EOC and 
endometrial cancer cohorts. Complete information for MIRV to be used in Study 
SL03-OHD-105 may be found in the MIRV IB and Elahere USPI.  
Thus, potential overlapping toxicities between SL-172154 and MIRV include IRR, fatigue, 
nausea, diarrhea and cytopenias. It is not expected that SL-172154 would exacerbate any other 
toxicities commonly observed with MIRV in this patient population. 
Potential risks of SL-172154 administration in SL03-OHD-105 study 
The potential risks noted below are based on observations in the SL-172154 toxicology studies, 
the Phase 1 clinical studies (as of 12 September 2022), or select toxicities reported with other 
CD47 or CD40-targeted agents. The RSI for SL-172154 is provided in the SL-172154 IB. 
1) IRRs and CRS: In Study SL03-OHD-101, 17 of the 26 total subjects (65.4%) had 44 
treatment-related IRR events. Twelve subjects (46.2%) had IRR events that led to infusion 
interruption. The median number of IRR events per subject was 2 with a range of 1 to 9. All 
treatment-related IRR events were Grade 1 or 2, except for 1 subject dosed with 3.0 mg/kg 
on Schedule 1 who had a Grade 3 event. No IRR was deemed to be serious. All IRR events 
resolved with no sequelae. Symptomatic manifestations of the IRR events variably include 
fever, chills, rigors, back pain, rash, hyper/hypotension, tachycardia, nausea, and visual 
symptoms. Most of the IRRs were reported to be relatively short in duration and occurred 
during the infusion or immediately postinfusion. No delayed IRRs were noted. Collectively, 
the frequency of subjects experiencing IRR events increased with increasing dose. However, 
at all dose levels IRR events were readily managed with temporary interruption of the 
infusion, treatment medications potentially including steroids, and/or slowing the rate of 
SL-172154 infusion at re-start; the majority of subjects received premedications (such as 
diphenhydramine, famotidine or other available histamine 2 (H2) receptor antagonist, and 
acetaminophen) prior to their next dose. Subjects receiving 10 mg/kg SL-172154 received 
primary prophylactic premedication beginning on Cycle 1 Day 1. All subjects received their 
full scheduled dose and no subjects have discontinued dosing of SL-172154 secondary to 
IRR. The constellation of symptoms, signs, and timing of the IRR events have not been 
consistent with CRS. This is supported by the absence of a significant IL-6 or TNFα response 
in subjects who have experienced IRR. 
The steps taken to minimize the risks associated with IRRs and CRS include administration 
in an outpatient oncology clinic or inpatient setting by experienced health care providers, 
mandatory premedication prior to SL-172154 administration for IRR prophylaxis, 
lengthening the SL-172154 infusion duration in Study SL03-OHD-105, management 
guidelines (e.g., SL-172154 infusion adjustments/interruptions, rescue treatments), and 
extended monitoring when indicated. Recommendations to identify and manage IRRs and 
CRS are outlined in the Toxicity Management Guidelines section of the protocol 
(Section 3.7.1). 
2) Immunogenicity: SL-172154 has > 99% identity to the corresponding human proteins and 
hence SL-172154 is considered to have a low risk of immunogenicity in humans. Subjects in 

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the clinical trial SL03-OHD-105 will be monitored starting at baseline and serially for ADA. 
In the event of a positive ADA response, antibody titer will be measured, and antibody 
isotype and neutralization may be characterized.  
3) Hematologic toxicity: Anemia and thrombocytopenia have been reported with CD47 targeted 
agents that have an active Fc-domain (e.g., magrolimab, TTI-621, TTI-622). Interference 
with crossmatch has been reported with some CD47 targeted agents (e.g., magrolimab, 
ALX-148). G3/4 hematologic toxicities have only been noted in the 10mg/kg dose level of 
SL-172154 and include lymphopenia (2/5 subjects), anemia (1/5 subjects) and 
thrombocytopenia (1/5 subjects) and all were considered treatment-related. The subject with 
anemia had a baseline medical condition of anemia. Following the data-cut off, there has 
been one event of G3 neutropenia in the 3.0 mg/kg dose level. In Study SL03-OHD-105, 
complete blood counts (CBCs) will be assessed frequently during treatment to monitor for 
hematologic toxicity. Supportive therapy will be provided according to standard medical 
practice; dose modifications for hematologic toxicity for each agent will follow according to 
recommendations provided in the protocol and product information for PLD or MIRV. To 
date, hemolysis has not been observed in SL03-OHD-101. The absence of hemolytic anemia 
is likely due to the inactive Fc domain of SL-172154 [Chow, 2019]. To investigate the 
possible risk of interference with pretransfusion testing due to SL-172154, blood 
phenotyping, type and screen (ABO/Rh), and direct antiglobulin test (DAT) was performed 
before and following exposure to SL-172154 in SL03-OHD-101. No interference with 
pretransfusion testing (as evidenced by ability to resolve crossmatch) has been observed in 
subjects treated to date in SL03-OHD-101.  
4) Immune-Related Adverse Events (irAEs): As experience with CD47 and CD40 targeted 
agents has expanded, it has become apparent that the typical irAEs described with cytotoxic 
T cell lymphocyte-associated antigen 4 (CTLA-4) and PD-1 inhibitors are not being observed 
with these agents. irAEs have not been reported in the current safety profile of SL-172154. 
Nevertheless, it is unknown if irAEs resulting from a breakdown of self-tolerance could 
occur with SL-172154 administration with PLD or with MIRV. 
In summary, this Phase 1 study has taken the following precautions to minimize potential risks: 
(1) the study is being conducted at centers that have extensive experience with this class of 
agents and the management of associated toxicities; (2) the starting dose of SL-172154 is a dose 
that has been safely administered to patients with ovarian cancer; (3) patients treated at each 
SL-172154 dose level would be observed for the duration of the DLT assessment period to 
confirm tolerability of the combination dose; (4) increasing the SL-172154 infusion duration 
time, (5) administration of SL-172154 in an oncology treatment center/hospital allows for close 
monitoring of subjects for AEs and for timely action; (6) guidelines for management of AEs 
based on established guidelines [Lee, 2014; Haanen, 2017; Puzanov, 2017; Rosello, 2017b; 
Brahmer, 2018; Porter, 2018; Lee, 2019] are provided in the protocol; and (7) a Safety 
Monitoring Committee (SMC) will meet at least monthly (or as data warrant) during dose 
escalation to review emerging toxicities and assess the impact of these toxicities on study 
conduct; the SMC will continue with ongoing review of safety data during dose expansion. As 
dose escalation in SL03-OHD-105 will be informed by data from SL03-OHD-101, safety and PK 
data from SL03-OHD-101 will be shared with the SMC for SL03-OHD-105 to ensure that the 
SMC is fully informed of the IV SL-172154 monotherapy data. Doses explored in 
SL03-OHD-105 will not exceed the highest dose cleared for safety in SL03-OHD-101.  

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1.7.2 Potential Benefits 
SIRPα-Fc fusion proteins and anti-CD47 antibodies, as well as CD40L-Fc fusion proteins and 
CD40 agonist antibodies, are being investigated in clinical trials and have demonstrated 
preliminary evidence of anti-tumor activity [Vonderheide, 2007; Kornbluth, 2012; Ingram, 2017; 
Lin, 2017; Petrova, 2017; Advani, 2018; Kauder, 2018; Merz, 2018; Sikic, 2019; Vitale, 2019].  
The clinical benefits of SL-172154 in combination with either PLD or MIRV in subjects with 
platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers are unknown as no 
clinical trials have been conducted to date.  
SL-172154 targets both the CD40/CD40L and the SIRPα/CD47 axes. There are currently no 
reported multitargeted agents or trials for CD47 inhibitors in combination with CD40 agonists. 
High expression of CD47 is reported across ovarian and related cancers in a large percentage of 
tumors (~80%) demonstrating detectable CD47 expression (TCGA data; [Wang, 2015; 
Brightwell, 2016] and CD47 is a tumor associated antigen in this cancer type [Li, 2017].  
As a monotherapy, CD47 inhibitors have demonstrated relatively low response rates and tumor 
responses have only been observed with Fc-competent agents [Chow, 2019]. Magrolimab 
demonstrated an ORR of 10% in relapsed/refractory acute myeloid leukemia (AML)/ 
myelodysplastic syndrome (MDS) patients [Sallman, 2019] and 15% (2/13) of ovarian cancer 
patients [Sikic, 2019]. Sporadic clinical responses have also been reported in patients with 
relapsed, refractory non-Hodgkin’s lymphoma (NHL) treated with TTI-622 monotherapy [Patel, 
2020].  
Magrolimab in combination with avelumab reported stable disease in 56% of patients (N=18 
platinum-resistant or refractory ovarian cancer) who had at least one response evaluation, with an 
unconfirmed partial response (PR) reported in one of these patients [Lakhani, 2020]. Multiple 
combination studies with CD47 inhibitors have also been tested in other hematologic and solid 
tumor malignancies. Magrolimab in combination with azacitidine has demonstrated activity in 
MDS and AML, with a complete response (CR) rate of 50% in previously untreated patients with 
MDS (n=24), and 42% in previously untreated patients with AML (n=43) [Sallman, 2019; 
Sallman, 2020]. The combination appears to compare favorably with historical data from 
azacitidine monotherapy [Fenaux, 2009; DiNardo, 2020]. Additionally, activity signals have 
been reported in patients with relapsed refractory NHL treated with magrolimab [Advani, 2018] 
or ALX-148 in combination with rituximab [Kim, 2020] as well as ALX-148 plus trastuzumab in 
HER2+ gastric/gastroesophageal junction tumors [Chow, 2019]. Taken together, these data 
indicate that CD47 inhibitors combined with chemotherapy or ADCP-competent antibodies 
demonstrate encouraging signals relative to historical data for the contributing components.  
Several different CD40 agonistic antibodies have been studied in early phase trials [Beatty, 
2017]. Sporadic responses in solid and hematologic malignancies including renal cell cancer, 
melanoma, diffuse large B cell lymphoma and Hodgkin’s lymphoma have been noted with 
monotherapy CD40 agonists. The CD40 agonist, dacetuzumab, demonstrated monotherapy 
responses (1 CR and 5 PRs among n=50 subjects) in diffuse large B cell lymphoma [Advani, 
2009]. However, a critical component that is believed to mediate the anti-tumor effect is the 
presence of tumor antigen, which is necessary for CD40-activated APCs to induce antigen-
specific T cell adaptive immunity. This is the hypothesis for several other ongoing clinical trials 
combining CD40 agonists with vaccines and chemotherapy [Beatty, 2017]. 

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1.8 
Study Rationale 
The mechanism of action of SL-172154 is designed to pair the costimulatory role of CD40L in 
augmenting the antigen cross-presenting ability of DCs with the increased phagocytic activity of 
macrophages through CD47-SIRPα checkpoint inhibition. Importantly, because the ECDs of 
SIRPα and CD40L are physically linked to one another and localized to the TME, APCs and 
tumor cells receive these signals in a coordinated manner, potentially leading to a more potent 
and durable anti-tumor response.  
The investigation of SL-172154 in ovarian and related cancers is supported by the following 
factors: (1) mechanism of action of SL-172154, (2) high levels of CD47 expression, (3) 
enhanced tumor growth inhibition with mSIRPα-Fc-CD40L in combination with doxorubicin in 
preclinical murine xenograft models, and (4) potentiation of phagocytic activity when 
SL-172154 was combined with MIRV with the potential to broaden the activity of MIRV into 
FRα medium and low tumors.  
SL03-OHD-105 is designed as a Phase 1b open-label trial to evaluate the safety, PK, PD, and 
preliminary efficacy of SL-172154 administered with either PLD or MIRV in subjects with 
platinum-resistant ovarian and related cancers. PLD is commonly used in clinical practice in this 
patient population, with well-described safety, PK and PD profiles. MIRV is being investigated 
for the treatment of PROC patients with efficacy, safety and PK profiles reported. Each 
component is anticipated to have distinct mechanisms of activity, and both PLD and MIRV have 
the potential to bridge innate and adaptive immunity when combined with SL-172154, thus 
potentially improving treatment outcomes without increasing toxicity. Anticipated overlapping 
toxicities are minimal when combining SL-172154 with PLD (IRRs, fatigue, nausea, 
constipation, diarrhea and cytopenias) or with MIRV (IRR, fatigue, nausea, diarrhea and 
cytopenias). The possible benefits of each of the combination regimens proposed in this trial 
outweigh the potential risks in the patient population proposed for enrollment in 
SL03-OHD-105. 
Upon identification of the SL-172154 dose for each of the combination regimens from dose 
escalation groups, dose expansion cohorts will enroll additional subjects to receive either PLD or 
MIRV with the selected SL-172154 dose. 

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combination regimen, SL-172154 (3.0 mg/kg starting dose, IV) will be administered on Day 8 
and Day 15 with either PLD (40 mg/m2, IV, Day 1 of each 28-day cycle) or MIRV (6.0 mg/kg 
AIBW, IV, Day 1 of each 21-day cycle). For each combination regimen, subjects will be 
enrolled in sequential cohorts of approximately 3 subjects and evaluated for DLTs (Section 3.5) 
during the first cycle of therapy, which is the DLT evaluation period (28 days for the PLD 
cohort; 21 days for the MIRV cohort). The planned dose escalation of SL-172154 is outlined in 
Table 1 (PLD Cohort) and Table 2 (MIRV Cohort) for each of the combination regimens. The 
dose escalation cohorts will utilize the modified Toxicity Probability Interval (mTPI-2) design 
[Guo, 2017] with target DLT rate of 30% for the MTD. The dose escalation decision rules based 
on mTPI-2 model are outlined in Section 9.1.1. Dose escalation of SL-172154 in each of the 
combination regimens will continue until a safe dose of SL-172154 administered with either 
PLD or MIRV is identified.  
In selecting the dose of SL-172154 to be evaluated in the dose expansion cohort of each 
combination regimen, the totality of the data from the dose escalation phase will be considered, 
including safety of the combination and PD activity. Upon identification of the selected 
SL-172154 dose administered with PLD, a dose expansion cohort will enroll up to approximately 
20 subjects (including subjects from dose escalation at the same dose level) to further evaluate 
the safety and efficacy of the study treatment. Similarly, upon identification of the selected 
SL-172154 dose administered with MIRV, a dose expansion cohort will enroll up to 
approximately 70 subjects (including subjects from dose escalation at the same dose level) to 
further evaluate the safety and efficacy of the study treatment. The same patient population will 
be enrolled in both the dose escalation and dose expansion portion of the study for each of the 
combination regimens. 
For all subjects in all cohorts, premedication as prophylaxis for IRR with dexamethasone (8 mg 
IV), an antipyretic and antihistamines should be administered at least 30 minutes prior to each 
SL-172154 administration. For dosage and schedule of prophylactic premedications, please see 
Section 5.1.1. For subjects enrolled to receive MIRV, premedication with an antipyretic, 
antihistamine, and dexamethasone will be administered at least 30 minutes prior to each MIRV 
administration as described in Section 5.3.2.1. 
Throughout the treatment period for all subjects, an ongoing review of available safety data will 
be undertaken by a SMC as described in Section 7.8. All subjects (dose escalation and dose 
expansion) will receive SL-172154 administered with either PLD or MIRV until documented 
disease progression, unacceptable toxicity or intolerance, withdrawal of consent, or the subject 
meets other criteria for discontinuation (whichever occurs first) as defined in Section 3.1.1. 
3.1.1 Sample Size 
The planned sample size is approximately 102 subjects, depending on the number of dose levels 
evaluated in dose escalation for each of the combinations. Approximately 24 subjects will be 
enrolled in dose escalation cohorts (12 subjects in PLD cohorts and 12 subjects in MIRV 
cohorts) and approximately 78 subjects will be enrolled in the dose expansion cohorts (an 
additional 14 subjects at the selected dose in PLD cohort and additional 64 subjects at the 
selected dose in MIRV cohort). See Section 9.1.4 for more details. 

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3.2 
Dose Escalation  
Subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer will be 
enrolled in dose escalation cohorts to receive either SL-172154 with PLD or SL-172154 with 
MIRV. For the MIRV cohort, subjects must have a tumor that is positive for FRα expression as 
defined by the Ventana FOLR1 Assay. Subjects can be enrolled to only 1 of the combination 
regimens in this study.  
3.2.1 SL-172154 Administered with Pegylated Liposomal Doxorubicin (PLD) 
SL-172154 (3.0 mg/kg starting dose) will be administered by IV infusion on Days 8 and 15 of 
each 28-day cycle. Premedication as prophylaxis for IRR with dexamethasone (8 mg IV), an 
antipyretic and antihistamines should be administered at least 30 minutes prior to each SL-
172154 administration as described in Section 5.1.1. PLD (40 mg/m2, IV) will be administered 
on Day 1 of each 28-day cycle. Administer the first dose (Cycle 1 Day 1) of PLD as a 1 mg/min 
infusion; after Cycle 1, if tolerated, PLD can be delivered as a 1-hour infusion. Premedication 
(any agent except steroid) as prophylaxis for nausea and vomiting with PLD may be 
administered per institutional guidelines. 
The planned dose escalation of SL-172154 is outlined in Table 1; additional doses and/or 
schedules may be explored based on emerging safety, PK and PD data. SL-172154 doses 
explored in SL03-OHD-105 will not exceed the highest dose determined to be safe and tolerable 
in the monotherapy dose escalation study SL03-OHD-101.  
Subjects will be enrolled in cohorts of approximately 3 subjects into sequential dose levels of 
SL-172154 administered with PLD and evaluated for DLT during the 28-day DLT evaluation 
period. DLT criteria are defined in Section 3.5. Treatment will be administered in 28-day cycles 
until at least one of the study treatment discontinuation criteria is met (Section 3.1.1). During 
therapy, management of PLD-related toxicity should follow the guidelines provided in the 
current PLD label, or local guidelines and are described in Section 3.7.2. Subjects will be 
followed according to the Schedule of Assessments (SOA) in Section 6.1. 
The safety as well as available PK, PD, and efficacy data from these subjects will inform the 
dose of SL-172154 selected to be further evaluated in dose expansion when administered in 
combination with PLD to subjects with platinum-resistant ovarian, primary peritoneal, or 
fallopian tube cancer. 
Table 1 
SL-172154 Dose Escalation Plan When Administered with PLD 
Dose 
Levela 
SL-172154 Doseb 
[D8 and 15 in each 28d cycle] 
SL-172154 
Infusionc 
Pegylated liposomal doxorubicin (PLD) 
-1d 
1.0 mg/kg 
60 min ± 10 min 
PLD (40 mg/m2) IV administered on Day 1 of 
each 28-day cycle 
 
Administer first dose on study (C1D1) as 
1 mg/min IV infusion; after Cycle 1, if 
tolerated, PLD can be delivered as a 1-hour 
infusion 
1 
(Starting 
Dose) 
3.0 mg/kg 
120 min ± 15 min 
2 
6.0 mg/kg 
180 min ± 15 min 
Abbreviations: AIBW = adjusted ideal body weight; C1D1 = Cycle 1 Day 1; D = day; IV = intravenously; mTPI-2 = modified 
toxicity probability interval; PLD = pegylated liposomal doxorubicin  

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a. 
Doses explored in SL03-OHD-105 will not exceed the highest dose determined to be safe and tolerable in the monotherapy 
dose escalation study SL03-OHD-101. 
b. 
The actual body weight in kilograms (kg) will be used for SL-172154 dose calculation in all subjects whose body weight is 
≤ 100 kg. For subjects with body weight > 100 kg, the dose to be administered should be the same as that calculated for 
a subject weighing 100 kg. 
c. 
Infusion time may change based on final drug volume needed for administration, safety and tolerability of the infusion for 
the subject and/or observed safety findings during the study. Please refer to the Study Pharmacy Manual (SPM) for details. 
d. 
SL-172154 dose level -1 at 1.0 mg/kg will be evaluated if 3.0 mg/kg is not safe per mTPI-2. 
3.2.2 SL-172154 Administered with Mirvetuximab Soravtansine (MIRV) 
SL-172154 (3.0 mg/kg starting dose) will be administered by IV infusion on Day 8 and Day 15 
of 21-day cycles. Premedication as prophylaxis for IRR with dexamethasone (8 mg IV), an 
antipyretic and antihistamines should be administered at least 30 minutes prior to each 
SL-172154 administration as described in Section 5.1.1. MIRV (6.0 mg/kg AIBW, IV) will be 
administered on Day 1 of each 21-day cycle. Premedication with antipyretic, antihistamine, and 
dexamethasone will be administered at least 30 minutes prior to each MIRV administration as 
described in Section 5.3.2.1. Prophylactic use of eye drops with MIRV administration is 
described in Section 5.3.2.2. 
The planned dose escalation of SL-172154 is outlined in Table 2; additional doses and/or 
schedules or intermediate doses may be explored based on emerging safety, PK, and PD data. 
SL-172154 doses explored in SL03-OHD-105 will not exceed the highest dose determined to be 
safe and tolerable in the monotherapy dose escalation study SL03-OHD-101. 
Subjects will be enrolled in cohorts of approximately 3 subjects into sequential dose levels of 
SL-172154 administered with MIRV and evaluated for DLT during the 21-day DLT evaluation 
period. DLT criteria are defined in Section 3.5. Treatment will be administered in 21-day cycles 
until at least one of the study treatment discontinuation criteria is met (Section 3.1.1). During 
therapy, management of MIRV-related toxicity should follow the guidelines provided in 
Section 3.7.3 and the MIRV IB or the current USPI, as applicable. Subjects will be followed 
according to the SOA in Section 6.2. 
The safety as well as available PK, PD, and efficacy data from these subjects will inform the 
dose of SL-172154 selected to be further evaluated in dose expansion when administered in 
combination with MIRV to subjects with platinum-resistant ovarian, primary peritoneal, or 
fallopian tube cancer. 

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Table 2 
SL-172154 Dose Escalation Plan When Administered with MIRV 
Dose 
Levela 
SL-172154 Doseb 
[D8 and D15 in each 21d cycle] 
SL-172154 
Infusionc 
Mirvetuximab soravtansine (MIRV)e 
-1d 
1.0 mg/kg 
60 min ± 10 min 
6.0 mg/kg AIBW, IV administered on Day 1 of 
each 21-day cycle 
 
Administer first dose on study (C1D1) at rate 
of 1 mg/min; after 30 min increase rate to 
3.0 mg/min if well tolerated. If well-tolerated 
after 30 min at 3.0 mg/min, infusion rate may 
be increased to 5.0 mg/min. Subsequent 
infusions should be delivered at the tolerated 
rate. 
1 
(Starting 
dose) 
3.0 mg/kg 
120 min ± 15 min 
2 
6.0 mg/kg 
180 min ± 15 min 
Abbreviations: AIBW = adjusted ideal body weight; C1D1 = Cycle 1 Day 1; D = day; IV = intravenously; MIRV = mirvetuximab 
soravtansine; mTPI-2 = modified toxicity probability interval 
a. 
Doses explored in SL03-OHD-105 will not exceed the highest dose determined to be safe and tolerable in the 
monotherapy dose escalation study SL03-OHD-101. 
b. 
The actual body weight in kilograms (kg) will be used for SL-172154 dose calculation in all subjects whose body weight 
is ≤ 100 kg. For subjects with body weight > 100 kg, the dose to be administered should be the same as that calculated 
for a subject weighing 100 kg. 
c. 
Infusion time may change based on final drug volume needed for administration, safety, and tolerability of the infusion for 
the subject and/or observed safety findings during the study. Please refer to the Study Pharmacy Manual (SPM) for 
details. 
d. 
SL-172154 dose level -1 at 1.0 mg/kg will be evaluated if 3.0 mg/kg is not safe per mTPI-2. 
e. 
Administer premedication at least 30 min prior to the start of MIRV infusion (see Section 5.3.2.1 for details). 
3.3 
Dose Expansion  
The goal of the dose expansion cohort is to further evaluate the safety, PD effects, and efficacy 
of the regimen at the dose identified in the dose escalation part of the study. Enrollment to the 
dose expansion cohort for each combination regimen will not commence until the SL-172154 
dose has been selected for the combination with PLD or MIRV.  
3.3.1 SL-172154 Administered with PLD  
Subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer will be 
enrolled to receive SL-172154 and PLD at the dose identified in the dose escalation part of the 
study. Premedication as prophylaxis for IRR with dexamethasone (8 mg IV), an antipyretic and 
antihistamines should be administered at least 30 minutes prior to each SL-172154 
administration as described in Section 5.1.1. Approximately 14 subjects will be enrolled in the 
dose expansion cohort. The goal is to enroll approximately 20 subjects at the potential RP2D for 
this combination regimen, including subjects in dose escalation and dose expansion that have 
received the same dose of SL-172154. Treatment will be administered in 28-day cycles until at 
least one of the study treatment discontinuation criteria is met (Section 3.1.1). Alternate dose 
level(s) may be evaluated at the discretion of the Sponsor based on emerging clinical or 
nonclinical data in the SL-172154 program. 

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3.3.2 SL-172154 Administered with MIRV  
Subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer whose 
tumors are positive for FRα expression (PS2+ ≥ 25%) as defined by the Ventana FOLR1 Assay 
will be enrolled to receive SL-172154 and MIRV at the dose identified in the dose escalation part 
of the study. Premedication as prophylaxis for IRR with dexamethasone (8 mg IV), an 
antipyretic and antihistamines should be administered at least 30 minutes prior to each 
SL-172154 administration as described in Section 5.1.1. In addition, premedication as 
prophylaxis for IRR with antipyretic, antihistamines, and dexamethasone should be administered 
at least 30 minutes prior to each MIRV administration as described in Section 5.3.2.1. 
Approximately 64 subjects will be enrolled in the MIRV dose expansion cohort. Approximately 
70 subjects will be enrolled in this MIRV cohort which is anticipated to include approximately 
20 subjects at the potential SL-172154 RP2D in either dose escalation or dose expansion for each 
of the following three tumor FRα expression subgroups: high (PS2+ ≥ 75%), medium (PS2+ ≥ 
50% and < 75%), and low (PS2+ ≥ 25% and < 50%). This estimation is based on the anticipated 
frequency of patients with high grade serous ovarian cancer who fall into each of these FRα 
expression subgroups. If this distribution is not achieved in any subgroup, approximately 10 
additional subjects may be enrolled in this dose expansion cohort in order to achieve these 
subject numbers. Treatment will be administered in 21-day cycles until at least one of the study 
treatment discontinuation criteria is met (Section 3.1.1). Alternate dose level(s) or treatment 
schedule(s) may be evaluated at the discretion of the Sponsor based on emerging clinical or 
nonclinical data in the SL-172154 program. 
3.4 
Selection of Recommended Phase 2 Dose 
If an MTD is not observed, the MAD would then be the highest dose of SL-172154 administered 
as specified in the protocol. Selection of the recommended dose for SL-172154 for further study 
in combination with PLD and in combination with MIRV will be based upon the totality of the 
safety, tolerability, PK, PD, and efficacy data in subjects treated with each of the regimens in 
dose escalation and dose expansion cohorts. The RP2D is a dose of SL-172154 that can be safely 
administered with standard of care doses of PLD or with the recommended dose of MIRV. In 
addition, preliminary efficacy of each of the combination regimens will be assessed to determine 
whether either or both of the regimens warrant further evaluation in a Phase 2 study. 
3.5 
Definition of Dose-Limiting Toxicity 
Protocol-defined DLT criteria are applicable to the dose escalation portion of the study. The 
determinant period for DLT is the first cycle of treatment (i.e., 28 days for PLD cohorts, 21 days 
for MIRV cohorts); however, there is provision in the criteria below for AEs that occur beyond 
this period to be considered in the determination of the RP2D. All toxicities except for CRS and 
ocular AEs will be graded as per NCI CTCAE v5. CRS will be graded per the American Society 
for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Criteria for CRS 
(described in Section 3.7.1.2); ocular AEs for the MIRV cohort will be graded per the tables 
provided in the Appendix Section 16.6. AEs clearly related to the underlying disease, disease 
progression, intercurrent illness, or concomitant medications are not considered DLTs. AEs that 
are clearly related to PLD or MIRV only do not have to be considered DLTs, unless the 
investigator considers the AE to be exacerbated by SL-172154. DLT is defined as an event 
considered related or possibly related to SL-172154 and meets one of the following criteria: 

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• Any death not clearly related to underlying disease or intercurrent illness 
• Elevations in liver transaminases (aspartate aminotransferase [AST], alanine 
aminotransferase [ALT]) or total bilirubin: 
o In subject who enroll with AST/ALT/total bilirubin ≤ upper limit of normal 
(ULN), AST or ALT elevation of > 8x ULN or total bilirubin > 5x ULN. 
o In subjects who enroll with AST/ALT/total bilirubin > UNL, AST or ALT 
elevation of > 8x baseline or total bilirubin > 5x baseline. 
o Evidence of Hy’s Law (AST or ALT > 3x ULN [or baseline*] with concurrent 
increase in total bilirubin > 2x ULN [*or baseline] without evidence of cholestasis 
or alternative explanation such as disease progression or viral hepatitis. 
*ULN or baseline dependent on value at enrollment as described above. 
• Any AE that requires permanent discontinuation of SL-172154  
• Any Grade 3 or greater AE except for those listed below: 
o Grade 3 fatigue lasting ≤ 7 days 
o Grade 3 anemia 
o Grade 3 or 4 neutropenia not associated with fever (temperature > 38.5°C) that 
improves to Grade 2 within 7 days  
o Grade 3 or 4 lymphopenia 
o Grade 3 thrombocytopenia not associated with clinically significant bleeding and 
does not require medical intervention 
o Grade 3 anorexia, nausea, vomiting, or diarrhea, provided that it does not require 
tube feeding, total parenteral nutrition, or require or prolong hospitalization 
o Grade 3 laboratory abnormalities which resolve to Grade 1 or baseline within 
72 hours with or without intervention 
o Grade 3 hypertension that can be controlled (i.e., systolic BP < 140 mmHg and 
diastolic BP < 90 mmHg) with medical therapy 
o Grade 3 or 4 amylase and/or lipase abnormalities that are not associated with 
clinical signs/symptoms or finding on imaging consistent with pancreatitis 
o Grade 3 endocrine disorder (thyroid, pituitary, hyperglycemia and/or adrenal 
insufficiency) that is managed with treatment with resolution of symptoms within 
14 days after treatment onset 
o Vitiligo or alopecia of any grade 
Other toxicities may be considered a DLT as determined by the investigator in conjunction with 
the SMC.  
3.6 
Concomitant Medications, Treatments, and Procedures 
Investigators may prescribe concomitant medications or treatments deemed necessary to provide 
supportive care except for prohibited medications (Section 3.6.1). Best supportive care should be 

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provided (including antibiotics, bisphosphonates, receptor activator of nuclear factor kappa B 
ligand (RANKL) inhibitors, nutritional support, correction of metabolic disorders, hydration, 
optimal symptom control, and pain management including palliative radiotherapy) for all 
subjects when clinically indicated. The Medical Monitor should be consulted prior to starting 
palliative radiotherapy and prior to restarting study treatment after the completion of 
radiotherapy. 
Subjects receiving recombinant erythropoietin (EPO) or darbepoetin-α before study start may 
continue to receive pretreatment doses. Primary prophylactic use of erythropoietic and 
granulocyte growth factors initiated during the first cycle of therapy is not permitted. In 
subsequent cycles, the use of erythropoietic and granulocyte growth factors in accordance with 
American Society of Clinical Oncology (ASCO) guidelines may be implemented at the 
discretion of the investigator. 
Use of anticoagulant agents is allowed as clinically indicated. 
Use of intranasal, inhaled, topical, injected (e.g., intra-articular injection) or local steroid or 
immunosuppressive medication is permitted. Temporary use of systemic corticosteroids (e.g., 
prior to computed tomography [CT] to prevent contrast allergies, premedication prior to each 
dose of MIRV administration) is acceptable. 
Primary prophylaxis of nausea and vomiting using all agents except a steroid is permitted for 
PLD according to institutional guidelines. 
For subjects enrolled in a MIRV cohort, an antiemetic (e.g., 5-HT3 serotonin receptor 
antagonists such as palonosetron, granisetron, or ondansetron) medication is recommended 
before each MIRV dose; additional antiemetics and/or antidiarrheal (e.g., loperamide) 
medications may be used any time at the discretion of the investigator. 
COVID-19 vaccines (except for live attenuated vaccines for COVID-19) are permitted during the 
study. If administered, COVID-19 vaccines should not be administered on the same day as any 
of the study medications; please discuss with the Medical Monitor regarding the timing of 
COVID-19 vaccine administration during this study. 
3.6.1 Prohibited Medications or Treatments 
Subjects must be instructed not to take any medications, including over-the-counter products 
without first consulting with the investigator. The following medications are prohibited during 
the study: 
• Any investigational anti-cancer therapy not described in this protocol 
• Any concurrent therapy for anticancer intent (other than study medications), including 
radiotherapy (except palliative radiotherapy after consultation with the Sponsor Medical 
Monitor), or systemic therapy including chemotherapy, hormonal or hormonal 
suppression therapy, immunotherapy, or biologic therapy. 
• Steroid and immunosuppressive medication usage: data indicate that corticosteroids have 
an adverse effect on T cell function and that they inhibit and damage lymphocytes 
[Schleimer, 1984]. Furthermore, as with all immunotherapies intended to augment 
cell-mediated immunity, there is a risk that concomitant immunosuppressives such as 

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steroids will counteract the intended benefit of the proposed SL-172154 therapy. 
Therefore, the use of steroids during this trial is as follows: 
o Therapeutic use: Subjects who require immunosuppressive medications (e.g., 
corticosteroids) for management of irAE or IRRs that the investigator assesses as 
possibly related or related to SL-172154 should be managed per Toxicity 
Management Guidelines in Section 3.7.1.1. 
o Steroid premedication for CT-contrast allergies is permitted. 
o Steroid premedication prior to each dose of MIRV administration and SL-172154 
administration for IRR prophylaxis is permitted. 
o Primary prophylactic use of steroids for nausea/vomiting is not permitted. 
o Non-steroidal, systemic immunosuppressive medications are not permitted. 
o If steroids are required for managing any specific conditions, please contact the 
Medical Monitor. 
• [MIRV Cohort] Folate-containing supplements  
• Live attenuated vaccines (including live attenuated vaccines for COVID-19) during the 
study and through 30 days after the last dose of SL-172154.  
3.6.2 Medications to be used with Caution 
Please refer to the current listing of drugs that are cytochrome P450 (CYP450) substrates, 
including CYP3A4, CYP2D6 and P-glycoprotein (P-gp) substrates, at: 
https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-
table-substrates-inhibitors-and-inducers#table3-1.  
SL-172154 
SL-172154 is a therapeutic protein that may induce the transient release of cytokines including 
IL-6 which in turn, may inhibit the activity of CYP450 enzymes including CYP3A4 activity 
[Evers, 2013]. Although not tested clinically, a drug-drug interaction may occur with the 
co-administration of medications that are CYP450 substrates. Drugs metabolized by CYP450 
enzymes may have reduced clearance or an increase in half-life or peak plasma concentration 
and should be used with caution. There may be an increased risk of side effects for drugs that are 
CYP450 substrates. Where possible consider substitutions for these medicinal products if 
therapeutic effects cannot be monitored. 
PLD 
Doxorubicin is a major substrate of CYP3A4 and CYP2D6, and P-gp. Clinically significant 
interactions have been reported with inhibitors of CYP3A4 (e.g., ketoconazole, erythromycin, 
ciprofloxin), CYP2D6 (e.g., paroxetine, fluoxetine, and/or P-gp (e.g., verapamil), resulting in 
increased concentration and clinical effect of doxorubicin. 
Inducers of CYP3A4 (e.g., phenobarbital, phenytoin, St. John’s Wort) and P-gp inducers may 
decrease the concentration of doxorubicin. If possible, avoid concurrent use of doxorubicin with 
strong inhibitors and strong inducers of CYP3A4, CYP2D6, or P-gp. 

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MIRV 
In vitro metabolism studies demonstrated that DM4 is predominantly metabolized by thiol 
s-methyltransferase to form S-methyl DM4, which is further metabolized into sulfoxide 
methyl-DM4. As S-methyl DM4 has been shown to be primarily metabolized by CYP3A, its 
exposure could potentially be increased in the presence of strong CYP3A inhibitors. Drinking 
greater than one serving (250 mL) of grapefruit juice per day should be avoided. 
Both DM4 and S-methyl DM4 are substrates for MDR1 efflux transporter. Their exposure could 
potentially increase in the presence of MDR1 efflux transporter. In vitro metabolism data also 
indicates that DM4 is a time-dependent inhibitor of CYP3A4. The risk of a significant in vivo 
drug-drug interaction caused by inhibition of CYP3A4 or MDR1 is unknown. Treatment of 
patients with concomitant medications that are inhibitors of MDR1, sensitive substrates of 
CYP3A or are CYP3A substrates with a narrow therapeutic index should be used with caution 
and carefully monitored. Please consult with the Medical Monitor if further guidance is needed. 
3.7 
Toxicity Management Guidelines  
All AEs should be assessed using NCI-CTCAE v5.0 criteria. CRS will be graded per the ASTCT 
Consensus Grading Criteria for CRS (described in Section 3.7.1.2). Ocular AEs for MIRV will 
be graded per the tables in Appendix Section 16.6. These guidelines are not meant to be 
prescriptive, and investigators should always use clinical judgement. Investigators should always 
err on the side of caution if treatment-related toxicity is suspected. Subjects should be thoroughly 
evaluated to rule out any alternative etiology (e.g., disease progression, concomitant medications, 
and infections). In the absence of a clear alternative etiology, the possibility of an 
immune-related AE should be considered. 
Every effort should be made to administer study treatment on the planned dose and schedule. If 
PLD or MIRV dosing is delayed, SL-172154 should also be delayed so that the dosing interval 
between PLD or MIRV and SL-172154 can be preserved. This will result in the cycle being 
delayed. If an SL-172154 dose is not given, the dose should be considered skipped, and the cycle 
should not be delayed. Please consult with the Medical Monitor if further guidance is needed. 
3.7.1 Toxicity Management Guidelines for SL-172154  
The toxicity management guidelines provided in this section represent general guidance for AEs 
that are considered by the investigator to be possibly related or related to treatment with 
SL-172154.  
Table 3 describes the dose levels to be used for dose reductions due to AEs that are considered 
by the investigator to be possibly related or related to treatment with SL-172154. Only one level 
dose reduction is permitted for AE management and then SL-172154 administration should be 
held. Investigators always have the option to perform a more conservative dose modification if 
clinically indicated (i.e., dose interruption as opposed to dose reduction). Any AE deemed to be 
related to SL-172154 that requires a dose hold of more than 28 days will result in permanent 
discontinuation of SL-172154.  

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Table 3 
SL-172154 Dose Levels for Dose Reductions 
Starting SL-172154 Dose Level 
(mg/kg) 
Dose Level Reduction (mg/kg) 
1.0 
Interrupt SL-172154 until toxicity resolves to ≤ Grade 1 or baseline and then 
restart at same dose level or discontinue.  
Reduction of SL-172154 below 1.0 mg/kg will not be permitted. 
3.0 
1.0 mg/kg 
6.0 
3.0 mg/kg 
 
 

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3.7.1.1 Management of Infusion-Related Reactions [SL-172154]  
General Guidance for Infusion-Related Reactions (IRRs) [Rosello, 2017a] 
IRRs have been temporally related to SL-172154 administration. Subjects must be closely monitored for signs and symptoms of IRRs with prompt institution of 
treatment. Appropriate drugs and medical equipment to treat hypersensitivity reactions (HSRs), IRRs, and CRS must be immediately available, and study 
personnel must be trained to recognize and treat these toxicities. Premedication for IRR prophylaxis with dexamethasone (8 mg IV), an antipyretic and 
antihistamines should be administered at least 30 minutes prior to each SL-172154 administration as outlined in Section 5.1.1. Additional premedication with 
dexamethasone one day prior to SL-172154 infusion is not required but can be optionally given. The dose and administration method of prophylactic 
premedication can be modified at the Investigator’s discretion. Subjects should be notified that symptoms may occur during the first infusion and for up to 
several hours afterwards or with subsequent infusions. In the SL03-OHD-101 study, IRRs occurred during the infusion or within 2 hours after the end of 
infusion. Instruct subjects to contact their physician if symptoms or signs of an IRR occur. If IRR events occur, ad hoc labs should be collected as noted in 
Section 6.5.9.1. 
Severity  
Management 
Grade 1 
• 
Infusion interruption not indicated.  
• 
Vital signs should be measured after the onset of an IRR approximately every 15 minutes through the completion of the infusion 
followed by approximately every 15 minutes for one hour after completion of the SL-172154 infusion and then approximately every 
30 minutes for the second hour after completion of the SL-172154 infusion. 
• 
Monitor subjects with close observation in an outpatient or inpatient setting until recovery from symptoms  
Grade 2 
• 
Temporarily interrupt SL-172154.  
• 
Vital signs should be measured after the onset of an IRR approximately every 15 minutes through the completion of the infusion 
followed by approximately every 15 minutes for one hour after completion of the SL-172154 infusion and then approximately every 
30 minutes for the second hour after the completion of the SL-172154 infusion. 
• 
Begin IV infusion of normal saline and treat symptoms as indicated and per institutional guidelines, e.g., with antipyretic and 
antihistamines; consider opioids (e.g., meperidine) for rigors, leukotriene inhibitor, bronchodilator therapy, or corticosteroids as 
appropriate.  
• 
Monitor subjects with close observation in an outpatient or inpatient setting until recovery from symptoms. Consider if admission to 
hospital is necessary. 

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General Guidance for Infusion-Related Reactions (IRRs) [Rosello, 2017a] 
• 
Restart the infusion after resolution of symptoms. Based on the severity of symptoms, reduce the rate to ≤50% of the rate at which 
the reaction occurred. 
• 
If symptoms recur, then no further SL-172154 will be administered at this visit. 
• 
Subsequent Infusions:  
o If the Grade 2 IRR signs and symptoms were not severe, the investigator may administer the next two infusions at the current 
dose but at ≤50% rate. If the symptoms do not recur, the infusion rate may be increased back to the original rate stated in the 
protocol.  
o If the Grade 2 IRR signs and symptoms were severe, the investigator may reduce the SL-172154 dose for the next two infusions 
to 1 mg/kg. If the symptoms do not recur, SL-172154 dose may be increased back to 3 mg/kg at ≤50% of the original rate. If 
tolerated, the rate may be increased back to the original rate stated in the protocol. 
Recurrent Grade 2 
• 
If the Grade 2 IRR recurred after reducing the dose to 1 mg/kg and the signs and symptoms are severe, permanently discontinue 
SL-172154 
Grade 3 
• 
Immediately discontinue infusion of SL-172154  
• 
Vital signs should be measured after the onset of an IRR approximately every 15 minutes for one hour after discontinuation of SL-
172154 infusion and then approximately every 30 minutes for hours 2 and 3 after the discontinuation of the SL-172154 infusion. 
• 
Begin IV infusion of normal saline and treat symptoms as indicated and per institutional guidelines e.g., epinephrine, bronchodilators, 
diphenhydramine, famotidine or other available H2 receptor antagonist, corticosteroids, consider opioids (e.g., meperidine) for rigors, 
oxygen, fluids, vasopressors, etc. Epinephrine is the drug of choice in an anaphylactic reaction and its administration should not be 
delayed.  
• 
Monitor subjects with close observation in an outpatient or inpatient setting for 12 hours or until recovery from symptoms. Strongly 
consider admission to hospital. 
• 
Rechallenge should not be attempted in cases of true anaphylaxis. In other cases, once the subject has completely recovered, 
carefully consider if it is safe for the subject to receive SL-172154 at the next scheduled dose with premedication and dose 
reduction.  
o Reduce the SL-172154 dose for the next two infusions to 1 mg/kg at ≤ 50% of the rate stated in the protocol. These two 
subsequent infusions of SL-172154 (after an event of Grade 3 event of IRR) must be administered in an inpatient or outpatient 
setting with prolonged observation for a minimum of 12 hours after the completion of the infusion.  
o If symptoms do not recur at 1 mg/kg SL-172154 dose, subsequent infusions may be administered at the original rate stated in 
the protocol. If no further symptoms, the SL-172154 dose may be re-escalated to 3 mg/kg but administered at ≤ 50% of the rate 
stated in the protocol. 
Recurrent Grade 3 
• 
If the Grade 3 IRR recurred, permanently discontinue SL-172154 

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General Guidance for Infusion-Related Reactions (IRRs) [Rosello, 2017a] 
Grade 4 
• 
Permanently discontinue SL-172154. 
• 
Admit to hospital for close observation until resolution of symptoms. 
• 
Vital signs should be measured after the onset of an IRR approximately every 15 minutes for one hour after discontinuation of 
SL-172154 infusion and then approximately every 30 minutes for hours 2 and 3 after the completion of the SL-172154 infusion. 
• 
Manage severe IRRs per institutional standards (e.g., epinephrine, diphenhydramine, famotidine or other available H2 receptor 
antagonist, corticosteroids, consider opioids (e.g., meperidine) for rigors, bronchodilators, oxygen, fluids etc.). Epinephrine is the drug 
of choice in an anaphylactic reaction and its administration should not be delayed.  
 
 
 

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3.7.1.2 Management of Cytokine Release Syndrome  
CRS will be graded using the ASTCT Consensus Grading Criteria for CRS (Table 4). 
Table 4 
ASTCT Consensus Grading Criteria for CRS [Lee, 2019] 
CRS Parameter 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Fever1 
Temperature ≥ 38°C 
Temperature ≥ 38°C 
Temperature ≥ 38°C 
Temperature ≥38°C 
 
 
With 
Hypotension 
None 
Not requiring vasopressors 
Requiring a vasopressor with 
or without vasopressin 
Requiring multiple 
vasopressor (excluding 
vasopressin) 
 
 
And/Or2 
Hypoxia 
None 
Requiring low-flow nasal 
cannula3 or blow-by 
Requiring low-flow nasal 
cannula3, facemask, 
nonrebreather mask, or 
Venturi mask 
Requiring positive pressure 
(e.g., CPAP, BiPAP, 
intubation and mechanical 
ventilation) 
Abbreviations: ASTCT = American Society for Transplantation and Cellular Therapy; CPAP = continuous positive airway pressure; BiPAP = bilevel positive airway pressure  
Organ toxicities associated with CRS may be graded according to CTCAE v5.0 but they do not influence CRS grading.  
1. 
Fever is defined as temperature ≥ 38°C not attributable to any other cause. In subjects who have CRS and receive antipyretic or anti-cytokine therapy, such as 
tocilizumab or steroids, fever is no longer required to grade subsequent CRS severity. In this case, CRS grading is driven by hypotension and/or hypoxia. 
2. 
CRS grade is determined by the more severe event: hypotension or hypoxia not attributable to any other cause. For example, a patient with temperature of 39.5°C, 
hypotension requiring 1 vasopressor, and hypoxia requiring low-flow nasal cannula is classified as Grade 3 CRS. 
3. 
Low-flow nasal cannula is defined as oxygen delivered at ≤ 6 L/minute. Low flow also includes blow-by oxygen delivery, sometimes used in pediatrics. High-flow nasal 
cannula is defined as oxygen delivered at > 6 L/minute. 
 
 
 
 

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General Guidance for Cytokine Release Syndrome (CRS) [Lee, 2014; Lee, 2019; BREYANZI® USPI, 2021; Porter, 2018] 
Cytokine release syndrome (CRS) is a non-antigen specific, systemic inflammatory response that occurs as result of high-level immune activation with 
concomitant elevations of cytokines (e.g., IL-6, IL-10, TNF-α, IL-2, interferon gamma [IFNɣ]). CRS can be fatal or have life-threatening reactions. Evaluate for 
and treat other causes of fever, hypoxia, and hypotension. Determine CRS grade per the ASTCT Consensus Grading criteria for CRS in Table 4 and manage 
CRS according to this guidance or per institutional guidance. NOTE: CRS may have a similar presentation to a type 1 HSR and may be clinically 
indistinguishable. Ensure that 2 doses of tocilizumab are available prior to infusion of SL-172154. When tocilizumab is not available, consider using a drug with 
similar mechanism of action such as anti-IL-6 receptor monoclonal antibodies (e.g., sarilumab) or anti-IL-6 mAbs (e.g., siltuximab). If CRS events occur, ad hoc 
labs should be collected as noted in Section 6.5.9.1. 
Severity (ASTCT CRS 
Consensus Grading) 
Management 
Any Grade 
• 
Permanently discontinue SL-172154 if any grade CRS occurs at Cycle 1 Day 2 or later due to ADAs against SL-172154 
Grade 1 
• 
Interrupt SL-172154  
• 
Vital signs should be measured approximately every 15 minutes for the first hour after discontinuation of SL-172154 infusion 
and then approximately every 30 minutes for the second hour. 
• 
Monitor subjects with close observation in an outpatient or inpatient setting for 12 hours or until recovery from symptoms.  
• 
Maintain IV access. Symptomatic treatment with antipyretic, antiemetics, analgesics, antihistamines (H1/H2 inhibitors) as 
needed; monitor fluid balance; assess for infection. Consider opioids (e.g., meperidine) for rigors. Regularly evaluate for signs of 
further deterioration 
Resume SL-172154 when all symptoms/ clinical features for CRS resolved, and follow the guidelines below: 
• 
Subjects who have experienced grade 1 CRS should be hospitalized for the subsequent infusion of SL-172154; subjects should 
be under prolonged observation for a minimum of 12 hours after the completion of the infusion. 
• 
For all subsequent infusions, infuse SL-172154 at the same dose level over at least twice the infusion time. If no recurrence of 
symptoms, subsequent infusions can be performed in an outpatient setting.  
• 
Consider premedication (e.g., antipyretic, antihistamines) per institutional guidelines 
 
 

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General Guidance for Cytokine Release Syndrome (cont.) 
Grade 2 
• 
Interrupt SL-172154  
• 
Vital signs should be measured approximately every 15 minutes for the first hour after discontinuation of SL-172154 infusion 
and then approximately every 30 minutes for the second hour. 
• 
Closely monitor cardiac and other organ function in an outpatient or inpatient setting for 12 hours or until recovery from 
symptoms. Consider admission to hospital for management of symptoms, evidence of organ dysfunction or administration of 
therapy. 
• 
Monitor subjects with continuous cardiac telemetry and pulse oximetry, closely monitor other organ functions. 
• 
Start IV infusion with normal saline. Administer oxygen if needed. Treat with antipyretic, H1/H2 antagonists (diphenhydramine, 
famotidine, or other available H2 receptor antagonist), and/or corticosteroids and manage per institutional guidelines.  
o If corticosteroids are initiated, continue corticosteroids for at least 3 doses or until complete resolution of symptoms, 
and consider corticosteroid taper. 
• 
Consider opioids (e.g., meperidine) for rigors.  
• 
Consider tocilizumab use for subjects with persistent signs and symptoms after interrupting SL-172154 and after corticosteroid 
treatment for CSR. 
o Administer tocilizumab as per your institutional guidelines and local prescribing information.  
• 
Subjects with extensive comorbidities or those of older age should be treated as for Grade 3. Subjects with worsening 
symptoms should be treated as for Grade 3. 
Resume SL-172154 at one dose level lower when all symptoms/ clinical features for CRS resolved and follow the guidelines below:  
• 
Subjects who experience Grade 2 CRS should be hospitalized for the next two subsequent infusions of SL-172154. 
Subjects should be under prolonged observation for a minimum of 12 hours after the completion of the infusion. 
• 
For all subsequent infusions, infuse SL-172154 at least at twice the infusion time. If no recurrence of symptoms, 
subsequent infusions can be performed in an outpatient setting.  
• 
Premedicate with dexamethasone 20 mg, antipyretic, antihistamines (H1/H2 inhibitors), and manage per institutional 
guidelines. 
 
 

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General Guidance for Cytokine Release Syndrome (cont.) 
Grade 3 
• 
Interrupt SL-172154 
o Permanently discontinue SL-172154 if CRS does not resolve within 72 hours with management. 
• 
Vital signs should be measured approximately every 15 minutes for the first hour after discontinuation of SL-172154 infusion 
and then approximately every 30 minutes for the second hour. 
• 
Hospitalization required for close monitoring and management of symptoms related to organ dysfunction. 
• 
Monitor subjects with continuous cardiac telemetry and pulse oximetry. Consider performing an ECHO/MUGA to assess cardiac 
function.  
• 
Treat hypotension with IV fluid for blood pressure support and/or pressers. Cryoprecipitate or fresh frozen plasma may be 
required for coagulopathy. Manage per institutional guidelines. 
• 
Implement additional management per institutional standards (e.g., epinephrine, diphenhydramine, famotidine or other available 
H2 receptor antagonist, corticosteroids, bronchodilators, oxygen, fluids, meperidine for rigors, etc.). Epinephrine is the drug of 
choice in an anaphylactic reaction and its administration should not be delayed. 
• 
Administer tocilizumab as per your institutional guidelines and local label.  
• 
Second-line therapies to be considered:  
o Methylprednisolone 2 mg/kg/day IV. If corticosteroids are initiated, continue corticosteroids for at least 3 doses or until 
complete resolution of symptoms, and consider corticosteroid taper. For subjects with severe neurologic symptoms, 
consider using dexamethasone due to more efficient penetration of the blood-brain barrier. 
o anti-TNF-α mAbs (infliximab) or soluble TNF-α receptor (etanercept), or IL-1R-based inhibitors (anakinra). 
Resume SL-172154 at one dose level lower only when all symptoms/ clinical features of CRS resolve within 72 hours and follow the 
guidelines below: 
• 
Subjects who experience Grade 3 CRS should be hospitalized for the next two subsequent infusions of SL-172154. 
Subjects should be under prolonged observation for a minimum of 12 hours after the completion of the infusion. 
• 
For all subsequent infusions, infuse SL-172154 at least at twice the infusion time. If no recurrence of symptoms, 
subsequent infusions can be performed in an outpatient setting. 
• 
Premedicate with dexamethasone 20 mg, antipyretic, antihistamines (H1/H2 inhibitors), and manage per institutional 
guidelines. 
• 
If Grade 3 CRS recurs, permanently discontinue SL-172154. 

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General Guidance for Cytokine Release Syndrome (cont.) 
Grade 4 
• 
Permanently discontinue SL-172154. 
• 
Hospitalization required for close monitoring and management of symptoms related to organ dysfunction. 
• 
Vital signs should be measured approximately every 15 minutes for the first hour after discontinuation of SL-172154 infusion 
and then approximately every 30 minutes for the second and third hours. 
• 
Consider intensive-care supportive therapy 
• 
Monitor subjects with continuous cardiac telemetry and pulse oximetry  
• 
Consider performing an ECHO/MUGA to assess cardiac function.  
• 
Treat hypotension with IV fluid for blood pressure support and/or pressers. Administer oxygen for treatment of hypoxia. 
Cryoprecipitate or fresh frozen plasma may be required for coagulopathy. Manage per institutional guidelines. 
• 
Implement additional management per institutional standards (e.g., epinephrine, diphenhydramine, famotidine or other available 
H2 receptor antagonist, corticosteroids, bronchodilators, oxygen, fluids, meperidine for rigors, etc.). Epinephrine is the drug of 
choice in an anaphylactic reaction and its administration should not be delayed 
• 
Administer tocilizumab as per your institutional guidelines and local prescribing information. 
• 
Second-line therapies to be considered:  
o Methylprednisolone 2 mg/kg/day IV. If corticosteroids are initiated, continue corticosteroids for at least 3 doses or until 
complete resolution of symptoms, and consider corticosteroid taper. For subjects with severe neurologic symptoms, 
consider using dexamethasone due to more efficient penetration of the blood-brain barrier. 
o anti-TNF-α mAbs (infliximab) or soluble TNF-α receptor (etanercept), or IL-1R-based inhibitors (anakinra). 
 
 
 
 

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3.7.1.3 Management of Hepatotoxicity  
General Guidance for Hepatotoxicity 
Monitor signs, symptoms, and laboratory evidence of liver dysfunction. Evaluate alternative etiologies, including liver function test (LFT) elevations in the setting 
of IRR and/or CRS; review medications for hepatotoxic drugs and alcohol history; consider performing liver screen: hepatitis A, B, C serology, hepatitis E PCR, 
antinuclear antibody (ANA)/smooth muscle antibody/liver kidney microsomal antibodies /soluble liver antibody/liver-pancreas antigen/liver cytosol auto-
antibodies, iron studies. Consider imaging for progressive disease/thrombosis. Guidelines are based on elevations in ALT, AST, and bilirubin per CTCAE v5.0. 
Discontinue SL-172154 for Hy’s law as follows: AST or ALT ≥ 3 x ULN in the setting of total bilirubin ≥ 2 x ULN without evidence of cholestasis and no other 
reason can be found to explain the combination of increased aminotransferases and total bilirubin, such as viral hepatitis A, B or C, preexisting or acute liver 
disease, or another drug capable of causing the observed injury. Grade 3 ALT/AST or bilirubin will be evaluated to determine if events meet the DLT criteria. 
Severity  
Management 
Grade 1 
• 
Continue SL-172154 with close monitoring. 
• 
Monitor liver function at least weekly; if liver function is stable, reduce frequency of blood tests 
Grade 2 
• 
Monitor liver function approximately every 3 days. If persistent or rising liver chemistries or significant clinical symptoms, hold the 
next scheduled SL-172154 dose. 
• 
Consider hepatology consult and liver biopsy is optional.  
• 
If immune etiology is suspected, start oral prednisone 0.5 to 1 mg/kg/day (or equivalent of methylprednisolone) with 4 week taper. 
Resume SL-172154 at one dose level lower when toxicity ≤ Grade 1 and corticosteroid taper to ≤ 10 mg/day prednisone or 
equivalent. 
• 
For Grade 2 ALT/AST increase that resolves to Grade ≤1 within 7 days, administer next dose at same dose level.  
• 
For Grade 2 ALT/AST increase that does not resolve to Grade ≤1 within 7 days:  
o Hold/skip the scheduled SL-172154 dose.  
o Resume next dose at the same dose level after ALT/AST elevations resolve to Grade ≤1. 
Grade 3 
• 
Hold SL-172154 and monitor liver function approximately every 3 days. 
• 
Grade 3 ALT/AST increase:  
o Hold/skip the scheduled SL-172154 dose. 
o Resume next dose at one dose level lower after ALT/AST elevations resolve to Grade ≤1 
• 
Permanently discontinue SL-172154 for liver function test abnormality that meets following criteria in subjects who enroll with 
AST/ALT/total bilirubin ≤ ULN: AST or ALT > 8 x ULN or total bilirubin > 5 x ULN for greater than 3 days 
• 
Permanently discontinue SL-172154 for liver function test abnormality that meets following criteria in subjects who enroll with 
AST/ALT/total bilirubin > ULN: AST or ALT > 8 x baseline or total bilirubin > 5 x baseline for greater than 3 days.  

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• 
If persistent or rising liver chemistries, or significant clinical symptoms and an immune etiology is suspected, start oral prednisone 
0.5 to 1 mg/kg/day (or equivalent of methylprednisolone) with 4-week taper. Obtain hepatology consult and assessments as 
above, monitor liver function daily; consider liver biopsy. 
• 
After careful consultation with hepatology, consider resuming SL-172154 at one dose level lower when toxicity ≤ Grade 1 and 
corticosteroid taper to ≤ 10 mg/day prednisone or equivalent. 
Grade 4 
• 
Permanently discontinue SL-172154. 
• 
Consider hospitalization; obtain hepatology consult; assessments as above; monitor liver function daily; consider liver biopsy.  
• 
If an immune etiology is suspected, immediately start methylprednisolone 1 to 2 mg/kg (start with 2 mg/kg for Grade 4) or 
equivalent. If refractory after 3 days, consider mycophenolate mofetil (MMF). Avoid the use of infliximab in immune mediated 
hepatitis. 
 
3.7.1.4 Management of Hematologic AEs  
General Guidance for Hematologic Toxicity 
In the event of cytopenia, it is important to use physical exams, complete blood counts (CBCs), serum chemistries including bilirubin fractionation, D-dimer 
testing, and review of peripheral smears to look for evidence of RBC agglutination, microangiopathy, spherocytosis, and evidence of RBC destruction (e.g., 
schistocytosis, fragments). A hematologic AE needs to be distinguished from transient changes in laboratory values that can occur following SL-172154 
administration (e.g., transient decrease in hemoglobin, lymphocytes, neutrophils, monocytes, platelets). The transient declines in peripheral blood counts 
following SL-172154 administration are thought to be due to margination of cells outside of the circulatory system in response to target engagement (especially 
CD40), and the cytokines released. In study SL03-OHD-101, recovery was generally observed within 24 hours. Development of persistent or progressive 
cytopenias should prompt evaluation of potential causes. In cases where an obvious cause cannot be identified, an autoimmune cause should be considered 
and investigated accordingly. No autoimmune cytopenias have been reported to date with SL-172154. In vitro studies showed binding of SL-172154 to CD47 
on RBCs, however, there has been no reports of crossmatch interference to date in the clinical trials. The following are recommendations for SL-172154 dosing 
in the presence of anemia or thrombocytopenia in the setting of combination cytotoxic anti-cancer therapy. Investigators always have the option to perform a 
more conservative dose modification if clinically indicated. 
Adverse Event 
Severity 
Management  
Anemia 
Grade 1 
• 
Continue SL-172154 with close clinical follow-up and laboratory evaluation 
Grade 2 
• 
Continue SL-172154 with close clinical follow-up and laboratory evaluation  
Grade 3 
• 
Continue SL-172154 with close clinical follow-up and laboratory evaluation.  

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• 
Consider if RBC transfusion is necessary to relieve anemia symptoms or to return subject to an acceptable 
hemoglobin (Hgb) range per institutional practice. If transfusion is required, recommend completing RBC 
transfusion at least 2 hours prior to the start of SL-172154 dose. 
• 
Determine the etiology of anemia, consider Hematology consult. 
 
Grade 4 
• 
Hold SL-172154 until AE has reverted to an acceptable hemoglobin (Hgb) range.  
• 
Consider RBC transfusion to relieve anemia symptoms or to return subject to an acceptable hemoglobin (Hgb) 
range per institutional practice.  
• 
Determine the etiology of anemia, consider Hematology consult.  
• 
Discontinue SL-172154 permanently if no other etiology can be determined and SL-172154 is deemed to be the 
cause of anemia. Transient decrease in hemoglobin that is associated with SL-172154 infusion may not 
necessarily require discontinuation of SL-172154. Please consult the Medical Monitor. 
• 
If anemia is not due to SL-172154, restart SL-172154 on the next scheduled dosing day at the same dose level.  
 
General Guidance for Hematologic Toxicity (cont.) 
Adverse Event 
Severity 
Management 
Thrombocytopenia 
Grade 1 
• 
Continue SL-172154 with close clinical follow-up and laboratory evaluation 
Grade 2 
• 
Continue SL-172154 with close clinical follow-up and laboratory evaluation 
Grade 3 
• 
Continue SL-172154 with close clinical follow-up and laboratory evaluation. In case of recurrence where SL-
172154 deemed to be the cause, reduce dose by one dose level. 
Grade 3 with 
bleeding or 
Grade 4 
• 
Hold SL-172154 until AE is ≤ Grade 2. Restart SL-172154 on the next scheduled dosing day at one dose level 
lower.  
• 
Consider platelet transfusion relieve thrombocytopenia symptoms or to return subject to an acceptable platelet 
count per institutional practice. 
• 
Determine the etiology of thrombocytopenia (including chemotherapy), consider Hematology consult.  
• 
At the first recurrence of Grade 3 with bleeding or Grade 4, discontinue SL-172154.  
 
 
 

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3.7.1.5 Management of Other AEs Not Specified  
Severity 
Dose Modification 
Toxicity Management 
All Grades 
Note: Dose modifications are not required for AEs not deemed to be related to 
SL-172154 (i.e., events due to underlying disease) or for laboratory 
abnormalities not deemed to be clinically significant. 
• 
Treat accordingly, as per institutional standard 
Grade 1 
No dose modification required. 
• 
Treat accordingly, as per institutional standard 
Grade 2 
Consider reducing the SL-172154 by one dose level or holding SL-172154 until 
resolution to ≤ Grade 1 or baseline. 
• 
Treat accordingly, as per institutional standard 
Grade 3 
Hold SL-172154 until resolution to ≤ Grade 1 or baseline. 
For AEs that downgrade to ≤ Grade 2 within 7 days or resolve to ≤ Grade 1 or 
baseline within 14 days, resume SL-172154 at one dose level lower. Otherwise, 
discontinue SL-172154.  
(Note: For Grade 3 labs, decision to hold should be based on accompanying 
clinical signs/symptoms, the investigator’s clinical judgment, and consultation 
with the Sponsor). 
• 
Treat accordingly, as per institutional standard 
Grade 4 
Permanently discontinue SL-172154. 
(Note: For Grade 4 labs, decision to discontinue should be based on 
accompanying clinical signs/symptoms, the investigator’s clinical judgment, and 
consultation with the Sponsor). 
• 
Treat accordingly, as per institutional standard 
 

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3.7.2 Toxicity Management Guidelines for PLD 
The toxicity management guidelines provided in this section represent general guidance for AEs 
that are considered by the investigator to be possibly related or related to treatment with PLD. 
Dose modifications/interruptions or delays and treatment discontinuation of PLD for toxicity 
management should comply with local institutional guidelines or the current regional prescribing 
information for management of AEs related to PLD. If the country-specific prescribing 
information is more conservative, the current local guidelines should be used including the 
special precautions for patients who reach lifetime maximums of 450 mg/m2. 
In the event of significant toxicity, PLD dosing may be delayed and/or dose reduced as described 
below. In the event of multiple toxicities, dose modification should be based on the worst 
toxicity observed. Table 5 describes the dose reductions to be used for AEs that are considered 
by the investigator to be possibly related or related to treatment with PLD. 
Table 5 
PLD Dose Reduction for Management of Toxicities 
Dose Level 
Dose Level Reduction (mg/kg) 
Starting Dose 
40 mg/m2 
First Dose Reduction 
30 mg/m2 
Second Dose Reduction 
20 mg/m2 
3.7.2.1 Management of Hematologic Toxicity [PLD Cohort] 
Neutropenia or Thrombocytopenia 
PLD Dose Modification 
Grade 1 
• No dose modification 
Grade 2 
• Delay PLD until toxicity resolves to ANC 1.5 x 109/L, platelets 
75 x 109/L. Resume PLD at previous dose. 
Grade 3 
• Delay PLD until toxicity resolves to ANC 1.5 x 109/L, platelets 
75 x 109/L. Resume PLD at previous dose. For prolonged or 
recurrent grade 3 toxicity, follow institutional standard practices.  
Grade 4 
• Delay PLD until toxicity resolves to ANC 1.5 x 109/L, platelets 
75 x 109/L. Resume PLD at one reduced dose level and 
consider prophylactic granulocyte growth factor support. 
Abbreviation: ANC = absolute neutrophil count 
3.7.2.2 Management of Infusion-Related Reaction [PLD Cohort] 
Serious and sometimes life-threatening IRRs can occur with PLD. The majority of the infusion-
related events occur during the first infusion. Ensure that medications to treat IRRs, and 
cardiopulmonary resuscitation equipment are available for immediate use prior to initiation of 
PLD. Administer first dose of PLD on study (C1D1) as 1 mg/min IV infusion; after Cycle 1, if 
tolerated, PLD can be delivered as a 1-hour infusion. Management guidelines for PLD associated 
IRRs are noted below. 

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Infusion-Related Reaction 
Toxicity Management 
Grade 1 or Grade 2 
• 
Temporarily stop PLD until resolution then resume at a reduced infusion 
rate per local practice.  
• 
Following Grade 1 or Grade 2 infusion reactions to PLD, PLD should be 
administered per institutional guidelines.  
• 
If there is no institutional guideline, the following is recommended: 5% of 
the total dose should be infused slowly over the first 15 minutes. If 
tolerated without reaction, the infusion rate may then be doubled for the 
next 15 minutes. If tolerated, the infusion rate may then be completed 
over the next hour for a total infusion time of 90 minutes. 
Grade 3 or Grade 4 
• 
Permanently discontinue PLD 
3.7.2.3 Management of Mucocutaneous Toxicity [PLD Cohort] 
The following are PLD dose modification recommendations for the management of 
mucocutaneous toxicity, including stomatitis and palmar-plantar erythrodyesthesia (hand foot 
syndrome). 
Severity 
PLD Dose Modification 
Grade 1 
• 
If no previous Grade 3 or 4 mucocutaneous AE: Continue PLD as planned. 
• 
If previous Grade 3 or 4 AE: delay PLD dose up to 2 weeks, then resume PLD at 
decreased dose level 
Grade 2 
• 
Delay PLD dosing up to 2 weeks or until resolved to Grade 1. 
• 
If no resolution to ≤ Grade 1 within 2 weeks, discontinue PLD. 
• 
If resolved to ≤ Grade 1 within 2 weeks, and no previous Grade 3 or 4 mucocutaneous 
AE: continue PLD treatment at previous dose. 
• 
If resolved to ≤ Grade 1 within 2 weeks but previous Grade 3 or 4 mucocutaneous AE: 
resume PLD treatment at decreased dose level 
Grade 3 
• 
Delay PLD dosing up to 2 weeks or until resolved to ≤ Grade 1. Then resume PLD 
treatment at decreased dose level. 
• 
Discontinue PLD if there is no resolution after 2 weeks. 
Grade 4  
• 
Delay PLD dosing up to 2 weeks or until resolved to ≤ Grade 1. Then resume PLD 
treatment at decreased dose level. 
• 
Discontinue PLD if there is no resolution after 2 weeks. 
3.7.2.4 Management of Left Ventricular Ejection Fraction Decreased [PLD Cohort] 
If a subject’s left ventricular ejection fraction (LVEF) drops below institutional limit of normal 
or by at least 15% (absolute percentage points) from baseline value, study treatment (SL-172154, 
PLD or combination) should be discontinued. LVEF should be re-assessed within 45 days and 
every three months until full recovery. Upon full recovery, defined as LVEF increase to within 
5% (absolute percentage points) of baseline within 45 days from LVEF nadir, study treatment 
(SL-172154, PLD or combination) can be resumed at investigator’s discretion. Continuation of 
treatment should be followed by additional LVEF evaluation within 2 weeks. 

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3.7.3.3 Monitoring and Management of Nausea and Vomiting [MIRV Cohort] 
MIRV-related nausea (46% all grades; 1% Grade ≥ 3) and vomiting (16% all grades; 
1% Grade ≥ 3) have been reported in patients treated with MIRV, despite premedication with 
dexamethasone. Therefore, it is recommended that an antiemetic (e.g., 5-HT3 serotonin receptor 
antagonists such as palonosetron, granisetron, or ondansetron) medication is provided before 
each MIRV dose (Section 3.6). Additional antiemetics may be used at any time at the discretion 
of the investigator, according to institutional or other practice guidelines, ASCO, European 
Society for Medical Oncology (ESMO), and NCCN. Subjects should be advised to contact their 
treating physician at the first sign of vomiting or worsening nausea. 
3.7.3.4 Monitoring and Management of Diarrhea [MIRV Cohort] 
Mild to moderate diarrhea has been reported in subjects treated with MIRV. Subjects should be 
advised to contact the investigator at the first sign of diarrhea. Subjects may then be treated 
according to standard institutional practice. One suggested regimen would be the administration 
of loperamide 2 mg at the first sign of loose stool, with repeat dosing every two hours until 
symptoms resolve [Wadler, 1998]. 
3.7.3.5 Ocular Disorders [MIRV Cohort] 
Changes in visual acuity resulting from reversible keratopathy have been reported in other 
studies of DM4-containing immunoconjugates that use the SPDB linker [Younes, 2012]. 
Subjects receiving MIRV in the Phase 1 and 3 trials (IMGN853-0401, IMGN853-0403) reported 
ocular AEs consistent with reversible keratopathy/corneal epitheliopathy. At the 6.0 mg/kg 
AIBW Q3W dose level, MIRV-related dry eye (26% all grades; 1% Grade ≥ 3), keratopathy 
(33% all grades; 1% Grade ≥ 3), blurred vision (42% all grades; 2% Grade ≥ 3), eye pain 
(13% all grades; 1% Grade ≥ 3), and photophobia (12% all grades; 1% Grade ≥ 3) were reported 
in Phase 3 study IMGN853-0403.  
3.7.3.5.1 
Monitoring and Preventive Measures [MIRV Cohort] 
In early dose escalation there was a relationship observed between MIRV plasma exposure and 
likelihood of an ocular event as well as with response. Exposure-response modeling suggested 
that a dose of 6.0 mg/kg AIBW provided adequate exposure for response while also maintaining 
overall exposure within a range that decreased the potential for ocular AEs. Due to the 
observation of ocular disorders consistent with reversible keratopathy/corneal epitheliopathy in 
subjects treated with MIRV, ocular function will be carefully monitored. Ocular symptom 
assessments will be performed at baseline and at Day 1 of every cycle thereafter (Section 6.2).  
A complete ophthalmic examination will be performed in all subjects receiving MIRV by an 
ophthalmologist, optometrist, physician assistant, or equivalent eye care professional and will 
include the following at a minimum: manifest refraction, best distance corrected visual acuity 
(BCVA), intra-ocular pressure (IOP) assessment, fundoscopy, and slit lamp examination to 
assess the cornea for keratopathy and other corneal abnormalities. The visual acuity assessment 
should be performed with refraction, rather than corrected or via pin hole. Fundoscopy is 
required at baseline and post-treatment visit (PTV) only.  
• A complete ophthalmic examination will be performed in all subjects receiving MIRV at 
baseline (within 21 days before C1D1), prior to Day 1 dosing in Cycles 3, 5, and 7 and at 

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the PTV (± 2 weeks) including subjects who are asymptomatic or have ≤ Grade 1 ocular 
AEs. Abnormal corneal findings in asymptomatic subjects will be managed as per 
Table 8. 
• Subjects receiving MIRV who experience CTCAE > Grade 1 ocular AEs while on study 
will have a complete ophthalmologic examination performed at the emergence of 
symptoms and at every other cycle thereafter until resolved to baseline or deemed 
irreversible in the opinion of the eye care professional. Subjects requiring an 
ophthalmological examination due to symptoms prior to Cycle 2 or 4 will then proceed to 
every other cycle (approximately 6 weeks) exams as indicated by findings and do not 
require the routine, asymptomatic exams at Cycle 3, 5, and 7. 
Subjects are advised to avoid using contact lenses while on MIRV except when benefit 
outweighs risk per an eye care professional. Eyelid hygiene should be performed as per direction 
of an eye care professional. Please refer to Section 5.3.2.2 for details on the use of lubricating 
artificial tears and recommendations for prophylactic steroid eye drops in subjects with ocular 
symptoms. The use of UVA/UVB sunglasses in full daylight is recommended during the study. 
If subjects report signs or symptoms of ocular AEs, including but not limited to blurred vision or 
eye irritation, the management and dose modification guidelines outlined in Table 8 and Table 9 
should be followed.  
3.7.3.5.2 
Management and Dose Modifications Guidelines [MIRV Cohort] 
If a subject develops new CTCAE > Grade 1 ocular symptoms, MIRV will be held until the 
subject undergoes a complete examination by an eye care professional. If a subject is found to 
have confluent superficial keratitis, a cornea epithelial defect, or a 3-line or more loss in BCVA, 
MIRV dosing must be interrupted until findings improve to nonconfluent keratitis, prior baseline, 
or complete resolution. Uveitis must improve to Grade 1 or better or prior baseline. Treatment 
with MIRV may resume if the ocular event improves as above within 28 days of the next 
scheduled MIRV dose (refer to Table 8 and Table 9 for details). Corneal AEs of any severity 
should be followed to complete resolution, pretreatment baseline, or are deemed to be 
irreversible according to the eye care professional. For 2 or more overlapping ocular adverse 
events (ocular disorders/corneal adverse reactions), dose modification should be based on the 
ocular adverse event of greater severity. Any other ocular AEs not specifically noted in Table 8 
or Table 9 will be managed at the discretion of the treating physician in consultation with their 
eye care professional.  
Subsequent eye examinations will be scheduled to occur in every other cycle going forward from 
the time that the corneal AE was initially reported until resolution of the corneal toxicity to 
subject’s prior baseline or complete resolution or until it is deemed irreversible even if the results 
of the subject’s ocular symptom assessment show no obvious clinical findings. For subjects with 
ongoing keratitis/keratopathy, a cornea epithelial defect, or a 3-line or more loss in BCVA at the 
PTV, an ophthalmic examination should be done every 30 days until complete resolution, 
stabilization without likelihood of improvement in the opinion of the eye care professional, or 
return to pretreatment baseline. Ocular symptoms (e.g., blurred vision) should also be assessed at 
this time. The visual acuity assessment should be performed with refraction, rather than 
corrected or via pin hole. Refraction is crucial for cases where subjects report blurred vision or 
other ocular AEs. 

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Management of ocular AEs with inflammatory characteristics or other non-corneal/visual acuity 
ocular AEs should include measures as indicated by an eye care professional. 
Recommended dosage modifications for corneal AEs should be based on both corneal 
examination findings using the system outlined in Table 8 and changes in BCVA. Dose 
modifications for non-corneal ocular AEs are at the discretion of the treating physician, in 
collaboration with an eye care professional. 
Note: Table 8 describes the management of corneal adverse reactions with regard to MIRV 
dosing. See Table 15 and Table 16 in Appendix Section 16.6 for grading of ocular AEs. 
Table 8 
Management of Corneal Adverse Reactions (Keratitis/Keratopathy) 
Ocular Exam Findinga 
Management 
Guidelines for MIRV Dose 
Modification 
Nonconfluent superficial 
keratitis or nonconfluent 
keratopathyb 
Complete eye examination as outlined in SOA 
(Section 6.2). 
Subjects should have frequent symptomatic ocular 
assessments and repeat eye examinations at least 
every 6 weeks until resolved to pretreatment 
baseline or nonconfluent superficial keratitis or 
better or are deemed to be irreversible by the 
investigator, even after treatment discontinuation, 
if needed 
Monitor with scheduled ocular 
exam to complete resolution or 
return to pretreatment baseline. 
Continue MIRV dosing. 
Confluent superficial 
keratitis or confluent 
keratopathyb, cornea 
epithelial defect (+NaFl 
staining), or ≥ 3-line loss 
in BCVA 
Complete eye examination as outlined in SOA 
(Section 6.2).  
Subjects should have weekly symptomatic ocular 
assessments and repeat eye examinations at least 
every 6 weeks until resolved to pretreatment 
baseline or are deemed to be irreversible by the 
investigator, even after treatment discontinuation, 
if needed. 
Hold MIRV dosing until AE has 
resolved to pretreatment baseline 
or nonconfluent superficial 
keratitis or better. 
Subjects with corneal adverse 
reactions lasting < 14 days may 
be allowed to resume MIRV at 
the same dose level. Recurrence 
of toxicity on subsequent cycles 
despite best supportive care will 
require a dose reduction to one 
lower dose level. 
Subjects with corneal adverse 
reactions lasting ≥ 14 days but no 
more than 28 days may resume 
MIRV at one lower dose level. 
If findings persist >28 days, 
continuation at reduced dose 
level is at the discretion of the 
investigator in consultation with 
the Sponsor. 
Corneal ulcer or clinically 
significant stromal opacity 
or BCVA 20/200 or worse 
Complete eye examination as outlined in SOA 
(Section 6.2). 
Subjects should have weekly symptomatic ocular 
assessments and repeat eye examinations at least 
Hold MIRV dosing. 
Subjects may be allowed to 
resume MIRV at one lower dose 
level after AE has resolved to 

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Ocular Exam Findinga 
Management 
Guidelines for MIRV Dose 
Modification 
every 6 weeks until resolved to baseline or are 
deemed to be irreversible by the investigator, even 
after treatment discontinuation, if needed. 
nonconfluent keratitis or better or 
to pretreatment baseline within 
28 days. 
If findings persist >28 days, 
continuation at reduced dose 
level is at the discretion of the 
investigator in consultation with 
the Sponsor. 
Corneal perforation 
Complete eye examination as outlined in SOA 
(Section 6.2).  
Subjects should have weekly symptomatic ocular 
assessments and repeat eye examinations at least 
every 6 weeks until resolved to baseline or are 
deemed to be irreversible by the investigator, even 
after treatment discontinuation, if needed. 
Permanently discontinue MIRV 
dosing. 
a Normal = clear cornea, no epithelial defects. 
b  Nonconfluent microcystic epithelial change, punctate epithelial keratopathy, subepithelial inclusion cyst and/or nonconfluent 
superficial keratitis, superficial punctate keratitis, epithelial erosion 
Table 9 
Management of Ocular Disorders 
Refer to Table 8 for Corneal Adverse Reactions. 
Severity Grade 
(CTCAE v5.0) 
Management 
Guidelines for MIRV Dose Modifications 
Grade 1 
Follow SOA (Section 6.2) 
Monitor for worsening symptoms 
Continue MIRV dosing 
Grade 2 
Complete eye exam as outlined in SOA 
(Section 6.2) 
Repeat complete exam as clinically 
indicated.  
Subjects should have weekly 
symptomatic ocular assessments by the 
investigator until the symptoms resolve 
to Grade ≤ 1 or are deemed to be 
irreversible by the investigator. 
Hold MIRV dosing until AE has resolved to 
Grade 1 or better.  
Subjects with ocular symptoms lasting < 14 days 
may be allowed to resume MIRV at the same 
dose level. 
Subjects with ocular symptoms lasting ≥ 14 days 
but no more than 28 days may resume MIRV at 
one lower dose level.  
Recurrence of Grade 2 toxicity on subsequent 
cycles despite best supportive care will require a 
MIRV dose reduction of one dose level. 
Grade 3 
Complete eye exam as outlined in SOA 
(Section 6.2). Repeat complete exam as 
clinically indicated. 
Subjects should have weekly 
symptomatic ocular assessments by the 
investigator until the symptoms resolve 
Hold MIRV dosing. 
Subjects may be allowed to resume MIRV at a 
lower dose after AE has resolved to Grade 1 or 
better within 28 days. 
Recurrence of Grade 3 toxicity on subsequent 
cycles despite best supportive care will require a 
MIRV dose reduction of one dose level. 

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Severity Grade 
(CTCAE v5.0) 
Management 
Guidelines for MIRV Dose Modifications 
to Grade ≤ 1 or are deemed to be 
irreversible by the investigator. 
Grade 4 
Complete eye exam as outlined in SOA 
(Section 6.2). Repeat complete exam as 
clinically indicated. 
Subjects should have weekly 
symptomatic ocular assessments by the 
investigator until the symptoms resolve 
to Grade ≤ 1 or are deemed irreversible 
by the investigator. 
Permanently discontinue MIRV. 
 
3.7.3.6 
Monitoring of Noninfectious Pneumonitis [MIRV Cohort] 
Noninfectious pneumonitis has been observed after the administration of MIRV. Noninfectious 
pneumonitis may result in fatigue, shortness of breath, cough, or respiratory distress. 
Drug-induced pneumonitis may be immediately life threatening. If a subject presents with signs 
or symptoms consistent with pneumonitis and/or other clinically meaningful signs or symptoms 
of pulmonary toxicity, the subject should be immediately evaluated. Subjects are advised to 
notify their treating physician immediately if they experience new or worsening shortness of 
breath, cough, or respiratory distress. Subjects who are asymptomatic may continue dosing of 
MIRV with close monitoring. 
The management and treatment guidelines outlined in Table 10 should be followed. 
Table 10 
Management of Noninfectious Pneumonitis 
CTCAE v5.0 
Grade 
CTCAE v5.0 
Definition 
Medical Management of 
Pneumonitis 
Guidelines for Dose 
Modificationsa 
Grade 1 
Asymptomatic; 
clinical or 
diagnostic 
observations only; 
intervention not 
indicated 
• 
Radiologic assessments (CT 
scan and/or chest x-ray) should 
be performed as clinically 
indicated. 
• 
Monitor for pulmonary 
symptoms. 
• 
Continue dosing in 
asymptomatic subjects and 
monitor closely. 
Grade 2 
Symptomatic; 
medical 
intervention 
indicated; limiting 
instrumental ADL 
• 
Radiologic assessments (CT 
scan and/or chest x-ray) should 
be performed as clinically 
indicated. 
• 
Subject must be evaluated by a 
pulmonary specialist.  
• 
Treatment with corticosteroids 
may be indicated as 
recommended by a pulmonary 
specialist and/or institutional 
guidelines. 
• 
Hold dosing until symptoms 
resolve to Grade ≤ 1. 
• 
MIRV may be resumed at same 
dose level or one dose level 
lower after discussion with the 
Sponsor. 
Grade 3 
Severe symptoms; 
limiting self-care 
• 
Permanently discontinue MIRV. 

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CTCAE v5.0 
Grade 
CTCAE v5.0 
Definition 
Medical Management of 
Pneumonitis 
Guidelines for Dose 
Modificationsa 
ADL; oxygen 
indicated 
• 
Radiologic assessments (CT 
scan and/or chest x-ray) should 
be performed as clinically 
indicated.  
• 
Subject must be evaluated by a 
pulmonary specialist.  
• 
Treatment with corticosteroids 
until resolution of symptoms 
may be indicated as 
recommended by a pulmonary 
specialist and/or institutional 
guidelines.  
• 
Bronchoscopy with lavage 
and/or biopsy when clinically 
feasible should be performed.  
• 
The pneumonitis event must be 
followed until resolution. 
Grade 4 
Life-threatening 
respiratory 
compromise; 
urgent intervention 
indicated (e.g., 
tracheotomy or 
intubation) 
Abbreviations: ADL = activities of daily living; AE = adverse event; CT = computed tomography; MIRV = mirvetuximab 
soravtansine. 
a. Failure to meet retreatment criteria within 1 cycle (21 days) after the missed dose due to insufficient recovery from a 
treatment-related toxicity will result in treatment discontinuation unless otherwise specified in the management guidance 
for a particular toxicity 
3.7.3.7 
Management of Electrolyte Imbalance [MIRV Cohort] 
Prompt attention should be given to the correction of potential electrolytes imbalance, especially 
hypokalemia and hypomagnesemia. 
3.7.3.8 Potential Infusion-Related Reactions [MIRV Cohort] 
Some subjects treated with IV infusions of therapeutic drugs have experienced concurrent IRR 
(see CTCAE version 5.0). The signs and symptoms may vary and include, for example, 
headache, fever, facial flushing, pruritus, myalgia, nausea, chest tightness, dyspnea, vomiting, 
erythema, abdominal discomfort, diaphoresis, shivers, lightheadedness, hypotension, 
palpitations, and somnolence. Anaphylaxis might occur at any time during an infusion. Before 
any infusion is started, appropriate medical personnel, medication (e.g., epinephrine, inhaled beta 
agonists, antihistamines, and corticosteroids), and other required resources to treat anaphylaxis 
must be readily available. In general, investigators should manage acute allergic or HSRs 
according to Institutional practices. General guidelines for the management of acute IRRs and for 
subsequent retreatment are provided in Table 11. Delayed IRRs may occur; therefore, subjects 
should be advised to seek immediate medical treatment if symptoms newly develop and/or recur 
after discharge from clinic. 

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Table 11 
Management Guidelines for Potential Infusion-Related Reaction 
[MIRV Cohort] 
Infusion Reaction 
CTCAE v5.0 Severity Grade 
Management 
Grade 1: Mild, transient 
reaction 
• 
Maintain infusion rate unless progression of symptoms to Grade ≥ 2; if 
symptoms worsen, refer to guidelines below. 
• 
Promethazine (or equivalent) 150 mg PO per day (Q4h) PRN for nausea  
• 
Diphenhydramine (or equivalent) 25 to 50 mg PO or IV PRN 
• 
Methylprednisolone (or equivalent) 125 mg IV PRN 
Grade 2: Moderate 
• 
Interrupt infusion and disconnect infusion tubing from subject 
• 
Promethazine (or equivalent) 150 mg PO per day (Q4h) PRN for nausea 
• 
Diphenhydramine (or equivalent) 25 to 50 mg PO or IV PRN 
• 
Acetaminophen (or equivalent) 650 mg PO PRN 
• 
Methylprednisolone (or equivalent) 125 mg IV PRN 
• 
After recovery from symptoms, resume the infusion at 50% of the previous 
rate and if no further symptoms appear, gradually increase rate until infusion 
is completed. 
• 
For subsequent dosing in future cycles, subjects should be premedicated 
with dexamethasone (or equivalent) 8 mg PO BID the day before drug 
administration and acetaminophen (or equivalent) 650 mg PO, 
diphenhydramine (or equivalent) 25 to 50 mg PO, and dexamethasone 
10 mg IV 30 to 60 min before dosing. 
Grade 3: Severe, prolonged 
reaction not rapidly 
responsive to symptomatic 
medication and/or brief 
interruption of infusion; 
recurrence of symptoms after 
initial improvement; 
hospitalization indicated for 
clinical sequelae 
OR 
Grade 4: Life-threatening 
consequences, urgent 
intervention indicated 
• 
Immediately stop infusion and disconnect infusion tubing from subject. 
• 
Administer diphenhydramine (25 to 50 mg) IV (or equivalent) 
• 
Administer IV steroids (methylprednisolone (or equivalent) up to 0.5 mg/kg 
Q 6h) to treat ongoing reaction and prevent recurrence 
• 
Administer bronchodilators (nebulized albuterol/salbutamol, 2.5 to 5 mg in 
3 mL of saline or equivalent) as medically indicated 
• 
Administer normal saline as medically indicated 
• 
Administer epinephrine (0.2 to 0.5 mL of a 1:1000 dilution (0.2 to 0.5 mg) SQ 
or IM) as medically indicated. Epinephrine should only be used if all other 
treatment methods fail to manage the IRR. 
• 
Advise subject to seek emergency treatment and notify investigator/clinic if 
the infusion-related symptoms recur after discharge from clinic. 
• 
Report as an SAE (see Section 7.4). 
• 
Permanently discontinue study medication treatment 
Abbreviations: BID = twice a day; CTCAE = common terminology criteria for adverse events; IM = intramuscular; IRR = 
infusion-related reaction; IV = intravenously; PO = orally; PRN = as needed; SAE = serious adverse event; SQ = 
subcutaneous 
3.8 
Subject Withdrawal of Consent 
• A subject may withdraw from the study at any time at her own request; or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance, or administrative reasons. The latter is expected to be uncommon. The 
subject may withdraw consent from further treatment on the study and continue in the 
survival follow-up (SFU) portion of the study or may withdraw consent from further 

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participation in the study (e.g., permanently discontinue study treatment, any follow-up 
study procedures, no longer be contacted for survival). 
• At the time of study medication discontinuation, a PTV should be conducted, as shown in 
the SOA in Section 6.1 and Section 6.2. See SOA for data to be collected at the time of 
study discontinuation of study treatment and for any further evaluations that need to be 
completed. Every effort must be made to continue follow-up of subjects for 
protocol-specified safety follow-up procedures to capture AEs, SAEs, and unanticipated 
problems. 
• If the subject withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data or biological samples collected before such a 
withdrawal of consent. 
• If a subject withdraws from the study, she may request destruction of any samples taken 
and not tested, and the investigator must document this in the site study records. 
3.9 
Lost to Follow-Up 
• A subject will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
• The following actions must be taken if a subject fails to return to the clinic for a required 
study visit: 
o The site must attempt to contact the subject and reschedule the missed visit as 
soon as possible and counsel the subject on the importance of maintaining the 
assigned visit schedule and ascertain whether the subject wishes to and/or should 
continue in the study. 
o Before a subject is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the subject (where possible, 3 telephone 
calls and, if necessary, a certified letter sent to the subject’s last known mailing 
address or local equivalent methods). These contact attempts should be 
documented in the subject’s medical record. 
o Should the subject continue to be unreachable, she will be considered as lost to 
follow-up and withdrawn from the study. 
3.10 
Premature Termination or Suspension of Study 
The Sponsor reserves the right to close the study site or terminate the study at any time for any 
reason. Written notification, documenting the reason for study suspension or termination, will be 
provided by the Sponsor to investigators and the country regulatory authorities as required. If the 
study is prematurely terminated or suspended, the investigator will promptly inform the 
Institutional Review Board/Independent Ethics Committee (IRB/IEC) and will provide the 
reason(s) for the termination or suspension. Study sites will be closed upon study completion. A 
study site is considered closed when all required documents and study supplies have been 
collected or destroyed and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 

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Reasons for the early closure of a study site by the Sponsor or investigator may include but are 
not limited to: 
• 
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the Sponsor’s procedures, or Good Clinical 
Practice (GCP) guidelines 
• 
Inadequate recruitment of subjects by the investigator 
• 
Discontinuation of further development of SL-172154 
• 
Determination of unexpected, significant, or unacceptable risk to subjects  
3.11 
Study Treatment Discontinuation Criteria 
A subject will receive the assigned study treatment (e.g., SL-172154 and PLD or SL-172154 and 
MIRV) until any of the following events occur during the study: 
• 
Documented disease progression (radiological or clinical) 
• 
A subject suffers an AE that, in the judgement of the investigator, Sponsor, or 
Medical Monitor, presents an unacceptable risk to the subject  
• 
General or specific changes in the subject’s condition (e.g., a significant 
intercurrent illness or complication) that, in the judgement of the investigator, are 
unacceptable for further administration of study treatment  
• 
Subject decides to discontinue further study treatment 
• 
Occurrence of pregnancy 
• 
Significant non-compliance with protocol requirements 
• 
Death 
• 
Termination of the study by Sponsor 
If one agent in the assigned regimen is permanently discontinued for any reason, at the 
investigator’s discretion, the subject may continue to receive the other agent in the assigned 
regimen as monotherapy until meeting one of study treatment discontinuation criteria.  
In the event of permanent discontinuation of all study treatment, subjects should be strongly 
encouraged to complete all scheduled assessments at the PTV and the SFU contacts. 
3.12 
Duration of Follow-Up 
Subjects who are withdrawn from study treatment for unacceptable AE(s) should be followed 
until the event(s) are resolved, the subject is lost to follow-up, the AE is otherwise explained, or 
further recovery is not deemed to be feasible. Data on these events should be collected on the AE 
electronic case report form (eCRF). 
Subjects who permanently discontinue study treatment for reasons other than progression will 
continue with disease assessments until progression or start of another anti-cancer therapy. 
Subjects who discontinue study treatment for any reason other than withdrawal of consent will 
be followed for survival and will be contacted approximately every 3 months from PTV until 
death or the end of the study, whichever occurs first. During Survival Follow-up, the start date of 
the first anticancer therapy will be collected and entered in the electronic data capture (EDC) 
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3.13 
End-of-Study Definition 
The end of study is defined as the point of final data capture (e.g., the point at which all required 
data has been collected to answer the research questions in the protocol) or date the study is 
closed by the Sponsor, whichever occurs first. 
After the end-of-study, subjects who are still in survival follow-up part of the study should 
receive standard of care treatment as determined by their health care provider after completion of 
the study. 
4. 
STUDY POPULATION  
Patients may be considered for enrollment in the study if they meet all the eligibility criteria 
stated in Sections 4.1 and 4.2. Prospective approval of protocol deviations to recruitment and 
enrollment criteria, also known as protocol waivers or exemptions, is not permitted. 
4.1 
Inclusion Criteria 
Subjects must meet all the following criteria: 
1. Subject has voluntarily agreed to participate by giving written informed consent in 
accordance with ICH/GCP guidelines and applicable local regulations. 
2. Age ≥ 18 years. 
3. [PLD Cohort] Subject has a histologically confirmed diagnosis of high grade EOC 
(including primary peritoneal cancer or fallopian tube cancer).  
NOTE: Non-epithelial tumors and ovarian tumors with low malignant potential are excluded. 
4. [PLD Cohort] Subject must have platinum-resistant disease, defined as disease progression 
within 180 days (6 months) following the last administered dose of platinum therapy.  
NOTE: Progression should be calculated from the date of the last administered dose of 
platinum therapy to the date of the radiographic imaging showing progression. 
NOTE: Subjects who are primary platinum refractory, defined by progressing during or 
within 1 month of upfront platinum therapy, are excluded.  
5. [PLD Cohort] Subjects may have received any number of prior lines of therapy for EOC; 
however, they may not have received more than 1 prior line of systemic anticancer therapy 
for platinum-resistant disease.  
Lines of therapy are defined in this study as: 
• Adjuvant ± neoadjuvant is considered 1 line of therapy. 
• Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered part of the 
preceding line of therapy (i.e., not counted independently). 
• Therapy changed due to toxicity in the absence of progression will be considered part of 
the same line (i.e., not counted independently). 
• Hormonal therapy will be counted as a separate line of therapy unless it was given as 
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6. [MIRV Cohort] Subject has a histologically confirmed diagnosis of high grade serous EOC 
(including primary peritoneal cancer or fallopian tube cancer). 
NOTE: non-epithelial tumors and ovarian tumors with low malignant potential are excluded. 
7. [MIRV Cohort] Subject must have platinum-resistant disease as defined by: 
• Subjects who have only had 1 line of platinum-based therapy must have received at least 
4 cycles of platinum, must have had a response (complete response/remission [CR] or 
partial response/remission [PR]) and then progressed between > 3 months and ≤ 6 months 
after the date of the last dose of platinum. 
• Subjects who have received 2 or 3 lines of platinum therapy must have progressed on or 
within 6 months after the date of the last dose of platinum. 
NOTE: Progression should be calculated from the date of the last administered dose of 
platinum therapy to the date of the radiographic imaging showing progression. 
NOTE: Subjects who are platinum refractory during front-line treatment are excluded 
[primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) 
or has progressed within ≤ 3 months of the last dose of first-line platinum-containing 
chemotherapy]. 
8. [MIRV Cohort] Subjects must have received at least 1 but no more than 3 prior systemic 
lines of anticancer therapy.  
Lines of therapy are defined in this study as: 
• Adjuvant ± neoadjuvant is considered 1 line of therapy. 
• Maintenance therapy (e.g., bevacizumab, PARP inhibitors) will be considered part of the 
preceding line of therapy (i.e., not counted independently). 
• Therapy changed due to toxicity in the absence of progression will be considered part of 
the same line (i.e., not counted independently). 
• Hormonal therapy will be counted as a separate line of therapy unless it was given as 
maintenance. 
9. [MIRV Cohort] Willing to provide an archival tumor tissue block or slides or undergo new 
biopsy using a low-risk, medically routine procedure for IHC confirmation of FRα positivity. 
10. [MIRV Cohort] Subject’s tumor must be positive for FRα expression defined as PS2+ 
≥ 25% by the Ventana FOLR1 Assay.  
11. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 
12. Measurable disease by RECIST v1.1 using radiologic assessment. 

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• Myocarditis 
• Unstable angina within 6 months from first dose of study treatment 
• Acute myocardial infarction within 6 months from first dose of study treatment 
• Uncontrolled hypertension 
• NYHA Class III or IV congestive heart failure 
• Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular 
tachycardia, second- or third- degree atrioventricular block without a pacemaker, 
circulatory collapse requiring vasopressor or inotropic support, or arrhythmia 
requiring therapy) 
• History of hemorrhagic or ischemic stroke within 6 months prior to enrollment 
• Prior anthracycline-related cardiotoxicity or prior anthracycline exposure approaching 
the lifetime limit [PLD cohort only] 
14. [MIRV Cohort] History of cirrhotic liver disease (Child-Pugh Class B or C). 
15. [MIRV Cohort] Active or chronic corneal disorders, history of corneal transplantation, or 
active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled 
glaucoma, wet age-related macular degeneration requiring intravitreal injections, active 
diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, 
and/or monocular vision. 
16. Previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including 
noninfectious pneumonia. 
17. Untreated central nervous system (CNS) or leptomeningeal metastases. Subjects with treated 
CNS metastases must have completed definitive treatment (radiotherapy and/or surgery) 
> 2 weeks prior to first dose of study treatment and no longer require steroids. 
18. Women who are pregnant or breast feeding, or who plan to become pregnant or breast feed 
while receiving study treatment. 
19. Psychiatric illness/social circumstances that would limit compliance with study requirements 
and substantially increase the risk of AEs or compromised ability to provide written informed 
consent. 
20. Another malignancy that requires active therapy and that, in the opinion of the investigator 
and Sponsor, would interfere with monitoring of radiologic assessments of response to the 
study treatment.  
21. Has undergone allogeneic stem cell transplantation or organ transplantation. 
22. Known history or positive test for human immunodeficiency virus (HIV), or positive test for 
hepatitis B (positive for hepatitis B surface antigen [HbsAg]) or hepatitis C virus ([HCV]; if 
HCV antibody (Ab) test is positive check for HCV RNA).  
NOTE: Hepatitis B virus (HBV): Subjects who are hepatitis B core antibody [HbcAb] 
positive, but HbsAg negative are eligible for enrollment. HCV: Subjects who are HCV Ab 
positive, but HCV RNA negative are eligible for enrollment. 

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4.3 
Screen Failures 
Screen failures are defined as subjects who consent to participate in the clinical study but are not 
subsequently treated in the study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure subjects to meet the Consolidated Standards of 
Reporting Trials publishing requirements and to respond to queries from regulatory authorities. 
Minimal information includes demography, screen failure reason, eligibility criteria, and any 
SAEs related to study procedure(s). 
5. 
PHARMACEUTICAL PRODUCT INFORMATION 
5.1 
SL-172154 
5.1.1 Investigational Product Description 
Investigational Product Name: 
SL-172154 
Formulation description: 
Solution containing SL-172154 10 mg/mL. Refer to the Study 
Pharmacy Manual (SPM) for further description of the drug 
product. 
Dosage form: 
Supplied as frozen liquid solution in a glass vial. 
Unit dose strength(s)/Dose Level(s): 
SL-172154 10 mg/mL  
(Refer to Section 3.2 for dose levels) 
Physical Description: 
SL-172154 solution, 10 mg/mL in a glass vial closed with a 
FluroTec® rubber stopper and sealed with a flip-off aluminium 
seal. See the SPM for additional details. 
Route/ 
Administration/ Duration: 
• 
Delivered as IV solution via a syringe pump or IV infusion 
pump. See the SPM for additional details.  
• 
Duration of infusion depends on the dose. See the SPM for 
additional details. Infusion rate may change based on final 
drug volume needed for administration, safety, and 
tolerability of the infusion for the subject and/or observed 
safety findings during the study. 
o For the 3.0 mg/kg dose the duration of infusion is 
120 minutes (±15 min).  
o For the 6.0 mg/kg dose the duration of infusion is 
180 minutes (±15 min).  
o For the 1.0 mg/kg dose the duration of infusion is 
60 minutes (±10 minutes). 
• 
Premedication for IRR prophylaxis is to be administered at 
least 30 minutes prior to each SL-172154 administration, 
premedications are as follows: dexamethasone (8 mg IV), 
acetaminophen (650 to 1000mg PO), diphenhydramine 
(25 to 50mg, or equivalent, PO or IV), and famotidine 
(20 mg, or equivalent, IV or PO). If famotidine is used, IV 
administration is the preferred route for premedication. If IV 
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Investigational Product Name: 
SL-172154 
oral famotidine may be used instead and should be 
administered approximately 60 min prior to SL-172154.  
• 
Additional premedication with dexamethasone (8 mg IV) 
one day prior to SL-172154 administration is not required 
but can be optionally given. 
• 
The dose and administration method of prophylactic 
premedication can be modified at the Investigator’s 
discretion. 
Dosing instructions: 
Determine the number of vials needed based on the assigned 
dose level (in mg/kg) and the subject’s weight (in kg). See the 
SPM for instructions on dose preparation and information on 
compatible administration materials. Doses of SL-172154 are to 
be administered as an IV infusion via an infusion or syringe 
pump that can ensure precision to at least 0.1 mL/min. 
Secondary Packaging/Quantity/Label type 
This is an open-label study. Each vial of SL-172154 will be 
supplied in a single vial carton. See SPM for details. 
Manufacturer/ Source of Procurement: 
Manufactured for Shattuck Labs by Lyophilization Services of 
New England, Bedford, NH, USA 
SL-172154 will be provided to sites by the Sponsor. The contents of the label will be in 
accordance with all applicable regulatory requirements.  
5.1.2 Preparation, Handling, Administration, and Storage of SL-172154 
5.1.2.1 Preparation 
Standard aseptic technique including preparation of doses in a laminar flow hood is required.  
SL-172154 solution 10 mg/mL is supplied as a frozen liquid. Before use, thaw each vial of 
SL-172154 solution 10 mg/mL overnight under refrigerated conditions, protected from light, or 
at room temperature until completely thawed. Following thawing, gently swirl the vial to ensure 
uniformity. Only sterile normal saline (0.9%) should be used to dilute SL-172154. See the SPM 
for further details on the preparation of SL-172154. 
5.1.2.2 Handling 
Under normal conditions of handling and administration, SL-172154 is not expected to pose 
significant safety risks to site staff. A Safety Data Sheet (describing the occupational hazards and 
recommended handling precautions) will be provided to site staff if required by local laws or will 
otherwise be available from the Sponsor upon request. 
In the case of unintentional occupational exposure notify the Sponsor and consult the SPM. 
Refer to the SPM for detailed procedures for the disposal and/or return of unused SL-172154. 
5.1.2.3 Administration 
Doses of SL-172154 are to be administered as an IV infusion via an infusion pump or syringe 
pump that can ensure precision within at least 0.1 mL/min. DO NOT USE an in-line filter for 

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administration of SL-172154. Refer to the SL-172154 SPM for further details regarding 
administration. 
Infusion rate: The duration of infusion stipulated for each dose is outlined in Table 1 
(Section 3.2.1; PLD Cohort) and Table 2 (Section 3.2.2; MIRV Cohort).  
NOTE: A physician must be immediately available to respond to emergencies during all 
administrations of SL-172154. A fully functional resuscitation facility must be available. 
SL-172154 must not be administered via IV push or bolus but as an IV infusion using an infusion 
or syringe pump.  
5.1.2.4 Storage 
SL-172154 must be stored in a secure area under the appropriate physical conditions for the 
product. Access to and administration of SL-172154 drug product will be limited to the 
investigator and authorized site staff. SL-172154 must be dispensed or administered only to 
subjects enrolled in the study and in accordance with the protocol. 
SL-172154 drug product vials are to be stored frozen at a temperature -75°C ± 10°C. Please see 
SPM for guidance on temperature excursions outside of this range. Maintenance of a temperature 
log is required. The drug product should be stored protected from light. 
The expiry date will be on the single vial carton label, if required. 
5.1.3 Dosing and Change in Weight 
The actual body weight in kg will be used for SL-172154 dose calculation in all subjects whose 
body weight** is ≤ 100 kg. For subjects with body weight > 100 kg, the dose to be administered 
should be the same as that calculated for a subject weighing 100 kg. The subject should be dosed 
according to their C1D1 weight throughout the study (mg/kg) if there is no significant change in 
their weight from the weight recorded at the C1D1 visit. A change in weight (i.e., increase or 
decrease) of the subject by 10% or greater will require re-calculation of dose (mg/kg). All doses 
may be rounded to the nearest mg per institutional standard. 
**Subject weight should be per the institutional standard but no less precise than rounded to a 
whole number prior to calculating the dose to be administered (e.g., 72.5 kg should be rounded 
up to 73 kg, 72.4 kg should be rounded down to 72 kg). 
5.1.4 Monitoring Dose Administration  
SL-172154 must be administered in an outpatient oncology treatment center or inpatient unit to 
enable close monitoring of subjects and proactive management of AEs. The risks associated with 
administration of SL-172154 include infusion reactions and CRS as described in Section 1.7.1. 
Therefore, appropriate drugs and medical equipment to treat acute HSRs and monitoring and 
management of CRS must be immediately available, and study personnel must be trained to 
recognize and treat these toxicities. In case an event of CRS should occur, ensure that at least 
2 doses of tocilizumab are available prior to each infusion of SL-172154 (see Section 3.7.1.2 for 
toxicity management recommendations). When tocilizumab is not available, consider using drug 
with similar mechanism of actions such as anti-IL-6 receptor monoclonal antibodies (e.g., 
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Subjects will be monitored prior to, during, and after the completion of each SL-172154 
infusion. Vital signs will be measured as outlined in the SOA in Section 6.1 and Section 6.2; 
vital signs may also be measured at other timepoints as clinically indicated. 
5.1.5 SL-172154 Accountability and Treatment Compliance 
Product accountability records must be maintained throughout the course of the study. The 
investigator or designee is responsible for keeping accurate records of all SL-172154 supplies 
received from the Sponsor, the amount of SL-172154 dispensed for administration to the subjects 
and the amount of unused or partially used SL-172154 remaining at the conclusion of the trial. 
An accurate and current accounting of study treatments administered to each subject must be 
maintained on an ongoing basis by a member of the study site staff in the Drug Accountability 
Record throughout the course of the study. Treatment compliance will be monitored by drug 
accountability as well as the subject’s medical record and eCRF. Refer to the SL-172154 SPM 
for further detailed instructions on product accountability. 
Handling and Disposal: Local requirements for disposal of hazardous drugs should be followed 
at each participating clinical site. It is the investigator’s responsibility to arrange for disposal of 
all partially used or empty containers, provided that procedures for proper disposal have been 
established according to applicable federal, state, local and institutional guidelines and 
procedures, and provided that appropriate records of disposal are kept.  
Prior to the return or destruction of SL-172154, the Sponsor Study Monitor must have performed 
a complete reconciliation of all investigational drugs, ensuring accountability records are 
complete and accurate and are retained in the investigator Site file or pharmacy file. 
Investigational drug that is returned to the supplier or destroyed on site must be documented in 
the accountability documentation. Arrangements for the return of investigational drugs will be 
made by the Sponsor.  
Refer to the SL-172154 SPM for further instructions on handling and disposal requirements.  
5.1.6 Treatment of SL-172154 Overdose 
An overdose of SL-172154 is defined as the administration of a dose (> 10% of the intended 
dose) and/or schedule greater than the dose and/or schedule that had been studied to date. If an 
overdose is suspected, the investigator should contact the Sponsor to confirm the highest dose 
and schedule tested to date. In the event of an overdose of SL-172154, the investigator should: 
• Closely monitor the subject for AEs/SAEs and laboratory abnormalities for at least 
2 weeks following the infusion. No information on treatment of overdose of SL-172154 
is currently available. General supportive measures should be used as appropriate. The 
appropriate AE management guideline should be followed (Section 3.7.1) where 
applicable. Pharmacologic effect could persist even after SL-172154 is no longer 
detectable in the serum. Subject should have recovered from toxicities that occurred 
because of the excess dose before the next scheduled dose is administered. 
• Overdose itself is not typically considered an AE or SAE. However, if the overdose 
results in an AE, the AE must also be recorded on the AE eCRF. Overdose does not 
automatically make an AE serious, but if the consequences of the overdose meet the 
definition of a serious event, for example death or hospitalization, the event is serious and 
must be reported as an SAE (Section 7.4). 

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• Obtain a serum sample for PK analysis within 24 hours of the event if requested by the 
Sponsor (determined on a case-by-case basis). 
• Document the planned and actual dose in the eCRF. 
Decisions regarding dose interruptions for overdose of SL-172154 will be made by the 
investigator in consultation with the Sponsor Medical Monitor based on the clinical evaluation of 
the subject. 
5.2 
Pegylated Liposomal Doxorubicin (PLD) 
PLD (40 mg/m2) will be administered IV on Day 1 of each 28-day cycle. The first dose of PLD 
(Cycle 1 Day 1) should be administered as 1 mg/min IV infusion; after Cycle 1, if tolerated, 
subsequent doses of PLD can be delivered as a 1-hour infusion. Refer to the PLD local 
prescribing information for details regarding preparation, handling, administration, storage, 
instructions, and precautions. An accurate and current accounting of PLD administered to each 
subject must be maintained on an ongoing basis by a member of the study site staff throughout 
the course of the study. 
The dose amount required to prepare the PLD infusion solution will be based on the subject’s 
body surface area (m2). All subjects should be weighed within 3 days prior to dosing for every 
cycle to ensure they did not experience either a weight loss or gain > 10% from the weight used 
for the last dose calculation. For weight change less than 10% the decision to recalculate the 
PLD dose can be in accordance with institutional practice. If the subject experienced either a 
weight loss or gain > 10% compared to the weight used for the last dose calculation, the amount 
of PLD must be recalculated. Dose capping should not be performed. 
In order to mitigate IRRs, a premedication regimen may be administered as per local practice, 
which may include diphenhydramine 25 to 50 mg IV or oral equivalent, and/or 
acetaminophen/paracetamol 650 mg IV or oral equivalent. Primary prophylactic use of steroids 
for nausea/vomiting is not permitted. 
Discontinue PLD for burning or stinging sensation or other evidence indicating perivenous 
infiltration or extravasation. Manage confirmed or suspected extravasation as per institutional 
practice. 
5.3 
Mirvetuximab Soravtansine (MIRV) 
5.3.1 MIRV Product and Packaging Description 
The investigational product, MIRV, will be provided by the Sponsor, at a protein concentration 
of 5.0 mg/mL in an aqueous pH 5.0 buffered solution. See the MIRV IB for complete list of 
excipients. 
MIRV will be provided in a 20 mL glass, single-use Type I vial. The container closure for the 
Type I glass vials will consist of a 20 mm ethylene tetrafluoroethylene (ETFE)-coated serum 
stopper (FluroTec®) with a 20 mm aluminum TruEdge® seal with blue Flip-off® top.  
Refer to the SPM for labeling and storage information. 

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5.3.2 Preparation and Administration of MIRV 
5.3.2.1 Premedication for MIRV Treatment 
All subjects must receive 325 to 650 mg of acetaminophen/paracetamol (orally [PO] or IV), 
10 mg IV dexamethasone, and 25 to 50 mg diphenhydramine (IV or PO) (equivalent drugs of 
similar drug classes is also acceptable) at least 30 min before each infusion of MIRV. If 
individual subjects require more intensive treatment to prevent IRRs, investigators may modify 
the regimen accordingly. An antiemetic medication (e.g., 5-HT3 serotonin receptor antagonists 
such as palonosetron, granisetron or ondansetron or appropriate alternatives) is recommended 
before each MIRV dose and may be used at any time at the discretion of the treating physician. 
5.3.2.2 
Prophylactic Use of Eye Drops 
5.3.2.2.1 
Corticosteroid Eye Drops 
All subjects assigned to receive MIRV will be mandated to use corticosteroid eye drops as 
prescribed by the treating physician unless the risk outweighs the benefit as per the 
ophthalmologist/physician. All subjects will be instructed to self-administer 1% prednisolone 
(Pred Forte® or generic equivalent) 6 times daily on Days -1 to 4 and 4 times daily on Days 5 to 
8 of each cycle during the study. For individual subjects who cannot tolerate the preservative 
contained in 1% prednisolone, other corticosteroid eye drops may be substituted (e.g., 
difluprednate 0.05%; Durezol®) and administered on Days -1 to 8 of each cycle at a frequency 
prescribed by the eye care professional. If prednisolone eye drops cannot be obtained, alternate 
steroid eye drops are acceptable. 
5.3.2.2.2 
Lubricating Artificial Tears 
Subjects assigned to receive MIRV will be mandated to use lubricating artificial tears on a daily 
basis (as directed by the product prescribing information or the treating physician). Preservative-
free lubricating drops are recommended. Subjects should be advised to wait at least 15 minutes 
after corticosteroid eye drop administration before instilling lubricating eye drops. 
5.3.2.3 
Calculation for Adjusted Ideal Body Weight 
The total dose of MIRV is calculated on each subject’s AIBW using the formula provided in 
Appendix Section 16.4. The subject’s weight will be collected each cycle. Dosing will be based 
off the weight at baseline prior to C1D1 unless current weight is >10% different. If required per 
institutional policy, it is acceptable to recalculate AIBW at each cycle using the subject’s current 
weight. Sites must clearly document the weight used to calculate dose at each cycle. Dosing must 
be modified for significant (≥ 10%) changes in body weight (not influenced by weight gain or 
loss attributed to fluid retention). 
5.3.2.4 
Preparation of MIRV 
MIRV is an anticancer drug, and, as with other potentially toxic compounds, caution should be 
exercised when handling this compound. It is recommended that gloves and protective garments 
be worn during preparation. The desired amount of drug should be withdrawn from the vial(s) 
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Note: MIRV is incompatible with saline (0.9% sodium chloride). Therefore, dilutions should be 
made using 5% dextrose. Infusion bags should be labeled with the protocol number, subject 
number, storage temperature, dose, and volume of MIRV filtered into the bag, or labeled 
according to institutional protocol. Once the solution is prepared, the infusion bag should be 
stored at room temperature protected from direct sunlight, and the infusion must be completed 
within eight hours of preparation. Please refer to the SPM for further details. 
If necessary, MIRV from different drug lots may be mixed in a single-dose administration. 
MIRV is administered at 6.0 mg/kg AIBW as an IV infusion following preparation as outlined in 
the SPM. Details on required and compatible infusion materials are also included in the SPM.  
At C1D1 MIRV should be administered at a rate of 1 mg/min; after 30 min, the rate can be 
increased to 3.0 mg/min if well tolerated. If well tolerated after 30 min at 3.0 mg/min, the MIRV 
infusion rate may be increased to 5.0 mg/min. Subsequent infusions may be delivered at the 
tolerated rate. Therefore, the overall length of infusion will vary depending on dose and subject 
tolerability. After infusion, the IV line should be flushed with 5% dextrose as needed (PRN) to 
ensure delivery of the full dose.  
Subjects will be carefully observed during each infusion and vital signs are taken as outlined in 
the SOA (Section 6.2). Subjects will remain in the clinic under observation for 2 hours after the 
first MIRV infusion, and for at least 1 hour after each subsequent MIRV infusion. While in the 
treatment area, subjects should be closely monitored for AEs. 
5.3.3 MIRV Accountability 
Specific details regarding storage and handling of MIRV can be found in the SPM. 
Accountability and shipping documents for MIRV must be maintained by the investigator or 
designee (e.g., the study pharmacist). The investigator or designee must maintain an accurate 
record of all MIRV received, stored, dispensed, destroyed, and used in an Investigational Product 
Dispensing/Accountability Log or equivalent. These records must always be available for 
inspection, and a copy will be supplied to the Sponsor on request. Information recorded on the 
Accountability Log should include dates and quantities of drug received, dates and quantities of 
drug dispensed, subject number to whom drug is administered, lot number of drug administered, 
the recorder’s initials, and dates and quantities of drug destroyed or returned. Upon receipt, vials 
should be visually inspected for vial integrity (i.e., cracks or leaks) and a record of any damaged 
or suspect drug should be kept on the Accountability Log. 
Upon completion of the study, all MIRV dispatched to a site must be accounted for and unused 
supplies destroyed according to the site’s standard operating procedures (SOPs) or returned to 
depot (refer to SPM). The original drug reconciliation records shall be maintained at the site and 
a copy collected and sent to the Sponsor or designee once a representative of the company has 
confirmed the drug accountability.  
Drug accountability will be monitored. 
5.3.4 MIRV Study Treatment Compliance 
MIRV supplied for the study may not be used for any purpose other than the study or 
administered other than as described in this protocol.  

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If necessary, MIRV from different drug lots may be mixed in a single-dose administration. 
Under no circumstances is the investigator allowed to release MIRV supplies to any physician 
not named in the Food and Drug Administration (FDA) Form 1572 (or equivalent) or to 
administer these supplies to a patient not enrolled in this study. If investigational supplies are to 
be dispensed from any facility other than that supervised directly by the investigator (i.e., 
hospital pharmacy, satellite pharmacy), it is the responsibility of the investigator to ensure that 
all MIRV is stored and administered as described (refer to the SPM for instructions). 
5.3.5 MIRV Overdose and Medication Error 
There is no known treatment/antidote available for MIRV. Supportive measures should be 
instituted if an instance arises in which a subject suffers an overdose of MIRV. 
The Sponsor must be notified within 24 hours of any error leading to the administration of either 
10% more or 10% less than the intended dose; in such cases, the event must be reported in the 
clinical trial database. If an error resulted in a SAE, a Serious Adverse Event form must be 
submitted within 24 hours of the event (see Section 7.4). 
6. 
STUDY ASSESSMENTS AND PROCEDURES  
• Study procedures and their timing are summarized in the SOA. Protocol waivers or 
exemptions are not allowed. 
• Adherence to the study design requirements, including those specified in the SOA, is 
essential and required for study conduct. 
• All screening evaluations must be completed and reviewed to confirm that potential 
subjects meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all subjects screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
• Procedures conducted as part of the subject’s routine clinical management (e.g., blood 
count) and obtained before signing of the informed consent form (ICF) may be utilized 
for screening or baseline purposes provided the procedures met the protocol-specified 
criteria and were performed within the timeframe defined in the SOA. 
• Beginning with Cycle 2, if the start of a subsequent cycle (e.g., Day 1) is delayed, the 
current cycle length is extended [e.g., the cycle lasts longer than 28 days (PLD Cohort) or 
21 days (MIRV Cohort)]. The SL-172154 doses in that cycle are not delayed (e.g., 
administered on Day 8, 15). In addition, the length of subsequent cycles will remain 
unchanged (i.e., 28 days for PLD Cohort or 21 days for MIRV Cohort). 

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e. 
ECG: 12-lead electrocardiogram (ECG) must be performed at screening to serve as a baseline for comparison in the event of a cardiac AE/SAE during the study. ECG is to be performed 
within 30 days of the first dose of study treatment. 
f. 
ECHO/MUGA: Echocardiograph (ECHO) or multigated acquisition scan (MUGA) is to be performed for all subjects within 30 days of the first dose of study treatment. ECHO/MUGA is to be 
performed every 8 weeks (e.g., C3D1, C5D1, etc.) ±7 days during study treatment and at the PTV. The same methodology should be used at each assessment. 
g. 
Physical Examination: A full physical exam is required only at screening and PTV. Physical exams should be performed per standard of care during the on-treatment period. 
h. 
Vital Signs and Pulse Oximetry: Blood pressure (BP), heart rate (HR), temperature (T) and respiratory rate (RR) must be measured after the subject has been sitting for at least five minutes 
(min). Pulse oximetry will be collected to coincide with vital sign time points noted below. 
1. 
Collect vital signs/pulse oximetry on Day 1 of every Cycle at Predose (within 60 min of starting PLD infusion).  
2. 
Collect vital signs/pulse oximetry during Cycle 1 on Day 8 and Day 15: Predose (within 60 min of starting the SL-172154 infusion), at the end of infusion (EOI; ±5 min) and then 
0.5 hour [hr] (±5 min), 2 hr (±10 min), and 4 hr (±10 min) after end of infusion (EOI) of SL-172154. 
3. 
Collect vital signs/pulse oximetry on Day 8 and 15 of Cycle 2 and in each subsequent cycle: Predose (within 60 min of starting the infusion) and at the end of infusion [EOI] (±5 min) 
of SL-172154. 
4. 
For subjects experiencing any grade IRR, refer to Section 3.7.1.1for schedule of vital signs that should be measured at time of the IRR event. 
i. 
Pregnancy Test: A serum pregnancy test (beta-human chorionic gonadotropin [β-hCG]) or urine pregnancy test must be performed at screening for all FCBP within 4 days of the first dose of 
PLD on Cycle 1 Day 1. Repeat this test every 8 weeks during study treatment (i.e., C3D1, C5D1, C7D1, etc.) and at PTV. Contraception should be continued for at least 6 months (or for the 
duration required by local regulatory guidance) after the last dose of PLD or 3 months after the last dose of SL-172154, whichever is longer. 
j. 
Hematology/ Clinical Chemistry/ Coagulation/ TSH/ Free T4/ Antiviral Testing: will be performed at local laboratories according to the laboratory’s normal procedures. Laboratory tests 
required are provided in Section 6.5.9. 
k. 
Pharmacokinetic (PK) / Anti-Drug Antibody (ADA): Blood sample collection timings for SL-172154 PK/ADA measurement are outlined in Section 6.1.1. Blood volumes required will be 
provided in the Study Lab Manual (SLM). PK/ADA samples should not be collected from infusion port for drug delivery i.e., recommend having a separate line in the opposite arm for sample 
collection. 
1. 
 If a subject discontinues SL-172154 due to IRR and continues on PLD monotherapy, to the extent feasible, an additional ad-hoc ADA sample should be collected at a subsequently 
scheduled visit. 
2. 
All subjects should have just one additional blood sample collected for SL-172154 ADA assessment within 45-90 days of last dose of SL-172154 study treatment. 
l. 
Cytokines and Receptor Occupancy: Blood sample collection timing for cytokine and receptor occupancy assessments are outlined in Section 6.1.1. Blood volumes required will be 
provided in the SLM. Cytokine samples should not be collected from infusion port for drug delivery i.e., recommend having a separate line in the opposite arm for sample collection. 
m. Scans for Disease Assessment and CA-125: Baseline tumor assessments are required for all subjects within 28 days prior to the first dose of study treatment. CA-125 should also be 
obtained at screening within 28 days of first dose of study treatment. Baseline and on-treatment tumor assessments for all tumor types by RECIST v1.1 should include CT with contrast of 
chest, abdomen, and pelvis and other known sites of disease at each time point. Bone scan, PET/CT, and/or MRI should be performed only if clinically indicated. Tumor assessments must be 
performed at screening and at the following intervals until radiologic disease progression: during the last week (Days 22 to predose on Day 29) of every 2 cycles/8 weeks±1 week through 
Cycle 6, every 3 cycles/ 12 weeks±1 week thereafter up to year 2, and then every 6 cycles/ 24 weeks±1 week up to conclusion of the study. Subjects who discontinue study treatment for 
reasons other than disease progression (e.g., AE or withdrawal of consent) will be monitored for radiologic response until start of another anti-cancer therapy, disease progression, withdrawal 
of consent, or death. CA-125 should be measured to coincide with each scheduled radiographic tumor assessment as outlined above with the last required assessment for CA-125 performed 
at the PTV which occurs 30 days (±7 days) after the last dose of study treatment. If there is more than one week delay in any cycle, please perform all the subsequent disease assessments 
per schedule in weeks.  
 
n. 
SL-172154 Administration: Subjects will be monitored prior to and during each SL-172154 infusion. SL-172154 should be administered according to the prescribed dosing schedule in Cycle 
1 to align with the safety DLT assessment and sample (PK, ADA, etc.) collection schedules. Beginning on Cycle 2 Day 8, a window of ±2 days is allowed for scheduled dosing days for drug 
administration (NOTE: each dose must be administered at least 5 days apart from the previous dose). If the start of a subsequent cycle (e.g., Day 1) is delayed, the current cycle length is 
extended (e.g., the cycle lasts longer than 28 days). The doses of SL-172154 in that cycle are not delayed (e.g., administered on Day 8, 15). 

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o. 
PLD Administration: PLD will be administered according to the dosing schedule provided. If the start of a subsequent cycle (e.g., Day 1) is delayed, the current cycle length is extended 
(e.g., the cycle lasts longer than 28 days). In addition, length of subsequent cycles will remain unchanged (i.e., 28 days for PLD Cohort). 
p. 
AE Monitoring: Subjects will be followed continuously for AEs during the study and for 30 days after the last dose of SL-172154. After a subject is discontinued from SL-172154 due to 
progressive disease or for other reasons, any ongoing AE should be followed until resolution (or return to baseline) and documented in the eCRF. If another anti-cancer agent is started within 
30 days after the last dose of SL-172154, only SAEs and AEs that occur prior to the start of the new anticancer therapy should be recorded. In the event of a continuing SAE, the subject 
should be asked to return for follow-up until the SAE has resolved or is deemed to be continuing indefinitely. AEs will be characterized per NCI-CTCAE criteria v5.0 and events recorded in the 
eCRF 
q. 
Post-Treatment Visit (PTV): visit should occur 30 days (±7 days) after the last dose of study treatment. If the subject is going to start a new anticancer therapy before the PTV due date, PTV 
should be conducted prior to starting the new therapy. 
r. 
Survival Follow-Up (SFU): All subjects will be contacted after discontinuing study treatment to collect survival status. Subjects should be contacted every 3 months (±14 days) from the PTV 
until death, withdrawal of consent, lost to follow-up or end of study. Contact may include clinic visit, telephone contact, email or mail, chart review, or obituary notice to document survival 
status. Initiation of any subsequent anti-cancer therapy should also be reported. 
 
 

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Baseline CT or positron emission tomography (PET)/CT or Magnetic resonance imaging (MRI) tumor assessments are required for all subjects within 28 days prior to the first dose of study 
treatment.  
b. 
Assessment Window: With the exception of Screening assessments and unless otherwise specified, assessments performed at ≤ 4-week intervals will have a ±3-day window and 
assessments performed at > 4-week intervals will have a ±1-week window. No assessment window is permitted during the DLT-evaluable period in the dose escalation cohorts. 
c. 
Eligibility Evaluation: Subjects must meet eligibility criteria prior to first dose of study treatment. 
d. 
Blood Phenotyping (ABO/Rh) and DAT: will be performed at local laboratories according to the laboratory’s normal procedures. At screening the following tests will be performed: a) ABO 
and D group (ABO/Rh) type and antibody screen and antibody identification if required, b) DAT, and c) phenotype/genotype for, at a minimum, the minor antigens Rh C/c, E/e, K, Jk, Fy, and 
MNS. If assessment was performed within 21 days of the first dose of study treatment and all requested information is available, this can be used for baseline assessment 
e. 
ECG: 12-lead electrocardiogram (ECG) must be performed at screening to serve as a baseline for comparison in the event of a cardiac AE/SAE during the study. ECG is to be performed 
within 30 days of the first dose of study treatment. 
f. 
ECHO/MUGA: ECHO or MUGA is to be performed at screening to serve as a baseline for comparison in the event of a cardiac AE/SAE during the study. ECHO/MUGA is to be performed 
within 30 days of the first dose of study treatment. The same methodology should be used at each assessment. 
g. 
Ophthalmic Exam: Ophthalmic examinations will be performed in all subjects by an ophthalmologist, optometrist, or other qualified health care provider (“eye care professional”) within 
21 days before C1D1 (baseline) and at PTV (+/- 14 days) and will include the following: manifest refraction, BCVA, IOP assessment, fundoscopy baseline and PTV only), and slit lamp 
examination. If a subject receiving MIRV develops new ocular symptoms of CTCAE > Grade 1, that subject is required to have a complete examination conducted by an eye care 
professional prior to next MIRV administration. All subjects receiving MIRV, regardless of reporting symptoms, are required to have ophthalmological exams including BCVA, IOP, and slit 
lamp exam prior to Day 1 dosing in Cycle 3, 5, and 7. For subjects with ongoing keratitis/keratopathy, a cornea epithelial defect, or ≥ 3-line loss in BCVA after end of treatment with MIRV, an 
ophthalmic examination should be done every 30 days until resolution, stabilization, or return to baseline. Ocular symptoms (blurred vision, etc.) should also be assessed at this time. Subjects 
requiring an ophthalmological examination due to symptoms prior to Cycle 2 or 4 will then proceed to every other cycle (approximately 6 weeks) exams as indicated by findings and do not 
require the routine, asymptomatic exams at Cycle 3, 5, and 7. 
h. 
Physical Examination: A full physical exam is required only at screening and PTV. Physical exams should be performed per standard of care during the on-treatment period. 
i. 
Vital Signs and Pulse Oximetry: Blood pressure (BP), heart rate (HR), temperature (T) and respiratory rate (RR) must be measured after the subject has been sitting for at least five minutes 
(min). Pulse oximetry will be collected to coincide with vital sign time points noted below. 
1. 
Collect vital signs/pulse oximetry on Day 1 of every Cycle at Predose (within 60 min of starting the MIRV infusion); postinfusion vital signs should be collected as clinically indicated 
for potential infusion-related reaction. 
2. 
Collect vital signs/pulse oximetry during Cycle 1 on Day 8 and Day 15: Predose (within 60 min of starting the SL-172154 infusion), at the end of infusion (EOI; ±5 min) and then 
0.5 hour [hr] (±5 min), 2 hr (±10 min), and 4 hr (±10 min) after end of infusion (EOI) of SL-172154. 
3. 
Collect vital signs/pulse oximetry on Day 8 and Day 15 of Cycle 2 and in each subsequent cycle: Predose (within 60 min of starting the infusion) and at the end of infusion [EOI] 
(±5 min) of SL-172154. 
4. 
For subjects experiencing any grade IRR, refer to Section 3.7.1.1 for schedule of vital signs that should be measured at time of the IRR event.  
j. 
Ocular Symptom Assessment: will be performed by the treating physician or other qualified individual before the start of each cycle for all subjects. For subjects receiving MIRV 
reporting new CTCAE > Grade 1 ocular symptoms, treatment will be held until the subject is evaluated by an eye care professional for a complete examination. Refer to Table 8 and Table 9 
for additional details on management of ocular findings on study. 
k. 
Pregnancy Test: A serum pregnancy test (beta-human chorionic gonadotropin [β-hCG]) or urine pregnancy test must be performed at screening for all FCBP within 4 days of the first dose of 
MIRV on Cycle 1 Day 1. Repeat this test every 6 weeks during study treatment (i.e., C3D1, C5D1, C7D1, etc.) and at PTV. Contraception should be continued for at least 3 months after the 
last dose of either SL-172154 or MIRV. 
l. 
Hematology/ Clinical Chemistry/ Coagulation/ TSH/ Free T4/ Antiviral Testing: will be performed at local laboratories according to the laboratory’s normal procedures. Required 
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m. Pharmacokinetic (PK) / Anti-Drug Antibody (ADA): Blood sample collection timings for SL-172154 PK/ADA and MIRV PK/ADA measurement are outlined in Section 6.2.1. Blood volumes 
required will be provided in the Study Lab Manual (SLM). PK/ADA samples should not be collected from infusion port for drug delivery i.e., recommend having a separate line in the opposite 
arm for sample collection. 
1. 
 If a subject discontinues SL-172154 due to IRR and continues on MIRV monotherapy, to the extent feasible, an additional ad-hoc ADA sample should be collected at a 
subsequently scheduled visit.   
2. 
All subjects should have just one additional blood sample collected for SL-172154 ADA assessment within 45-90 days of last dose of SL-172154 study treatment. 
n. 
Cytokines and receptor occupancy: Blood sample collection timing for cytokine and receptor occupancy assessments are outlined in Section 6.2.1. Blood volumes required will be provided 
in the SLM. Cytokine samples should not be collected from infusion port for drug delivery, i.e., recommend having a separate line in the opposite arm for sample collection. 
o. 
Scans for Disease Assessment and CA-125: Baseline tumor assessments are required for all subjects within 28 days prior to the first dose of study treatment. CA-125 should also be 
obtained at screening within 28 days of first dose of SL-172154. Baseline and on-treatment tumor assessments for all tumor types by RECIST v1.1 should include CT with contrast of chest, 
abdomen, and pelvis and other known sites of disease at each time point. Bone scan, positron emission tomography (PET)/CT, and/or MRI should be performed only if clinically indicated. 
Tumor assessments must be performed at screening and at the following intervals until radiologic disease progression: during the last week of every even cycle (Days 16 to Day 22) every 
2 cycles/ 6 weeks±1 week through Cycle 18, every 3 cycles/ 9 weeks±1 week up to Cycle 27, and then every 4 cycles/ 12 weeks±1 week up to conclusion of the study. Subjects who 
discontinue study treatment for reasons other than disease progression (e.g., AE or withdrawal of consent) will be monitored for radiologic response until start of another anti-cancer therapy, 
disease progression, withdrawal of consent, or death. CA-125 should be measured to coincide with each scheduled radiographic tumor assessment as outlined above with the last required 
assessment of CA-125 performed at the PTV which occurs 30 days (±7 days) after the last dose of study treatment. If there is more than one week delay in any cycle, please perform all the 
subsequent disease assessments per schedule in weeks.  
p. 
FRα Expression Screening on Archival Tumor Tissue or Fresh: Archival tissue will be collected from all subjects after signing the prescreening consent (if separate from the main study 
consent). The prescreening period is not time limited. Central testing for positive FRα expression is required for all subjects to determine eligibility. All subjects must submit archival tumor 
tissue block or fresh cut slides from available block (FFPE slides). Those who do not have archival tumor tissue to submit will be required to undergo procedure to obtain a new biopsy using 
low-risk, medically routine procedure during the Prescreening period to confirm eligibility. If the archival tumor tissue does not meet FRα criteria, a new biopsy tumor sample may be submitted 
and used to confirm this criterion. 
q. 
Tumor Biopsy: Paired biopsies for exploratory PD analysis are required (pre- and on-treatment) to be obtained in subjects enrolled in the dose expansion cohort who have tumor accessible 
to core-needle biopsy and for whom there is an acceptable level of risk as per investigator assessment. Biopsies will be obtained at Screening (to evaluate the immune status of the tumor 
before SL-172154 treatment) and on or between Day 16 through Predose on Day 1 of Cycle 2.  
r. 
SL-172154 Administration: Subjects will be monitored prior to and during each SL-172154 infusion. SL-172154 should be administered according to the prescribed dosing schedule in 
Cycle 1 to align with the safety DLT assessment and sample (PK, ADA, etc.) collection schedules. Beginning on Cycle 2 Day 8, a window of ±2 days is allowed for scheduled dosing days for 
drug administration (NOTE: each dose must be administered at least 5 days apart from the previous dose). If the start of a subsequent cycle (e.g., Day 1) is delayed, the current cycle length 
is extended (e.g., the cycle lasts longer than 21 days). The doses of SL-172154 in that cycle are not delayed (e.g., administered on Day 8, 15). 
s. 
MIRV Administration: MIRV will be administered according to the dosing schedule provided. If the start of a subsequent cycle (e.g., Day 1) is delayed, the current cycle length is extended 
(e.g., the cycle lasts longer than 21 days). The length of subsequent cycles will remain unchanged (i.e., 21 days for MIRV Cohort). 
t. 
AE Monitoring: Subjects will be followed continuously for AEs during the study and for 30 days after the last dose of study treatment. After a subject is discontinued from study treatment due 
to progressive disease or for other reasons, any ongoing AE should be followed until resolution (or return to baseline) and documented in the eCRF. If another anti-cancer agent is started 
within 30 days after the last dose of study treatment, only SAEs and AEs that occur prior to the start of the new anticancer therapy should be recorded. In the event of a continuing SAE, the 
subject should be asked to return for follow-up until the SAE has resolved or is deemed to be continuing indefinitely. AEs will be characterized per NCI-CTCAE criteria v5.0 and events 
recorded in the eCRF 
u. 
Post-Treatment Visit (PTV): visit should occur 30 days (±7 days) after the last dose of study treatment. If the subject is going to start a new anticancer therapy before the PTV due date, PTV 
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6.3 
Demographics, Medical History and Screening Assessments 
6.3.1 Informed Consent 
All subjects must sign and date the latest approved version of the Informed Consent form before 
any trial specific procedures are performed and prior to starting study treatment. Refer to 
Section 13.3. 
For the MIRV cohort, subjects will sign a prescreening ICF to allow for central testing of fresh 
or archival tumor tissue by the assay required for study inclusion. If subjects meet entry criteria 
for FRα positivity (PS2+ ≥ 25%) as defined by the Ventana FOLR1 Assay, they may sign the 
main study ICF and can then proceed with remaining screening procedures per the SOA to be 
considered for enrollment to the MIRV cohort. In some cases, the prescreening ICF and main 
study ICF may be merged into a single ICF based on site-specific guidelines or preference. 
Any subject, regardless of whether or not his/her tumor meets the FRα positivity threshold, can, 
at the investigator’s discretion, consent to participate in the PLD cohort provided that she meets 
all other eligibility criteria. 
6.3.2 Eligibility Criteria  
Subjects must meet all the eligibility criteria outlined in the protocol to be eligible for 
participation. 
6.3.3 Subject Demographics 
The age, year of birth, sex, race, and ethnicity (as permitted by local regulation) of each subject 
will be recorded during Screening. 
6.3.4 Medical History 
A complete medical history will be taken during the Screening period. The history will include 
the background and progress of the subject’s malignancy and a description of prior therapies 
received to treat the disease under study and the response to these therapies. Breast cancer gene 
(BRCA) and homologous recombination deficiency (HRD) status will be recorded if known. 
6.3.5 Concomitant Medications and Procedures 
Concomitant medications and procedures will be recorded during the Screening period and 
throughout the study as specified in the SOA. 
6.4 
Evaluation of FRα Expression in Tumor Tissue [MIRV Cohort] 
FRα expression varies with tumor histology, as reported in the literature and demonstrated in 
preclinical studies (MIRV IB). FRα expression in tumor samples will be analyzed using the 
Ventana FOLR1 Assay, an immunohistochemical assay developed to detect FRα in cut slide 
specimens of formalin-fixed paraffin-embedded (FFPE) epithelial ovarian cancer tissue stained 
on the BenchMark ULTRA automated staining instrument using the Ventana OptiView DAB 
IHC Detection Kit. This assay will be conducted at a central laboratory. All subjects being 
considered for enrollment in the SL-172154 + MIRV cohort must submit tumor tissue block or 

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fresh cut slides from available block (FFPE slides) for analysis of FRα expression prior to 
enrollment.  
PS2+ is the terminology used to reference a scoring method based on membrane stain intensity 
level of 2 or greater. The PS2+ scoring method requires the pathologist (at the central laboratory) 
to assess the percentage of tumor cells with moderate (2) and/or strong (3) membrane staining 
compared to the total number of viable tumor cells. To be considered positive for FRα 
expression and eligibility for the study, ≥ 25% of viable tumor cells must exhibit level 2 and/or 
3 membrane staining intensity (see Ventana Assay details within the MIRV IB).  
Only subjects with the required FRα expression levels by Ventana FOLR1 Assay are eligible to 
enroll in the SL-172154 + MIRV Cohort. If a subject wishes to enroll and does not have archival 
material available for analysis, she must undergo a biopsy to assess FRα expression. Subjects for 
whom the only sites of disease would require biopsy procedures considered to be of significant 
risk must not be enrolled to receive MIRV in this study. These procedures include (but are not 
limited to) biopsies of the brain, lung/mediastinum, pancreas, or endoscopic procedures 
extending beyond the esophagus, stomach, or bowel.  
Instructions regarding processing and shipment of all samples for FRα testing are detailed in the 
applicable Study Lab Manual (SLM). 
6.5 
Safety Evaluations 
6.5.1 Physical Examination 
A complete physical examination should be performed by a qualified physician or their designee 
per the schedule described in Section 6.1 and Section 6.2. A full physical exam is only required 
at screening and PTV. The exam should include, at a minimum, assessments of the head and 
neck, eyes, ears, nose throat, skin, thyroid, cardiovascular, respiratory, gastrointestinal and 
neurological systems, lymph nodes and extremities. Height (at screening only) and weight will 
also be measured and recorded. Investigators should pay special attention to clinical signs related 
to previous serious illnesses. Physical exams should be performed per standard of care during the 
on-treatment period. 
6.5.2 ECOG Performance Status 
Subject’s performance status will be assessed using the ECOG performance status tool (see 
Appendix Section 16.1). 
6.5.3 Pulse Oximetry 
Oxygen saturation will be measured with a pulse oximeter at room air without supplementation. 
Refer to the SOA table for details on when to collect pulse oximetry (Section 6.1 and 
Section 6.2). 
6.5.4 Vital Signs 
Vital signs should be assessed in a semi-supine position at rest and will include temperature (T), 
systolic and diastolic blood pressure (BP), heart rate (HR), and respiratory rate (RR). BP and RR 
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without distractions. Refer to the SOA table for details on when to collect vital signs (Section 6.1 
and Section 6.2). 
6.5.5 Electrocardiogram - ECG 
A single 12-lead ECG will be obtained at Screening as outlined in the SOA using an ECG 
machine that automatically calculates HR and measures PR, QRS, QT, and corrected QT (QTc) 
intervals. ECGs should be performed as clinically indicated during the conduct of the study. Any 
treatment emergent abnormalities of clinical consequence should be reported as AEs.  
6.5.6 Echocardiogram (ECHO)/Multigated Acquisition Scan (MUGA) 
An ECHO or MUGA will be obtained at Screening for all subjects as outlined in the SOA 
(Section 6.1 and Section 6.2) to assess LVEF. The same methodology should be used at each 
assessment. For subjects enrolled to receive PLD in either dose escalation or dose expansion, an 
ECHO/MUGA will also be obtained every 8 weeks ± 7 days during the study treatment part of 
the study and also at the PTV. ECHO/MUGAs may also be performed as clinically indicated at 
any time during the conduct of the study. Any treatment emergent abnormalities of clinical 
consequence should be reported as AEs. 
6.5.7 Ocular Symptom Assessment [MIRV Cohort Only] 
Ocular symptom assessment will be performed at the screening visit and before the start of each 
cycle by the treating physician or other qualified individual. For subjects reporting CTCAE 
> Grade 1 ocular symptoms, study drug will be held until the subject is evaluated by an eye care 
professional. The ocular symptom assessment will also be performed at the PTV (Section 6.2). 
All ocular SAEs, and those ocular AEs assessed by the investigator as at least possibly related to 
MIRV, should continue to be followed until they resolve or stabilize, whichever comes first. 
6.5.8 Ophthalmic Examination [MIRV Cohort Only] 
An ophthalmic examination will be performed at the screening visit by an eye care professional 
and will include the following: manifest refraction, BCVA, IOP, fundoscopy, and slit lamp 
examination. Subjects who experience ocular AEs while on study will have a complete 
ophthalmologic examination performed at the emergence of the symptoms and at every other 
cycle thereafter until resolved to baseline or as specified in Table 8 and Table 9. All subjects in 
the MIRV cohort, regardless of the reporting of ocular symptoms and events during treatment, 
will have an ophthalmologic examination including BCVA, IOP, and slit lamp examination 
performed prior to Cycle 3, 5, and 7. All subjects will have an ophthalmologic exam at the PTV 
which will include manifest refraction, BCVA, fundoscopy, IOP, and slit lamp examination. The 
visual acuity assessment should be performed with refraction, rather than corrected or via pin 
hole. Refraction is crucial for cases where subjects report blurred vision or other ocular AEs. 
For subjects with ongoing keratitis/keratopathy, a cornea epithelial defect, or ≥ 3-line loss in 
BCVA after end of treatment with MIRV, an ophthalmic examination should be done every 
30 days until resolution, stabilization, or return to baseline. Ocular symptoms (blurred vision, 
etc.) should also be assessed at this time. Subjects requiring an ophthalmological examination 
due to symptoms prior to Cycle 2 or 4 will then proceed to every other cycle (approximately 
6 weeks) exams as indicated by findings and do not require the routine, asymptomatic exams at 
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6.5.9 Local and Central Clinical Laboratory Assessments 
Refer to the SOA (Section 6.1 and Section 6.2) for the timing and frequency of local laboratory 
tests performed. 
Local Clinical Labs 
Hematology 
Clinical Chemistry 
Hemoglobin  
Hematocrit 
Platelet Count 
Red Blood Cell Count  
White Blood Cell Count 
Mean Corpuscular Volume 
Blood urea nitrogen or Urea 
Creatinine 
Glucose 
Sodium 
Potassium 
Calcium 
Aspartate aminotransferase  
Alkaline phosphatase 
 
Magnesium 
Phosphorus 
Total Protein 
Albumin 
Lactate dehydrogenase 
Bicarbonate or CO2 
Total and direct bilirubin* 
Alanine aminotransferase 
Automated WBC Differential 
Antiviral Testing 
Thyroid 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
Hepatitis B: HbsAg / HBV core Ab 
Hepatitis C: HCV Ab / HCV RNA 
viral load 
Thyroid stimulating hormone 
(TSH)  
Free thyroxine 4 
Coagulation 
Serum/Urine Pregnancy Test  
Prothrombin time and International- normalized ratio 
Activated partial thromboplastin time 
Fibrinogen 
D-Dimer 
β-human chorionic gonadotropin  
Other 
Ferritin and haptoglobin (Screening and Cycle 1 Day 9) 
C-reactive protein (Screening) 
Blood Type and Screen (Screening) 
ABO/Rh 
D, C, E 
Kell, Kidd 
Direct antiglobulin test (DAT) 
Duffy, MNS 
Antibody Screen 
* Both total and direct bilirubin assessments should be performed, but if required per the standard practices, direct 
bilirubin can be omitted when total bilirubin is normal. 
Refer to the SOA (Section 6.1, Section 6.2, Section 6.1.1 and Section 6.2.1) for the timing and 
frequency of central laboratory tests performed. A separate SLM detailing the preparation, 
storage, and shipping requirements for these samples collected during the study will be provided. 
Central Laboratory Tests 
Peripheral Blood 
Pharmacokinetics 
SL-172154 serum concentration (all subjects) 
MIRV serum concentration [MIRV cohort only] 
Immunogenicity 
Anti-drug antibodies (ADA) to SL-172154  
MIRV ADA [MIRV cohort only] 

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Protein analysis (serum) 
Assessment of potential immune regulators such as cytokines 
Receptor occupancy 
Flow cytometry-based measurement for receptor occupancy of SL-172154 on 
CD47 and CD40 in select subsets of peripheral blood mononuclear cells 
Tumor Tissue 
Ventana FOLR1 Assay  
Confirmation of FRα positivity to meet eligibility criterion [MIRV Cohort only] 
IHC on paired tumor biopsies 
IHC/IF to assess changes in immune cell population, expression of targets and 
PD-L1. NGS based analysis of changes in target-associated regulatory networks. 
[MIRV Cohort only]  
6.5.9.1 Ad Hoc Labs for IRR or CRS AEs  
Ad hoc labs should be collected as noted if IRR or CRS events occur. The samples to be 
collected are provided below. 
Ad Hoc Laba,b 
Local Clinical Labs 
Central Labs 
Complete blood count with differential 
Chemistry Panel 
D-Dimer 
Coagulation panel 
Ferritin 
Haptoglobin 
C-Reactive Protein 
Pharmacokinetics (SL-172154 serum concentration) 
Anti-drug antibodies (SL-172154)c 
Cytokines  
Receptor occupancy  
ADA = anti-drug antibody; CRS = cytokine release syndrome; IRR = infusion-related reaction; MIRV = mirvetuximab 
soravtansine; PK = pharmacokinetic(s); PLD = pegylated liposomal doxorubicin 
a) Refer to the Study Lab Manual for sample collection, handling, storage and shipment instructions. PK will be measured with 
each corresponding ADA sample. 
b) Specific biomarker, PK, ADA, and clinical samples should be collected as soon as possible if an event of IRR or CRS.  
c) 
If a subject discontinues SL-172154 due to IRR and continues on PLD or MIRV monotherapy, to the extent feasible, an 
additional ad-hoc ADA sample should be collected at a subsequently scheduled visit. 
6.5.9.2 Pregnancy Testing 
All FCBP subjects must have a negative pregnancy test (serum or urine) at Screening. A separate 
assessment is required if a negative Screening pregnancy test is obtained more than 72 hours 
before the first dose of SL-172154. Subjects with a positive pregnancy test must be excluded 
from the study. Subjects with a negative pregnancy test result must agree to use an effective 
contraception method as described in Appendix Section 16.2.  
6.5.9.3 CA-125 
Serum CA-125 assessments will be performed within 28 days prior to the first dose of PLD or 
MIRV, and at each radiologic tumor assessment (Section 6.1 and Section 6.2). CA-125 should be 
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6.5.9.4 Blood type and Screen (ABO/Rh) and DAT 
SL-172154 does bind RBCs but has not been shown to cause hemolysis in non-human primates. 
However, treatment with SL-172154 may obscure the assessment of RBC phenotyping due to 
expected coating of SL-172154 on the RBC membrane. Thus, blood phenotyping, type and 
screen (ABO/Rh), and DAT should be performed at screening before exposure to SL-172154. At 
screening the following testing should be performed: 1) ABO and D group (ABO/Rh) type and 
antibody screen and antibody identification if required; 2) DAT; and 3) phenotype/genotype for, 
at a minimum, the minor antigens Rh C/c E/e, K, Jk, Fy and MNS. If the subject has had 
transfusion within 21 days of Cycle 1 Day 1 (e.g., Screening period) and the type/screen/DAT 
information is known, this information can be reported in the EDC as baseline and the 
assessment does not need to be repeated. However, if the requested information is unknown to 
the investigator/site staff, then the assessment is to be performed during the Screening period.  
6.6 
Pharmacokinetics 
The sampling schedule for PK assessment of SL-172154 was determined based on observed PK 
in the Phase 1 trial (SL03-OHD-101) of SL-172154 monotherapy administered to subjects with 
ovarian cancer. The sampling schedule for PK assessment of SL-172154 is outlined in Section 
6.1.1 and Section 6.2.1. 
The sampling schedule for PK assessment of MIRV is outlined in Section 6.2.1. If a dose delay 
occurs, then PK and PD assessments should be performed on the actual day of MIRV 
administration, and not on the original scheduled administration day. 
6.7 
Anti-Drug Antibody and Neutralizing Antibody Assessments 
Presence of ADA for SL-172154 will be assessed in samples collected according to the SOA 
(Section 6.1.1 and Section 6.2.1). Samples will also be collected for assessing the neutralization 
capacity for confirmed positive ADA samples. All subjects should have an additional blood 
sample collected for ADA/neutralizing antibodies and PK assessment within 45 to 90 days of last 
dose of study treatment. 
The immunogenic potential of MIRV (MIRV ADA, neutralizing antibodies) will also be 
assessed in samples collected according to the SOA (Section 6.2.1). 
6.8 
Cytokine Analysis 
Levels of serum cytokines may provide context to AEs observed in subjects following infusion 
of SL-172154 and may act as PD markers of activity. Refer to Section 6.1 and Section 6.2 for the 
schedule of the sample collection for these analyses. 
6.9 
Receptor Occupancy Analysis 
Receptor occupancy of SL-172154 on CD47 and CD40 in peripheral blood cells will be 
measured by flow cytometry. This analysis will provide evidence that SL-172154 is engaging the 
expected targets and allows receptor occupancy to be calculated and assessed across dose groups. 
Refer to Sections 6.1, 6.1.1, 6.2 and 6.2.1 for the schedule of the sample collection for these 
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6.10 
Tumor Biopsy 
6.10.1 Baseline and On-Treatment Fresh Tumor Biopsies [MIRV cohort only] 
The efficacy of cancer immunotherapy is conditioned by the infiltration of tumors by activated 
tumor-specific T cells. The activity of these T cells will be affected by the immunosuppressive 
environment in the tumor (e.g., T-regulatory cells, and suppressive myeloid cells such as 
myeloid-derived suppressor cells and M2 macrophages). Therefore, the direct evaluation of the 
“immune landscape” inside the tumor is of great value for understanding the mechanism of 
action of SL-172154 and optimizing cancer immunotherapy. IHC analyses will be performed on 
the fresh tumor samples. The immune infiltrate of the tumor will be assessed by visualizing and 
assessing the phenotype of cells in the tumor micro-environment by IHC. Additionally, 
treatment-related changes in the spatial distribution of immune cells within the TME has also 
been found to be linked to the response to immunotherapies and can be evaluated by these 
procedures. Changes in the immune profile of the tumor from baseline to on-treatment could also 
be used to predict clinical response or validate the mechanism of the immune response to 
SL-172154 in the context of cytotoxic agents. For each time point, three core needle biopsies 
should be obtained for research studies (see SLM for details).  
Baseline and on-treatment biopsies for exploratory PD analysis (to evaluate the immune status of 
the tumor before and on treatment) are required for all subjects in the SL-172154 + MIRV dose 
expansion cohort for whom the biopsy has minimal risk. Biopsy must be obtained at the 
following timepoints (the expected time of an immune response to SL-172154 therapy): 
• SL-172154 + MIRV Cohort: Screening/baseline and an on-treatment biopsy performed at 
Cycle 1 on or between Day 16 through predose on Day 1 of Cycle 2 in the MIRV cohort  
It is recommended that the biopsies are obtained from non-target lesions. The same lesion should 
be biopsied pre- and post-treatment. Where possible lymph node biopsies should be avoided as 
reliable measure of tumor infiltrating lymphocytes (or their activation) in a background of 
non-tumor lymphoid tissue is challenging. 
Biopsy Collection Safety Considerations and Procedure 
For a given subject, 3 core needle biopsies of the selected tumor lesion should be obtained at the 
time points noted in the SOA (Section 6.2). Please refer to the SLM for further processing and 
shipping instructions.  
Subjects who would require biopsy procedures considered to be of significant risk must not 
undergo paired tumor biopsy collection. These procedures include (but are not limited to) 
biopsies of the brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond 
the esophagus, stomach, or bowel. 
Contraindications to percutaneous biopsy: 
• Significant coagulopathy or anticoagulation treatment that cannot be adequately 
corrected.  
• Severely compromised cardiopulmonary function or hemodynamic instability. 
• Lack of a safe pathway to the lesion.  
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If a lesion is deemed appropriate for biopsy with minimal risk (no more than 2% risk of serious 
complication requiring hospitalization) to the subject by agreement between the investigators and 
Interventional Radiology, an attempt at biopsy should be made.  
The use of imaging to facilitate biopsies will be decided by members of the Interventional 
Radiology team at the clinical site and may include ultrasound, CT scan, or magnetic resonance 
imaging (MRI). Should CT scan be needed for biopsy, the number of scans for each procedure 
will be limited to the minimum number needed to safely obtain a biopsy. Tumor biopsies and 
local anesthesia will be performed only if they are of low-risk (< 2% major complication rate) to 
the subject as determined by the investigators and interventional radiologist. 
6.11 
Assessment of Anti-Tumor Activity 
The primary analysis of anti-tumor activity will be assessed according to RECIST v1.1 for solid 
tumors using CT with contrast of chest, abdomen, and pelvis and other known sites of disease. 
Bone scan, positron emission tomography (PET)/CT, and/or MRI should be performed only if 
clinically indicated. Tumor assessments must be performed at screening and at the following 
intervals until radiologic disease progression:  
• SL-172154 + PLD: during the last week (Day 22 to predose on Day 29) of every 2 
cycles/ 8 weeks±1 week through Cycle 6, and every 3 cycles/ 12 weeks ±1 week 
thereafter up to year 2 and then every 6 cycles/ 24 weeks ±1 week up to study conclusion. 
If there is more than one week delay in any cycle, please perform all the subsequent 
disease assessments per schedule in weeks.  
• SL-172154 + MIRV: during the last week (Day 16 to predose on Day 22) of every 
2 cycles / 6 weeks±1 week through Cycle 18, and every 3 cycles/ 9 weeks±1 week 
thereafter through Cycle 27, and every 4 cycles/ 12 weeks±1 week until study conclusion. 
If there is more than one week delay in any cycle, please perform all the subsequent 
disease assessments per schedule in weeks.  
 
Refer to Section 8 for additional details. 
6.12 
Unscheduled Visit  
Additional visits can be performed as appropriate and at the discretion of the investigator. 
Assessments completed during unscheduled visits will be captured in the eCRF. Clinical 
hematology and chemistry labs may be collected if considered necessary for subject assessment. 
All AEs or SAEs reported by the subject or observed by the investigator should be documented 
and reported; this includes relevant medical information gathered during the unscheduled visit 
related to clinical assessment of AEs or SAEs (Section 7.4). 
7. 
SAFETY ASSESSMENTS  
Safety surveillance reporting of AEs commences when a subject has signed the ICF, throughout 
the course of treatment, and up to 30 days after the last dose of investigational drug. If another 
anti-cancer agent is started within 30 days after the last dose of study medications, only SAEs 
and AEs that occur prior to starting the new anticancer therapy should be recorded. After signing 
of informed consent, but prior to initiation of study medications, only AEs (both serious or 

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nonserious) caused by a protocol-mandated procedure will be collected (e.g., AEs related to 
invasive procedures such as biopsies). All observed or volunteered AEs (serious or non-serious) 
and abnormal laboratory test findings, if applicable, whether suspected to have a causal 
relationship to study treatment or not will be recorded in the subject medical record and in the 
eCRF. For all AEs, sufficient information will be pursued and/or obtained to permit an adequate 
determination of seriousness and outcome of the event (i.e., whether it should be classified as a 
SAE or not) and an assessment of the causal relationship between the AE and SL-172154, PLD, 
or MIRV. All AEs (both serious and nonserious) will be followed in accordance with good 
medical practice until resolution, return to baseline, subject is lost to follow-up, the AE is 
otherwise explained, or it is deemed that further recovery is unlikely. Following the PTV, 
subjects with ongoing drug-related AEs and SAEs should be followed until resolution to baseline 
or stabilization of these events, unless the subject withdraws from the study or starts another 
anti-cancer treatment. Follow-up will stop when the subject begins another anti-cancer treatment. 
Refer to Section 7.4 for documentation and reporting of AEs. 
7.1 
Definitions for Safety Parameters 
Event 
Definition 
Adverse Event (AE) 
The AE observation period starts at the time of signing informed consent and includes baseline 
or washout periods, even if no study treatment has been administered.  
An AE is defined as any untoward medical occurrence in a subject to whom the drug has been 
administered, regardless of whether the event is considered related to that product. An AE is 
also defined as an undesirable medical condition due to a study-related procedure. 
Adverse Reaction (AR) 
AR is an untoward and unintended response in a subject to IP. A causal relationship between a 
trial medication and an AE is at least a reasonable possibility, i.e., the relationship cannot be 
ruled out. 
Serious Adverse Event 
(SAE) or Serious Adverse 
Reaction (SAR) 
An AE or suspected AR that is considered "serious" if, in the view of either the investigator or 
Sponsor, it results in any of the following outcomes:  
• Death (Note: death is an outcome not an event) 
• A life-threatening AE (an event in which the subject was at risk of death at the time of the 
event; it does not refer to an event which hypothetically might have caused death if it were 
more severe) 
• Inpatient hospitalization or prolongation of existing hospitalization 
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions 
• A congenital anomaly/birth defect.  
• Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, 
blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse. 
Laboratory test(s) that 
meet definition of an AE or 
SAE: 
• 
Any laboratory test result that meets the definition of an AE or SAE or requires holding or 
discontinuation of IP, or requires corrective therapy, must be documented appropriately. 
• 
Ad hoc labs should be collected as noted in Section 6.5.9.1 if an event of IRR or CRS 
occurs. 
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the subject’s medical record and 
recorded in the AE section of the eCRF. The laboratory reports must be filed with the source 

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Event 
Definition 
documents. Clinically significant abnormal laboratory findings are those which are not 
associated with the underlying disease, unless judged by the investigator to be more severe 
than expected for the subject's condition. 
All laboratory tests with clinically significant abnormal values during participation in the study 
should be repeated until the values return to normal or baseline or are no longer considered 
clinically significant by the investigator. 
If such values do not return to normal/baseline within a period judged reasonable by the 
investigator, the etiology should be identified, and the results recorded in the eCRF.  
If laboratory values from non-protocol specified laboratory assessments performed at the 
institution’s local laboratory require a change in subject management or are considered 
clinically significant by the investigator (e.g., AE, SAE or dose interruption), then the results 
must be recorded in the eCRF.  
Unexpected Adverse 
Reaction 
An adverse reaction (causality related Adverse Event), the nature, severity, or outcome of 
which is not consistent with the reference safety information section of the SL-172154 IB, 
MIRV IB or the current PLD prescribing information. Product reference safety information is 
contained in the current Guidance for Investigators in the SL-172154 and MIRV IBs provided 
to the investigator by the Sponsor and the current PLD label prescribing information. 
Suspected Unexpected 
Serious Adverse Reaction 
(SUSAR) 
Suspected Adverse Reaction (causality related AE) that is serious and unexpected. 
7.1.1 Events not Qualifying as AEs/SAEs 
The following are not considered to be AEs or SAEs: 
• Medical or surgical procedures (e.g., endoscopy, appendectomy). The condition that 
leads to the procedure is considered the AE. 
• Elective procedures, planned hospitalizations, and procedures for treatment of conditions 
noted in the subject’s medical history (present prior to signing the ICF) that have not 
worsened are not considered AEs.  
• Situations where an untoward medical occurrence did not occur (i.e., admission to 
hospital for social circumstances). 
• Anticipated day-to-day fluctuations of pre-existing medical conditions that were present 
at start of study. These conditions are considered part of the subject’s medical history and 
must be adequately documented on the appropriate page of the eCRF. 
• Clear progression of disease under study should not be reported as an AE or SAE unless 
the investigator considers the progression of underlying neoplasia to be atypical in its 
nature, presentation, or severity from the normal course of the disease in a particular 
subject. Signs and symptoms that are clearly consistent with the expected progression of 
the underlying cancer should not be reported as an AE, and hospitalizations due to the 
progression of cancer do not necessarily qualify for an SAE. Deaths that are clearly 
determined to be due to disease progression should not be reported as AEs/SAEs. 
• In the case where the medical condition is known when the subject enters the trial, only 
worsening (increased frequency or intensity of the episodes or attacks) will be 
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episodes enable diagnosis of a chronic disease, the episodes will be grouped together in 
the eCRF, and the diagnosis will be clearly described. 
• Laboratory abnormalities: An isolated, out-of-range laboratory result in the absence of 
any associated clinical finding may or may not be considered an AE; the investigator’s 
evaluation should be based on a consideration of the overall clinical context. 
7.2 
Classification of an Adverse Event 
All measures required for AE management and the ultimate outcome of the event will be 
recorded in the source document and reported to the Sponsor. 
7.2.1 Assessment of Severity  
The descriptions and grading scales found in the revised NCI-CTCAE version 5.0 will be 
utilized for AE reporting. A copy of these criteria can be downloaded from the website: 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm. 
For AEs not included in the NCI-CTCAE v5.0 grading system, the following guidelines will be 
used to describe severity: 
• Grade 1: mild 
• Grade 2: moderate 
• Grade 3: severe 
• Grade 4: life-threatening 
• Grade 5: death 
NOTE: A distinction should be drawn between serious and severe AEs. Severity is an estimate 
or measure of the intensity of an AE, while the criteria for serious AEs are indications of adverse 
subject outcomes for regulatory reporting purposes. A severe AE need not necessarily be 
considered serious, and a serious AE need not be considered severe. 
7.2.2 Assessment of Causality  
The clinician’s assessment of an AE's relationship to study treatment is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the study. 
If there is any doubt as to whether a clinical observation is an AE, the event should be reported. 
All AEs must have their relationship to the administered treatment (SL-172154 and PLD or 
MIRV) assessed. In a clinical trial, the drug(s) being administered must always be suspect. 
Investigators should consider alternative causes such as natural history of the underlying disease, 
concomitant medications, comorbidities, and other risk factors when making an assessment. 
To help assess causality, the following guidelines are used.  
• Related – There is reasonable causal relationship between the IP(s) being administered 
and the AE. The event responds to interruption of study drug and recurs with re-
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• Possibly Related - There is reasonable causal relationship between the IP(s) being 
administered and the AE. Information on whether the event responds to interruption of 
administered treatment and/or re-challenge is lacking or unclear. 
• Unlikely Related - There is a temporal relationship to administration of the IP(s) in the 
study, but there is not a reasonable causal relationship between the IP(s) being 
administered and the AE (i.e., the AE is doubtfully related to SL-172154, PLD, or 
MIRV). 
• Not Related – There is not a temporal relationship to administration of the IP(s) in the 
study (e.g., too early, too late, or SL-172154, PLD or MIRV not taken), or there is a 
reasonable causal relationship between another drug, concurrent disease, or circumstance 
and the AE. 
7.2.3 Expectedness 
The Sponsor will be responsible for determining whether an AE is expected or unexpected.  
• Unexpected - An AE will be considered unexpected if the nature, severity, or frequency 
of the event is not consistent with the safety information in Guidance for Investigators of 
the current SL-172154 IB or MIRV IB and the current PLD prescribing information. 
"Unexpected," as used in this definition, also refers to AEs or ARs that are mentioned in 
the IB or prescribing information as occurring with a class of drugs or as anticipated from 
the pharmacological properties of the drug not specifically mentioned as occurring with 
SL-172154, MIRV or PLD. 
• Expected - AEs that are common and known to occur for SL-172154, MIRV or PLD. 
Expectedness refers to the awareness of AEs previously observed, not on what might be 
anticipated from the properties of SL-172154, MIRV and PLD. 
7.3 
 Timing for Event Assessment and Follow-Up 
All AEs occurring while on study must be documented appropriately regardless of relationship. 
All AEs will be followed to adequate resolution. The occurrence of an AE or SAE may come to 
the attention of study personnel during study visits and interviews of a study subject presenting 
for medical care, or upon review by a study monitor.  
Any medical condition that is present at the time that the subject is screened will be considered 
as baseline (e.g., medical history) and not reported as an AE.  
7.4 
Procedures for Recording and Reporting of Adverse Events  
Event 
Reporting Procedures 
Adverse Event 
Subjects will be followed continuously for AEs during the study and for 30 days after the last 
dose of SL-172154. After a subject is discontinued from SL-172154 due to progressive disease 
or for other reasons, any ongoing AE should be followed until resolution (or return to 
baseline) and documented in the eCRF, regardless of whether the event(s) is attributed to trial 
medication. If another anti-cancer agent is started within 30 days of the last dose of 
SL-172154, only AEs and SAEs that occur before the new anticancer therapy should be 
recorded. The following information will be recorded: description, date of onset and end date, 
severity, assessment of relatedness to trial medication, and action taken. Follow-up 

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7.6 
Reporting of Events to Sponsor 
The following events should also be reported to the Sponsor within 24 hours of knowledge of the 
event: 
• An overdose of SL-172154 or MIRV 
• Suspected transmission of an infectious agent due to contamination of drug product 
• Other events related to misuse of SL-172154 or MIRV 
7.7 
Study Halting Rules 
Administration of SL-172154 will be halted if a fatal SAE related to SL-172154 is reported to 
the Sponsor. The Sponsor will inform the investigators immediately if such an event is reported. 
Screening and new study enrollment will be stopped. The Sponsor will convene an ad hoc 
meeting of the SMC to review the SAE and overall safety profile and provide recommendations. 
The study Sponsor will inform the regulatory authorities (i.e., FDA, European Medicines Agency 
(EMA), Health Canada, etc.) of the temporary halt and the disposition of the study. 
7.8 
Safety Oversight 
An SMC will be implemented in this study and will consist of investigators and Sponsor 
representatives. Study progress and safety data will be reviewed by the SMC throughout the 
conduct of the study. During the study while subjects are receiving treatment with SL-172154 
+MIRV or PLD, SMC meetings will be held to review relevant data with the investigators or 
designees during both dose escalation and dose expansion. These meetings will be held once a 
month (or more frequently if required) during dose escalation to share safety data and 
communicate results of ongoing analyses provided subjects have been enrolled and data are 
available to be reviewed. The SMC will operate in accordance with the SMC charter which will 
define roles and accountabilities as well as the process for safety review and meeting frequency. 
As dose escalation proceeds, the SMC will take into account data from Study SL03-OHD-105 as 
well as other knowledge obtained for SL-172154, including the data from the monotherapy 
SL-172154 dose escalation in Study SL03-OHD-101. Safety and PK data from Study 
SL03-OHD-101 will be shared with the SMC for SL03-OHD-105. Doses explored in 
SL03-OHD-105 will not exceed the highest dose cleared for safety in SL03-OHD-101. All dose 
escalation or safety decisions made by the SMC will be documented in writing with copies 
maintained at each site and in the Trial Master File at the Contract Research Organization. Based 
on the severity of the DLTs, indicators of potential anti-tumor activity, and other factors, a 
recommendation on whether to modify the dose and/or study design or continue enrollment will 
be made by the Sponsor collaboratively with input from the SMC. Regulatory authorities and 
IRBs/IECs will be notified of any decisions to prematurely halt the study or subject enrollment. 
See Section 14.1 for details on safety meetings.  
8. 
ANTI-TUMOR ACTIVITY ASSESSMENTS 
Although the clinical benefit of SL-172154 has not yet been established, the intent of offering 
SL-172154 is to provide a possible therapeutic benefit, and thus the subject will be carefully 
monitored for tumor response and symptom relief in addition to safety and tolerability. For the 
purposes of this study, subjects should be evaluated for response as outlined in the SOA. All 
subjects who underwent the first post-baseline disease assessment at the 8-week (PLD Cohort) or 

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6-week (MIRV Cohort) time point or progress or die before the first post-baseline disease 
assessment will be considered evaluable for response. 
Refer to the SOA (Section 6.1 and Section 6.2) and Section 6.11 for the schedule of disease 
assessments. More frequent disease assessments may be performed at the discretion of the 
investigator as clinically indicated. CA-125 levels should be measured concurrently with 
radiologic tumor assessments (Section 6.5.9.3) and reported in EDC however response 
determination will be solely based on radiologic assessment in this study.  
8.1 
Disease Assessment  
Imaging studies, preferably by contrasted computed tomography scan, for disease assessment of 
chest, abdomen and pelvis and all other sites of known disease will be performed at baseline and 
at the following intervals until disease progression as described in Section 6.11.  
PET-CT, MRI, and/or bone scan should be performed as clinically indicated. The same imaging 
modality used at baseline should be employed subsequently. All post-baseline assessments 
require imaging of disease sites identified by baseline scans. Confirmatory scans should be 
performed at least 4 weeks (> 28 days) after initial documentation of an objective response. 
Contrast enhanced imaging is required unless the subject is precluded from receiving contrast 
(e.g., hypersensitivity, renal impairment).  
If study treatment is withdrawn for reasons other than disease progression, radiographic disease 
assessments should continue as per the SOA until documented disease progression, the start of 
new anti-cancer therapy, withdrawal of consent or death. 
8.1.1 Assessment of Response 
Investigator-assessed response will be evaluated in this study using RECIST v1.1 [Eisenhauer, 
2009]. The RECIST v1.1 guideline is included in this document (Appendix Section 16.5). 
8.2 
Criteria for Treatment Beyond Initial Progression  
Subjects will be permitted to continue study treatment beyond initial progressive disease 
provided the subject does not have clinical symptoms of progression, is tolerating study 
treatment, has experienced no decline in their ECOG performance status and is gaining clinical 
benefit as assessed by the investigator. The subject must be made aware of the potential benefits 
and risks of continuing the study treatment in the setting of progressive disease by signing a 
separate written informed consent. 
The subject may continue to be treated beyond disease progression until one of the following 
criteria is met: 
• Develops clinical symptoms or signs such that the benefit-risk ratio of continuing therapy 
is no longer justified. 
• Experiences rapid progressive disease with risk to vital organs or critical anatomical sites 
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Population 
Description 
DLT-Evaluable 
All subjects enrolled in the dose escalation cohorts who receive at least 50% of the 
scheduled doses of SL-172154 and 1 dose of PLD or MIRV and complete the safety 
follow-up through the DLT evaluation period or experience any DLT during the DLT 
evaluation period. DLT-evaluable subjects will be used to guide dose escalation and to 
determine the MTD or MAD. 
Response-Evaluable  
Subjects in the All Treated Population who have either had at least one post-baseline 
disease assessment or who have discontinued study treatment due to disease 
progression or death before any post-baseline disease assessment.  
Pharmacokinetic 
Subjects in All Treated Population from whom at least one post-baseline PK sample is 
obtained and analyzed 
Pharmacodynamic 
Subjects in the All Treated Population for whom a baseline and at least one on-treatment 
PD sample is obtained and analyzed.  
9.2.2 Data Analysis During Dose Escalation 
During the dose escalation, the number of subjects with DLTs will be determined after each 
cohort of approximately 3 subjects has been evaluated for DLT. The summary of DLTs will be 
based on the DLT-Evaluable Population; the number of subjects with DLTs will be summarized 
by dose level for each of the combination dose escalation cohorts. Selected AE summary tables 
and listings may be provided during dose escalation to support dose escalation decisions. 
9.2.3 General Data Analysis Consideration 
Tabular summaries will be presented by dose levels/cohorts and total number of subjects in each 
of the combination regimens. Categorical data will be summarized by the number and percentage 
of subjects in each category. Continuous variables will be summarized by descriptive statistics.  
As it is anticipated that accrual will be spread across centers and summaries of data by center 
would be unlikely to provide valuable information, data from all participating centers will be 
pooled prior to analysis. All data up to the time of study completion/withdrawal from study will 
be included in the analysis for each subject, regardless of duration of treatment. 
9.2.4 Safety Analyses 
The safety evaluation for each combination regimen will be based on the All-Treated Population 
and the DLT evaluation will be based on the DLT-evaluable population.  
DLTs will be summarized by dose level/regimen for combination dose escalation cohorts. 
Frequency tables by dose levels will be used to describe safety and tolerability parameters such 
as: AEs, SAEs, fatal AEs and AEs leading to discontinuation of SL-172154, PLD or MIRV. 
Changes in toxicity grade for safety assessments (e.g., laboratory parameters, etc.) will also be 
summarized. Figures may also be presented where appropriate. AEs will be mapped to a Medical 
Dictionary for Regulatory Activities (MedDRA) preferred term and system organ classification. 
Concomitant medications will be coded using the World Health Organization Drug Dictionary. 
All toxicities except CRS and ocular AEs will be graded according to the NCI CTCAE v5.0. 
CRS will be graded per the ASTCT Consensus Grading Criteria for CRS (described in 

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Section 3.7.1.2); ocular AEs for the MIRV cohort will be graded per the tables provided in 
Appendix Section 16.6.  
Maximum Tolerated Dose: 
The MTD will be estimated using isotonic regression (based on the DLTs observed in 
DLT-evaluable subjects). Specifically, the MTD is the dose for which the isotonic estimate of the 
DLT rate is closest to the target DLT rate of 30% among all dose with the isotonic estimate of 
DLT rate ≥ 25%. If two or more doses tie for the smallest difference, the following rules will be 
performed: 
• If the estimated DLT rate < 30% for all doses, then select the higher dose among the tied 
doses; 
• If the estimated DLT rate for the tied doses are a combination of < 30% and > 30% for all 
doses, then select the higher dose among the tied doses; 
• If the estimated DLT rate > 30% for all doses, then select the lower dose among the tied 
doses; 
A Maximum Administered Dose (MAD) will be reported if the isotonic estimate of DLT rate is 
less than 25% for all dose levels. Otherwise, an MTD will be reported. 
9.2.5 Efficacy Analyses 
Anti-tumor activity data will be summarized by dose level and all subjects for each combination 
regimen in the All Treated population and Response-Evaluable population. For the MIRV 
combination regimen, the anti-tumor activity will be summarized for each of the three tumor 
FRα expression subgroups: high (PS2+ ≥ 75%), medium (PS2+ ≥ 50% and < 75%), and low 
(PS2+ ≥ 25% and < 50%). The ORR and CBR based on investigator-assessed response per 
RECIST v1.1 will be estimated along with a 95% confidence interval using the exact probability 
method. Change from baseline sum of diameters for target lesions will be provided for each 
subject. DOR and TTR will be evaluated, using the Kaplan-Meier method, for the subgroup of 
subjects with a confirmed response. The Kaplan-Meier method will be used to estimate the 
PFS/OS curve and PFS/OS rate at time point of interest.  
9.2.6 Pharmacokinetic Analysis 
Plasma concentrations for SL-172154 will be summarized using tabular and graphical format. 
SL-172154 PK parameters will be derived from the plasma concentration vs. time curve (using 
actual dose and collection times) using Phoenix WinNonlin version 6.3 or later (Pharsight 
Corp.), as data permits. SL-172154 PK parameters will be summarized and analyzed using 
appropriate statistical methods. The relationship between PK exposure parameters and ADA, 
safety, efficacy, and PD endpoints may be explored, as data permit, using appropriate graphical 
and statistical methods. 
Plasma concentrations for MIRV will also be summarized. All concentration data will be 
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Table 14 
 
Serum SL-172154 PK Parameters 
Parameter 
Description 
Cmax 
Maximum observed concentration 
Tmax 
Time of maximum observed concentration 
AUClast 
The area under the serum concentration time curve, from time 0 to the last 
quantifiable concentration, calculated by a combination of linear and logarithmic 
trapezoidal methods (Linear up/log down method). 
AUC0-t 
The area under the serum concentration time curve, from time 0 to time=t, calculated 
by a combination of linear and logarithmic trapezoidal methods (Linear up/log down 
method). 
AUC0-inf 
Area under the serum concentration time curve from time 0 extrapolated to infinity, 
calculated as AUClast + Clast/terminal elimination rate constant (λz). Reliability of 
AUC0-inf values is contingent on the percent of the total area obtained by 
extrapolation: 
AUC0-inf values with < 20% of the total area coming from Clast/λz are considered 
acceptable. 
Any exceptions to the above procedures will be clearly documented/justified in the 
PK report. 
AUCtau 
The area under the serum concentration time curve, over the dosing interval 
following doses > first dose, calculated by a combination of linear and logarithmic 
trapezoidal methods (Linear up/log down method) 
%AUCext 
Percentage of AUC0-inf due to extrapolation from Tlast to infinity 
t½ 
Terminal elimination half-life, estimated using the equation [ln(2)/λz] 
CL 
Clearance; calculated as Dose/AUC0-inf 
Vz 
Volume of distribution; calculated as Dose/(λz * AUC0-inf) 
Vss 
Volume of distribution at steady state 
PK parameters based on the elimination phase (e.g., AUC0-inf, t½, CL, Vz) will be calculated and reported as data allow. 
9.2.6.1 Immunogenicity Analysis 
The immunogenic potential of SL-172154 will be assessed by summarizing the 
number/proportion of subjects with positive and negative postdose ADA titer by SL-172154 dose 
level. ADA titer, neutralization capacity, duration of ADA response and whether ADA are 
transient or persistent will be listed for each individual and summarized by SL-172154 dose 
level. As data permit, the effect of ADA on PK and PD parameters, safety and efficacy will be 
explored using appropriate graphical and statistical methods. 
The immunogenic potential of MIRV will also be assessed. 
9.2.7 Pharmacodynamics Analysis 
The PD data analysis will be based on the PD population. PD biomarkers values will be 
summarized descriptively by SL-172154 dose level for each combination regimen.  

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10. 
CLINICAL MONITORING 
 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects 
are protected, that the reported trial data are accurate, complete, and verifiable, and that the 
conduct of the trial complies with the currently approved protocol/amendment(s), with GCP, and 
with applicable regulatory requirement(s).  
• Monitoring for this study will be performed by Sponsor or its designees  
• Details of clinical site monitoring are documented in a Clinical Monitoring Plan (CMP). 
The CMP describes in detail who will conduct the monitoring, at what frequency 
monitoring will be done, at what level of detail monitoring will be performed, and the 
distribution of monitoring reports.  
• Independent audits will be conducted by the Sponsor or designee of the Sponsor to ensure 
GCP and monitoring practices are performed consistently across all participating sites 
and that monitors are following the CMP.  
11. 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA AND DOCUMENTS 
11.1 
Source Data 
Source documents are where data are first recorded, and from which subjects’ eCRF data are 
obtained. These include, but are not limited to, hospital records (from which medical history and 
previous and concurrent medication may be summarized into the eCRF), clinical and office 
charts, laboratory and pharmacy records, diaries, microfiches, radiographs, and correspondence. 
11.2 
Access to Data 
The study monitor, other authorized representatives of the Sponsor, representatives of the 
IRB/IEC or regulatory authorities may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) and pharmacy records for the subjects in this study. The clinical study site will permit 
access to such records to permit study-related monitoring, audits and inspections.  
The study subject’s contact information will be securely stored at each clinical site for internal 
use during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by local IRB/IEC and Institutional regulations.  
Study subject research data, which is for purposes of statistical analysis and scientific reporting, 
will be transmitted to and stored by the Sponsor. This will not include the subject’s contact or 
identifying information. Rather, individual subject’s and their research data will be identified by 
a unique study identification number. The study data entry and study management systems used 
by clinical sites and by Sponsor research staff will be secured and password protected. At the end 
of the study, all study databases will be de-identified and archived by the Sponsor.  
11.3 
Data Recording and Record Keeping 
All trial data will be entered on electronic data entry systems that are validated and are 
maintained in accordance with Standard Operating Procedures. The subjects will be identified by 
a unique trial specific number and/or code in any database. Subject name and any other 
identifying detail will NOT be included in any trial data electronic file. 

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12. 
QUALITY ASSURANCE PROCEDURES 
The trial will be conducted in accordance with the current approved protocol, GCP, relevant 
regulations and standard operating procedures. Regular monitoring will be performed according 
to GCP. Data will be evaluated for compliance with the protocol, GCP, and accuracy in relation 
to source documents. Following written standard operating procedures, the monitors will verify 
that the conduct of the clinical trial and data generated, are documented, and reported in 
compliance with the protocol, GCP and the applicable regulatory requirements. 
13. 
ETHICS/PROTECTION OF HUMAN SUBJECTS 
13.1 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for 
the Protection of Human Subjects of Research codified in 45 Code of Federal Regulations (CFR) 
Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or the ICH E6 or in compliance with the 
Declaration of Helsinki, CIOMS, International Ethical Guidelines for Biomedical Research 
Involving Human Subjects (2002), or ethical policy statement specific to the country, whichever 
provides the most protection to human subjects. 
13.2 
Institutional Review Board/Independent Ethics Committee 
The protocol, ICF(s), recruitment materials, and all subject materials will be submitted to the 
IRB/IEC for review and approval. Approval of both the protocol and the consent form must be 
obtained before any subject is screened and enrolled. Any amendment to the protocol will 
require review and approval by the IRB/IEC before the changes are implemented to the study. 
All changes to the consent form will be IRB/IEC approved; a determination will be made 
regarding whether previously consented subjects need to be re-consented. 
13.3 
Informed Consent Process 
13.3.1 Consent/Assent and Other Informational Documents Provided to Subjects 
The investigator or his/her representative will explain the nature of the study to the subject or 
his/her legally authorized representative and answer all questions regarding the study. Subjects 
will be required to sign and date a study consent form prior to any study-related procedures are 
performed if they meet eligibility requirements of the protocol and wish to participate in the trial. 
If applicable, it will be provided in a certified translation of the local language.  
• Subjects must be informed that their participation is voluntary. Subjects or their legally 
authorized representative [defined as an individual or judicial or other body authorized 
under applicable law to consent on behalf of a prospective subject to the subject's 
participation in the procedure(s) involved in the research] will be required to sign a 
statement of informed consent that meets the requirements of 21 CFR 50, local 
regulations, ICH guidelines, Health Insurance Portability and Accountability Act 
requirements, where applicable, and the IRB/IEC or study center. 
• The medical record must include a statement that written informed consent was obtained 
before the subject was enrolled in the study and the date the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICF. 

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• Subjects must be re-consented to the most current version of the ICF(s) while receiving 
study treatment. 
• A copy of the signed and dated ICF(s) must be provided to the subject or the subject’s 
legally authorized representative. 
• Subjects who are rescreened are required to sign a new ICF. 
The ICF may contain a separate section or a separate ICF may be used for optional exploratory 
research. The investigator or authorized designee will explain to each subject the objectives of 
the exploratory research. Subjects will be informed that they are free to refuse to participate and 
may withdraw their consent at any time and for any reason during the study period.  
13.3.2 Consent Procedures and Documentation 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the study and continues throughout the individual’s study participation. Extensive discussion of 
risks and possible benefits of participation will be provided to the subjects. Consent forms will 
be IRB/IEC approved and the subject and/or the legally authorized representative will be asked 
to read and review the document. All subjects will receive a verbal explanation in terms suited to 
their comprehension of the purposes, procedures, and potential risks of the study and of their 
rights as research subjects. Subjects will have the opportunity to carefully review the written 
consent form and ask questions prior to signing. The subjects should have the opportunity to 
discuss the study with their surrogates or think about it prior to agreeing to participate. The 
subject and/or the subject’s legally authorized representative will sign and date the informed 
consent document prior to any procedures being done specifically for the study. The subject may 
withdraw consent at any time throughout the course of the trial. A copy of the signed and dated 
informed consent document will be given to the subject or the subject’s legally authorized 
representative for their records. The rights and welfare of the subjects will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they 
decline to participate in this study. 
13.4 
Subject and Data Confidentiality  
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and 
the Sponsor(s) and their agents. This confidentiality is extended to cover testing of biological 
samples in addition to the clinical information relating to subjects. Therefore, the study protocol, 
study documentation, data, and all other study-related information generated will be held in strict 
confidence. No information concerning the study, or the data will be released to any 
unauthorized third party without prior written approval of the Sponsor. 
The study monitor, auditors, other authorized representatives of the Sponsor including the 
contract research organization (CRO), if applicable, representatives of the IRB/IEC or the 
Sponsor supplying study product, the Federal government or its designee and applicable 
regulatory authorities will be granted direct access to the study subjects’ original medical records 
(including but not limited to office, clinic, hospital, or pharmacy records), all documents required 
to be maintained by the investigator, for verification of clinical trial procedures and/or data, 
without violating the confidentiality of the subjects, to the extent permitted by the law and 
regulations. 

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All documents will be stored safely in a secure location to protect confidentiality. On all 
trial-specific documents, other than the signed consent, the subject will be referred to by the trial 
subject identification number/code, not by name. At the end of the study, all records will 
continue to be kept in a secure location for as long a period as dictated by local IRB/IEC and 
Institutional regulations. 
Study subject research data, which is for purposes of statistical analysis and scientific reporting, 
will be transmitted to and stored a Sponsor location. This will not include the subject’s contact or 
identifying information. Rather, individual subjects and their research data will be identified by a 
unique study identification number. The study data entry and study management systems used by 
research staff at the clinical sites and by authorized representatives of the Sponsor will be 
secured and password protected. At the end of the study, all study databases will be de-identified 
and archived at a Sponsor location. 
13.4.1 Research Use of Stored Human Samples, Specimens, or Specimen Data  
Intended Use: Samples and data collected under this protocol may be used to study the PK and 
PD of SL-172154, PLD, and/or MIRV, as well as biomarkers associated with ovarian cancer 
and/or the mechanism of action of each study drug. Research may include the study of genomic 
alterations and changes in the TME which may correlate with drug safety or efficacy. 
Storage: Access to stored samples will be limited to specified study personnel/vendor personnel. 
Samples will be identified by unique subject identification (ID) codes. Samples and data will be 
stored using subject ID assigned by the Sponsor and investigators. An individual subject may 
choose to withdraw their consent at any time; however, the Sponsor will retain all data 
previously analyzed and will retain and continue to use any data or biological samples collected 
prior to the consent withdrawal, unless the subject specifically requests disposal of their samples. 
14. 
DATA HANDLING AND RECORD KEEPING 
14.1 
Communication and Data Dissemination Plan 
During the study while subjects are receiving study treatment in dose escalation as well as dose 
expansion cohorts, SMC meetings will be held to review relevant data with the investigators or 
designees (see Section 7.8 for details). These meetings will be held once a month (or more 
frequently if required) during dose escalation, provided subjects have been enrolled and data are 
available to be reviewed, to share safety data and communicate results of ongoing analyses. All 
available safety, PK, PD, and clinical outcome data for all subjects at the time of the scheduled 
SMC Meeting will be reviewed and summarized. Attendees of SMC meetings will include, but 
not be limited to clinical investigators (or designees), the Sponsor Medical Monitor and 
Statistician. The SMC will operate in accordance with the SMC charter which will define roles 
and accountabilities as well as the process for safety review and meeting frequency. 
The Sponsor will remain in constant contact with the clinical sites during the enrollment period 
to ensure that cohort enrollment during the dose escalation of this study is completed as per 
protocol. All dose escalation or safety decisions made by the SMC will be documented in writing 
with copies maintained at each site and the Trial Master File at the Contract Research 
Organization.  

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14.2 
Data Collection and Management Responsibilities 
An eCRF will be used to record all subject data specified by this protocol. The eCRF must be 
completed by designated and trained study personnel. The eCRF will be electronically signed by 
the Principal Investigator or a Sub-investigator listed on the Form FDA 1572 (or equivalent). 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the site investigator. The investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. All source documents should be completed in a 
neat, legible manner to ensure accurate interpretation of data. Source documents may include but 
are not limited to, study progress notes, e-mail correspondence, computer printouts, laboratory 
data, and drug accountability records. 
Data reported in the eCRF derived from source documents should be consistent with the source 
documents or the discrepancies should be explained and captured in a progress note and 
maintained in the subject’s official electronic study record.  
Clinical data (including, but not limited to AEs, concomitant medications, and expected ARs 
data) and clinical laboratory data will be entered into the study database, a 21 CFR Part 
11-compliant data capture system provided by the Sponsor. The data system includes password 
protection and internal quality checks, such as automatic range checks, to identify data that 
appear inconsistent, incomplete, or inaccurate. Clinical data will be entered into an electronic 
data capture system directly from the source documents.  
Study data will be entered into eCRFs at the study site. Prior to database lock, programmed 
computer edit checks and manual checks will be performed to check for discrepancies and 
reasonableness of the data. All issues resulting from these checks are to be resolved as quickly as 
possible with clarification from study sites. 
14.3 
Study Records Retention 
The Sponsor follows US regulations and ICH guidelines in its retention policy. 
US IND regulations (21 CFR 312.62c) require that records and documents pertaining to the 
conduct of this study and the distribution of investigational drug(s) including eCRFs, consent 
forms, laboratory test results, and medication inventory records be kept on file by the Principal 
Investigator for 2 years following the date a marketing application is approved for the drug for 
the indication for which it is being studied. If no application is to be filed or if the application is 
not approved for such indication, these records must be kept until 2 years after the investigation 
has been discontinued and regulatory authorities (i.e., FDA, Health Canada, European Medicines 
Agency, etc.) have been notified. ICH guidelines indicate that study documents should be 
retained until at least 2 years after the last approval of a marketing application in an ICH region 
and until there are no pending or contemplated marketing applications in an ICH region, or at 
least 2 years have elapsed since the formal discontinuation of clinical development of the IP. If 
there is a country or institutional policy that specific records and documents be retained for a 
longer period than described above, the applicable sites must comply with those policies in 
addition to US and ICH policies. 
No study records should be destroyed without prior written authorization from The Sponsor, if 
applicable. It is the responsibility of the Sponsor to inform the investigator when these 
documents no longer need to be retained. 

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14.4 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol or GCP requirements. 
The noncompliance may be either on the part of the subject, the investigator, or the study site 
staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly.  
It is the responsibility of the site to use continuous vigilance to identify and report deviations to 
the Sponsor Medical Monitor or designee as soon as protocol deviation is identified. All 
documentation regarding protocol deviations will be maintained in the regulatory file. All 
deviations must be addressed in study source documents and reported to the Sponsor. Protocol 
deviations must be sent to the local IRB/IEC per their guidelines. The site Principal Investigator 
is responsible for ensuring all study staff understands the local IRB/IEC reporting guidelines and 
adhere to all related requirements and documentation. 
14.5 
Publications and Data Sharing Policy 
The Sponsor will comply with the requirements for publication of study results. In accordance 
with standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating investigator will be designated by mutual agreement. Authorship will be determined 
by mutual agreement and in line with the International Committee of Medical Journal Editors 
authorship requirements.  
 
 

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16. 
APPENDICES 
16.1 
ECOG Performance Status Criteria 
Grade 
Description 
0 
Normal activity. Fully active, able to carry on all predisease performance without restriction 
1 
Symptoms but ambulatory. Restricted in physically strenuous activity, but ambulatory and able 
to carry out work of a light or sedentary nature (e.g., light housework, office work) 
2 
In bed < 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any 
work activities. Up and about more than 50% of waking hours. 
3 
In bed > 50% of the time. Capable of only limited self-care, confined to bed or chair more than 
50% of waking hours. 
4 
100% bedridden. Completely disabled. Cannot carry on any self-care. Totally confined to bed 
or chair. 
5 
Dead. 
Source: Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET et al. Toxicity and response criteria 
of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5 (6):649-55. 
 
 
 

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16.2 
Contraception Requirements 
Definition of Female of Childbearing Potential (FCBP) 
A female subject who is not sterile due to surgery (i.e., from bilateral tubal ligation/occlusion, 
bilateral oophorectomy, bilateral salpingectomy, or complete hysterectomy) or who does not 
have a congenital or acquired condition that prevents childbearing or who is not naturally 
postmenopausal for at least 12 consecutive months.  
Definition of Female of Non-Reproductive Potential  
Female subjects will be considered of non-reproductive potential if they:  
1. Are postmenopausal if defined as amenorrheic for 12 consecutive months without an 
alternative medical cause. In women < 50 years of age and/or perimenopausal, a high 
follicle stimulating hormone (FSH) level in the postmenopausal range may be used to 
confirm a postmenopausal state in women not using hormonal contraception or hormonal 
replacement therapy. In the absence of 12 consecutive months of amenorrhea, a single 
FSH measurement is insufficient. 
OR 
2. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or 
bilateral tubal ligation/occlusion, at least 6 weeks prior to screening. 
OR 
3. Have a congenital or acquired condition that prevents childbearing. 
Highly Effective Methods of Contraception (< 1% failure rate) 
A highly effective method of contraception is defined as one that results in a low failure rate 
(i.e., less than 1% per year) when used consistently and correctly. For contraception, subjects 
should comply with one of the following: 
1. Practice abstinence† from heterosexual activity  
OR 
2. Use (or have their partner use) acceptable contraception during heterosexual activity. 
 
Acceptable methods of contraception are‡: 
• Single method (one of the following is acceptable): 
o intrauterine device (IUD) 
o vasectomy of a female subject’s male partner 
o contraceptive rod implanted into the skin 

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• Combination methods 
o Female subjects: the following hormonal contraceptive methods (stable dose at 
least 3 months prior to first dose of study treatment) may be used by female 
subjects and requires use of a male condom for the male partner: 
 oral contraceptive pill (estrogen/progestin pill or progestin-only pill) 
 subcutaneous contraceptive injection  
 contraceptive skin patches 
 vaginal contraceptive rings 
 contraceptive implants into skin 
†Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is: 
(1) consistently employed during the entire period of risk associated with the administered drugs; (2) 
consistent with the subject’s preferred and usual lifestyle; and (3) considered acceptable by local 
regulatory agencies and IRBs/IECs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, 
postovulation methods) and withdrawal are not acceptable methods of contraception.  
‡If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not 
qualify as an acceptable method of contraception for subjects participating at sites in this country/region. 
Subjects should be informed that taking SL-172154, PLD, or MIRV may involve unknown risks 
to the fetus (unborn baby) if pregnancy were to occur during the study. To participate in the 
study, subjects of childbearing potential must adhere to the contraception requirement (described 
above) starting at least 14 days prior to the first dose of study treatment, during treatment, and 
through at least 6 months (or for the duration required by local regulatory guidance) after the last 
dose of PLD or at least 3 months after the last dose of MIRV or SL-172154, whichever is longer. 
16.2.1 Pregnancy Status 
In the rare event that beta-human chorionic gonadotropin (β-hCG) is elevated as a tumor marker, 
pregnancy should be excluded. At minimum, this requires obstetrics evaluation, serial β-hCG 
measurements and ultrasound to exclude pregnancy. 

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16.3 
Cockcroft-Gault Formula for Creatinine Clearance 
 
Creatinine clearance (mL/min)1 = Q x (140 – age [yr]) x ideal body weight [kg]2 
72 x serum creatinine [mg/dL] 
Q = 0.85 for females 
Q = 1.0 for males 
OR 
Creatinine clearance (mL/min)2 = K x (140 – age [yr]) x ideal body weight [kg]1 
serum creatinine [µmol/L] 
K = 1.0 for females 
K = 1.23 for males 
1. Creatinine clearance has a maximum value of 125 mL/min. 
If a subject’s actual body weight is less than his or her ideal body weight (IBW), then actual weight 
should be used. However, if the patient is obese, then a correction is used. If a subject’s actual weight 
>30% his or her ideal body weight, then AIBW should be used in the Cockcroft-Gault equation. 
See Section 16.4 for calculation of AIBW and IBW. 
 
Reference: 
Winter M. Impact of Various Body Weights and Serum Creatinine Concentrations on the Bias and 
Accuracy of the Cockcroft-Gault Equation. Pharmacotherapy: The Journal of Human 
Pharmacology and Drug Therapy.2012; 32:604-612. 
 

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16.4 
Adjusted Ideal Body Weight Calculation 
MIRV dose will be based on AIBW. 
 
Adjusted Ideal Body Weight (AIBW) 
AIBW = IBW1 + 0.4 (Actual weight – IBW1) 
 
Ideal Body Weight (IBW) 
IBW1 (female) = 0.9H1-92 
 
(1H=height in cm; W=weight in kg) 
 
 

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16.5 
RECIST 1.1 Criteria 
Measurable disease: Measurable tumor lesions (nodal, subcutaneous, lung parenchyma, solid 
organ metastases) are defined as those that can be accurately measured in at least one dimension 
(longest diameter to be recorded) as ≥ 10 millimeter (mm) with CT scan or clinical examination. 
Bone lesions are considered measurable only if assessed by CT scan and have an identifiable soft 
tissue component that meets these requirements (soft tissue component ≥ 10 mm by CT scan). 
Malignant lymph nodes must be ≥ 15 mm in the short axis to be considered measurable; only the 
short axis will be measured and followed. All tumor measurements must be recorded in mm (or 
decimal fractions of cm). Previously irradiated lesions are not considered measurable unless 
progression has been documented in the lesion. 
Malignant lymph nodes: pathological nodes must meet the criterion of a short axis of ≥ 15 mm 
by CT scan and only the short axis of these nodes will contribute to the baseline sum. All other 
pathological nodes (those with short axis ≥ 10 mm but < 15 mm) should be considered non-target 
lesions. Nodes that have a short axis < 10 mm are considered non-pathological and should not be 
recorded or followed. 
Non-measurable disease: All other lesions (or sites of disease), including small lesions (longest 
diameter < 10 mm [< 1 cm] or pathological lymph nodes with ≥ 10 to < 15 mm [≥ 1 to < 1.5 cm] 
short axis), are considered non-measurable disease. Bone lesions without a measurable soft tissue 
component, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis, 
inflammatory breast disease, lymphangitic involvement of lung or skin, and abdominal masses 
followed by clinical exam are all non-measurable. Lesions in previously irradiated areas are 
non-measurable unless progression has been demonstrated. 
Note: Cystic lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) since they are, by 
definition, simple cysts. 
‘Cystic lesions’ thought to represent cystic metastases can be considered as measurable lesions, 
if they meet the definition of measurability described above. However, if non-cystic lesions are 
present in the same subject, these are preferred for selection as target lesions. 
Target lesions: When more than one measurable tumor lesion is present at baseline all lesions 
up to a maximum of 5 lesions in total (and a maximum of 2 lesions per organ), representative of 
all involved organs, should be identified as target lesions and recorded and measured at 
baseline. Target lesions should be selected on the basis of their size (lesions with the longest 
diameter), be representative of all involved organs, but in addition should be those that lend 
themselves to reproducible repeated measurements. It may be the case that, on occasion, the 
largest lesion does not lend itself to reproducible measurement in which circumstance the next 
largest lesion which can be measured reproducibly should be selected. A sum of the diameters 
(longest for non-nodal lesions, short axis for nodal lesions) for all target lesions will be 
calculated and reported as the baseline sum diameters. If lymph nodes are to be included in the 
sum, then only the short axis is added into the sum. At baseline, the sum of the target lesions 
(longest diameter of tumor lesions plus short axis of lymph nodes: overall maximum of 5) is to 
be recorded. 
After baseline, a value should be provided on the eCRF for all identified target lesions for each 
assessment, even if very small. If extremely small and faint lesions cannot be accurately 

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measured but are deemed to be present, a default value of 5 mm may be used. If lesions are too 
small to measure and indeed are believed to be absent, a default value of 0 mm may be used. The 
baseline sum diameters will be used as reference to further characterize any objective tumor 
regression in the measurable dimension of the disease. 
Non-target lesions: All non-measurable lesions (or sites of disease) plus any measurable lesions 
over and above those listed as target lesions are considered non-target lesions and should also 
be recorded at baseline. Measurements of these lesions are not required, but the presence, 
absence, or in rare cases unequivocal progression of each should be noted throughout follow-up.  
16.5.1 Evaluation of Response 
Complete Response (CR): Disappearance of target and non-target lesions and normalization of 
tumor markers. Pathological lymph nodes must have short axis measures < 10 mm (Note: 
continue to record the measurement even if < 10 mm and considered CR). Residual lesions 
(other than nodes < 10 mm) thought to be non-malignant should be further investigated (by 
cytology, specialized imaging or other techniques as appropriate for individual cases) before CR 
can be accepted. Response should be confirmed in a subsequent scan ≥ 4 weeks after the scan 
showing CR. 
Partial Response (PR): At least a 30% decrease in the sum of the measures (longest diameters 
for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the 
baseline sum of diameters. Non-target lesions must be non-progressive disease. Response should 
be confirmed in a subsequent scan ≥ 4 weeks after the scan showing PR. 
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for progressive disease, taking as reference the smallest sum diameters while on study. 
Documented at least once ≥ 4 weeks from baseline. 
Progressive Disease (PD): At least a 20% increase in the sum of diameters of measured lesions 
taking as references the smallest sum of diameters recorded on study (including baseline) AND 
an absolute increase of ≥ 5 mm. Appearance of new lesions will also constitute progressive 
disease (including lesions in previously unassessed areas). In exceptional circumstances, 
unequivocal progression of non-target disease may be accepted as evidence of disease 
progression, where the overall tumor burden has increased sufficiently to merit discontinuation 
of treatment or where the tumor burden appears to have increased by at least 73% in volume. 
Modest increases in the size of one or more non-target lesions are NOT considered unequivocal 
progression. If the evidence of progressive disease is equivocal (target or non-target), treatment 
may continue until the next assessment, but if confirmed, the earlier date must be used. 
An Overall Response assessment will be reported with each protocol-specified timepoint for a 
disease assessment. The following table provides a summary of the overall response status at 
each timepoint for subjects who have measurable disease at baseline. 

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Target Lesions 
Non-target Lesions 
New Lesions 
Overall Response 
CR 
CR 
No 
CR 
CR 
Non-CR/non-PD 
No 
PR 
CR 
Not evaluated 
No 
PR 
PR 
Non-PD or not all evaluated 
No 
PR 
SD 
Non-PD or not all evaluated 
No 
SD 
Not all evaluated 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, NE = not evaluable 
 
 
 

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16.7 
Summary of Changes from Version 0.0 to 1.0 
This amendment applies to all Investigator sites participating in this study. This amendment 
includes modifications to eligibility criteria, updated text for dose modification guidelines and 
updated ocular assessments for MIRV cohorts, and the collection of PD samples in the dose 
expansion cohorts. Minor editorial changes (including protocol version number, approval date, 
and the table of contents) as well as minor clarification edits to the text are incorporated in this 
amendment. A summary of the changes to this protocol from Version 0.0 (dated 13 May 2022) 
are described in the table below: 
Section 
Description/Rationale 
Throughout 
Replaced ranitidine with famotidine or other available histamine 2 receptor 
antagonist throughout. 
Premedication revised from “approximately” to “at least” 30 min prior to either 
SL-172154 or MIRV. 
Removed references to chemokines and chemokine assessments. 
Study Schema 
Revised for clarity and to match current protocol. 
Synopsis 
Revised to reflect changes in the protocol. 
1.4.7 Summary of Clinical Data 
for SL-172154 
Updated to reflect data provided in the SL-172154 IB Supplement with data 
cut-off date of 12 September 2022. 
2 Exploratory objective and 
outcome measure 
Revised and updated exploratory outcome measures to reflect current study. 
3.1.1 Sample size  
Revised description of sample size to clarify how many subjects would be 
treated with SL-172154 in each cohort (PLD or MIRV). 
Table 1, and 2 and Section 
5.1.1 and other places  
Time of infusion for 6.0 mg/kg SL-172154 increased to 180 ± 15 min from 
120 ± 15 min to mitigate the risk of IRR 
3.5, 9.2.4 
Updated grading of CRS to reflect use of the ASTCT Consensus Grading 
Criteria for CRS as described in Table 4. 
3.5, 3.7, 9.2.4 
Updated grading of ocular symptoms and events for MIRV cohort per the tables 
in Appendix 16.6 to align with Immunogen’s post- FDA approval updates 
3.7.1.1 and 3.7.1.2 
Revised to describe collection of ad hoc labs during IRR events and during 
CRS events. 
3.7.1.2 
Revised dosing of tocilizumab to “per institutional guidelines and local 
prescribing information”. 
3.7.1.4 
Revised guidance for hematologic toxicity for SL-172154 based on the 
hematology laboratory data from SL03-OHD-101 study which demonstrates 
transient decrease consistent with margination and not myelosuppression or 
destruction. Added a reminder that investigators can make more conservative 
dose modification if clinically indicated. 
3.7.2.1 
Revised guidance for hematologic toxicity for PLD to be consistent with the 
PLD prescribing information: removed the text requiring PLD discontinuation if 
PLD was delayed by 14 days as this is not in the label or standard of care). 
Added dose reduction for recurrent Grade 3 in accordance with institutional 
practice. 

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3.7.3.2 
Added dose reduction guidelines for Grade 2-4 thrombocytopenia associated 
with MIRV; added permanent discontinuation for recurrence of Grade 4 
thrombocytopenia. 
3.7.3.5.1 and 6.5. 8 
Revised text describing procedures and timing of ophthalmic exam and eye 
care in subjects in MIRV Cohort based on updates from Immunogen 
3.7.3.5.2 and Table 8 
6.5.8 
Revised text and table describing management, care and dosing modifications 
in the event of ocular symptoms in subjects in MIRV Cohort. 
3.11 Discontinuation criteria 
Clarification of conditions under which a subject may be removed by the 
Investigator. 
4.1 Inclusion criterion 4 
Clarification of calculation of days for disease progression. 
4.1 Inclusion criterion 5 
Removal of requirement for prior bevacizumab therapy in PLD cohort. 
4.1 Inclusion criterion 8 
Removal of requirement for prior bevacizumab therapy in MIRV cohort. 
4.1 Inclusion criterion 10 
Clarified that positive for FRα expression is defined as PS2+ ≥ 25% by the 
Ventana FOLR1 Assay. 
4.1 Inclusion criterion 16 
Removed mandatory pretreatment and on-treatment biopsies for PLD cohort 
(required for MIRV cohort only). 
4.2 Exclusion criterion 7 
Clarified exclusion due to immunosuppressive medication. 
4.2 Exclusion criterion 9 
Clarified exclusion due to autoimmune disease to add requiring treatment in 
past 2 years. 
5.1.6 
Defined overdose of SL-172154 as > 10% of intended dose. 
5.3.2.3  
Revised text describing calculation of adjusted ideal body weight per 
institutional policy for MIRV dosing. 
Section 6  
Revised text to ensure doses of SL-172154 are not delayed.  
Clarify that the length of subsequent cycles remains unchanged 
6.1 Schedule SL-172154 + PLD 
• 
Added eligibility evaluation at D1. 
• 
Removed assessment on C1D9 for Type and screen, blood phenotyping, 
DAT. 
• 
Allowing ECHO or MUGA to be used; same methodology to be used 
throughout. 
• 
Revised footnote “d” to reflect removal of C1D9 assessment. 
• 
Added footnote “g” clarifying that a full physical exam is required only at 
screening and PTV 
• 
Added vital sign collection and pulse oximetry assessment on D8 of C3 
and subsequent cycles. 
• 
Revised footnote “k1” to reflect that all subjects have blood sample 
collection for ADA and PK within 45-90 days of last dose. 
• 
Added blood collection for receptor occupancy at D8, 9, 15 in Cycle 1. 
• 
Added hematology and clinical chemistry lab tests on C2D8. 
• 
Revised footnote “m” that CA-125 can be obtained within 28 days of first 
dose. 
• 
Added collection of ConMeds at Screening visit. 
• 
Added collection of AEs at Screening visit. 

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Description/Rationale 
• 
Removed tumor biopsy assessment from table and footnote describing it. 
Removed “D16-22” column that contained this assessment. 
6.1.1  
• 
Added blood collection for receptor occupancy. Added cytokine samples to 
dose expansion cohort 
• 
Revised footnote designations to clarify collection windows. 
• 
Added to footnote 6 that collection of blood sample for SL-172154 PK and 
ADA should be within 45-90 days of last dose. 
6.2 Schedule SL-172154 + 
MIRV 
• 
Added eligibility evaluation at D1.Removed assessment at C1D9 for Type 
and screen, blood phenotyping, DAT. 
• 
Added collection of TSH, free T4 at Screening visit. 
• 
Allowing ECHO or MUGA to be used; same methodology to be used 
throughout. 
• 
Revised ophthalmic exam to clarify timing at screening visit, prior to C3, C5 
and C7, and at PTV. 
• 
Revised footnote “d” to reflect removal of C1D9 assessment. 
• 
Revised text in footnote “g” to reflect updated ophthalmic examinations and 
timing. 
• 
Added footnote “h” clarifying that a full physical exam is required only at 
screening and PTV. 
• Added hematology and clinical chemistry lab tests on C2D8. 
• 
Added collection of vital signs and pulse oximetry assessment at D8 of C3 
and subsequent cycles. 
• 
Revised text in footnote “j” to reflect updated ocular symptom assessment 
and timing. 
• 
Revised footnote “m1” to reflect that all subjects have blood sample 
collection for ADA and PK within 45-90 days of last dose. 
• 
Added blood collection for receptor occupancy at D8, 9, 15 in Cycle 1. 
• 
Revised collection of tumor biopsy from prescreen to screening visit. 
• 
Added collection of Concomitant Medicines at Screening visit. 
• 
Added collection of AEs at prescreen and screening visit. 
• 
Removed immunophenotyping from footnote “n”. 
• 
Revised footnote “o” that CA-125 can be obtained within 28 days of first 
dose. 
6.2.1 
• 
Removal of cytokine sample taken at predose and 2h post-EOI. 
• 
Added blood collection for receptor occupancy. Added cytokine samples to 
dose expansion cohort 
• 
Revised footnote designations to clarify collection windows. 
• 
Added to footnote 6 for collection of blood sample for SL-172154 PK and 
ADA should be within 45-90 days of last dose. 
6.5.9 
• Rearranged tests in the local labs section for clarity.  
• Added receptor occupancy to central lab tests 
6.5.9.1 
Added receptor occupancy to Ad hoc Labs 

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6.5.9.3 
Revised to serum CA-125 can be obtained within 28 days of first dose (as 
noted for footnote “m” in 6.1 and footnote “o” in 6.2) 
6.5.9.4 
Removed assessment for blood type and screen, blood phenotyping, and DAT 
at Cycle 1 Day 9. 
 Based on the data from SL03-OHD-101, a first-in-human Phase I study in 
platinum resistant ovarian cancer, there was no interference in RBC 
crossmatch and there was no interference in ABO/Rh typing.  
6.7 
Revised text to reflect collection of blood sample for ADA and PK within 
45-90 days of last dose of study treatment. 
6.9 
Section on receptor occupancy analysis added. 
6.10.1 
Removed biopsy for SL-172154+ PLD cohort. 
Removed paragraph as archival tissue not acceptable for screening tumor 
biopsy. 
6.11 
Clarification that anti-tumor activity assessment occurs every 3 cycles up to 
year 2 and then every 6 cycles up to study conclusion in the PLD cohort. 
7.4 
Corrected e-mail address for SAE reporting 
9.2.4 
Changed safety analyses to include CRS and ocular grading systems 
13.3.2 
Clarified and simplified the Consent Procedures and Documentation 
paragraphs. 
13.4.1 
Revisions to description of intended use of samples and data collected. 
Clarification of retention and use of analyzed data and biological samples under 
conditions of subject withdrawal of consent.  
Former 13.5 
Removal of section describing storage and future use of specimens collected 
for this study. 
16.3 Cockcroft- Gault Formula 
Revised to describe use of adjusted ideal body weight (AIBW) for subjects with 
actual weight >30% of ideal body weight. Removed IBW calculations. Refer to 
section 16.4 for AIBW and IBW calculations. Devine reference removed and 
Winter reference added. 
Appendix 16.6 Ocular 
Symptoms and Other Ocular 
Events 
Table 15 and 16 added to describe grading of ocular AEs to align with 
Immunogen’s other MIRV protocols 
Appendix 16.7 
Summary of Changes added. 
 
 
 

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16.8 
Summary of Changes from Version 1.0 to 2.0 
This amendment applies to all Investigator sites participating in this study. This amendment 
includes dexamethasone premedication prior to SL-172154 dosing, with revised guidelines for 
management of IRR despite premedication, and the addition of dose modifications in the context 
of Grade 2/3 liver enzyme elevations (the subject of SL03-OHD-105 Protocol Safety Update 
Memo dated 23-Oct-2023); and clarification of the method visual acuity assessment (the subject 
of SL03-OHD-105 Protocol Clarification Memo No. 4 dated 05-Dec-2023). Other revisions 
include updates to collection of samples for SL-172154 PK and ADA, and addition of C-reactive 
protein assessments at screening and to ad-hoc labs collected in the event of CRS or IRR AEs.  
A summary of the changes to this protocol from Version 1.0 (dated 20-Jun-2023) are described 
in the table below: 
 
Section 
Description/Rationale 
Throughout the protocol 
Based on data from ongoing studies with SL-172154, dexamethasone 8 mg IV 
is added to prophylactic premedication prior to each dose of SL-172154. 
Subject of SL03-OHD-105 Protocol Memo dated 23-Oct-2023. 
Section 3.6.1 Prohibited 
Medications or Treatments 
Adjustments on use of steroids for IRR made based on dexamethasone use for 
premedication. 
Section 3.7.1.1 Management of 
IRR [SL-172154] 
Provided guidelines for Grade 2, recurrent Grade 2, Grade 3, and recurrent 
Grade 3 IRR following SL-172154 dosing if it occurs despite premedication with 
dexamethasone. Subject of SL03-OHD-105 Protocol Memo dated 23-Oct-2023. 
Section 3.7.1.3 Management of 
Hepatotoxicity 
Modifications to the guidance table for dose of SL-172154 in the context of 
Grade 2 or 3 liver enzyme elevations, based on emerging data from this study. 
Subject of SL03-OHD-105 Protocol Memo dated 23-Oct-2023. 
Section 3.7.1.4 Management of 
Hematologic AEs 
Addition of consult with Medical Monitor for management of Grade 4 
hematologic AE in event of transient decrease in hemoglobin. 
Section 3.7.3.2 Dose 
Modifications for MIRV-Related 
AEs 
Modifications to the guidance table for dose of MIRV in the context of Grade 3 
liver enzyme elevations, based on emerging data from this study. Subject of 
SL03-OHD-105 Protocol Memo dated 23-Oct-2023. 
Section 3.7.3.5.1 Monitoring 
and Preventive Measures 
[MIRV Cohort] 
Section 3.7.3.5.2 Management 
and Dose Modifications 
Guidelines [MIRV Cohort];  
Section 6.5.8 Ophthalmic 
Examination [MIRV Cohort 
Only] 
Added clarification that visual acuity assessment should be performed with 
refraction. Subject of SL03-OHD-105 Clarification Letter No. 4 dated 05-Dec-
2023. 
Section 6.1 Schedule of 
Assessment – PLD; 
Section 6.2 Schedule of 
Assessment – MIRV;  
Section 6.5.9 Local and Central 
Clinical Laboratory 
Assessments 
Addition of C-reactive protein at screening as a baseline assessment and under 
ad hoc labs 
 

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Section 
Description/Rationale 
Section 6.1; 6.2 Schedules of 
assessments 
Correction in the table re: C1D9 SL-172154 PK collection to match 
Section 6.1.1 and Section 6.2.1. 
Sections 6.1, 6.1.1, 6.2, 6.2.1 
Schedules of assessments 
Section 6.5.9 Local and Central 
Clinical Laboratory 
Assessments 
Section 6.5.9.1 Ad Hoc Labs for 
IRR or CRS AEs 
• 
Based on emerging data, removal of SL-172154 PK sample collections 
from C3 onwards, PTV or SFU) and updates to corresponding footnotes. 
• 
Addition of footnote to describe collection of ad hoc SL-172154 ADA if 
subject discontinues SL-172154 due to IRR but continues on PLD or 
MIRV.  
Section 6.11 Assessment of 
Anti-Tumor Activity 
Removal of statement regarding scans during delay for toxicity management. to 
avoid confusion. 
Section 7.1.1 Events not 
Qualifying as AEs/SAEs 
Clarification that deaths due to disease progression should not be reported as 
AE/SAEs. 
Section 7.2.2 Assessment of 
Causality 
Clarification that underlying disease history should be considered in 
assessment of causality. 
Section 9.2.1 Analysis 
Populations 
Clarification of definition of response-evaluable population. 
 
 
 

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16.9 
Summary of Changes from Version 2.0 to 2.1 
This is a country specific amendment for Spain and applies to Investigator sites participating in 
this study in Spain. At the AEMPS request,16.8 Summary of Changes from Version 1.0 to 2.0 
was revised to include detailed justification and reason for each of the changes. In addition, some 
of the text that was deleted due to an oversight in Section 3.7.1.1, Management of IRRs, was 
added back into Protocol Amendment version 2.1, and the text was revised as needed to reflect 
the updated IRR guidance.  
A summary of the changes to this protocol from Version 2.0 (dated 29-Feb-2024) are described 
in the table below: 
Section 
Description/Rationale 
Throughout the protocol 
Description of Change: Based on data from ongoing studies with SL-172154, 
dexamethasone 8 mg IV is added to prophylactic premedication prior to each 
dose of SL-172154. Subject of SL03-OHD-105 Protocol Memo dated 23-Oct-
2023. 
Rationale/Justification: Infusion-related reaction (IRR) is a common SL-
172154-related treatment emergent AE. Addition of dexamethasone as primary 
prophylaxis to the standard premedication regimen of acetaminophen, H1 and 
H2 blockade was shown to be effective in reducing the incidence and severity 
of IRR symptoms in a parallel study (SL03-OHD-104). The data from SL03-
OHD-104 study were shared with the safety monitoring committee for the 
SL03-OHD-105 study. The safety monitoring committee agreed to the addition 
of dexamethasone 8 mg IV to the premedication prior to each dose of SL-
172154 in the current study.  
Section 3.6.1 Prohibited 
Medications or Treatments 
Description of Change: Adjustments on use of steroids for IRR made based 
on dexamethasone use for premedication. 
Rationale/Justification: Previous version of the protocol prohibited primary 
prophylactic use of steroids for the prevention of SL-172154 associated IRR. 
With the addition of dexamethasone to the premedication regimen prior to each 
SL-172154 infusion, the previous text was no longer applicable. Therefore, it 
was deleted, and clarification was added that steroid premedication prior to 
each SL-172154 administration for IRR prophylaxis is required.  
Section 3.7.1.1 Management of 
IRR [SL-172154] 
Description of Change: Provided guidelines for Grade 2, recurrent Grade 2, 
Grade 3, and recurrent Grade 3 IRR following SL-172154 dosing if it occurs 
despite premedication with dexamethasone. Subject of SL03-OHD-105 
Protocol Memo dated 23-Oct-2023. 
Rationale/Justification: Previous version of the IRR management guidance 
was applicable for IRRs that occurred without dexamethasone prophylactic 
premedication. With the addition of dexamethasone premedication prior to each 
SL-172154 infusion, more conservative guidance for SL-172154 administration 
was necessary for managing Grade 2 and Grade 3 IRRs that may occur 
despite dexamethasone premedication.  
• 
The guidance for Grade 2 IRRs was revised to (1) allow for SL-172154 
dose reduction (from 3 mg/kg to 1 mg/kg) based on severity of symptoms; 
(2) if the symptoms did not recur at the reduced dose (1 mg/kg) in 
subsequent administrations, the dose could be increased back to the 
original dose (3 mg/kg) at ≤50% of the rate specified in the protocol; (3) if 
tolerated at this rate with subsequent administrations, the rate could be 

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increased to the original rate stated in the protocol; and  (4) recurrent 
Grade 2 IRR associated with significant signs or symptoms despite dose 
reduction, requires permanent discontinuation.  
• 
The guidance for Grade 3 IRR was revised to clarify a stepwise approach 
(1) if the reduced dose of SL-172154 (1 mg/kg) is tolerated at a reduced 
infusion rate (of ≤50%) during subsequent two infusions, the rate can be 
increased back to the original rate stated in the protocol; and (2) if the 
reduced dose of SL-172154 (1 mg/kg) is tolerated at the original rate 
stated in the protocol, then the dose may be re-escalated to the original 
dose (3 mg/kg). 
• 
Due to oversight, some of the original guidance for Grade 2 and Grade 3 
IRR management was removed in amendment 2.0. This information is 
added back in the current version. 
Section 3.7.1.3 Management of 
Hepatotoxicity 
Description of Change: Modifications to the guidance table for dose of SL-
172154 in the context of Grade 2 or 3 liver enzyme elevations, based on 
emerging data from this study. Subject of SL03-OHD-105 Protocol Memo dated 
23-Oct-2023. 
Rationale/Justification: Both SL-172154 and MIRV can cause liver enzyme 
elevations, and the attribution to a specific agent may not always be clear. 
Additionally, the liver enzyme elevations are transient and recover without 
intervention (especially the use of steroids). Based on the emerging data from 
this study, the dose modifications recommended for SL-172154 (with MIRV or 
PLD) in the context of Grade 2 or 3 liver enzyme elevations were updated to 
take into account the transient nature of the elevations.  
Section 3.7.1.4 Management of 
Hematologic AEs 
Description of Change: Addition of consult with Medical Monitor for 
management of Grade 4 hematologic AE in event of transient decrease in 
hemoglobin. 
Rationale/Justification: Per the guidance for hematological toxicities in 
Section 3.7.1.4, permanent discontinuation of SL-172154 is required if no other 
etiology can be determined and SL-172154 is determined to be the cause of 
Grade 4 anemia. A transient decrease in hemoglobin (i.e., spontaneous 
recovery without intervention) associated with SL-172154 infusion may not 
necessarily require discontinuation of SL-172154. In the event of a transient 
decrease in hemoglobin consultation with the medical monitor was 
recommended. This clarification was added to the protocol. 
Section 3.7.3.2 Dose 
Modifications for MIRV-Related 
AEs 
Description of Change: Modifications to the guidance table for dose of MIRV 
in the context of Grade 3 liver enzyme elevations, based on emerging data 
from this study. Subject of SL03-OHD-105 Protocol Memo dated 23-Oct-2023. 
Rationale/Justification: Both SL-172154 and MIRV can cause liver enzyme 
elevations, and the attribution to a specific agent may not always be clear. The 
dose modifications for MIRV were clarified in Table 7.  
Grade 3 ALT/AST increase:  
Hold MIRV until resolved to Grade ≤1.  
• If resolution to Grade ≤1 within 7 days, resume at the same dose level.  
• If resolution to Grade ≤1 takes more than 7 days, resume MIRV at one 
dose level lower starting at the next cycle. 

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Section 3.7.3.5.1 Monitoring 
and Preventive Measures 
[MIRV Cohort] 
Section 3.7.3.5.2 Management 
and Dose Modifications 
Guidelines [MIRV Cohort];  
Section 6.5.8 Ophthalmic 
Examination [MIRV Cohort 
Only] 
Description of Change: Added clarification that visual acuity assessment 
should be performed with refraction. Subject of SL03-OHD-105 Clarification 
Letter No. 4 dated 05-Dec-2023. 
Rationale/Justification: It is a common practice to correct for refraction during 
visual acuity assessments. However, for subjects on the MIRV arm undergoing 
visual acuity assessment, refraction is crucial to accurately identify ocular AEs. 
Therefore, corrections to refraction should not be made during the visual acuity 
assessments. This clarification was added to the protocol.  
Section 6.1 Schedule of 
Assessment – PLD; 
Section 6.2 Schedule of 
Assessment – MIRV;  
Section 6.5.9 Local and Central 
Clinical Laboratory 
Assessments 
Description of Change: Addition of C-reactive protein at screening as a 
baseline assessment and under ad hoc labs 
Rationale/Justification: Elevated C-reactive protein levels may be associated 
with cytokine release syndrome (CRS) or IRR AEs. It is helpful to know 
baseline (pretreatment) C-reactive protein levels as well as determine C-
reactive protein levels when a CRS or IRR is suspected to accurately assess 
these AEs. Therefore, C-reactive protein assessment was added at baseline 
and as ad hoc assessments in cases of suspected CRS or IRR AEs.  
Section 6.1; 6.2 Schedules of 
assessments 
Description of Change: Correction in the table re: C1D9 SL-172154 PK 
collection to match Section 6.1.1 and Section 6.2.1. 
Rationale/Justification: 24hr PK sample is collected after Cycle1 Day 8 
(C1D8) dosing and this sample falls on C1D9. Although explained in text and 
correctly shown in 6.1.1 and 6.2.1, the main schedule of assessment Tables 
6.1 and 6.2 were missing the notation on C1D9. This error was corrected.  
Sections 6.1, 6.1.1, 6.2, 6.2.1 
Schedules of assessments 
Section 6.5.9 Local and Central 
Clinical Laboratory 
Assessments 
Section 6.5.9.1 Ad Hoc Labs for 
IRR or CRS AEs 
Description of Change: 
• 
Based on emerging data, removal of SL-172154 PK sample collections 
from C3 onwards, PTV or SFU) and updates to corresponding footnotes. 
Rationale/Justification: Analysis of serum concentrations of SL-172154 in a 
completed Phase I study in ovarian cancer patients (SL03-OHD-101) showed 
that following single and multiple IV infusions of 0.1 to 10 mg/kg SL-172154, 
maximum mean serum SL-172154 concentrations were reached at the end of 
infusion followed by multi-phasic decline and rapid clearance. SL-172154 
concentrations were only detectable (>10.0 ng/mL) post-EOI for up to 2 hours 
for ≤1.0mg/kg and up to 8 hours for 3.0 mg/kg. Based on these data, pre-dose 
SL-172154 infusion PK sample collection was removed from C3 onwards as 
concentrations should not be detectable this long after dosing. 
Description of Change: 
• 
Addition of footnote to describe collection of ad hoc SL-172154 ADA if 
subject discontinues SL-172154 due to IRR but continues on PLD or 
MIRV.  
Rationale/Justification: If an IRR leads to discontinuation of SL-172154, 
patients have the option to continue on PLD or MIRV monotherapy. To 
investigate for the presence of antidrug antibodies to SL-172154, text was 
added to ensure additional ADA sample would be collected at a subsequent 
visit, if feasible. 
Section 6.11 Assessment of 
Anti-Tumor Activity 
Description of Change: Removal of statement regarding scans during delay 
for toxicity management. to avoid confusion. 

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Rationale/Justification: There was a sentence about not having to repeat 
scans when subsequent cycles are delayed for toxicity management. This 
sentence was unclear, not relevant, and led to confusion. It was therefore 
removed.  
Section 7.1.1 Events not 
Qualifying as AEs/SAEs 
Description of Change: Clarification that deaths due to disease progression 
should not be reported as AE/SAEs. 
Rationale/Justification: For the purpose of clarification, a sentence was 
added to explain that deaths that are clearly determined to be due to disease 
progression should not be reported as AEs/SAEs. 
Section 7.2.2 Assessment of 
Causality 
Description of Change: Clarification that underlying disease history should be 
considered in assessment of causality. 
Rationale/Justification: A sentence was added to remind that Investigators 
should consider alternative causes such as natural history of the underlying 
disease, concomitant medications, comorbidities, and other risk factors when 
making an assessment of causality. 
Section 9.2.1 Analysis 
Populations 
Description of Change: Clarification of definition of response-evaluable 
population. 
Rationale/Justification: The definition of response-evaluable population was 
always intended to include subjects who discontinue study treatment due to 
disease progression or death before any post-baseline disease assessment. 
For clarity, “discontinued study treatment due to” was added to the protocol. 
 
 
 

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16.10 Summary of Changes from Version 2.0/2.1 to 3.0 
This amendment applies to all Investigator sites participating in this study. In this amendment the 
protocol was updated to include information from two protocol memos: 1. Protocol safety memo 
No. 2 regarding guidelines for management of IRR (dated 21-Jun-2024) and Protocol 
clarification memo No. 5 (dated 18-Apr-2024) regarding disease assessment schedule.  A 
summary of the changes from Protocol Version 2.0 are described in the table below: 
Section 
Description/Rationale 
Section 3.7.1.1 
Management of IRR 
[SL-172154] 
(changes previously 
included in version 
2.1 for Spain) 
Description of Change: Due to oversight, some of the relevant guidance that was in 
amendment 1.0 for Grade 2 and Grade 3 IRR management was removed in amendment 2.0. 
This correction was shared with the investigators in a memo dated 21-Jun-2024 and the 
deleted text was added back to the current version of the protocol, and minor edits were 
made to restructure the section. The updated sections are shown below; text that is added 
back is shown in italics and new text in regular font: 
Grade 2 • 
Temporarily interrupt SL-172154.  
• 
Vital signs should be measured after the onset of an IRR approximately every 15 
minutes through the completion of the infusion followed by approximately every 15 
minutes for one hour after completion of the SL-172154 infusion and then 
approximately every 30 minutes for the second hour after the completion of the SL-
172154 infusion. 
• 
Begin IV infusion of normal saline and treat symptoms as indicated and per institutional 
guidelines, e.g., with antipyretic and antihistamines; consider opioids (e.g., meperidine) 
for rigors, leukotriene inhibitor, bronchodilator therapy, or corticosteroids as 
appropriate.  
• 
Monitor subjects with close observation in an outpatient or inpatient setting until 
recovery from symptoms. Consider if admission to hospital is necessary. 
• 
Restart the infusion after resolution of symptoms.  Based on the severity of symptoms, 
reduce the rate to ≤50% of the rate at which the reaction occurred. 
• 
If symptoms recur, then no further SL-172154 will be administered at this visit. 
• 
Subsequent Infusions:  
o If the Grade 2 IRR signs and symptoms were not severe, the investigator may 
administer the next two infusions at the current dose but at ≤50% rate. If the 
symptoms do not recur, the infusion rate may be increased back to the original rate 
stated in the protocol.  
o If the Grade 2 IRR signs and symptoms were severe, the investigator may reduce 
the SL-172154 dose for the next two infusions to 1 mg/kg. If the symptoms do not 
recur, SL-172154 dose may be increased back to 3 mg/kg at ≤50% of the original 
rate. If tolerated, the rate may be increased back to the original rate stated in the 
protocol. 
Grade 3 • 
Immediately discontinue infusion of SL-172154  
• 
Vital signs should be measured after the onset of an IRR approximately every 15 
minutes for one hour after discontinuation of SL-172154 infusion and then 
approximately every 30 minutes for hours 2 and 3 after the discontinuation of the SL-
172154 infusion. 
• 
Begin IV infusion of normal saline and treat symptoms as indicated and per institutional 
guidelines e.g., epinephrine, bronchodilators, diphenhydramine, famotidine or other 
available H2 receptor antagonist, corticosteroids, consider opioids (e.g., meperidine) for 
rigors, oxygen, fluids, vasopressors, etc. Epinephrine is the drug of choice in an 
anaphylactic reaction and its administration should not be delayed.  
• 
Monitor subjects with close observation in an outpatient or inpatient setting for 12 hours 
or until recovery from symptoms. Strongly consider admission to hospital. 

CONFIDENTIAL 
 
SL03-OHD-105 
Compound: SL-172154 
 
Version no: 3.0 
 
Page 166 of 166 
Section 
Description/Rationale 
• 
Rechallenge should not be attempted in cases of true anaphylaxis. In other cases, 
once the subject has completely recovered, carefully consider if it is safe for the subject 
to receive SL-172154 at the next scheduled dose with premedication and dose 
reduction.  
o Reduce the SL-172154 dose for the next two infusions to 1 mg/kg at ≤50% of the 
rate stated in the protocol. These two subsequent infusions of SL-172154 (after an 
event of Grade 3 IRR) must be administered in an inpatient or outpatient setting 
with prolonged observation for a minimum of 12 hours after the completion of the 
infusion.  
o If symptoms do not recur at 1 mg/kg SL-172154 dose, subsequent infusions may be 
administered at the original rate stated in the protocol. If no further symptoms, the 
SL-172154 dose may be re-escalated to 3 mg/kg but administered at ≤ 50% of the 
rate stated in the protocol.  
 
Rationale/Justification: IRR management guidance in amendment 1.0 was applicable for 
IRRs that occurred without dexamethasone prophylactic premedication. With the addition of 
dexamethasone premedication prior to each SL-172154 infusion, more conservative guidance 
for SL-172154 administration was necessary for managing Grade 2 and Grade 3 IRRs that 
may occur despite dexamethasone premedication. Updates were made in amendment 2.0 
and the rationale is included below. However, while doing so, some of the relevant guidance 
from amendment 1.0 was accidentally deleted. This information is added back in the current 
version. 
• 
The guidance for Grade 2 IRRs was revised to (1) allow for SL-172154 dose reduction 
(from 3 mg/kg to 1 mg/kg) based on severity of symptoms; (2) if the symptoms did not 
recur at the reduced dose (1 mg/kg) in subsequent administrations, the dose could be 
increased back to the original dose (3 mg/kg) at ≤50% of the rate specified in the 
protocol; (3) if tolerated at this rate with subsequent administrations, the rate could be 
increased to the original rate stated in the protocol; and  (4) recurrent Grade 2 IRR 
associated with significant signs or symptoms despite dose reduction, requires 
permanent discontinuation. 
• 
The guidance for Grade 3 IRR was revised to clarify a stepwise approach (1) if the 
reduced dose of SL-172154 (1 mg/kg) is tolerated at a reduced infusion rate (of ≤50%) 
during subsequent two infusions, the rate can be increased back to the original rate 
stated in the protocol; and (2) if the reduced dose of SL-172154 (1 mg/kg) is tolerated at 
the original rate stated in the protocol, then the dose may be re-escalated to the original 
dose (3 mg/kg). 
Section 6.1; 6.2 
Schedules of 
assessments; 
Section 6.11 
Assessment of Anti-
Tumor Activity 
(changes applicable 
from version 2.0 and 
2.1 to version 3.0) 
Description of Change:  
Text was revised to allow disease assessments to be performed per schedule in Weeks 
instead of treatment Cycles 
Rationale/Justification:  
Per the protocol, disease assessment scans should be performed at screening and during the 
last week of scheduled Cycle (Cycle 2, 4 etc.) until radiologic disease progression. However, 
delays in treatment Cycles due to adverse events have resulted in scan delays for several 
subjects. To avoid this issue, if there is more than one week delay in any Cycle, all the 
subsequent disease assessments can be performed per schedule in Weeks. This information 
was also communicated to the Investigators in a clarification memo dated 18-Apr-2024.