A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer - KisMET-01
Phase: PHASE1
Conditions: NSCLC, NSCLC Stage IV, NSCLC Stage IIIB, Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Advanced Non-Small Cell Lung Cancer, Advanced Non-Small Cell Non-Squamous Lung Cancer
Sponsor: Mythic Therapeutics

TITLE: A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of 
Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung 
Cancer – KisMET-01
Sponsor:
Mythic Therapeutics, Inc.
100 Beaver Street
Waltham, MA 02453
Protocol Number:
MYTX-011-01
IND Number:
159721
CTIS Number:
2023-504630-22-00
Study Drug(s):
MYTX-011
Medical Monitor:
Ting-Hui Wu, MD, MSc
Email:
twu@mythictx.com
Telephone:
+1 (410) 934-2930
Version:
7.0
Date:
August 29, 2025
This document is confidential. Acceptance of this document constitutes agreement that no 
unpublished information contained herein shall be published or disclosed without prior written 
approval, except that this document may be disclosed to the appropriate Institutional Review 
Boards/Ethics Committees under the condition that they keep it confidential.

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Protocol MYTX-011-01 V7.0
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SPONSOR APPROVAL
The undersigned have reviewed the format and content of this protocol and have approved 
Protocol MYTX-011-01 for issuance.
Protocol Title: A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of 
Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer –
KisMET-01
Protocol ID: MYTX-011-01
Study Drug: MYTX-011
Protocol Version: 7.0
Date: August 29, 2025
SPONSOR CHIEF MEDICAL OFFICER, Mythic Therapeutics, Inc.
Paul Basciano, MD
Print Name
Signature
Date
SPONSOR MEDICAL MONITOR, Mythic Therapeutics, Inc.
Ting-Hui Wu, MD, MSc
Print Name
Signature
Date

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PROTOCOL ACCEPTANCE FORM 
Protocol Title: A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of 
Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer – 
KisMET-01
Protocol ID: MYTX-011-01 
Version: 7.0 
Final Date: August 29, 2025 
 
I have read the attached protocol and agree that it contains all the necessary details for 
performing the study. 
I will provide copies of the protocol and of the Investigator’s Brochures to all members of the 
study team for whom I am responsible and who participate in the study. I will discuss this 
material with them to ensure that they are fully informed regarding the conduct of the study. 
Once the Institutional Review Board/Independent Ethics Committee (IRB/IEC) has approved the 
protocol, I will not modify this protocol without obtaining the prior approval of Mythic 
Therapeutics, Inc. and of the IRB/IEC. I will submit the protocol modifications and/or any 
informed consent modifications to Mythic Therapeutics, Inc. and the IRB/IEC, and approval will 
be obtained before any modifications are implemented. 
I understand the protocol and will work according to it, the principles of Good Clinical Practice 
(current ICH guidelines), and the Declaration of Helsinki (1964). 
 
 
 
 
 
 
Investigator - Print Name 
Signature 
Date 

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TABLE OF CONTENTS 
SPONSOR APPROVAL .................................................................................................................2
PROTOCOL ACCEPTANCE FORM .............................................................................................3
TABLE OF CONTENTS.................................................................................................................4
LIST OF TABLES ...........................................................................................................................8
LIST OF FIGURES .........................................................................................................................9
LIST OF ABBREVIATIONS ........................................................................................................10
1.
STUDY SYNOPSIS ...................................................................................................14
2.
INTRODUCTION ......................................................................................................24
2.1. 
Background .................................................................................................................24
2.1.1. 
Overview of MYTX-011 ............................................................................................24
2.1.2. 
Summary of Nonclinical Studies ................................................................................24
2.2. 
Risk/Benefit ................................................................................................................25 
2.3. 
Rationale for Starting Dose .........................................................................................26
2.4. 
Rationale for Study Design .........................................................................................26 
2.5. 
Population to Be Studied.............................................................................................28
3. 
OBJECTIVES AND ENDPOINTS ............................................................................29 
3.1. 
Objectives for Part 1: MYTX-011 Dose Escalation ...................................................29 
3.1.1. 
Primary Objectives ......................................................................................................29 
3.1.2. 
Secondary Objectives ..................................................................................................29 
3.1.3. 
Exploratory Objectives ...............................................................................................29 
3.2. 
Objectives for Part 2: MYTX-011 Dose Expansion ...................................................29 
3.2.1. 
Primary Objectives ......................................................................................................29 
3.2.2. 
Secondary Objectives ..................................................................................................30 
3.2.3. 
Exploratory Objectives ...............................................................................................30 
3.3. 
Endpoints ....................................................................................................................30 
3.3.1. 
Part 1 Dose Escalation ................................................................................................30 
3.3.2. 
Part 2 Dose Expansion ................................................................................................31 
4. 
STUDY DESIGN ........................................................................................................32 
4.1. 
Part 1: MYTX-011 Dose Escalation ...........................................................................33 

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4.1.1. 
RP2D Selection Criteria ..............................................................................................36
4.1.2.
Intrapatient Dose Escalation .......................................................................................36
4.2. 
Part 2: MYTX-011 Dose Expansion ...........................................................................36
4.3. 
DLT Evaluation Criteria .............................................................................................39
4.4. 
Study Duration ............................................................................................................40
4.5. 
End of Study Definition ..............................................................................................40
5. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................40
5.1.
Inclusion Criteria.........................................................................................................40
5.2.
Exclusion Criteria .......................................................................................................44
5.3.
Discontinuation from Study ........................................................................................47
5.3.1. 
End of Treatment ........................................................................................................47
5.3.2. 
Subject Discontinuation/Withdrawal from the Study .................................................47
5.3.3. 
Lost to Follow-Up .......................................................................................................48
5.3.4. 
Replacement of Subjects .............................................................................................48
5.3.5. 
Screen Failures ............................................................................................................48
5.3.6. 
Study Discontinuation/Termination ............................................................................49
6. 
STUDY ASSESSMENT AND TREATMENT SCHEDULE ....................................50 
6.1. 
Trial Assessments .......................................................................................................60 
6.1.1. 
Baseline Assessments .................................................................................................60 
6.1.2. 
Efficacy Assessments ..................................................................................................61 
6.1.3. 
Safety Assessments .....................................................................................................63 
6.1.4. 
Other Assessments ......................................................................................................69 
7. 
STUDY DRUG(S) AND CONCOMITANT THERAPY ..........................................70 
7.1. 
MYTX-011..................................................................................................................70 
7.2. 
Study Drug(s) Administration .....................................................................................70 
7.2.1. 
Guidelines for Administration of MYTX-011 ............................................................71 
7.3. 
Preparation, Handling, Storage, and Accountability ...................................................71 
7.3.1. 
Preparation, Handling, and Storage ............................................................................71 
7.3.2. 
Preparation and Dilution .............................................................................................72 
7.3.3. 
Study Drug Accountability .........................................................................................72 

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7.4.
Assignment to Study Intervention...............................................................................72
7.5.
Management of Potential Toxicities ...........................................................................73
7.5.1. 
Management of Infusion-Related Reactions ...............................................................79
7.5.2. 
Management of Ocular AEs ........................................................................................80
7.5.3. 
Monitoring and Management of Suspected Interstitial Lung Disease/Pneumonitis ...83
7.5.4. 
Management of Dermatological AEs ..........................................................................84
7.5.5. 
Infusion Site Extravasation .........................................................................................84
7.6.
Concomitant Therapy and Prohibited Medications ....................................................84
7.6.1. 
Supportive Care Guidelines ........................................................................................85
8.
STATISTICAL CONSIDERATIONS ........................................................................87
8.1.
Analysis Populations ...................................................................................................87
8.2.
Sample Size .................................................................................................................87
8.2.1. 
Enrichment Cohorts ....................................................................................................88
8.2.2. 
Sample Size for Part 2 .................................................................................................88
8.2.3. 
Additional Enrollment.................................................................................................91
8.3.
Subject Disposition .....................................................................................................92
8.4. 
Subject Demographics and Baseline Characteristics ..................................................92
8.5.
Statistical Methodology ..............................................................................................92
8.5.1. 
General Considerations ...............................................................................................92
8.5.2. 
Dose Escalation for MTD: BOIN Design ...................................................................92
8.5.3. 
Cohort Expansion Monitoring for Efficacy ................................................................93
8.6.
Efficacy Analyses .......................................................................................................93
8.6.1. 
Pharmacokinetic and Immunogenicity Analyses ........................................................94
8.6.2. 
Exploratory Analyses ..................................................................................................95
8.7. 
Safety Analyses ...........................................................................................................96
8.8. 
Missing Value Handling Procedures...........................................................................97 
9. 
ADVERSE EVENT REPORTING AND CRITERIA ...............................................98 
9.1. 
Definition of Adverse Event .......................................................................................98 
9.2. 
Criteria for Serious Adverse Events ............................................................................98 
9.2.1. 
Situations Not Considered SAEs ................................................................................99 

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9.2.2. 
Serious versus Severe AEs..........................................................................................99
9.2.3.
Adverse Event/Serious Adverse Event Grading.........................................................99
9.2.4. 
Adverse Events of Special Interest ...........................................................................100
9.2.5. 
Adverse Events/Serious Adverse Event Causality Assessment................................100
9.2.6. 
Adverse Event/Serious Adverse Event Recording....................................................100 
9.2.7. 
Persistent or Recurrent Adverse Events....................................................................102
9.2.8. 
Deaths........................................................................................................................103
9.3.
Hospitalization, Prolonged Hospitalization, or Surgery ...........................................103
9.4. 
Stopping Rules ..........................................................................................................103
9.5. 
Pre-Existing Medical Conditions ..............................................................................103 
9.6. 
Pregnancy ..................................................................................................................104 
9.7. 
Medication Errors and Study Drug Overdose ...........................................................104
9.8. 
Reference Safety Information...................................................................................105
9.9.
Safety Reporting to Regulatory Agencies, Ethics Committees, and Investigators ...105
10.
CLINICAL DATA COLLECTION AND MONITORING .....................................106
10.1. 
Safety Oversight Committees ...................................................................................106
10.1.1. 
Safety Review Committee ........................................................................................106
10.1.2. 
Independent Data Safety Monitoring Board .............................................................106
10.2.
Site Monitoring Plan .................................................................................................107
10.3.
Curricula Vitae and Financial Disclosures ................................................................107
10.4.
Data Ownership and Publication...............................................................................107
11.
ETHICAL, FINANCIAL, AND REGULATORY CONSIDERATIONS................108
11.1.
IRB/IEC Approval ....................................................................................................108
11.2.
Regulatory Approval .................................................................................................109
11.3.
Financial Disclosure ..................................................................................................109
11.4.
Insurance and Indemnity ...........................................................................................109
11.5.
Informed Consent ......................................................................................................109
11.6.
Subject Confidentiality .............................................................................................110
11.7.
Investigator and Staff Information ............................................................................112
11.8. 
Financial Information ................................................................................................113

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12.
RECORD RETENTION AND DOCUMENTATION OF THE STUDY ................114
12.1.
Documentation Required to Initiate Study................................................................114
12.2.
Study Documentation and Storage ............................................................................114
12.3.
Amendments to the Protocol .....................................................................................116
12.4.
Data Collection .........................................................................................................116
12.5. 
Study Monitoring, Auditing, and Inspecting ............................................................116
12.6. 
Quality Assurance and Quality Control ....................................................................117
12.7. 
Disclosure and Publication Policy ............................................................................117
13. 
REFERENCES..........................................................................................................119 
APPENDIX A. CONTRACEPTION GUIDELINES ...............................................................122
APPENDIX B. NEW YORK HEART ASSOCIATION CLASSIFICATIONS ......................124 
APPENDIX C. RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 1.1  
(RECIST 1.1) ...................................................................................................125 
APPENDIX D. ECOG PERFORMANCE STATUS ...............................................................129
APPENDIX E. CREATININE CLEARANCE BY MODIFIED COCKCROFT-GAULT 
FORMULA ......................................................................................................130 
 
LIST OF TABLES 
Table 1: 
Dose Escalation Rules ................................................................................................35
Table 2: 
Part 1 Study Assessment and Treatment Schedule .....................................................52
Table 3:
Part 2 Study Assessment and Treatment Schedule.....................................................56
Table 4: 
Schedule of Triplicate Electrocardiogram Collections with Pharmacokinetic 
Sampling (Subjects Enrolled in Part 1 and Part 2) .....................................................63
Table 5:
Hematology and Chemistry Laboratory Tests............................................................65
Table 6: 
Schedule of PK and ADA Sampling (Subjects Enrolled in Part 1 Dose 
Escalation) ..................................................................................................................67
Table 7: 
Schedule of PK and ADA Sampling (Subjects Enrolled in Part 2 Dose 
Expansion) ..................................................................................................................68
Table 8: 
Planned Dose Levels ...................................................................................................70
Table 9: 
Part 1 Dose Modification Levels for MYTX-011 ......................................................73
Table 10: Part 2 Dose Modification Levels for MYTX-011 ......................................................73
Table 11: Management of Toxicities Defined as Study Treatment-Related Only......................75
Table 12: Schedule of Prophylactic Measures for Ocular Adverse Events ................................81

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Table 13:
Dose Modification Recommendation for Ocular Adverse Events1............................82
Table 14: Management of Confirmed Interstitial Lung Disease/Pneumonitis ...........................84
Table 15: ORR and Associated 95% Confidence Interval for N=80 Subjects ...........................91
Table 16: Response Based on Evaluation of Target Lesions at Each Assessment...................126
Table 17: Response Based on Evaluation of Nontarget Lesions at Each Assessment .............127
Table 18: Evaluation of Timepoint Response ...........................................................................127
LIST OF FIGURES 
Figure 1: 
Study Design Schematic.............................................................................................32
Figure 2: 
Q3W Dosing Regimen ................................................................................................50
Figure 3: 
Dose Break Regimen ..................................................................................................51

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LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
ADA 
anti-drug antibodies
ADC 
antibody-drug conjugate  
ADCC 
antibody-dependent cellular cytotoxicity 
ADCP 
antibody-dependent cellular phagocytosis 
ADL 
activities of daily living 
AE 
adverse event 
AESI 
adverse event of special interest
ALK 
anaplastic lymphoma kinase 
ALT 
alanine aminotransferase 
ANC
absolute neutrophil count
aPTT 
activated partial thromboplastin time 
AST
aspartate aminotransferase 
AUC 
area under the concentration-time curve
BAL 
bronchoalveolar lavage 
BOIN 
Bayesian Optimal Interval 
BOP2 
Bayesian Optimal Phase 2
BoR
best observed response 
BUN 
blood urea nitrogen 
BCVA 
best corrected visual acuity 
C, c 
Cycle, cycle 
CABG 
coronary artery bypass graft 
CDC 
complement-dependent cytotoxicity
cfDNA
circulating free deoxyribonucleic acid
CFR 
Code of Federal Regulations 
CL
clearance 
Clast
last measurable concentration 
Cmax 
maximum concentration 
cMET
protein product of the MET gene
CNS 
central nervous system
COVID-19 
coronavirus disease 2019 
CR 
complete response 
CT
computed tomography 
CTA 
Clinical Trial Agreement 
CTCAE 
Common Terminology Criteria for Adverse Events 
ctDNA 
Circulating tumor deoxyribonucleic acid  
CV 
curriculum vitae 
D, d 
Day, day 

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Abbreviation 
Definition 
DAR 
drug-to-antibody ratio
DCR 
disease control rate 
DLT
dose-limiting toxicity
DNA 
deoxyribonucleic acid
DOR 
duration of response 
DSMB
Data Safety Monitoring Board
EC
Ethics Committee 
ECG 
electrocardiogram
ECHO 
echocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form
EDC 
electronic data capture 
eGFR 
estimated glomerular filtration rate 
EGFR
epidermal growth factor receptor [gene]
EOT 
end of treatment 
FDA 
Food and Drug Administration 
FIH 
first in human 
FISH 
fluorescence in situ hybridization 
FSH
follicle stimulating hormone 
GCP 
Good Clinical Practice  
GLP
Good Laboratory Practice 
HbA1c 
hemoglobin A1c 
HBcAb 
hepatitis B core antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus
HCV 
hepatitis C virus
HCVAb
hepatitis C antibody
HED 
human equivalent dose 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
human immunodeficiency virus 
IB 
Investigator’s Brochure
ICF 
informed consent form
ICH 
International Council for Harmonisation  
IgG1 
immunoglobulin G1
IHC 
immunohistochemistry 
ILD 
interstitial lung disease 
INR 
international normalized ratio 
IRB/IEC
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) 
IRR
infusion-related reaction 

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Abbreviation 
Definition 
IRT 
Interactive Response Technology 
ISF 
Investigator Study File
IV
intravenous(ly)
L858R 
substitution of leucine (L) with arginine (R) at position 858 
LVEF
left ventricular ejection fraction 
MET
MET proto-oncogene, receptor tyrosine kinase
mg
milligram 
mL 
milliliter(s) 
MMAE 
monomethyl auristatin E 
MRI
magnetic resonance imaging 
MTD 
maximum tolerated dose 
MUGA 
multigated acquisition scan
NCI 
National Cancer Institute
NE 
not estimable 
NSCLC 
non-small cell lung cancer 
NYHA
New York Heart Association 
ORR 
overall response rate 
OS
overall survival 
PD
progressive disease 
PET 
positron emission tomography
PFS
progression-free survival 
P-gp
P-glycoprotein
PHI 
protected health information 
PK
pharmacokinetic(s) 
PR
partial response 
PT
prothrombin time 
PTCA
percutaneous transluminal coronary angioplasty
Q3W 
every 3 weeks 
QTc 
corrected QT interval 
RBC 
red blood cell
RECIST 1.1 
Response Evaluation Criteria in Solid Tumors 1.1 
RNA 
ribonucleic acid 
RP2D 
recommended Phase 2 dose 
SAE
serious adverse event
SAP
Statistical Analysis Plan
SCr 
serum creatinine 
SD
stable disease 
SDV 
source document verification 
SEER 
Surveillance, Epidemiology, and End Results

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Abbreviation 
Definition 
SJS 
Stevens-Johnson syndrome 
SRC 
Safety Review Committee 
SSF
Site Study File
SUSAR 
suspected unexpected serious adverse drug reaction
T790M 
substitution of threonine (T) with methionine (M) at position 790 
TEAE
treatment-emergent adverse event
TEN 
toxic epidermal necrolysis
TIA 
transient ischemic attack
TKI 
tyrosine kinase inhibitor
Tlast
time of last measurable concentration 
Tmax 
time to maximum concentration
TTR
time to response 
UK 
United Kingdom 
ULN 
upper limit of normal 
US
United States 
vcMMAE 
valine-citrulline-monomethyl auristatin E; linker/payload for MYTX-011 
(mc-vc-PAB-MMAE), a monomethyl auristatin E derivative with valine-citrulline 
(vc) linker 
Vd
volume of distribution 
Vss 
volume of distribution at steady state 

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1. 
STUDY SYNOPSIS 
Name of Sponsor: Mythic Therapeutics, Inc. 
Name of Investigational Product: MYTX-011 
Product Identifier: MYTX-011-01 
Title of Study: A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate 
MYTX-011 in Subjects with Non-Small Cell Lung Cancer – KisMET-01 
Study Center(s): Approximately 100 sites globally will participate. Initially approximately 10 sites will be 
selected, then upon expansion additional sites will be added. 
Enrollment Duration: Enrollment is expected to last approximately 36 months. 
BACKGROUND AND RATIONALE 
MYTX-011 is a cMET-targeted valine-citrulline monomethyl auristatin E (vcMMAE) antibody-drug conjugate 
(ADC) with a fully humanized immunoglobulin (Ig)G1. The drug-to-antibody ratio (DAR) for MYTX-011 is 2:1. 
MYTX-011 binds to cMET with high affinity and specificity.  
MYTX-011 has been engineered to have pH-dependent binding, which results in higher internalization and 
payload delivery to cMET+ tumor cells. This is manifested as increased internalization in cMET+ tumor cells in 
vitro compared to a non-engineered parent ADC and greater in vivo efficacy in murine non-small cell lung cancer 
(NSCLC) cMET+ tumor xenograft models compared to reference cMET-targeting ADCs with higher DAR 
values.  
The linker/payload of MYTX-011 (vcMMAE) has been well-characterized nonclinically and/or clinically for 
several marketed monomethyl auristatin E (MMAE)-containing ADCs. The nonclinical and clinical toxicities of 
MMAE-containing ADCs also have been well described in the literature (Fisher 2021; Saber and Leighton 2015). 
Preliminary safety and efficacy data from in vitro and in vivo nonclinical assessments of MYTX-011 further 
support development as a treatment for NSCLC in appropriately designed clinical research studies. 
The study will be conducted in 2 parts. Part 1 will assess the safety and tolerability of MYTX-011 and identify 
the dose to be studied in Part 2. Part 2 will include subjects with NSCLC with cMET expression, a population 
with a current unmet medical need. 
OBJECTIVES AND ENDPOINTS 
Part 1: MYTX-011 Dose Escalation 
Objective 
Endpoint
Primary 
 
To evaluate the safety and tolerability of 
MYTX-011 
 
To determine the RP2D and/or MTD of 
MYTX-011 
 
Incidence and severity of TEAEs, AEs, and 
clinically significant changes from baseline in 
vital signs, ECGs, and laboratory parameters 
 
The RP2D will be selected as a biologically 
active dose at or below the MTD (or the highest 
dose tested if the MTD is not identified during 
the study) 
 
MTD will be determined by DLTs during 
Cycle 1. The observation period for DLTs is 
Cycle 1. 
Secondary 
 
To characterize the PK profile of MYTX-011, 
including total ADC, total antibody, and free 
MMAE 
 
PK values for MYTX-011 including but not 
limited to total antibody, conjugated payload, 
and free payload (Cmax, Tmax, Clast, Tlast, AUC, 
half-life, CL, Vss) 

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To determine the optimal biological dose of 
MYTX-011 for use in Part 2 Cohorts A, B2, 
and E2 based on safety, PK, and preliminary 
anti-tumor activity 
 
To assess the incidence and persistence of 
ADAs to MYTX-011 
 
To determine preliminary anti-tumor activity of 
MYTX 011 
 
Presence of ADAs at multiple timepoints during 
the study 
 
ORR (confirmed CR + confirmed PR) by 
RECIST 1.1 
 
DOR for subjects who achieve CR or PR 
 
DCR (CR+PR+SD), best overall response, and 
time to response 
 
PFS and OS 
Exploratory 
 
To measure the level of cMET expression in 
tumor tissue and presence of alterations in MET 
 
Levels of cMET expression 
 
Presence of alterations in MET 
 
To assess biomarkers and predictors of 
response and resistance to MYTX-011 in tumor 
and blood (e.g., molecular, genetics, protein) 
 
Biomarkers and predictors of response and 
resistance to MYTX-011 in tumor and blood 
(e.g., molecular, genetics, protein) 
Part 2: MYTX-011 Dose Expansion  
Objective 
Endpoint
Primary 
To evaluate preliminary anti-tumor activity of 
MYTX-011 in subjects with the following: 
 
Advanced non-squamous NSCLC without 
actionable EGFR mutations, with high cMET 
expression 
 
Advanced non-squamous NSCLC without 
actionable EGFR mutations, with intermediate 
cMET expression 
 
Advanced squamous cell NSCLC without 
actionable EGFR mutations, with cMET 
expression  
 
Advanced non-squamous or adenosquamous 
NSCLC without actionable EGFR mutations, 
with low cMET expression  
 
Advanced NSCLC harboring actionable EGFR 
mutation, with high or intermediate cMET 
expression 
 
Advanced non-squamous or adenosquamous 
NSCLC without actionable EGFR mutations, 
with ultra-low cMET expression 
 
ORR (confirmed CR+PR) in each expansion 
cohort according to RECIST 1.1 
Secondary 
 
To evaluate the safety and tolerability of 
MYTX-011 
 
To characterize the PK profile of MYTX-011, 
including total ADC, total antibody, and free 
MMAE 
 
To characterize anti-tumor activity of 
MYTX 011 
 
To explore the optimal biological dose of 
MYTX-011 in various subgroups.  
 
Efficacy assessments according to RECIST 1.1 
in each expansion cohort, including:  
o 
DOR for subjects who achieve confirmed 
CR or PR 
o 
Time to response 
o 
Best overall response 
o 
DCR (confirmed CR+PR+SD) 
o 
PFS 
o 
OS 

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To assess the incidence and persistence of 
ADA to MYTX-011 
 
Incidence and severity of TEAEs, treatment-
related AEs, and clinically significant changes 
from baseline in vital signs, ECGs, and 
laboratory parameters 
 
PK values for MYTX-011 including but not 
limited to total antibody, conjugated payload, 
and free payload (Cmax, Tmax, Clast, Tlast, AUC, 
half-life, CL, Vss) 
 
Presence of ADA at multiple timepoints during 
the study 
Exploratory 
 
To measure the level of cMET expression in 
tumor tissue and presence of alterations in MET 
 
Levels of cMET expression 
 
Presence of alterations in MET 
 
Correlation to response 
 
To assess biomarkers and predictors of 
response and resistance to MYTX-011 in tumor 
and blood (e.g., molecular, genetics, protein) 
 
Biomarkers and predictors of response and 
resistance to MYTX-011 in tumor and blood 
(e.g., molecular, genetics, protein) 
ADA = anti-drug antibody; ADC = antibody-drug conjugate; AE = adverse event; AUC = area under the 
concentration-time curve; CL = total clearance; Clast = last measurable concentration; Cmax = maximum 
concentration; cMET = protein product of the MET gene; CR = complete response; DCR = disease control rate; 
DLT = dose-limiting toxicity; DOR = duration of response; ECG = electrocardiogram; EGFR = epidermal growth 
factor receptor [gene]; MET = MET proto-oncogene, receptor tyrosine kinase; MMAE = monomethyl auristatin 
E; MTD = maximum tolerated dose; NSCLC = non-small cell lung cancer; ORR = overall response rate; 
OS = overall survival; PFS = progression-free survival; PK = pharmacokinetics; PR = partial response; 
RECIST = Response Evaluation Criteria in Solid Tumors; RP2D = recommended Phase 2 dose; SD = stable 
disease; TEAE = treatment-emergent adverse event; Tlast = time of last measurable concentration; Tmax = time to 
maximum concentration; Vss = volume of distribution at steady state 
METHODOLOGY
Part 1: Dose Escalation 
In Part 1, subjects will be enrolled to evaluate the safety of escalating doses of MYTX-011 and to establish the 
RP2D and/or maximum tolerated dose (MTD).  
The dose escalation scheme is based on a 3-subject cohort minimum Bayesian Optimal Interval (BOIN) design 
(Yuan et al. 2016), a model-assisted design that employs an escalation/de-escalation procedure, similarly 
implemented as a classical 3 + 3 design, but optimized to minimize the probability of making an erroneous 
decision. Dose-limiting toxicities (DLTs) occurring during Cycle 1 (e.g., 21 days) will be considered when 
implementing the dosing algorithm and decisions. A Safety Review Committee (SRC) will review and assess data 
collected during the study to guide dose escalation and the determination of the RP2D. 
A sentinel dosing strategy will be used during Part 1 dose escalation for increasing doses (i.e., the dose level is 
the highest dose level that has been explored). A minimum of 24 hours must elapse between dosing of the first 
subject and subsequent subjects at each dose level. If no safety concerns are noted in the first subject at each dose 
level, subsequent subjects may be enrolled.  
If a new dose level is opened at a lower/intermediate dose after exploring a higher dose level (i.e., de-escalation), 
sentinel dosing is not needed unless severe acute toxicities, e.g., Grade 3 or higher infusion-related reaction 
(IRR), occurred within 24 hours after study drug administration in higher dose levels, or the SRC recommends 
sentinel dosing for the lower dose level. 
The first dose of study drug (this term is used interchangeably with “investigational product”) will be 
administered over 90 minutes or longer. Subjects will be observed closely for at least 2 hours following the initial 
dose for fever, chills, or other IRRs. Subsequent infusions may be administered over 60 minutes or longer if prior 
infusions were well tolerated. The average infusion rate must not exceed 1000 mg/hour. For active patients on the 

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study who receive MYTX-011 over 30-60 minutes regularly without experiencing IRR, the infusion duration of 
prior cycles may be maintained.
Part 2: Dose Expansion 
The recommended Phase 2 dose (RP2D) and alternative dose for Part 2 randomized cohorts have been established 
based on Part 1 data assessed to date. These doses are as follows: 
RP2D is a 5 mg/kg dose break regimen; dose every 21 days for 2 cycles, then 3-week dose break, i.e., 
6 weeks between doses 2 and 3, then repeat this pattern of 2 cycles of treatment, followed by a 3-week 
dose break until end of treatment (this regimen is referred to as 5 mg/kg dose break regimen throughout 
the protocol). 
Alternative dose for randomized cohorts A, B2, E2 is 4 mg/kg every 21 days. 
Cohorts for evaluation of efficacy in Part 2 of the study are:  
 
Cohort A: Advanced non-squamous NSCLC without actionable EGFR mutations, with high cMET 
expression by immunohistochemistry (IHC) 
be randomized 1:1 to 1 of 2 dose levels. An interim analysis for futility will be performed.  
 
Cohort B: Advanced non-squamous NSCLC without actionable EGFR mutations, with 
analysis for futility will be performed. 
 
Cohort B2: Advanced non-squamous NSCLC without actionable EGFR mutations, with 
Cohort B2 
may open if Cohort B passes interim analysis for futility (i.e., futility criteria are not met). Subjects 
will be randomized 1:1 to 1 of 2 dose levels. 
 
Cohort C: Advanced squamous cell NSCLC without actionable EGFR mutations, with cMET 
efficacy will be performed. 
 
Cohort D: Advanced non-squamous or adenosquamous NSCLC without actionable EGFR 
mutations, with low cMET expression by IHC 
, that does not 
meet inclusion criteria for Cohorts A, B, or B2 
 
Cohort E: Advanced NSCLC harboring actionable EGFR mutation, with high or intermediate 
cMET expression by IHC 
).  
 
Cohort E2: Advanced NSCLC harboring actionable EGFR mutation, with high or intermediate 
passes the interim analysis for futility (i.e., futility criteria are not met). Subjects will be randomized 
1:1 to 1 of 2 dose levels. 
 
Cohort F: Advanced non-squamous or adenosquamous NSCLC without actionable EGFR 
mutations, with ultra-
does not meet inclusion criteria for Cohorts A, B, B2, or D. 
Cohorts A-E may be opened for enrollment simultaneously or in a staggered manner at the discretion of the 
Sponsor, with the exception of Cohorts B2 and E2, which may be opened if Cohorts B or E, respectively, pass 
interim analyses for futility (i.e., if futility criteria are not met). Subjects in Cohorts A, B2, and E2 may be 
randomized to receive 1 of 2 doses: either the RP2D selected at the end of dose escalation or an alternative dose 
that is at or below the MTD (or the highest dose tested during dose escalation if the MTD is not determined). 
Subjects in Cohorts B, C, D, E, and F will receive MYTX-011 at the RP2D determined at the end of Part 1. As 
noted in the paragraphs below, additional doses, based on emerging data, may be explored in these cohorts as 
well.  
Cohort F will be opened on a country-by-country basis, with country-specific timing contingent upon Sponsor’s 
meeting any necessary submission and approval requirements related to the specific IHC assay used to determine 

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cMET expression. Sites will only be permitted to enroll patients in Cohort F after all necessary country and site 
level diagnostic approvals are in place.  
Additional Doses in Part 2 
While the RP2D and Alternate doses have been identified based on initial data from Part 1, as additional safety 
and efficacy data are obtained from both Parts 1 and 2 of the study, other doses may be incorporated into one or 
more Part 2 cohorts to further guide dose selection for future evaluations. The dose(s) to be included will not 
exceed the MTD (or the highest dose tested and found not to exceed the MTD during dose escalation (Part 1) if 
the MTD is not determined).  
Additional dose(s) for evaluation in Part 2 may be added in two ways: 
 
As a substitute for the RP2D or Alternative dose  
 
As an additional dose level beyond the RP2D and Alternative doses 
When added as a substitute for the RP2D or Alternative dose, the interim and final cohort sizes and rules for 
futility and efficacy will be applied to this new dose as described for the RP2D or Alternate dose in each cohort 
as described in Section 8.2.2; enrollment will be re-initiated to account for the additional dose. If added as an 
additional dose beyond the RP2D and Alternative dose, the rules governing the RP2D for futility, efficacy, and 
cohort size will be applied. If the RP2D has been evaluated and not found to meet rules for futility, the additional 
doses may enroll without futility assessment.  
Any randomization (in Cohorts A, B2, or E2) already underway may be re-initiated with the additional dose 
level(s) for evaluation as a substitute for the RP2D or Alternative dose. Randomization may also be added to 
Cohorts C, D, and F to evaluate additional doses versus RP2D (provided the RP2D has not been found to be 
futile). Randomization is not required for the evaluation of additional dose(s) and its implementation will be 
determined by the Sponsor based on the current status of doses evaluated within those cohorts. 
STUDY DRUG AND TREATMENT REGIMEN 
MYTX-011 will be administered by intravenous (IV) infusion in 21-day cycles, or in a dose break regimen. Dose 
levels are summarized below. The SRC may recommend changing the frequency of the dosing regimen if the 
emerging data suggest that the current regimen is not optimal (e.g., to every 2 or 4 weeks). Additionally, 
intermediate dose levels and/or different dosing schedules may be implemented by the Sponsor or recommended 
by the SRC and will be communicated to clinical study sites via administrative memorandum. 
Planned Dose Levels 
Dose Level 
Dose (mg/kg)1,2 
-13 
0.3 
1 
1.0 
2 
2.0 
3 
3.3 
4 
5.0 
5 
6.7 
6 
8.3 
7 
10.0 
1 Subjects weighing >100 kg will receive a fixed dose, whereas subjects weighing up to 100 kg will receive the 
mg/kg dose specified. Based on emerging PK, safety, and preliminary anti-tumor activity data during the study, 
the SRC may recommend changing the fixed dose to a mg/kg dose for subjects who weigh >100 kg. 
2 Intermediate dose level/s and/or different dosing schedule may be implemented by the Sponsor or 
recommended by the SRC to assess the safety, PK, and preliminary anti-tumor activity data.  

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3 If a dose de-escalation is needed at dose level 1 based on the BOIN design, the SRC will review the emerging 
data and determine if the study should be amended, terminated, or a lower dose explored. The lowest dose to be 
explored may be 0.3 mg/kg, but SRC may recommend a different dose based on emerging data. 
ELIGIBILITY 
Inclusion Criteria
Subjects must meet all the following inclusion criteria to be eligible for participation in this study. 
1. Part 1 
a. 
Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for 
curative therapy), or metastatic NSCLC and have received available standard of care therapy. 
b. There is no limit on the number of prior therapies that can have been received. 
2. Part 2 (Cohorts A-D, F) 
a. 
Known to not have an actionable EGFR mutation. Subjects with or without other driver mutations 
are permitted to enroll. 
b. Must have received (or be ineligible for) available standard of care therapy. 
c. 
Must have progressed on at least 1 line of prior systemic therapy in the locally advanced/metastatic 
setting. 
Note: multiple tyrosine kinase inhibitor (TKI) for the same actionable mutation count as 1 line of 
therapy. Maintenance therapy is not considered a separate line of therapy. Rechallenge of the same 
therapy regimen, or part of the regimen within 6 months of discontinuation date of the therapy is 
not considered a separate line of therapy. Adjuvant and neoadjuvant therapies count as 1 line of 
therapy if given within 6 months of study entry. The same rules above apply to all 
inclusion/exclusion criteria regarding prior lines of therapy. 
d. Subjects without any actionable gene alteration: must have progressed on (or be considered 
ineligible for), or be intolerant to, platinum-based chemotherapy and immune checkpoint inhibitor 
(as monotherapy or in combination with chemotherapy), and have not received more than 2 lines of 
prior systemic therapy in the locally advanced/metastatic setting. 
e.
Subjects with actionable gene alterations (other than EGFR) for which immune checkpoint 
inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): 
must have progressed on (or be considered ineligible for), or be intolerant to, anticancer therapy 
targeting driver gene alterations and platinum-based chemotherapy, and have not received more 
than 3 lines of prior systemic therapy in the locally advanced/metastatic setting. 
f. 
Subjects with actionable gene alterations (other than MET exon 14 skipping mutation) for which 
immune checkpoint inhibitor is standard of care: must have progressed on (or be considered 
ineligible for), or be intolerant to, anticancer therapy targeting driver gene alteration and platinum-
based chemotherapy, and also progressed on (or be considered ineligible for), or be intolerant to, 
immune checkpoint inhibitor (as monotherapy or in combination with platinum-based 
chemotherapy), and have not received more than 3 lines of prior systemic therapy in the locally 
advanced/metastatic setting. 
g. Subjects with MET exon 14 skipping mutation must have progressed on, or be intolerant to, at least 
one MET TKI if available, and have not received more than 2 lines of prior systemic therapy in the 
locally advanced/metastatic setting. 
3. Part 2 
a. 
Cohort A 
i. 
Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate 
for curative therapy), or metastatic non-squamous NSCLC. 

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ii.
confirmed by central laboratory testing.  
b. Cohorts B and B2 (Cohort B2 may be opened if Cohort B passes interim analysis for futility) 
i. 
Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate 
for curative therapy), or metastatic non-squamous NSCLC. 
ii. 
Tumor sample with intermediate cMET expression by IHC (3+ with tumor cell positivity of 
 
c. 
Cohort C 
i. 
Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate 
for curative therapy), or metastatic squamous NSCLC. 
ii. 
confirmed by central laboratory testing. 
d. Cohort D 
i. 
Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate 
for curative therapy), or metastatic non-squamous or adenosquamous NSCLC. 
ii. 
Have low cMET expression on tumor biopsy confirmed centrally by IHC (2+ with tumor cell 
or B2.  
e. 
Cohorts E and E2 (Cohort E2 may be opened if Cohort E passes interim analysis for futility) 
i. 
Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate 
for curative therapy), or metastatic NSCLC. 
ii. 
%) 
confirmed by central laboratory testing.  
iii. 
Harbors actionable EGFR mutations, including exon 21 substitution of leucine with arginine at 
position 858 (L858R), exon 19 deletions, exon 20 variation, and other uncommon sensitizing 
EGFR mutations. 
iv. 
Have previously received and had disease progression following at least 1 EGFR TKI or 
discontinued treatment due to intolerable toxicity (does not apply to subjects with 
exon 20 insertion), and have progressed on, intolerable to, or ineligible for platinum-based 
chemotherapy. Subjects with exon 21 L858R, exon 19 deletions, or substitution of threonine 
with methionine at position 790 (T790M) should have received osimertinib or other 3rd 
generation EGFR TKI if available. Subjects with exon 20 insertion should have received 
amivantamab if available. 
v. 
Must have received an available standard of care therapy and have progressed on at least 1 line 
and no more than 3 lines of prior systemic therapy in the locally advanced/metastatic setting.  
vi. 
Prior exposure to cMET-targeted antibody (either monoclonal, bi-specific, tri-
specific)/bicycle/small peptide therapies is allowed. Prior cMET-targeted ADC or ADC that 
contains antitubulin payload are not allowed. 
f. 
Cohort F 
i. 
Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate 
for curative therapy), or metastatic non-squamous or adenosquamous NSCLC. 
ii. 
Have ultra-low cMET expression on tumor biopsy confirmed centrally by IHC (1+ with tumor 
  
For All Subjects Enrolled in Part 1 and Part 2 
4. Subject has at least 1 measurable lesion per RECIST 1.1(Appendix C) 

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5. ECOG performance status 0 or 1; see Appendix D
6.
Adults 
7. 
alopecia, stable immune related toxicity such as hypothyroidism on hormone replacement, adrenal 
 anemia) 
8. 
 
9. Adequate organ function as defined as: 
a. 
3 (without growth factors within 1 week of first 
dose of study drug administration) 
b. 
study drug administration)  
c. 
red blood cell [RBC] transfusion not allowed within 1 week prior to first 
dose of study drug administration) 
d. International normalized ratio (INR) activated partial thromboplastin time (aPTT) and prothrombin 
× institution’s ULN unless the subject is receiving anticoagulants. Subjects on 
stable anticoagulant dose are permitted to enroll 
e. 
Calculated creatinine clearance >30 mL/min as calculated by the Modified Cockcroft-Gault 
formula. Refer to Appendix E and Section 5.1 
f. 
× 
× ULN for subjects with Gilbert syndrome 
g. 
× ULN for subjects without liver metastases. For subjects with liver 
metastases, 
× ULN 
h. 
× ULN for subjects without liver and/or bone metastases.  
i. 
 
j. 
Hemoglobin A1c 
subjects must be on a stable dose of antidiabetic medications 
first dose of study drug) 
10. For women of childbearing potential and men with partners of childbearing potential, agreement to use 
a highly effective method of birth control for the duration of the study treatment and for at least 6 
months after the last dose of study drug. See Appendix A. 
11. Able to provide informed consent, and willing and able to comply with study protocol requirements. 
Exclusion Criteria 
Subjects who meet any of the following exclusion criteria will be excluded from this study:
1. NSCLC with adenosquamous histology (for Cohorts A, B, B2, and C only; subjects with advanced 
NSCLC with adenosquamous histology are allowed in Cohorts D, E, E2, and F). 
2. Radiation to the lung within 6 weeks prior to screening. For all other sites (except lung), therapeutic or 
palliative radiation within 2 weeks prior to the first dose of study drug. Must have recovered from all 
radiation-related toxicity. 
3. Major surgery within 28 days prior to first dose of study drug administration. This 28-day washout 
period also applies to any surgical intervention that involves the eye or orbital region. 
4. Systemic anticancer therapy including investigational drugs, within the lesser of 28 days or 5 half-lives 
of the prior therapy before starting study drug (14 days or 5 half-lives for small molecule targeted 
therapy).  
Concurrent use of hormonal therapy for breast cancer or prostate cancer is permitted.  
5. Previously received cMET-targeted antibody or ADC, bicycle, or small peptide therapies targeting 
cMET. 
Note: For Cohort E: Prior exposure to cMET-targeted antibody/bicycle/small peptide therapies is 
allowed, but subjects who have previously received cMET-targeted ADC will be excluded. 

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6.
Previously received ADC that contains antitubulin (e.g., MMAE, MMAF) payload, regardless of ADC 
target.
7. Use of any concomitant or prohibited therapies outlined in Section 7.6 
8. Untreated, uncontrolled central nervous system (CNS) metastases and/or leptomeningeal disease. 
Subjects with CNS metastases (not applicable for leptomeningeal disease) who have had surgical 
resection at least 4 weeks prior to first dose of study drug or who have received radiation therapy to all 
known sites of CNS disease ending at least 2 weeks prior to first dose of study drug are eligible if: 
a. 
There is no evidence of disease progression after at least 2 weeks after the end of definitive 
therapy; and 
b. The subject is neurologically stable and either off or on a non-increasing dose (in the past 
2 weeks) of systemic steroids.
9. Untreated or uncontrolled human immunodeficiency virus (HIV) infection. For HIV treatments, anti-
viral therapies must not be strong CYP3A4 inhibitors or inducers while receiving MYTX-011. 
The subject must receive/switch to anti-viral therapy that does not interfere with CYP3A4 at least 
4 weeks prior to first dose of study drug. For a subject with HIV to be considered controlled, they must: 
a. 
Have a consistent CD4 count of at least 350/mm3 and undetectable viral load within 3 months 
before first dose of study drug. If the patient switched to a different anti-viral regimen prior to first 
dose of study drug, one serology test that meets the above qualification must be performed at least 
3 weeks after starting new anti-HIV regimen. 
b. Have no history of opportunistic infection within 3 months before first dose of study drug. 
10. Untreated hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.  
a. 
HBV: Subjects with serological evidence of chronic HBV infection should have an HBV viral load 
below the limit of quantification to be eligible. In addition, subjects with positive HBsAg should be 
on anti-HBV therapy at enrollment and while receiving MYTX-011. 
b. HCV: Subjects with history of HCV infection should have completed curative antiviral treatment 
and have HCV viral load below the limit of quantification. 
11. Myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA) or 
coronary artery bypass grafting (CABG) or cerebrovascular event (stroke or transient ischemic attack 
[TIA]) within 6 months of first dose of study drug, symptomatic congestive heart failure (New York 
Heart Association [NYHA] >Class II; see Appendix B), or ventricular arrhythmias requiring treatment.  
12. Elevated corrected QT interval (QTc) >480 ms based on Fridericia’s correction formula. 
13. History of interstitial lung disease or pneumonitis that required treatment with systemic steroids or 
evidence of active interstitial lung disease or pneumonitis. A history of prior radiation pneumonitis in 
the radiation field (fibrosis) is permitted, but the radiation pneumonitis must have resolved to Grade 1 
no less than 6 months prior to study entry.  
14. Subject requires systemic steroid therapy: prednisone 10 mg daily or equivalent. Inhaled steroids or 
topical steroid use is permitted. 
15. Clinically significant systemic illness that could pose undue risk to the subject or confound the ability to 
interpret study results.  
16. Active infection requiring IV antibiotics, antivirals, or antifungal medication within 14 days of Cycle 1 
Day 1. 
17. Neuropathy > Grade 1 for any reason. 
18. History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver 
disease. 
19. Active or chronic eye disorders specified below: 
a. 
Severe ocular surface/corneal disorder, such as primary or secondary Sjögren’s syndrome, severe 
dry eye disease (any cause), history of corneal transplantation, ocular chronic graft-versus-host 

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disease, active corneal infection (including herpetic keratitis), neurotrophic keratopathy, or other 
forms of severe ocular surface disease.
b. Conditions that may interfere with assessment of vision, such as  
o 
Monocular status (functional vision in only one eye) 
o 
Severe visual impairment in one or both eyes (from any cause) 
o 
Active ocular conditions requiring ongoing procedural intervention (e.g., intravitreal injections 
for wet age-related macular degeneration). 
c. 
Uncontrolled glaucoma. 
d. Patients with best-corrected visual acuity (BCVA) worse than 20/50 (Snellen) or logMAR >0.4 in 
either eye at baseline are excluded. 
This means:  
Eligible: 20/50 
4 logMAR)   
Not eligible: Worse than 20/50 (>0.4 logMAR, e.g., 20/60, 20/70, etc.). 
20. History of another malignancy within the past 3 years prior to screening except adequately treated basal 
cell or squamous cell skin cancer, carcinoma in situ of the breast or cervix, or organ-confined prostate 
cancer. Subjects with another malignancy must have completed definitive treatment (e.g., surgery, 
radiation, chemoradiation, or chemotherapy depending on standard of care of the specific malignancy) 
more than 3 years prior to screening; subjects may receive adjuvant therapy within 3 years of screening. 
For all regions except the United Kingdon (UK): Patients with other indolent in situ cancers may be 
permitted to enroll, contingent upon approval by the Sponsor Medical Monitor. 
21. Known active coronavirus disease 2019 (COVID-19) infection determined by positive COVID-19 
antigen test or polymerase chain reaction (PCR) test, or has signs and symptoms associated with 
COVID-19 within 14 days prior to first dose of study drug. Subjects must have a negative test and/or no 
further signs and symptoms associated with COVID-19 within 14 days of administration of first dose of 
study drug. Subjects who screen fail due to COVID-19 may be rescreened after they have recovered 
from COVID-19 after discussion with the Sponsor Medical Monitor. 
22. Known hypersensitivity to monoclonal antibodies. 
23. Pregnant (positive pregnancy test at screening) or lactating female. 
24. Known hypersensitivity to MYTX-011 or any of its excipients 

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2. 
INTRODUCTION 
2.1. 
BACKGROUND 
2.1.1. 
Overview of MYTX-011 
MYTX-011 is a cMET-targeted val-cit-monomethyl auristatin E (vcMMAE) antibody-drug 
conjugate (ADC) with a fully humanized immunoglobulin (Ig)G1. The drug-to-antibody ratio 
(DAR) for MYTX-011 is 2:1. MYTX-011 binds to cMET with high affinity and specificity. 
MYTX-011 has been engineered to have pH-dependent binding, which results in higher 
internalization and payload delivery to cMET+ tumor cells. 
The linker/payload of MYTX-011 (vcMMAE) has been well-characterized nonclinically and/or 
clinically for several marketed monomethyl auristatin E (MMAE)-containing ADCs. 
The nonclinical and clinical toxicities of MMAE-containing ADCs also have been well described 
in the literature (Fisher 2021; Saber and Leighton 2015). 
Initial dose escalation data from this ongoing MYTX-011-01 study (KisMET-01) were presented 
at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Johnson et al. 
2024
-011, with doses 
ranging from 1.0-6.7 mg/kg (in Part 1); dose escalation was ongoing. 
Subsequent dose escalation data was presented at the 2025 ASCO Annual Meeting (Heist et al. 
2025). Data were included from 92 patients who had received 
-011, with doses 
ranging from 1.0-8.3 mg/kg in Part 1. Preliminary efficacy data demonstrated the anti-tumor 
activity of MYTX-011 across a range of cMET-expressing NSCLC patients, regardless of cMET 
level, histology and molecular subtype.  
2.1.2. 
Summary of Nonclinical Studies 
MYTX-011 binds human and cynomolgus monkey cMET with high affinity. Binding of 
MYTX-011 to cMET is pH dependent. MYTX-011 has been engineered to enhance the 
internalization and delivery of the cytotoxic payload to cancer cells. MYTX-011 can cause cell 
cycle arrest and cytotoxicity in cMET+ human lung cancer cell lines. The anti-cMET 
monoclonal antibody (mAb) component of MYTX-011 did not show agonist activity 
(e.g., cellular proliferation or cell signaling) in cMET+ cancer cells. The anti-cMET mAb 
component of MYTX-011 showed no (or limited) antibody-dependent cell-mediated 
cytotoxicity, antibody-dependent cellular phagocytosis, or cell-mediated cytotoxicity Fc effector 
functions.  
MYTX-011 has potent in vitro activity in cMET+ human lung cancer cell lines and in vivo 
activity in murine xenograft models of non-small cell lung cancer (NSCLC). 
Based on electrocardiograms (ECGs), heart rate, blood pressure, and daily and detailed weekly 
clinical observations, there were no cardiovascular, central nervous system (CNS), or respiratory 
system functional effects observed in monkeys during 25 days of every 3 weeks (Q3W) 
intravenous (IV) administration of MYTX-011 at 18 mg/kg/dose. 

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The nonclinical pharmacokinetics (PK) and toxicokinetics of MYTX-011 were characterized in 
monkeys and support the proposed Q3W dosing regimen in humans. Data from these studies 
suggest that the nonclinical PK of MYTX-011 is as expected for a vcMMAE-containing ADC 
and is consistent for an IgG1. 
The nonclinical toxicity profile of MYTX-011 has been evaluated through the conduct of a 
pivotal 25-day repeat-dose IV toxicity study in monkeys. MYTX-011 was administered to 
monkeys Q3W via IV injection for up to 25 days (2 total doses) at 0, 6, 12, or 18 mg/kg/dose. 
Primary MYTX-011-related findings in the pivotal repeat-dose toxicity study were limited to 
minimal to moderate decreases in red blood cell (RBC) mass parameters, reticulocytes, 
included atypical mitotic figures in multiple 
hematopoiesis in the bone marrow at 18 mg/kg/dose. All MYTX-011 changes were fully 
reversible by the end of the 6-week recovery period. The clinical pathology and microscopic 
findings were most likely MMAE-payload related toxicities (i.e., neutropenia, decreases in bone 
morrow hematopoiesis, and atypical mitotic figures in tissues and organs). 
2.2. 
RISK/BENEFIT 
No prior clinical studies have been conducted with MYTX-011; therefore, the only clinical data 
to date is from MYTX-011-01 (current ongoing study), and the benefits and safety profile of 
MYTX-011 have not been established in humans.  
The potential risks of MYTX-011 are based on literature review of the clinical toxicity of ADCs 
with a vcMMAE linker/payload showed that the adverse event (AE) profiles for ADCs are 
consistent and independent of the antibody target (Masters et al. 2018).The potential risks 
associated with MYTX-011 administration are based on clinical experience with other vcMMAE 
ADCs approved by the US Food and Drug Administration (FDA): enfortumab vedotin-ejfv 
(PADCEV® [package insert] 2021), polatuzumab-vedotin-piiq (POLIVY® [package insert] 
2023), brentuximab vedotin (ADCETRIS® [package insert] 2023), and tisotumab-vedotin-tftv 
(TIVDAK® [package insert] 2021). The potential risks of MYTX-011 are also informed by 
published literature on telisotuzumab vedotin, another investigational cMET-targeted ADC, 
investigational vcMMAE ADCs that are site-specific DAR2 drug conjugates, and the 
MET targeted therapies emibetuzumab, capmatinib, and tepotinib.  
Preliminary safety and efficacy data from in vitro and in vivo nonclinical assessments of 
MYTX-011 further support development as a treatment for advanced NSCLC in appropriately 
designed clinical research studies. 
Please refer to the MYTX-011 Investigator’s Brochure (IB) for additional information. 
The benefit to risk assessment is in favor of studying MYTX-011 in subjects with cMET-
expressing advanced NSCLC. Doses up to 6.7 mg/kg were shown to be tolerable in Part 1 of this 
study. Clinical data, exposure-response, exposure-safety analyses, and PK modeling from Part 1 
supported the selection of 5 mg/kg every 21 days for 2 cycles, followed by a 3-week dose break, 

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then repeat as RP2D and 4.0 mg/kg every 21 days, as an alternative regimen, given the benefit-
risk considerations.
Based on ongoing review of the data from Parts 1 and 2 of the study, the sponsor may determine 
that one of the two dose regimens (RP2D or Alternative Dose) being administered in Part 2 
appears to show a better benefit:risk ratio than the other. In this case, the Sponsor may decide to 
assign ongoing patients and all newly enrolled patients to the dose regimen that appears to have 
the more favorable benefit:risk ratio, and no longer assign doses via randomization.  
As additional safety and efficacy data are obtained from both Parts 1 and 2 of the study, other 
doses (not to exceed the MTD or the highest dose tested during Part 1 dose escalation if the 
MTD is not determined) may be incorporated into one or more Part 2 cohorts to further guide 
dose selection for pivotal evaluations and the overall benefit:risk profile of MYTX-011. 
2.3. 
RATIONALE FOR STARTING DOSE
The selection of the starting dose was based on the established guidelines (DeGeorge et al. 1998; 
Saber and Leighton 2015), using the Good Laboratory Practices repeat-dose toxicity study 
conducted in cynomolgus monkeys. In this study, a dose of 18 mg/kg administered Q3W was 
defined as the highest non-severely toxic dose. This dose was converted to the human equivalent 
dose (HED), based on normalization of the dose to body surface area, and a safety factor of 6 
was applied to the HED. Based on the results of the nonclinical studies, a starting dose of 
1 mg/kg administered IV Q3W was selected for the planned study. Furthermore, nonclinical 
doses of MYTX-011 at 0.5 mg/kg were efficacious in a mouse NSCLC xenograft tumor model 
with high levels of cMET expression (MYTX-011 IB, Figure 8), supporting the rationale that a 
starting dose of 1 mg/kg might have clinical activity in patients who have tumors with high 
cMET expression. Please see the IB for additional details. 
2.4. 
RATIONALE FOR STUDY DESIGN 
Lung cancer is the leading cause of death worldwide with an estimated 1.8 million deaths (Sung 
et al. 2021). In the United States (US), lung cancer accounts for 12.3% of all new cancer cases 
and 21.4% of all cancer deaths (National Cancer Institute 2023). The 5-year relative survival of 
lung cancer is 22.9%. 
The treatment of lung cancer depends on the histology, stage, and presence of driver mutations 
and the general condition of the patient (Alexander et al. 2020; Mithoowani and Febbraro 2022). 
The treatment for patients with advanced lung cancer typically consists of cytotoxic 
chemotherapy and/or immunotherapies. Patients with actionable mutations are treated with 
targeted therapies (Alexander et al. 2020). 
In NSCLC, expression of cMET is upregulated by gene amplification (2% to 5% of patient 
tumors), exon 14 skipping mutations (2% to 4%), and expression (30% to 60%) (Salgia 2017). 
In NSCLC, cMET upregulation has been studied as a resistance mechanism for several approved 
epidermal growth factor receptor (EGFR)-targeted kinase inhibitors, and this resistance may 
limit their effectiveness (Fernandes et al. 2021). 

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In addition to NSCLC, cMET is also deregulated in many other cancers including gastric, head 
and neck, pancreatic, and colon cancer (Sierra and Tsao 2011).
Several cMET-targeted therapies are being, or have been, evaluated in clinical trials (such as 
telisotuzumab vedotin [ADC] and emibetuzumab [naked antibody]). Kinase inhibitors 
capmatinib (Tabrecta®) and tepotinib (Tepmetko®) have received accelerated approval from the 
US FDA for select subpopulations of patients with NSCLC whose tumors have a mutation that 
leads to MET exon 14 skipping and other kinase inhibitors targeting MET signaling are in 
clinical development. 
Recently, a cMET-targeted ADC in clinical development, telisotuzumab vedotin, showed a 
~35% response rate in patients with cMET highly expressing non-squamous NSCLC without 
EGFR mutations (Camidge et al. 2024), and telisotuzumab adizutecan (ABBV-400), another 
cMET-targeting ADC with a topoisomerase 1 inhibitor payload, showed a response rate ~48% in 
second line and later patients with non-squamous, EGFR wild-type NSCLC (De Miguel et al. 
2024); suggesting the potential of ADCs to be effective in a much broader population of patients 
with NSCLC whose tumors express cMET but are not dependent on cMET signaling. 
This is a first in human (FIH), Phase 1, multicenter, open-label, dose escalation, and expansion 
study designed to evaluate the safety, tolerability, and PK of MYTX-011, to determine the 
recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), and to evaluate the 
preliminary anti-tumor activity in subjects with previously treated advanced NSCLC with cMET 
expression. 
The study will be conducted in two parts. Part 1 will assess the safety and tolerability of 
MYTX-011 and identify the dose to be studied in Part 2. Part 2 will include subjects with 
advanced NSCLC with cMET expression, a population with a current unmet medical need. 
In Part 1, subjects will be enrolled to evaluate the safety of escalating doses of MYTX-011 as 
monotherapy and to establish the RP2D and/or MTD. The dose escalation scheme is based on a 
3-subject cohort minimum Bayesian Optimal Interval (BOIN) design (Yuan et al. 2016), 
a model-assisted design that employs an escalation/de-escalation procedure, similarly 
implemented as a classical 3 + 3 design, but optimized to minimize the probability of making an 
erroneous decision. 
The RP2D will be selected as a biologically active dose at or below the MTD (or the highest 
dose tested if an MTD is not identified during the study) and will be informed by safety and 
tolerability, PK data, and preliminary anti-tumor activity of MYTX-011 based on Response 
Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). 
Part 2 of the study will be initiated once the RP2D has been determined and will enroll subjects 
into different cohorts (A-F) based on cMET positivity cutoff, histological types, and/or EGFR 
mutation status. All cohorts are defined to explore preliminary anti-tumor activity in populations 
with different thresholds of cMET positivity that were selected based on data for cMET 
expression and efficacy observed with MYTX-011 in nonclinical models, published data for 
responses to cMET-targeting agents, and practical considerations given available data on the 

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prevalence of subject tumors with different expression levels. Cohorts A, B2, and E2 are also 
specifically designed to explore 2 dose levels in a randomized fashion to explore the optimal 
biological activity. Cohorts B2 and E2 may be opened if Cohorts B or E, respectively, pass 
interim analyses for futility (i.e., futility criteria are not met). 
The study will be conducted in accordance with the protocol, International Council for 
Harmonisation (ICH) E6, Good Clinical Practices (GCP), and applicable regulatory 
requirements. 
2.5. 
POPULATION TO BE STUDIED
During dose escalation (Part 1 of the study), subjects with NSCLC that is locally advanced, 
recurrent (and not a candidate for curative therapy), or metastatic and that has failed available 
standard of care therapy will be enrolled irrespective of cMET status. cMET status by 
immunohistochemistry (IHC) may be assessed at any timepoint (including pre-screening). 
Part 2 of the study will enroll subjects with previously treated advanced NSCLC that has failed 
available standard of care therapy into the following cohorts: 
 Cohort A: Advanced non-squamous NSCLC without actionable EGFR mutations, with 
 
 Cohort B: Advanced non-squamous NSCLC without actionable EGFR mutations, with 
 
 Cohort B2: Advanced non-squamous NSCLC without actionable EGFR mutations, with 
. 
Cohort B2 may open if Cohort B passes interim analysis for futility (i.e., futility criteria 
are not met). Subjects will be randomized 1:1 to 1 of 2 dose levels 
 Cohort C: Advanced squamous cell NSCLC without actionable EGFR mutations, with 
 
 Cohort D: Advanced non-squamous or adenosquamous NSCLC without actionable 
EGFR mutations, with low cMET expression by IHC (2+ with tumor cell positivity of 
, that does not meet inclusion criteria for Cohorts A, B, or B2 
 Cohort E: Advanced NSCLC harboring actionable EGFR mutation, with high or 
intermediate cMET expression by IHC 
 
 Cohort E2: Advanced NSCLC harboring actionable EGFR mutation, with high or 
. Cohort 
E2 may open if Cohort E passes the interim analysis for futility (i.e., futility criteria are 
not met). Subjects will be randomized 1:1 to 1 of 2 dose levels 
 Cohort F: Advanced non-squamous or adenosquamous NSCLC without actionable 
EGFR mutations, with ultra-low cMET expression by IHC (1+ with tumor cell positivity 
 
Additional dosing cohorts defined by other dose levels to be evaluated may be added as 
noted in Section 4.2. 

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3. 
OBJECTIVES AND ENDPOINTS 
3.1. 
OBJECTIVES FOR PART 1: MYTX-011 DOSE ESCALATION 
3.1.1. 
Primary Objectives 
To evaluate the safety and tolerability of MYTX-011
 To determine the RP2D and/or MTD of MYTX-011 
3.1.2.
Secondary Objectives
 To characterize the PK profile of MYTX-011, including total ADC, total antibody, and 
free MMAE  
To determine the optimal biological dose of MYTX-011 for use in Part 2 Cohorts A, B2,
and E2 based on safety, PK, and preliminary anti-tumor activity 
 To assess the incidence and persistence of anti-drug antibodies (ADA) to MYTX-011 
To determine preliminary anti-tumor activity of MYTX-011
3.1.3. 
Exploratory Objectives 
 To measure the level of cMET expression in tumor tissue and presence of alterations in 
MET 
 To assess biomarkers and predictors of response and resistance to MYTX-011 in tumor 
and blood (e.g., molecular, genetics, protein)
3.2. 
OBJECTIVES FOR PART 2: MYTX-011 DOSE EXPANSION  
3.2.1. 
Primary Objectives 
To evaluate preliminary anti-tumor activity of MYTX-011 in subjects with the following:
 Advanced non-squamous NSCLC without actionable EGFR mutations, with high cMET 
expression 
 Advanced non-squamous NSCLC without actionable EGFR mutations, with intermediate 
cMET expression 
 Advanced squamous cell NSCLC without actionable EGFR mutations, with cMET 
expression 
 Advanced non-squamous or adenosquamous NSCLC without actionable EGFR 
mutations, with low cMET expression,  
 Advanced NSCLC harboring actionable EGFR mutations, with high or intermediate 
cMET expression  
 Advanced non-squamous or adenosquamous NSCLC without actionable EGFR 
mutations, with ultra-low cMET expression. 

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3.2.2. 
Secondary Objectives 
 To evaluate the safety and tolerability of MYTX-011  
To characterize the PK profile of MYTX-011, including total ADC, total antibody, and 
free MMAE 
To characterize anti-tumor activity of MYTX-011
 To explore the optimal biological dose of MYTX-011 in various subgroups 
 To assess the incidence and persistence of ADA to MYTX-011
3.2.3.
Exploratory Objectives
 To measure the level of cMET expression in tumor tissue and presence of alterations in 
MET 
 To assess biomarkers and predictors of response and resistance to MYTX-011 in tumor 
and blood (e.g., molecular, genetics, protein)
3.3. 
ENDPOINTS 
3.3.1. 
Part 1 Dose Escalation 
3.3.1.1. 
Primary 
 Safety and tolerability will be defined as the incidence and severity of treatment-
emergent adverse events (TEAEs), treatment-related AEs, and clinically significant 
changes from baseline in vital signs, ECGs, and laboratory parameters.  
 The RP2D will be selected as a biologically active dose at or below the MTD (or the 
highest dose tested if the MTD is not identified during the study)  
 MTD will be determined by dose-limiting toxicities (DLTs) during Cycle 1. 
The observation period for DLTs is Cycle 1 (21 days). 
3.3.1.2. 
Secondary
 PK values for MYTX-011 including, but not limited to, total antibody, conjugated 
payload, and free payload (maximum concentration [Cmax], time to maximum 
concentration [Tmax], last measurable concentration [Clast], time to last measurable 
concentration [Tlast], area under the concentration-time curve [AUC], half-life, total 
clearance [CL], volume of distribution at steady state [Vss]) 
 Presence of anti-drug antibodies (ADAs) at multiple timepoints during the study 
 Overall response rate (ORR; confirmed complete response [CR] + confirmed partial 
response [PR]) using RECIST 1.1 
Note: CR and PR must be confirmed by 2 tumor imaging assessments conducted at least 
4 weeks apart. 
 Duration of response (DOR) for subjects who achieve a confirmed CR or PR 

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 Time to response 
 Best overall response 
Disease control rate (DCR; confirmed CR+PR+stable disease [SD])
Progression-free survival (PFS)
 Overall survival (OS) 
Details of anti-tumor activity endpoints are specified in the Statistical Analysis Plan (SAP). 
3.3.1.3. 
Exploratory 
 Level of cMET expression in tumor tissue and presence of alterations in MET 
 Biomarkers and predictors of response and resistance to MYTX-011 in tumor and blood 
(e.g., molecular, genetics, protein)
3.3.2. 
Part 2 Dose Expansion 
3.3.2.1. 
Primary 
 ORR (confirmed CR+PR) in each expansion cohort according to RECIST 1.1 
3.3.2.2. 
Secondary 
 Efficacy assessments according to RECIST 1.1 in each expansion cohort, including:
 DOR for subjects who achieve confirmed CR or PR 
 Time to response 
 Best overall response 
DCR (confirmed CR+PR+SD)
PFS
OS
 Details of anti-tumor activity endpoints are specified in the Statistical Analysis Plan
(SAP). Incidence and severity of TEAEs, treatment-related AEs, and clinically significant 
changes from baseline in vital signs, ECGs, and laboratory parameters 
 PK values for MYTX-011 including, but not limited to, total antibody, conjugated 
payload, and free payload (Cmax, Tmax, Clast, Tlast, AUC, half-life, CL, Vss) 
 Presence of ADA at multiple timepoints during the study  
3.3.2.3. 
Exploratory 
 Level of cMET expression in tumor tissue based on IHC assay, alterations in MET, and 
correlation to response  
 Biomarkers and predictors of response and resistance to MYTX-011 in tumor and blood 
(e.g., molecular, genetics, protein) 

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4. 
STUDY DESIGN 
This is an FIH, Phase 1, multicenter, open-label, dose escalation, and expansion study designed 
to evaluate the safety, tolerability, and PK of MYTX-011, to determine the RP2D and/or MTD, 
and to evaluate the preliminary anti-tumor activity in subjects with previously treated advanced 
NSCLC with cMET expression. 
The study will be conducted in two parts:
 Part 1 dose escalation 
 Part 2 dose expansion 
The study design schematic is displayed in Figure 1. 
Figure 1: 
Study Design Schematic 
 
AdenoSqCC = adenosquamous; BOIN = Bayesian Optimal Interval; cMET = protein product of the MET gene; 
EGFR = epidermal growth factor receptor [gene]; mut = mutated; Non-SqCC = nonsquamous; NSCLC = non-small 
cell lung cancer; R = randomization; RECIST = Response Evaluation Criteria in Solid Tumors; 
RP2D = recommended Phase 2 dose; SqCC = squamous 

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If Cohort B passes the interim analysis for futility (i.e., futility criteria are not met for Cohort B), 
a randomization cohort for subjects with intermediate cMET expression (Cohort B2) may be 
opened. Subjects in Cohort B2 will be randomized 1:1 to 2 dose levels (i.e., RP2D and 
alternative dose) up to 40 subjects in total. 
If Cohort E passes the interim analysis for futility (i.e., futility criteria are not met for Cohort E), 
the Cohort E2 may be opened for randomization. Cohort E2 has the same eligibility criteria as 
Cohort E. 
Cohort F will be opened on a country-by-country basis, with country-specific timing contingent 
upon Sponsor’s meeting any necessary submission and approval requirements related to the 
specific IHC assay used to determine cMET expression. Sites will only be permitted to enroll 
patients in Cohort F after all necessary country and site level diagnostic approvals are in place. 
4.1. 
PART 1: MYTX-011 DOSE ESCALATION 
In Part 1, subjects will be enrolled to evaluate the safety of escalating doses of MYTX-011 and 
to establish the RP2D and/or MTD. 
The dose escalation scheme is based on a 3-subject cohort minimum BOIN design (Yuan et al. 
2016), a model-assisted design that employs an escalation/de-escalation procedure, similarly 
implemented as a classical 3 + 3 design, but optimized to minimize the probability of making an 
erroneous decision. DLTs occurring during Cycle 1 will be considered when implementing the 
dosing algorithm and decisions. A Safety Review Committee (SRC) will review and assess data 
collected during the study to guide dose escalation and the determination of the RP2D. 
A sentinel dosing strategy will be used during Part 1 dose escalation for increasing doses 
(i.e., the dose level is the highest dose level that has been explored). A minimum of 24 hours 
must elapse between dosing of the first subject and subsequent subjects at each dose level. If no 
safety concerns are noted in the first subject at each dose level, subsequent subjects may be 
enrolled. 
If a new dose level is opened at a lower dose after exploring a higher dose level (i.e., de-
escalation), sentinel dosing is not needed unless severe acute toxicities, e.g., Grade 3 or higher 
infusion-related reaction (IRR), occurred within 24 hours after study drug administration in 
higher dose levels, or the SRC recommends sentinel dosing for the lower dose level. 
The first dose of study drug will be administered over 90 minutes or longer. Subjects will be 
observed closely for at least 2 hours following the initial dose for fever, chills, or other IRRs. 
Subsequent infusions may be administered over 60 minutes or longer if prior infusions were well 
tolerated. The average infusion rate must not exceed 1000 mg/hour. For active patients on the 
study who receive MYTX-011 over 30-60 minutes regularly without experiencing IRR, the 
infusion duration of prior cycles may be maintained. 
The target DLT rate for the MTD is 0.3. Subjects will be enrolled and treated in cohorts of size 3. 
Definitions of DLTs are provided in Section 4.3, and only those DLTs that occur within Cycle 1 
will be considered for dose selection decisions. 

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The dose escalation will occur as per planned dose level (see Table 8). Intermediate dose levels 
may be introduced during the dose escalation and will be selected based on safety, PK, and anti-
tumor activity at dose levels previously explored. Subjects in the first cohort will receive study 
drug at dose level 1. Study dose escalation/de-escalation and elimination rules are presented in 
Table 1 and are summarized as follows:  
1. Starting with dose level 1, a minimum of 3 subjects will be treated and followed for 
1 cycle for the occurrence of a DLT. A minimum of 3 subjects will be treated at any dose 
level under evaluation. 
2. Given the observed number of DLTs among the evaluable subjects treated at a current 
dose, an action to either escalate (E), eliminate (DU), de-escalate (D), or stay (S) at the 
current dose will be applied to the subsequent cohort of 3 subjects. A dose level with an 
action to escalate is determined to be safe. 
3. Starting dose level 1 can be de-escalated to dose “Level -1.” Intermediate doses between 
dose “Level -1” and dose level 1 are permitted if dose “Level -1” was determined to be 
safe. 
4. If the next action is to escalate (E): 
a. The next cohort of 3 subjects will be treated at a dose higher than the current dose, 
and equal to or less than the next higher dose. 
b. If the next higher dose has been eliminated, the next cohort of 3 subjects may be 
treated either at the current dose, or at an intermediate dose; if an intermediate dose is 
used, it will be no greater than halfway between the current dose and the next higher 
dose that was eliminated. 
c. If the current dose is the highest dose, the next cohort of 3 subjects will be treated at 
the current dose. 
5. If the next action is dose elimination (DU), the current dose and higher doses will be 
eliminated as unacceptably toxic and will not be used again in the remainder of the study. 
6. If the next action is dose elimination (DU) or de-escalation (D): 
a. The next cohort of 3 subjects will be treated at a dose lower than the current dose, 
which can be either a previously used dose that was determined to be safe or an 
intermediate dose; if an intermediate dose is used, it will be no greater than halfway 
between the current dose and the previously used, adjacent lower dose level that was 
determined to be safe. 
b. If the current dose is dose level 1 and no lower previously used dose was determined 
to be safe, then the next cohort of 3 subjects will be treated at dose “Level -1”. 
7. If the next action to be taken is stay (S), the next cohort of 3 subjects will be treated at the 
current dose. 
8. If the current dose is the lowest dose (“Level -1”) and the rule indicates dose de-
escalation, the next cohort of 3 subjects will be treated at the lowest dose unless the 
number of DLTs reaches the elimination boundary, at which point the study will be 
terminated for safety. No MTD will be declared in this case. 

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The above steps will be repeated following the BOIN design, until the RP2D is identified, at 
which point the dose escalation Part 1 of the study is complete. Part 1 of the study may also be 
considered complete if the number of evaluable subjects treated at the current dose is at least 9. 
 
Table 1: 
Dose Escalation Rules 
 
Number of Evaluable Subjects 
Number of Subjects with DLTs
 3
4 
5 
6 
7 
8 
9 
0
E
E
E
E
E
E
E
1 S 
S 
E 
E 
E 
E 
E 
2 D
D 
D 
S 
S
S
E 
3 DU 
DU 
D 
D 
D 
D 
S 
4 
 
DU 
DU
DU 
D 
D 
D 
5 
 
 
DU
DU 
DU 
DU
DU 
BOIN = Bayesian Optimal Interval; D = de-escalation; DLT = dose-limiting toxicity; DU = dose elimination; 
E = escalate; S = treat at current dose 
Note: The above table is shown to illustrate how the BOIN design is applied. The protocol does not limit enrollment 
to 9 subjects per dose level. 
The above algorithm employs safety overdose control where a dose and higher dose levels will 
be eliminated from further consideration if, given the number of observed DLTs at the current 
dose, there is a greater than 0.95 probability that the true DLT rate is higher than 30% and at 
least 3 subjects evaluable for DLT have been treated. When the lowest dose is eliminated, the 
study will be stopped for safety. Under this probability cutoff of 0.95, the dose with 3/3, 4/6, or 
5/9 subjects experiencing DLT will be eliminated.  
Once all the enrolled subjects complete the DLT observation period and the trial is not stopped 
early, the BOIN design applies an isotonic regression to select the MTD. 
Additional subjects may be enrolled in enrichment cohorts at dose levels that have previously 
been determined to be safe (including planned dose levels and intermediate dose levels) to better 
understand the safety, tolerability, PK, and preliminary anti-tumor activity of MYTX-011. 
No more than 10 subjects will be enrolled per enrichment cohort. For doses and/or dosing 
schedules where favorable benefit-risk has been demonstrated, up to 20 subjects may be enrolled 
for further dose optimization after approval by the SRC. Enrollment into enrichment cohorts may 
continue throughout the conduct of the study until all enrichment cohort slots are filled or it is 
determined that additional enrollment is not required. DLTs will not be assessed for subjects 

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enrolled into enrichment cohorts. In addition, the Sponsor may enroll subjects with certain levels 
of cMET expression (i.e., high, intermediate, low, or ultra-low cMET expression as defined in 
Part 2) in enrichment cohorts or intermediate dose levels in which preliminary anti-tumor 
activity is observed. 
4.1.1.
RP2D Selection Criteria
The RP2D will be selected as a biologically active dose at or below the MTD (or the highest 
dose tested if an MTD is not identified during the study) and will be informed by safety and 
tolerability, PK data, and preliminary anti-tumor activity of MYTX-011 according to 
RECIST 1.1 from subjects in Part 1 of the study. 
4.1.2.
Intrapatient Dose Escalation 
Subjects assigned to a dose level lower than the RP2D in Part 1 may be considered for 
intrapatient dose escalation to the RP2D or an alternative (or any additional doses) being 
evaluated in Part 2, with Sponsor Medical Monitor or designee approval. To be considered for 
intrapatient dose escalation, individual subjects need to have completed at least 4 cycles of 
MYTX-011 at their initial dose and be deriving clinical benefit from the treatment in the opinion 
of the Investigator. In order to be treated with a higher dose, the subject must not have 
treatment-related AEs at the initial dose level assigned or have required any dose 
modification(s)
subject would need to receive and tolerate a dose between the assigned dose and RP2D for at 
least 2 cycles before escalating to the RP2D. 
4.2. 
PART 2: MYTX-011 DOSE EXPANSION 
The dose expansion portion of the study will be initiated once the RP2D has been determined. 
 Cohort A: Advanced non-squamous NSCLC without actionable EGFR mutations; with 
high cMET expression by IHC (3+ with tumor cell positivity of 50%). Subjects will be 
randomized 1:1 to 1 of 2 dose levels. An interim analysis for futility will be performed. 
 Cohort B: Advanced non-squamous NSCLC without actionable EGFR mutations; with 
intermediate cMET expression by IHC (3+ with tumor cell positivity of 25% to 
An interim analysis for futility will be performed. 
 Cohort B2: Advanced non-squamous NSCLC without actionable EGFR mutations; with 
Cohort B2 may open if Cohort B passes the interim analysis for futility (i.e., futility 
criteria are not met). Subjects will be randomized 1:1 to 1 of 2 dose levels.
 Cohort C: Advanced squamous cell NSCLC without actionable EGFR mutations, with 
cMET expression by IHC (2+ with tumor cell positivity of 25%). An interim analysis 
for futility and efficacy will be performed. 

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 Cohort D: Advanced non-squamous or adenosquamous NSCLC without actionable 
EGFR mutations, with low cMET expression by IHC (2+ with tumor cell positivity of 
, that does not meet inclusion criteria for Cohorts A, B, or B2.
Cohort E: Advanced NSCLC harboring actionable EGFR mutation, with high or 
intermediate cMET expression by IHC 
Cohort E2: Advanced NSCLC harboring actionable EGFR mutation, with high or 
Cohort 
E2 may open if Cohort E passes the interim analysis for futility (i.e., futility criteria are 
not met). Subjects will be randomized 1:1 to 1 of 2 dose levels. 
 Cohort F: Advanced non-squamous or adenosquamous NSCLC without actionable EGFR 
mutations, with ultra-low cMET expression by IHC (1+ with tumor cell positivity of 
 
Cohorts A-F may be opened for enrollment simultaneously or in a staggered manner at the 
discretion of the Sponsor, with the exception of Cohorts B2 and E2, which will open if 
Cohorts B or E, respectively, pass interim analyses for futility (i.e., if futility criteria are not 
met). Subjects in Cohorts A, B2, and E2 will be randomized to receive 1 of 2 doses: either the
RP2D selected at the end of dose escalation or an alternative dose that is at or below the MTD 
(or the highest dose tested during dose escalation if the MTD is not determined). Subjects in 
Cohorts B, C, D, E and F will receive MYTX-011 at the RP2D determined at the end of Part 1. 
As noted in the paragraphs below, additional doses, based on MYTX-011 data, may be explored 
in these cohorts as well. 
Additional Doses in Part 2 
While the RP2D and Alternative dose were selected based on the available data, additional data 
are anticipated from both Parts 1 and 2 of the study that may impact choice of doses in one or 
more cohorts. In light of this, other doses may be incorporated into one or more Part 2 cohorts
after the RP2D and Alternative dose have been declared. The dose(s) to be included will not 
exceed the MTD (or the highest dose tested during dose escalation (Part 1) if the MTD is not 
determined) . 
Additional dose(s) for evaluation in Part 2 may be added in two ways: 
 As a substitute for the RP2D or Alternative dose  
 As an additional dose level beyond the RP2D and Alternative doses 
When added as a substitute for the RP2D or Alternative dose, the interim and final cohort sizes 
and rules for futility and efficacy will be applied to this new dose as described for the RP2D or 
Alternate dose in each cohort as described in Section 8.2.2; enrollment will be re-initiated to 
account for the additional dose. If added as an additional dose beyond the RP2D and Alternative 
dose, the rules governing the RP2D for futility, efficacy, and cohort size will be applied. If the 
RP2D has been evaluated and not found to meet rules for futility, the additional doses may enroll 
without futility assessment.  

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Any randomization (in Cohorts A, B2, or E2) already underway may be re-initiated with the 
additional dose level(s) for evaluation as a substitute for the RP2D or Alternative dose. 
Randomization may also be added to Cohorts C, D, and F to evaluate additional doses versus 
RP2D (provided the RP2D has not been found to be futile). Randomization is not required for 
the evaluation of additional dose(s) and its implementation will be determined by the Sponsor 
based on the current status of doses evaluated within those cohorts. 
Any new doses to be tested in a cohort will be assigned a new identifier. 
Screening and Treatment 
After providing informed consent, subjects will undergo screening assessments (up to 28 days 
prior to first dose of study drug). 
All subjects enrolled in Part 2 will be required to provide tumor tissue for assessing cMET tumor 
expression using an IHC-based assay performed at a central laboratory prior to study enrollment. 
Subjects with actionable mutation, including fusion of EML4-ALK, ROS1, RET, or NTRK1-3 or 
mutation of EGFR, BRAF, KRAS, or HER2, are: 
1. Required to provide tumor tissue sampled after progression or discontinuation of the most 
recent actionable mutation-targeted therapy (e.g., tyrosine kinase inhibitor [TKI], 
monoclonal/bispecific antibody, ADC) and are  
2. Requested but not required, to also provide available archival tumor tissue sampled prior 
to the first actionable mutation-targeted therapy (e.g., tyrosine kinase inhibitor [TKI], 
monoclonal/bispecific antibody, ADC. 
This specific tumor tissue requirement for actionable mutations does not apply to subjects with 
MET exon 14 skipping mutation or MET amplification without other actionable mutations. 
cMET values must meet the thresholds per the enrollment criteria. If archival tumor tissue is not 
available, subjects will be required to provide tissue from a new biopsy obtained during 
screening for cMET biomarker testing during the screening period. Confirmation of cMET status 
by IHC at the central laboratory must be obtained before the subject can be dosed in Part 2 of the 
study. Pre-screening may be conducted >28 days before Cycle 1 Day 1, after appropriate 
informed consent has been obtained. Pre-screening includes provision of an archival tumor 
sample or fresh tissue biopsy sample, and cMET testing at the central laboratory.  
Subjects enrolled in Cohort D must have IHC-based cMET expression that does not meet 
inclusion criteria for Cohorts A, B, or B2. Subjects enrolled in Cohort F must have IHC-based 
cMET expression that does not meet criteria for Cohorts A, B, B2 or D. 
During dose expansion, anti-tumor activity, safety, and PK of MYTX-011 will be assessed. 
MYTX-011 will be administered IV every 21 days (± 2 days) or may be administered a dose 
break regimen upon enrollment or as per the dose modification guidelines until disease 
progression, unacceptable toxicity, voluntary withdrawal of consent, or completion of study, 
whichever occurs first. If the Investigator deems that a subject with disease progression is 
benefiting from treatment, the Investigator may request that the subject remain on treatment after 
disease progression (requires Medical Monitor approval). Subjects who achieve a confirmed CR 

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by 2 tumor imaging assessments conducted at least 4 weeks apart may continue to receive 
treatment until meeting any of the end of treatment (EOT) criteria (Section 5.3.1).
Computed tomography (CT) scans with contrast (or magnetic resonance imaging [MRI]) will be 
performed during screening, then every 6 weeks (± 7 days) counting from Cycle 1 Day 1 through 
Week 24. After Week 24, scans will be performed every 12 weeks (± 2 weeks) thereafter until 
disease progression or EOT. Per RECIST 1.1, confirmatory CT scans may be done at 
unscheduled visits. Subjects who discontinue study drug due to reasons other than disease 
progression or withdrawal of consent will continue to undergo tumor assessments independent of 
study drug administration schedule, until demonstration of disease progression, withdrawal of 
consent, the start of another anticancer therapy, or death. Subjects will be assessed every 
12 weeks (±2 weeks) after the EOT visit until progression of disease is observed, death, or 
withdrawal of consent. During the 2-year long-term follow-up, disease status, survival status, and 
start of anticancer therapy will be collected. 
4.3. 
DLT EVALUATION CRITERIA 
The DLT observation period is the time from the first dose of study drug to the end of Cycle 1 
(cycle = 21 days). DLTs will be assessed during Dose Escalation (Part 1). Subjects will be 
considered evaluable for DLT if they receive their planned dose of MYTX-011 for Cycle 1 and 
have either completed Cycle 1 or are withdrawn during Cycle 1 due to a DLT. DLTs will not be 
assessed for subjects enrolled in the enrichment cohorts.
A DLT is defined as any of the following AEs that occur during the DLT observation period and 
are not clearly due to the underlying disease or extraneous causes, graded according to the 
National Cancer Institute (NCI) Version 5.0: 
 Grade 4 neutropenia or thrombocytopenia lasting 7 days despite supportive care
In United Kingdom (UK) only, Grade 4 neutropenia or thrombocytopenia lasting 
days despite supportive care
 Grade 4 neutropenia complicated by fever 38.0°C or infection  
 Grade 3 or higher thrombocytopenia complicated by significant (Grade 2) hemorrhage 
 Grade 4 anemia 
 Grade 3 or higher aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 
elevation 
 Any case consistent with Hy’s Law 
 AST or ALT >3 × upper limit of normal (ULN) and 
 Total bilirubin >2 × ULN and 
 Alkaline phosphatase >2 × ULN and 
 No other reason for liver injury 

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 Grade 3 or 4 non-hematologic toxicity, excluding:
Grade 3 nausea and/or vomiting, diarrhea or constipation that resolves to 
Grade 1 within 3 days following appropriate supportive care
Other Grade 3 or higher electrolyte abnormality that lasts up to 72 hours, is not 
clinically complicated, and resolves spontaneously or responds to conventional 
medical interventions 
 Grade 3 amylase or lipase that is not associated with symptoms or clinical 
manifestations of pancreatitis, or radiological imaging findings of pancreatitis 
 Alopecia 
 Grade 3 IRR 
Any death not clearly due to the underlying disease or extraneous causes.
4.4. 
STUDY DURATION 
Overall, subjects may remain in the study for up to approximately 4 years (or longer), including:
 Screening: up to 28 days prior to Cycle 1 Day 1 
 Treatment Period: up to study drug discontinuation (Section 5.3.1) 
 Long-Term Follow-up: up to 2 years after EOT 
4.5. 
END OF STUDY DEFINITION 
Primary Completion: Time when the last subject is assessed for purposes of final data 
collection for the primary analysis. The primary analysis will occur when target enrollment in 
Parts 1 and 2 is complete and each subject completes at least 6 months on study or withdraws 
from the study, whichever occurs first. The actual timing of the primary analysis may differ 
across the cohorts.  
End of Study: Time of the final analysis after the last subject completes EOT assessment.
5. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
5.1. 
INCLUSION CRITERIA 
Subjects must meet all the following inclusion criteria to be eligible for participation in this 
study: 
1. Part 1
a. Have histologically or cytologically confirmed locally advanced, recurrent (and 
not a candidate for curative therapy), or metastatic NSCLC and have received 
available standard of care therapy.

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b. There is no limit on the number of prior therapies that can have been received. 
2. Part 2 (Cohorts A-D and F)
a. Known to not have an actionable EGFR mutation. Subjects with or without other 
driver mutations are permitted to enroll. 
b. Must have received (or be ineligible for) available standard of care therapy. 
c. Must have progressed on at least 1 line of prior systemic therapy in the locally 
advanced/metastatic setting. Note: multiple TKI for the same actionable mutation 
count as 1 line of therapy. Maintenance therapy is not considered a separate line 
of therapy. Rechallenge of the same therapy regimen, or part of the regimen 
within 6 months of discontinuation date of the therapy is not considered a separate 
line of therapy. Adjuvant and neoadjuvant therapies count as 1 line of therapy if 
given within 6 months before study entry. The same rules above apply to all 
inclusion/exclusion criteria regarding prior lines of therapy.
d. Subjects without any actionable gene alteration: must have progressed on (or be 
considered ineligible for), or be intolerant to, platinum-based chemotherapy and 
immune checkpoint inhibitor (as monotherapy or in combination with 
chemotherapy), and have not received more than 2 lines of prior systemic therapy 
in the locally advanced/metastatic setting. 
e. Subjects with actionable gene alterations (other than EGFR) for which immune 
checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma 
kinase [ALK] translocation): must have progressed on (or be considered ineligible 
for), or be intolerant to, anticancer therapy targeting driver gene alterations and 
platinum-based chemotherapy, and have not received more than 3 lines of prior 
systemic therapy in the locally advanced/metastatic setting. 
f. Subjects with actionable gene alterations (other than MET exon 14 skipping 
mutation) for which immune checkpoint inhibitor is standard of care: must have 
progressed on (or be considered ineligible for), or be intolerant to, anticancer 
therapy targeting driver gene alteration and platinum-based chemotherapy, and 
also progressed on (or be considered ineligible for) or be intolerant to immune 
checkpoint inhibitor (as monotherapy or in combination with platinum-based 
chemotherapy ,and have not received more than 3 lines of prior systemic therapy 
in the locally advanced/metastatic setting. 
g. Subjects with MET exon 14 skipping mutation must have progressed on, or be 
intolerant to, at least one MET TKI if available, and have not received more than 
2 lines of prior systemic therapy in the locally advanced/metastatic setting. 
3. Part 2
a. Cohort A
i.
Have histologically or cytologically confirmed locally advanced, recurrent 
(and not a candidate for curative therapy), or metastatic non-squamous 
NSCLC. 

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ii.
Tumor sample with high cMET expression by IHC (3+ with tumor cell 
 
b. Cohorts B and B2 (Cohort B2 may be opened if Cohort B passes interim analysis 
for futility) 
i. 
Have histologically or cytologically confirmed locally advanced, recurrent 
(and not a candidate for curative therapy), or metastatic non-squamous 
NSCLC. 
ii. 
Tumor sample with intermediate cMET expression by IHC (3+ with tumor 
to 
 
c. Cohort C 
i.
Have histologically or cytologically confirmed locally advanced, recurrent 
(and not a candidate for curative therapy), or metastatic squamous NSCLC. 
ii.
Tumor sample with cMET expression by IHC (2+ with tumor cell positivity 
 
d. Cohort D
i.
Have histologically or cytologically confirmed locally advanced, recurrent 
(and not a candidate for curative therapy), or metastatic non-squamous or 
adenosquamous NSCLC.
ii. 
Have low cMET expression on tumor biopsy confirmed centrally by IHC 
(2+ 
for Cohorts A, B, or B2.  
e. Cohorts E and E2 (Cohort E2 may be opened if Cohort E passes interim analysis 
for futility) 
i.
Have histologically or cytologically confirmed locally advanced, recurrent 
(and not a candidate for curative therapy), or metastatic NSCLC. 
ii. 
Have high or intermediate cMET expression by IHC (3+ with tumor cell 
%) confirmed by central laboratory testing.  
iii. 
Harbor actionable EGFR mutations, including exon 21 substitution of 
leucine with arginine at position 858 (L858R), exon 19 deletions, exon 20 
variation, and other uncommon sensitizing EGFR mutations. 
iv. 
Have previously received and had disease progression following at least 1 
EGFR TKI or discontinued treatment due to intolerable toxicity (does not 
apply to subjects with exon 20 insertion), and have progressed on, 
intolerable to, or ineligible for platinum-based chemotherapy. Subjects with 
exon 21 L858R, exon 19 deletions, or substitution of threonine with 
methionine at position 790 (T790M) should have received osimertinib or 
other 3rd generation EGFR TKI if available. Subjects with exon 20 insertion 
should have received amivantamab if available. 

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v.
Must have received an available standard of care therapy and have 
progressed on at least 1 line of prior therapy and no more than 3 lines of 
prior systemic therapy in the locally advanced/metastatic setting.  
Note: multiple lines of EGFR TKI count as 1 line of therapy. Maintenance 
therapy is not considered a separate line of therapy. Rechallenge of the same 
therapy regimen, or part of the regimen within 6 months of discontinuation 
date of the therapy is not considered a separate line of therapy. Adjuvant and 
neoadjuvant therapies count as 1 line of therapy if given within 6 months 
before study entry. 
vi. 
Prior exposure to cMET-targeted antibody (either monoclonal, bi-specific, 
tri specific)/bicycle/small peptide therapies is allowed. Prior cMET-targeted 
ADC or ADC that contains antitubulin payload are not allowed. 
f. Cohort F 
i.
Have histologically or cytologically confirmed locally advanced, recurrent 
(and not a candidate for curative therapy), or metastatic non-squamous or 
adenosquamous NSCLC.
ii. 
Have ultra-low cMET expression on tumor biopsy confirmed centrally by 
criteria for Cohorts A, B, B2, or D. 
For all subjects enrolled in Part 1 and Part 2: 
4. Subject has at least 1 measurable lesion per RECIST 1.1 (Appendix C)
5. ECOG performance status 0 or 1; see Appendix D 
6. Adults 
 
7. Resolution of acute effects of prior therapy or 
(except alopecia, stable immune related toxicity such as hypothyroidism on hormone 
[or equivalent], or 
anemia) 
8. 
 
(ECHO) or MUGA scan 
9. Adequate organ function as defined as 
a. 
3 (without growth factors within 
1 week of first dose of study drug administration) 
b. 
3 (Platelet transfusion not allowed within 1 week prior to 
first dose of study drug administration)  
c. 
of study drug administration) 
d. 
institution’s ULN unless the subject is receiving anticoagulants. Subjects on stable 
anticoagulant dose are permitted to enroll. 

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e. Calculated creatinine clearance >30 mL/min as calculated by the Modified Cockcroft-
Gault formula. Refer to Appendix E
f. 
g. 
 
h. 
and/or bone metastases. 
i. 
j. Hemoglobin A1c (HbA1c) 
  
10. For women of childbearing potential and men with partners of childbearing potential, 
agreement to use a highly effective method of birth control for the duration of the study 
treatment and for at least 6 months after the last dose of study drug. See Appendix A. 
11. Able to provide informed consent, and willing and able to comply with study protocol 
requirements.
5.2. 
EXCLUSION CRITERIA 
Subjects who meet any of the following exclusion criteria will be excluded from this study: 
1. NSCLC with adenosquamous histology (for Cohorts A, B, B2, and C only; subjects with 
advanced NSCLC with adenosquamous histology are allowed in Cohorts D, E, E2 and F). 
2. Radiation to the lung within 6 weeks prior to screening. For all other sites (except lung),
therapeutic or palliative radiation within 2 weeks of the first dose of study drug. 
Must have recovered from all radiation-related toxicity. 
3. Major surgery within 28 days before first dose of study drug administration. 
This 28-day washout period includes any surgical intervention that involves the eye or 
orbital region. 
4. Systemic anticancer therapy including investigational drugs, within the lesser of 28 days 
or 5 half-lives of the prior therapy before starting study drug (14 days or 5 half-lives for 
small molecule targeted therapy).  
Concurrent use of hormonal therapy for breast cancer or prostate cancer is permitted. 
5. Previously received cMET-targeted antibody or ADC, bicycle, or small peptide therapies 
targeting cMET. 
Note: For Cohort E: Prior exposure to cMET-targeted antibody/bicycle/small peptide 
therapies is allowed, but subjects who have previously received cMET-targeted ADC will 
be excluded.  
6. Previously received ADC that contains antitubulin (e.g., MMAE, MMAF) payload, 
regardless of ADC target. 
7. Use of any concomitant or prohibited therapies outlined in Section 7.6. 

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8. Untreated, uncontrolled CNS metastases and/or leptomeningeal disease. Subjects with 
CNS metastases (not applicable for leptomeningeal disease) who have had surgical 
resection at least 4 weeks prior to first dose of study drug or who have received radiation 
therapy to all known sites of CNS disease ending at least 2 weeks prior to first dose of 
study drug are eligible if:
a. There is no evidence of disease progression after at least 2 weeks after the end of 
definitive therapy; and
b. The subject is neurologically stable and either off or on a non-increasing dose 
(in the past 2 weeks) of systemic steroids.
9. Untreated or uncontrolled human immunodeficiency virus (HIV) infection. For HIV 
treatments, anti-viral therapies must not be strong CYP3A4 inhibitors or inducers while 
receiving MYTX-011. The subject must receive/switch to anti-viral therapy that does not 
interfere with CYP3A4 at least 4 weeks prior to first dose of study drug. For a subject 
with HIV to be considered controlled, they must:  
a. Have a consistent CD4 count of at least 350/mm3 and undetectable viral load 
within 3 months prior to first dose of study drug. If the patient switched to a 
different anti-viral regimen prior to first dose of study drug, one serology test that 
meets the above qualification must be performed at least 3 weeks after starting 
new anti-HIV regimen. 
b. Have no history of opportunistic infection within 3 months prior to first dose of 
study drug. 
10. Untreated hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 
a. HBV: Subjects with serological evidence of chronic HBV infection should have 
an HBV viral load below the limit of quantification to be eligible. In addition, 
subjects with positive HBsAg should be on anti-HBV therapy at enrollment and 
while receiving MYTX-011. 
b. HCV: Subjects with history of HCV infection should have completed curative 
antiviral treatment and have HCV viral load below the limit of quantification. 
11. Myocardial infarction, unstable angina, PTCA or CABG or cerebrovascular event (stroke 
or transient ischemic attack [TIA]) within 6 months before first dose of study drug, 
symptomatic congestive heart failure (New York Heart Association [NYHA] >Class II; 
see Appendix B), or ventricular arrhythmias requiring treatment.  
12. Elevated corrected QT interval (QTc) >480 ms based on Fridericia’s correction formula. 
13. History of interstitial lung disease or pneumonitis that required treatment with systemic 
steroids or evidence of active interstitial lung disease or pneumonitis. A history of prior 
radiation pneumonitis in the radiation field (fibrosis) is permitted, but the radiation 
pneumonitis must have resolved to Grade 1 no less than 6 months prior to study entry.  
14. Subject requires systemic steroid therapy: prednisone 10 mg daily or equivalent. Inhaled 
steroids or topical steroid use is permitted. 

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15. Clinically significant systemic illness that could pose undue risk to the subject or 
confound the ability to interpret study results.  
16. Active infection requiring IV antibiotics, antivirals, or antifungal medication within
14 days of Cycle 1 Day 1. 
17. Neuropathy > Grade 1 for any reason. 
18. History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically 
significant liver disease. 
19. Active or chronic eye disorders specified below: 
a. Severe ocular surface/corneal disorder, such as primary or secondary Sjögren’s 
syndrome, severe dry eye disease (any cause), history of corneal transplantation, 
ocular chronic graft-versus-host disease, active corneal infection (including 
herpetic keratitis), neurotrophic keratopathy, or other forms of severe ocular 
surface disease. 
b. Conditions that may interfere with assessment of vision, such as  
o Monocular status (functional vision in only one eye) 
o Severe visual impairment in one or both eyes (from any cause) 
o Active ocular conditions requiring ongoing procedural intervention (e.g., 
intravitreal injections for wet age-related macular degeneration). 
c. Uncontrolled glaucoma 
d. Patients with best corrected visual acuity (BCVA) worse than 20/50 (Snellen) or 
logMAR >0.4 in either eye at baseline are excluded. 
This means:  
Eligible
 
Not eligible: Worse than 20/50 (> 0.4 logMAR, e.g., 20/60, 20/70, etc.)  
20. History of another malignancy within the past 3 years prior to screening except 
adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast 
or cervix, or organ-confined prostate cancer. Subjects with another malignancy must have 
completed definitive treatment (e.g., surgery, radiation, chemoradiation, or chemotherapy 
depending on standard of care of the specific malignancy) more than 3 years prior to 
screening; subjects may receive adjuvant therapy within 3 years of screening. For all 
regions except the UK: Patients with other adequately-treated, indolent in situ cancers 
may be permitted to enroll contingent upon approval by the Sponsor Medical Monitor. 
21. Known active coronavirus disease 2019 (COVID-19) infection determined by positive 
COVID-19 antigen test or PCR test, or has signs and symptoms associated with 
COVID-19 within 14 days prior to first dose of study drug. Subjects must have a negative 
test and/or no further signs and symptoms associated with COVID-19 within 14 days of 
administration of first dose of study drug. Subjects who screen fail due to COVID-19 
may be rescreened after they have recovered from COVID-19 after discussion with the 
Sponsor Medical Monitor. 

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22. Known hypersensitivity to monoclonal antibodies.
23. Pregnant (positive pregnancy test at screening) or lactating female. 
24. Known hypersensitivity to MYTX-011 or any of its excipients. 
5.3. 
DISCONTINUATION FROM STUDY 
5.3.1. 
End of Treatment 
For patients who discontinue treatment, end of treatment (EOT) is defined as the documented 
date of the decision to discontinue treatment, or death, whichever is earlier; if neither date is 
available, EOT will be defined as D42 from the last dose received. EOT visit must be performed 
within 30 days of the documented date of EOT. End of participation is defined as the last data 
collection timepoint, including follow-up visits and data collected for overall survival unless 
ocular adverse events have not resolved, follow up until resolution to baseline or within 1-2 lines 
of baseline. Discontinuation from study drug and discontinuation from study might be linked or 
might be separate events, depending on the triggering action, decision, or outcome. Subjects will 
be discontinued from study drug for any of the following reasons: 
 Disease progression, unless Medical Monitor approves continued treatment 
 If the Investigator deems that a subject is benefiting from treatment, the 
Investigator may request that the subject remain on treatment after disease 
progression (requires Medical Monitor approval) 
 Intolerable toxicity 
 Subject requests to withdraw consent from study 
 Subject requests to withdraw consent from treatment  
 Pregnancy 
 Initiation of therapeutic intervention not permitted by the protocol 
 Investigator discretion 
 Noncompliance with study procedures 
 Discontinuation of the study by the Sponsor 
5.3.2. 
Subject Discontinuation/Withdrawal from the Study 
Subjects who discontinue from study drug will complete an EOT visit and continue to be 
followed for AEs and other protocol-required procedures according to Table 2 and Table 3 
(unless subject withdraws consent from study).  
Subjects may voluntarily withdraw consent from the study at the subject’s own request any time 
and for any reason, and no further study data will be collected. The Investigator must make an 
effort to determine the primary reason for withdrawal. The Sponsor will continue to retain and 
use all research results that have already been collected for study evaluation. All biological 
samples that have already been collected may be retained and analyzed at a later date unless 

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Sponsor receives a written notification that the subject has withdrawn permission to analyze the 
samples.
5.3.3. 
Lost to Follow-Up 
If the subject is lost to follow-up, the study personnel must make reasonable efforts to contact the 
subject and determine the reason for discontinuation, including at least 3 documented attempts to 
contact the subject. In accordance with local regulations, information from public records may be 
used to collect missing survival data.  
5.3.4. 
Replacement of Subjects 
During Part 1 dose escalation, subjects who discontinue or withdraw from the study prior to 
completion of the DLT observation period not due to a DLT may be replaced. In addition, 
subjects who are enrolled in Part 1 dose escalation cohorts but do not receive study drug will be 
replaced.  
5.3.5. 
Screen Failures 
5.3.5.1. 
Screening and Rescreening Procedures 
After written informed consent has been obtained, subjects will be screened to assess eligibility 
for study participation. If a laboratory assessment listed in the inclusion/exclusion criteria is 
outside the protocol-specified range, then the assessment may be repeated/subject rescreened 
once during the screening period. If the repeat value is outside the protocol-specified inclusion/ 
exclusion criteria, then the subject will not be enrolled in the study. 
If the subject has not met all eligibility criteria at the end of the screening period, the subject will 
be considered a screen failure.  
Rescreening: Subjects may be rescreened at the discretion of the Investigator and in consultation 
with the Sponsor Medical Monitor. The subject must be reconsented if the rescreening occurs 
more than 30 days after the original informed consent form (ICF) was signed. The following 
assessments do not need to be repeated during rescreening if they were performed during the 
initial screening within the timeframes noted below: 
 ECHO or MUGA scan does not need to be repeated if initial test was medically 
acceptable and if performed within 60 days prior to Cycle 1 Day 1  
 Hepatitis serologies do not need to be repeated if performed within 12 weeks prior to first 
dose of study drug 
 Baseline ophthalmology examination does not need to be repeated if performed within 
8 weeks prior to first dose of study drug 
5.3.5.2. 
Information to Be Collected for Subjects Who Are Screen Failures 
The following information will be collected for subjects who are screen failures: 
 Demographics  

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 Inclusion/exclusion criteria 
 Date informed consent signed
Screen failure date and reason
Withdrawal of consent (if applicable)
 AE or serious adverse event (SAE) related to study procedures during the screening 
period (if applicable)  
5.3.6. 
Study Discontinuation/Termination 
The Sponsor has the right to terminate the study at an individual site or specific cohorts or the 
study in its entirety. Reasons for terminating the study or specific cohorts may include, but are 
not limited to: 
 The emergence of an unacceptable risk to subjects 
 The criteria for futility are met 
 General lack of enrollment or inadequate recruitment of subjects by an Investigator at a 
specific study site 
 Failure of an Investigator or site to adhere to the protocol or regulatory requirements 
 The Sponsor’s decision to suspend or discontinue development of the study drug 
 The Sponsor’s decision to suspend or discontinue further development of the study drug 
in specific cohorts 
If the Sponsor decides to terminate the study or study site, the Sponsor will promptly notify the 
Investigator(s) and relevant regulatory agencies. The Investigator will be responsible for 
notifying the Institutional Review Board/Ethics Committee of the early termination. Should the 
study be terminated early, the subject should be seen as soon as possible, and the same 
assessments performed as for discontinued or withdrawn subjects. 

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6.
STUDY ASSESSMENT AND TREATMENT SCHEDULE
After providing informed consent, subjects will undergo screening assessments (up to 28 days 
prior to first dose of study drug) as indicated in Table 2 and Table 3. Tumor samples will be 
analyzed for cMET expression, at any time for Part 1. Tumor samples must be provided 
prospectively to assign subjects to Part 2. Confirmation of cMET status by IHC at a central 
laboratory is required for Part 2 before the subject can be enrolled in the study. Pre-screening 
may be conducted >28 days before Cycle 1 Day 1, after appropriate informed consent has been 
obtained. Pre-screening includes provision of an archival tumor sample or fresh tissue biopsy 
sample and cMET testing at the central laboratory. Subjects with actionable mutation, including 
fusion of EML4-ALK, ROS1, RET, or NTRK1-3 or mutation of EGFR, BRAF, KRAS, or HER2,
are required to provide tumor tissue sampled after progression or discontinuation of the most 
recent actionable mutation-targeted therapy (e.g., TKI, monoclonal/bispecific antibody, ADC). 
This specific tumor tissue requirement for actionable mutations does not apply to subjects with 
MET exon 14 skipping mutation or MET amplification without other actionable mutations. Blood 
samples collected on study may be tested retrospectively for MET alterations (e.g., amplification/
exon 14 skipping).
Once enrolled in the study, MYTX-011 will be administered IV every 21 days (±2 days) or to a 
dose break regimen i.e. every 21 days (±2 days) for 2 cycles, followed by a 3-week dose break 
(±7 days) regimen, until disease progression, unacceptable toxicity, voluntary withdrawal of 
consent, or completion of study, whichever occurs first. Refer to Figure 2 and Figure 3. 
For subjects on a dose break regimen, if an unplanned delay (e.g., due to an adverse event) 
longer than 14 days takes place between the two consecutive 21-day cycles, it is recommended to 
reset the dose break schedule after the subject has received two consecutive 21-day cycles to 
maintain dose intensity. Please reach out to the Sponsor Medical Monitor for questions related to 
the dose break regimen.
Figure 2:
Q3W Dosing Regimen

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Figure 3:
Dose Break Regimen
If the Investigator deems that a subject with disease progression is benefiting from treatment, the 
Investigator may request that the subject remain on treatment after disease progression (requires 
Medical Monitor approval). Subjects who achieve a confirmed CR by 2 tumor imaging 
assessments conducted at least 4 weeks apart may continue to receive treatment until meeting 
any of the EOT criteria (Section 5.3.1). 
CT scans (or MRI) with contrast will be performed at the timepoints in Table 2 and Table 3
independent of study drug administration schedule until EOT, death, or withdrawal of consent. 
Subjects who discontinue study drug due to reasons other than disease progression or withdrawal 
of consent will continue to undergo tumor assessments until demonstration of disease 
progression, withdrawal of consent, or death. Subjects will be assessed (this can be done via 
telephone) every 3 months after the EOT visit until progression of disease is observed, 
withdrawal of consent, or death. During the 2-year long-term follow-up, disease status, survival 
status, and start of anticancer therapy will be collected.  
This study includes a screening period (up to 28 days), treatment period, EOT visit, and long-
term survival follow-up (up to 2 years). 

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6.1.
TRIAL ASSESSMENTS
6.1.1. 
Baseline Assessments 
6.1.1.1. 
Informed Consent 
Subjects potentially eligible for study enrollment must sign an ICF prior to initiation of any 
study-specific assessments or procedures.  
6.1.1.2. 
Medical History, Demographics, and Disease History 
Medical (including smoking) and surgical history, current medical conditions, and demographics 
will be captured at screening.  
Details of NSCLC will be recorded at screening including date of initial diagnosis, histological 
classification, date metastatic disease was identified, stage at study entry, and current sites of 
active disease/metastases. Prior therapies (surgeries, radiation, systemic anticancer therapies) 
along with dates, number of cycles, best observed response (BoR) to each treatment, DOR to 
each treatment (if subject had a response), and date of most recent disease progression will be 
recorded. Programmed death ligand 1 status (if positive and % positivity) and presence of other 
actionable mutations (including MET, KRAS, ALK, ROS1, BRAF, NTRK, RET) if known should 
be recorded. EGFR mutational status should be recorded. Other known mutations should also be 
captured.  
6.1.1.3. 
Tumor Tissue for cMET IHC Prior to Study Entry 
Part 1: Tumor samples are requested at screening for subjects in Part 1. These samples are 
collected for analysis of cMET by IHC at the central laboratory. Archival tissue can be submitted 
or tumor biopsies performed during pre-screening or screening after the appropriate informed 
consent has been obtained. For Part 1, confirmation of cMET status is strongly preferred but is 
not an eligibility requirement.  
Part 2: Tumor samples are required before enrollment into Part 2. Confirmation of cMET status 
by IHC at the central laboratory is required for subjects to be enrolled in Part 2. Subjects with 
actionable mutation, including fusion of EML4-ALK, ROS1, RET, or NTRK1-3 or mutation of 
EGFR, BRAF, KRAS, or HER2, are required to provide tumor tissue sampled after progression or 
discontinuation of the most recent actionable mutation-targeted therapy (e.g., TKI, 
monoclonal/bispecific antibody, ADC). This specific tumor tissue requirement for actionable 
mutations does not apply to subjects with MET exon 14 skipping mutation or MET amplification 
without other actionable mutations. If more than 1 cMET IHC result from different tumor 
samples is available, eligibility for enrollment and cohort assignment will be based on the results 
from the tumor sample taken most recently. If more than 1 cMET IHC result is available from 
the tissue taken from the same date, eligibility for enrollment and cohort assignment will be 
based on the result with the lowest cMET expression.  
Part 1 and Part 2: Archival tissue can be submitted or tumor biopsies performed during 
pre-screening or screening after the appropriate informed consent has been obtained. 

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Pre-screening may be conducted >28 days before Cycle 1 Day 1, after appropriate informed 
consent has been obtained. Pre-screening includes provision of an archival tumor sample or fresh 
tissue biopsy sample and cMET testing at the central laboratory. 
Core needle biopsy, excisional biopsy, or incisional biopsy is preferred for obtaining tumor 
tissue. Acceptable cytology samples include those acquired via fine needle aspiration, 
bronchoalveolar lavage (BAL), and bronchial brush, as well as pleural/pericardial fluids that can 
be spun down and made into paraffin-embedded cell blocks. Cytology samples must NOT be 
placed into alcohol or alcohol-based fixative/preservative prior to fixation in 10% neutral 
buffered formalin. Cytology smears from any other source are not acceptable for cMET testing 
via IHC. 
See Laboratory Manual for more information about submitting samples. 
6.1.1.4. 
Blood Specimens for Circulating Nucleic Acid Profiling 
Whole blood samples will be collected for biomarker research from all subjects as specified in 
Table 2 and Table 3. Samples will be tested for circulating nucleic acids (e.g., circulating free 
DNA) to evaluate their association with the observed clinical responses to MYTX-011. 
6.1.2. 
Efficacy Assessments 
6.1.2.1. 
Assessment of Anti-tumor Activity/Response Assessment 
The extent of disease and response assessment will be evaluated by contrast-enhanced 
CT scan/MRI based on RECIST 1.1 criteria (Appendix C). Assessments should include the 
chest, abdomen, pelvis, brain, and other known sites of disease. Imaging will be assessed locally 
by the Investigator. Sites should retain digital copies of radiological images. Radiology images 
may be requested for potential retrospective independent review.  
Confirmation of Investigator-assessed ORR and DOR will be performed in study Parts 1 and 2, 
through an Independent Review Committee. See Study Manual for details. 
Screening assessments will be done within the screening period (within 28 days prior to first 
dose of MYTX-011) and will be used as the baseline scan. A scan obtained for standard of care 
before informed consent is obtained but within 28 days of first dose is allowed to be used as the 
baseline scan. The same method of assessment/imaging modality should be used at subsequent 
visits for a given subject.  
CT scans with contrast (preferred) will be performed during screening, then every 6 weeks 
(±7 days) counting from Cycle 1 Day 1 through Week 24. After Week 24, CT scans will be done 
every 12 weeks until disease progression or withdrawal of consent. Per RECIST 1.1, 
confirmatory CT scans may be done at unscheduled visits. If contrast cannot be used, a non-
contrast CT scan of the chest and a contrast-enhanced MRI of the abdomen and pelvis may be 
performed. If both contrast-enhanced CT and MRI are contraindicated, non-contrast imaging 
may be performed after the local radiologist determines that the lesions are clearly traceable and 
assessable on non-contrast imaging. The same technique must be used throughout the course of 

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the study. For subjects who develop contraindications to contrast after baseline contrast CT is 
done, the decision as to non-contrast CT or MRI (enhanced or non-enhanced) should be 
performed at the discretion of the Investigator in consultation with the radiologist and to 
optimize comparison to prior scans if possible. A radiographic response (CR or PR) should be 
confirmed by a repeat scan at least 4 weeks after the first documentation of response.  
Gadolinium-enhanced MRI of the brain will be conducted during screening to assess for brain 
metastases and every 6 weeks counting from Cycle 1 Day 1, if brain metastases are present. 
If MRI contrast is contraindicated, MRI without contrast is acceptable. If an MRI is 
contraindicated, then a CT scan with contrast may be performed. 
A bone scan and/or positron emission tomography (PET) scan is allowed for subjects at baseline 
and during the study if bone metastases are considered and at the discretion of the Investigator as 
per standard of care; however, the CT/MRI scans should be used for tumor assessments as 
described above.  
Subjects who discontinue study drug due to reasons other than disease progression or withdrawal 
of consent will continue to undergo tumor assessments until demonstration of disease 
progression, withdrawal of consent, or death. Subjects will be assessed every 12 weeks 
(±2 weeks) after the EOT visit until progression of disease is observed. For subjects who 
discontinued treatment due to clinical progression, an image assessment after date of clinical 
progression should be performed for documentation of radiographic progression whenever 
possible. Documentation of further image assessment is not required after radiographic 
progression with the exception of treatment beyond progression. 
6.1.2.2. 
Tumor Tissue for Exploratory Analyses 
Tumor biopsy samples (archival or fresh tissue) collected for screening, if available in sufficient 
quantity, may also be used to assess tumor genes or proteins of interest that are associated with 
the drug response. These tumor specimens for assessment of candidate protein or nucleic acid 
(e.g., DNA, ribonucleic acid [RNA]) biomarkers can predict or identify those subjects who are 
most likely to benefit from treatment with the study drug. Biomarkers that may be analyzed 
include, but may not be limited to, cMET expression and alterations in the MET gene. 
6.1.2.3. 
Fresh Tumor Biopsy for Exploratory Analyses 
Optional, fresh on-treatment tumor biopsies will be collected only at the timepoints outlined in 
Table 2 and Table 3 if consented to by the subject and if the procedure is deemed safe by the 
Investigator. A fresh tumor biopsy consists of an incisional or excisional biopsy, or a core needle 
biopsy, of a primary or metastatic lesion. Fine needle aspiration is an acceptable approach if the 
aforementioned procedures cannot be performed, and samples should be fixated in 10% neutral 
buffered formalin (alcohol-containing buffers are prohibited). These samples will be used to 
evaluate DNA, RNA, or protein biomarkers as pharmacodynamic readouts to measure activity of 
MYTX-011 in the disease tissue. The tumor tissue will be processed as specified in the 
Laboratory Manual. 

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6.1.3.
Safety Assessments
6.1.3.1. 
ECOG Performance Status 
ECOG performance status will be performed at screening and at timepoints indicated in Table 2
and Table 3. 
6.1.3.2. 
Vital Signs and Physical Examination 
Vital signs (temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation) 
should be measured prior to study drug administration and at timepoints noted in Table 2 and 
Table 3. Vital signs should be assessed prior to any scheduled blood draws and after the subject 
has been resting for 5 minutes. Height and weight will be recorded at timepoints noted in Table 2 
and Table 3. 
weight, then the dose will be recalculated based on the updated weight. 
6.1.3.3. 
Electrocardiogram 
Triplicate 12-lead electrocardiograms (ECGs) will be read locally at screening and at timepoints 
noted in Table 4 and will include measurement of heart rate and intervals for PR, QT, QRS, R-R, 
and QTc. The QTc will be calculated using Fridericia’s correction formula. The Investigator
should assess abnormalities in the ECG for clinical significance. Pre-dose ECG should be 
performed on Day 1 of each designated cycle. 
 
Table 4: 
Schedule of Triplicate Electrocardiogram Collections with Pharmacokinetic 
Sampling (Subjects Enrolled in Part 1 and Part 2) 
Cycle 
Day 
-28 to -1 
Scheduled Timepoint 
Screening
Any time
1 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion 
2 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion 
3 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion 
4 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion 
6 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion 
12 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion 
EOT Visit 
Any time 
EOT = end of treatment 
Note: Pre-dose ECG should be performed on Day 1 of each designated cycle. 
All ECG recordings must be performed using an institutionally approved ECG. Lead placement 
should be as consistent as possible. ECG recordings should be performed after the subject has 

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been resting in a supine position for approximately 10 minutes. Circumstances that may induce 
changes in heart rate, including environmental distractions (e.g., television, radio, conversation), 
should be avoided during the pre-ECG resting period and during ECG recording. 
All ECGs should be collected and available if requested by the Sponsor for independent review 
by a central laboratory. Instructions for the collection and transmission of ECGs to the central 
ECG laboratory will be provided in the event this is requested. 
For safety monitoring purposes, the Investigator must review, sign, and date all ECG tracings. 
Copies of ECG tracings will be kept as part of the subject’s permanent study file at the site. 
The following should be recorded on the appropriate eCRF page: heart rate, R-R interval, QRS 
interval, PR duration, uncorrected QT interval, and QTcF, based on the machine readings of the 
individual ECG tracings. Any morphologic waveform changes or other ECG abnormalities must 
be documented on the eCRF page. All eligibility and subject management decisions should be 
made based on the local reading of the ECG. 
6.1.3.4. 
ECHO/MUGA Scan 
An ECHO or MUGA scan will be performed at screening to assess LVEF.  
6.1.3.5. 
Physical Examination 
Physical examinations (complete or symptom directed) will be conducted at timepoints noted in 
Table 2 and Table 3. 
6.1.3.6. 
Ophthalmic Assessments 
Refer to Table 2 and Table 3 for the assessment schedule.
All ophthalmic assessment visits (including screening) must document the best corrected visual 
acuity (BCVA) (distance) using either manifest refraction or subject’s glasses (with pinhole). 
If vision is affected by conditions unrelated to study drug (e.g., cataracts, age-related macular 
degeneration), establish a new baseline visual acuity. 
Full or comprehensive ophthalmic examination should be conducted by an eye care professional 
at screening (prior to first administration of study drug), at 1 year post Cycle 1 Day 1, EOT visit, 
and as clinically indicated. This should include BCVA, slit lamp examination with ocular surface 
staining, dilated fundus exam, and an optional Schirmer’s test score (with or without anesthesia). 
Partial ophthalmic examinations, including BCVA and slit lamp examination with ocular surface 
staining, are required prior to every other cycle (within 2 weeks before upcoming dose) and 
during the dose break period (if applicable). If an unscheduled visit falls within the required 
exam window for an ophthalmic exam, it may replace the scheduled assessment. Partial exams 
may be replaced by full exams if clinically necessary, as determined by the managing eye care 
professional.
Perform a full ophthalmic exam at the EOT visit. If the subject’s reported ocular AE persists, 
continue follow-up until recovery or until deemed clinically insignificant (e.g., AE returns to Gr. 
1 or within 1-2 lines of baseline vision) by the eye care professional. Subjects with ongoing 
ocular AE at EOT visit should continue to undergo partial ophthalmic exams (full ophthalmic 

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exams may replace partial exams per the eye care provider’s discretion) every 3-4 weeks (or 
shorter interval as clinically indicated) until resolution or return to baseline. 
Ocular symptom assessments (e.g., blurred vision, redness, dryness or excessive watering, 
itching, burning sensation, light sensitivity, eye pain) should be evaluated prior to each 
MYTX 011 dose. Grade symptoms on a 0-10 scale (0 = none, 10 = worst). 
Any subjects who develop new or worsening ocular AEs should be referred to an eye care 
professional for evaluation. Refer to dose modification guidelines for management of ocular AEs 
(Section 7.5.2). 
6.1.3.7. 
Laboratory Assessments
Laboratory assessments will be collected as specified in Table 2 and Table 3. Additional 
laboratory testing may be done to ensure subject safety at the discretion of the treating 
Investigator.  
Laboratory assessments on days of MYTX-011 administration should be obtained at timepoints 
noted in Table 2 and Table 3 prior to MYTX-011 administration, and the results should be 
reviewed prior to administration of MYTX-011.  
The Investigator should assess out-of-range clinical laboratory values for clinical significance. 
Clinically significant abnormalities should be reported as an AE.  
6.1.3.7.1. 
Local Laboratory Assessments 
1. Hematology and chemistry, including the tests shown in Table 5. 
Table 5: 
Hematology and Chemistry Laboratory Tests 
Hematology 
Hematocrit 
Neutrophils 
Platelet count 
Hemoglobin 
Lymphocytes 
 
Erythrocyte count 
Monocytes 
 
Leukocyte count 
Eosinophils 
 
Absolute neutrophil count 
Basophils 
 
Chemistry 
Albumin 
Creatinine 
Aspartate aminotransferase 
Alkaline phosphatase 
Glucose 
Alanine aminotransferase 
Bicarbonate/carbon 
dioxide 
Lactate 
dehydrogenase 
Sodium 
Blood urea nitrogen 
Magnesium 
Total bilirubin (direct bilirubin if total bilirubin is 
elevated) 
Calcium 
Phosphorus 
Total protein 
Chloride 
Potassium 
Uric acid 
Amylase 
Lipase 
 
2. HbA1c at screening 

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3. Serum pregnancy test (for women of childbearing potential) at screening (within 3 days 
before first dose) 
4. Urine or serum pregnancy test (for women of childbearing potential) prior to each 
administration of MYTX-011 and at the EOT visit and monthly for 6 months after EOT 
as per local requirements  
5. Coagulation laboratory tests include PT, aPTT, and INR 
6. Serum virology includes hepatitis B surface antigen (HBsAg), hepatitis B core antibody 
(HBcAb), and hepatitis C virus antibody (HCVAb) at screening. If HBsAg, HBcAb, 
and/or HCVAb results are positive, subjects must be evaluated for the presence of active 
HBV or HCV by a polymerase chain reaction (PCR) test 
7. Urinalysis by dipstick to include pH, specific gravity, protein, glucose, ketones, blood, 
nitrite, leukocytes, and microscopy assessment (if indicated) 
8. For patients with HIV, HIV viral load and CD4 count must be measured at screening and 
every 3 months while the patient is receiving study treatment, or as clinically indicated or 
based on local standard of care 
6.1.3.7.2. 
Central Laboratory Assessments 
Samples collected at the timepoints shown in Table 6 and Table 7 will be shipped to and 
analyzed at a central laboratory. Pre-dose PK samples need to be collected on the same day as 
study drug infusion (Day 1 of each designated cycle). In the event of missed PK sample 
collection, for example due to dose delays or adverse events, PK samples may be collected at 
alternative timepoints using the unscheduled visit laboratory kit. Refer to the Laboratory Manual 
for processing, handling, and shipping instructions. 
 

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Table 6:
Schedule of PK and ADA Sampling (Subjects Enrolled in Part 1 Dose 
Escalation)
Cycle Day
Scheduled Timepoint 
(PK) MYTX-011 (Total Antibody, Total ADC, and MMAE)* 
Scheduled 
Timepoint
(ADA)
1 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion, 2, 4, 6 hours post-
infusion (±30 minutes) 
Pre-dose 
2 
24 hours (±1 hour) post-infusion  
4 
3 days (72 hours ±4 hours) post-infusion  
8 
7 days (168 hours ±8 hours) post-infusion  
15 
14 days (336 hours ±24 hours) post-infusion  
2 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
3 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion, 2, 4, 6 hours post-
infusion (±30 minutes) 
Pre-dose 
2 
24 hours (±1 hour) post-infusion  
4 
3 days (72 hours ±4 hours) post-infusion  
8 
7 days (168 hours ±8 hours) post-infusion  
15 
14 days (336 hours ±24 hours) post-infusion  
4 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
6 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
8 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
10 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
12 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
15
1
Pre-dose and 30 minutes (±5 minutes) post-infusion
Pre-dose
EOT Visit Any time  
Any time 
ADA = anti-drug antibodies; ADC = antibody-drug conjugate; EOT = end of treatment; MMAE = monomethyl 
auristatin E; PK = pharmacokinetic. 
Note: Pre-dose PK samples need to be collected on the same day as study drug infusion (Day 1 of each designated 
cycle). 
Note: In the event of missed PK sample collection, for example due to dose delays or adverse events, PK samples 
may be collected at alternative timepoints using the unscheduled visit laboratory kit. 
* All post-infusion times refer to time after the end of infusion. 

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Table 7:
Schedule of PK and ADA Sampling (Subjects Enrolled in Part 2 Dose 
Expansion) 
Cycle 
Day 
Scheduled Timepoint 
(PK) MYTX-011 (Total Antibody, Total ADC, and MMAE)* 
Scheduled 
Timepoint
(ADA) 
1 
1 
Pre-dose and 30 minutes (±5 minutes) and 2 hours (±15 minutes) post-
infusion 
Pre-dose 
2 
24 hours (±1 hour) post-infusion 
 
8 
7 days (168 hours ±8 hours) post-infusion  
 
2 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
3 
1 
Pre-dose and 30 minutes (±5 minutes) and 2 hours (±15 minutes) post-
infusion  
Pre-dose 
2 
24 hours (±1 hour) post-infusion  
 
8 
7 days (168 hours ±8 hours) post-infusion  
 
4 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
6 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
8 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
10 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
12 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
15 
1 
Pre-dose and 30 minutes (±5 minutes) post-infusion  
Pre-dose 
EOT Visit 
Any time 
Any time 
ADA = anti-drug antibodies; ADC = antibody-drug conjugate; EOT = end of treatment; MMAE = monomethyl 
auristatin E; PK = pharmacokinetic. 
Note: Pre-dose PK samples need to be collected on the same day as study drug infusion (Day 1 of each designated 
cycle). 
Note: In the event of missed PK sample collection, for example due to dose delays or adverse events, PK samples 
may be collected at alternative timepoints using the unscheduled visit laboratory kit. 
* All post-infusion times refer to time after the end of infusion. 
6.1.3.8. 
Adverse Events 
AEs will be collected from the time of informed consent and then continuously throughout the 
study until 30 days after last administration of MYTX-011. Adverse events of special interest 
(AESIs) and SAEs considered related to MYTX-011 should be reported to the Sponsor even 
after the 30-day period has been completed. Investigators will assign a severity grade based on 
the NCI CTCAE Version 5.0. See Section 9.2.6 for more details. 
6.1.3.9. 
Concomitant Medications 
All medications (including over-the-counter medications) taken within 30 days prior to first dose 
of study drug, during the treatment period, and for 30 days after the last dose of study drug, will 
be recorded at each visit from Screening through EOT. During the course of the study, any 
changes in concomitant medications should be recorded. Concomitant medications should 

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include the name of the medication, indication for use, dose and frequency, route of 
administration and start and stop dates/ongoing (as applicable). 
6.1.4. 
Other Assessments 
6.1.4.1. 
Pharmacogenomics 
A blood sample will be collected and may be used to assess genetic variants (unless prohibited 
by local regulations).
The results of pharmacogenetic analyses and other exploratory studies will not be placed in the 
subject’s medical records, and the results will not be available to the subject, sites, or other third 
parties, except as specified in the ICF. The subject retains the right to request that stored sample 
material for exploratory biomarker and pharmacogenetic analyses be destroyed by contacting the 
Investigator. The Investigator will notify the Sponsor if the subject requests the samples be 
destroyed. Information collected from samples prior to the request for destruction will be 
retained by the Sponsor.  
6.1.4.2. 
Disease Status and Survival during Long-Term Follow-up
During long-term follow-up survival, information, disease status, and start of anticancer 
therapies will be captured. Follow-up can be done via telephone. Information may also be 
accessed from the medical records.  

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7.
STUDY DRUG(S) AND CONCOMITANT THERAPY
7.1. 
MYTX-011 
Classification:
cMET-targeted ADC
Chemical Name: 
Q397, an IgG1, anti-(human antigen cMET) with a humanized heavy 
chain and light chain kappa with engineered site-specific cysteine 
(V205C), conjugated DAR 2.0 maleimidocaproyl-valinecitrulline-p-
aminobenzyloxycarbonyl monomethylauristatin E. 
How Supplied: 
10 mL in a 50 mL single-use vial, 100 mg/vial (10 mg/mL 
concentration), as a frozen liquid 
Route of 
Administration: 
Intravenous 
Packaging: 
MYTX-011 will be provided as a vial in a kit. 
Availability: 
MYTX-011 is available from Mythic Therapeutics, Inc. 
The MYTX-011 IB is the primary source for safety information. The IB includes a discussion on 
potential risks and AESIs that may be predicted to occur. Refer to the most recent IB, which is 
updated periodically, for current information. 
7.2. 
STUDY DRUG(S) ADMINISTRATION 
MYTX-011 will be administered via IV infusion in 21-day cycles or on a dose break regimen. 
The Planned Dose levels are summarized in Table 8 below. 
Table 8:
Planned Dose Levels
Dose Level
Dose (mg/kg)1,2
-13 
0.3 
1 
1.0 
2 
2.0 
3 
3.3 
4 
5.0 
5 
6.7 
6 
8.3 
7 
10.0 
BOIN = Bayesian Optimal Interval; PK = pharmacokinetics; SRC = Safety Review Committee 

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1 mg/kg dose for subjects weighing up to 100 kg. Subjects weighing >100 kg will receive a fixed dose. Fixed dose 
for these subjects will be the same dose as subjects who weigh 100 kg. Based on emerging PK, safety, and 
preliminary anti-tumor activity data during the study, the SRC may recommend changing the fixed dose to a 
mg/kg dose for subjects who weigh >100 kg. 
2 Intermediate dose level(s) and/or a different dosing schedule may be implemented by the Sponsor or
recommended by the SRC to assess the safety PK, and preliminary anti-tumor activity data.  
3  If a dose de-escalation is needed at dose level 1 based on the BOIN design, the SRC will review the emerging data 
and determine if the study should be amended, terminated, or a lower dose explored. The lower dose to be 
explored may be 0.3 mg/kg, but the SRC may recommend a different dose based on emerging data. 
7.2.1.
Guidelines for Administration of MYTX-011
MYTX-011 will be administered as an IV infusion over 60-90 minutes (or longer) Q3W or on a 
dose break schedule. The initial dose (Cycle 1 Day 1) will be administered over 90 minutes or 
longer. If there are no infusion-associated reactions with the first dose, subsequent doses may be 
administered over 60 minutes or longer. Flexibility is allowed to extend the infusion time beyond 
90 minutes, while remaining compliant with the Pharmacy Manual requirements for preparation 
and administration of MYTX-011. The average infusion rate must not exceed 1000 mg/hour. For 
active patients on the study who receive MYTX-011 over 30-60 minutes regularly without 
experiencing IRR, the infusion duration of prior cycles may be maintained. See Section 7.5.1 for 
management of IRRs. 
Dosing of MYTX-011 will be on a mg/kg basis for subjects weighing up to 100 kg. Subjects 
weighing >100 kg will receive a fixed dose. The fixed dose for these subjects will be the same 
dose as subjects who weigh 100 kg. Based on emerging PK, safety, and preliminary anti-tumor 
activity data during the study, the SRC may recommend changing the fixed dose to a mg/kg dose 
for subjects who weigh >100 kg. The subject’s weight at screening will be used to calculate the 
subject’s dose for the duration of treatment. If, over the course of treatment, the subject’s weight 
changes by 10% of the initial weight, then the dose will be recalculated based on the updated 
weight.  
Subjects will be observed closely for IRRs during the infusion and for at least 2 hours following 
the initial dose. Subjects will be monitored closely during the infusion and for at least 30 minutes 
after for subsequent infusions.  
MYTX-011 should not be administered as an IV push or IV bolus. MYTX-011 should be 
administered through a dedicated IV line and not mixed with other medications. MYTX-011 
infusion should be completed within the time period specified in the Pharmacy Manual.  
7.3. 
PREPARATION, HANDLING, STORAGE, AND ACCOUNTABILITY 
7.3.1. 
Preparation, Handling, and Storage 
Please refer to the Pharmacy Manual for detailed instructions on storage, preparation, and 
administration of MYTX-011. Procedures for proper handling, storage, and disposal of 
anticancer drugs should be followed in accordance with institutional guidelines. 

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MYTX-011 is provided as a single-use vial containing 100 mg of MYTX-011 as a frozen liquid. 
7.3.2. 
Preparation and Dilution 
Appropriate aseptic technique should be used for preparation of MYTX-011. Any 
partially used vials should be discarded according to standard institutional guidelines. 
 Determine the number of vials needed based on the subject’s weight and assigned dose.  
 MYTX-011 will be thawed then diluted in normal saline (0.9% sodium chloride). After 
dilution with normal saline, the infusion should be initiated as soon as possible. If not 
used immediately, the infusion bag containing MYTX-011 can be stored refrigerated at 
2°C to 8°C or room temperature for up to 4 hours (including the infusion time). MYTX-
011 should not be refrozen. 
 MYTX-011 should be administered IV with an integrated or externally connected 0.2 or 
0.22 
 
 MYTX-011 should not be mixed with or administered with other medicinal products. 
7.3.3. 
Study Drug Accountability 
The Sponsor will provide MYTX-011 for administration in the study. Accountability for 
investigational medicinal product at the site is the responsibility of the Investigator.  
Study drug must be stored at the site in a secure, limited access environment in accordance with 
the required storage conditions (refer to Pharmacy Manual). Accurate records of all study drug 
received and dispensed must be maintained. Only subjects enrolled in the study may receive the 
study drug. The Sponsor or its designee will review drug accountability at the site on an ongoing 
basis.  
At the completion of the study, unused study drug must be held for final study drug 
accountability prior to being returned to the Sponsor or destroyed at the site per the Sponsor 
instructions.  
For detailed information on study drug receipt, storage, dispensation, accountability, 
returns/destruction please refer to the Pharmacy Manual. 
7.4. 
ASSIGNMENT TO STUDY INTERVENTION 
Study subjects who have signed an informed consent will be registered to the study and receive a 
unique study identifier. See Study Manual for further details and step-by-step instructions for 
registration and enrollment of subjects in the Interactive Response Technology (IRT) system. 
Each subject will have a unique subject ID. Subjects must be registered into the Suvoda system 
prior to any drug being dispensed to the site or to the subject.  
In Part 2, Cohorts A, B2, and E2 may randomize subjects to 1 of 2 dose levels (the RP2D and 
1 other dose); the optimal biological dose will further be evaluated based on anti-tumor activity, 
safety, and PK. Additional dose levels and randomizations may be added to any Part 2 cohort, as 
discussed in Section 4.2. 

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7.5.
MANAGEMENT OF POTENTIAL TOXICITIES
Dose modification levels for each planned dose level and known intermediate dose levels in Part 
1 are provided in Table 9. Dose modification levels for the RP2D and alternative dose in Part 2 
are provided in Table 10. Ongoing Part 1 subjects have the option (based on investigator 
discretion) to follow Part 2 dose modification guidance outlined in Table 10. Dose modification 
schemes that deviate from Table 9 (e.g., larger magnitude of dose reduction) can be considered 
as an option only with the approval of the Sponsor Medical Monitor or designee. There will be 
no dose modifications for Grade 1 or Grade 2 AEs unless specified in Table 11, Table 13, or 
Table 14. 
Table 9: 
Part 1 Dose Modification Levels for MYTX-011  
Dose Modification 
Dose (mg/kg) 
1.0 
1.5 
2.0 
2.6 
3.3 
4.0 
5.0 
5.8 
6.2 
6.7 
7.2 
7.5 
8.3 
10.0* 
1st dose modification  
 
0.3 
1.0 
1.5 
2.0 
2.6 
3.3 
4.0 
4.0 
5.0 
5.0 
5.0 
5.0 
6.7 
8.3 
2nd dose modification  
 
 
0.3 
1.0 
1.5 
2.0 
2.6 
3.3 
3.3 
4.0 
4.0 
4.0 
4.0 
5.0 
6.7 
3rd dose modification  
 
 
 
 
2.0 
2.6 
2.6 
3.3 
3.3 
3.3 
3.3 
4.0 
5.0 
* For dose levels not tested in the study by the time of Protocol version 7.0, the dose modification scheme may 
change depending on emerging clinical and pharmacokinetic data.  
Italics = Intermediate dose levels 
Note: For subjects enrolled in Part 1 receiving a dose break regimen, it is recommended to follow Part 2 dose 
modification levels in Table 10. 
Table 10: 
Part 2 Dose Modification Levels for MYTX-011 
Dose Modification 
Dosing Schedule (mg/kg) 
6.7 dose break 
6.2 dose break 
5.0 dose break 
4.0 Q3W 
1st dose 
modification  
 
5.0 dose break 
5.0 dose break 
4.0 dose break 
4.0 dose break 
2nd dose 
modification  
 
4.0 dose break 
4.0 dose break 
3.3 dose break 
3.3 dose break 
3rd dose 
modification  
 
3.3 dose break 
3.3 dose break 
2.6 dose break 
2.6 dose break 
Notes: Recommend the same dose level if 
 
occurs. Dose reduction should be considered after ocular AE returns to baseline for 
. Reduction of 
more than 3 dose levels requires approval from the Sponsor Medical Monitor. 
For subjects on dose break regimen, if an unplanned delay (e.g., due to an adverse event) longer than 14 days takes 
place between the two consecutive 21-day cycles, it is recommended to reset the dose break schedule after the 

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subject has received two consecutive 21-day cycles after resuming treatment to maintain dose intensity. Please 
contact the Sponsor Medical Monitor for questions related to dose break regimen. 
Once the dose of study treatment has been modified because of toxicity, all subsequent cycles 
should be administered at that lower dose level unless further dose modification is required. 
Subjects may not resume original dose or dose increase if a reduction due to toxicity was 
required. For subjects treated at a dose of 1 mg/kg, only 1 dose modification will be allowed. For 
4.0 mg/kg, 3 dose modifications will be allowed. For all other dose 
levels, if toxicity continues after 2 dose modifications, then the subject will be withdrawn from 
study treatment, unless the subject is deriving clinical benefit from the treatment in the opinion 
of the Investigator and further dose modification is approved by the Sponsor Medical Monitor.  
Subjects enrolled in Part 2 should follow the dose modification defined in Table 10. Ongoing 
subjects in Part 1 may choose to follow the dose modification in Table 10 per the investigator’s 
discretion. 
Cycles will continue in consecutive order regardless of dose delays. In the event of a dose delay, 
the subsequent cycle will begin once the subject meets the criteria to resume treatment. The cycle 
number will not be reset or skipped due to the delay. 
Investigators should contact the Sponsor Medical Monitor or designee to discuss questions 
regarding dose modification or discontinuation of study treatment. 
Guidelines for management of toxicities and dose modifications in subjects with treatment-
related toxicities are specified in Table 11, Table 13, or Table 14 but do not replace Investigator 
judgment, and dose modification can be discussed with the Sponsor Medical Monitor on a 
case by-case basis per Investigator discretion.

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Table 11:
Management of Toxicities Defined as Study Treatment-Related Only
Worst Toxicity CTCAE 
Grade Unless Otherwise 
Specified (Value) 
Dose Modification Guidelines 
IRR 
Infusion Reaction Grade 1 
Transient flushing or rash, 
fever 
intervention not indicated 
Management 
Stop infusion immediately and keep line open. 
Monitor vital signs (blood pressure, pulse, respiration, and temperature) every 
15 ± 5 minutes until resolution. 
Resume infusion once infusion reaction resolves (complete infusion within 4 
hours of dilution): 
 
After Investigator considers subject clinically stable, restart infusion at 50% 
of previous rate (i.e., from 2 mL/min to 1 mL/min) under continuous 
observation.  
 
Maintain dose level. 
 
Administer oral pre-medication (e.g., 1000 mg of 
acetaminophen/paracetamol, 50-100 mg diphenhydramine hydrochloride or 
alternative antihistamine), within 60 minutes of restarting the infusion. 
 
If the AE recurs at the reinitiated slow rate of infusion, and despite oral pre-
medication, then the dose should be skipped, and the subject should receive 
pre-medication for any subsequent administration. 
Infusion Reaction Grade 2 
Intervention or infusion 
interruption indicated; 
responds promptly to 
symptomatic treatment 
(e.g., antihistamines, 
NSAIDS, narcotics); 
prophylactic medications 
ours 
Management 
 
Stop infusion immediately and keep line open. 
 
Provide supplemental oxygen and fluids, as needed. 
 
Monitor vital signs (e.g., blood pressure, pulse, respiration, and temperature) 
every 15 ± 5 minutes until resolution. 
 
Administer medications for symptomatic relief as needed: 
o 
Urticaria: Diphenhydramine or alternative (25-100 mg IV) as needed 
every 4 to 6 hours. 
o 
Fever: Acetaminophen/paracetamol (650-1000 mg by mouth) as needed 
every 4 to 6 hours. 
o 
Rigors: Meperidine 25 mg IV as needed every 6 hours. 
o 
Corticosteroids can be administered. 
 
Resume infusion once infusion reaction resolves (complete infusion within 4 
hours of dilution): 
o 
After Investigator considers subject clinically stable, restart infusion at 
50% of previous rate (i.e., from 2 mL/min to 1 mL/min) under 
continuous observation. 
o 
Maintain dose level. 
o 
Administer oral pre-medication (e.g.,1000 mg of 
acetaminophen/paracetamol, 50-100 mg diphenhydramine 
hydrochloride or alternative antihistamine), within 60 minutes of 
restarting the infusion. 
o 
If the AE recurs at the reinitiated slow rate of infusion, and despite oral 
pre-medication, then the dose should be skipped, and the subject should 
receive pre-medication for any subsequent administration. 

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Table 11:
Management of Toxicities Defined as Study Treatment-Related Only
(Continued) 
Worst Toxicity CTCAE Grade Unless 
Otherwise Specified (Value) 
Dose Modification Guidelines 
IRR (continued) 
Infusion Reaction Grade 3
Prolonged (e.g., not rapidly responsive to 
symptomatic medication and/or brief 
interruption of infusion); recurrence of 
symptoms following initial improvement; 
hospitalization indicated for clinical sequelae 
(e.g., renal impairment, pulmonary infiltrates) 
Management 
 
Discontinue infusion immediately and discontinue subject 
from study treatment. 
 
Provide supplemental oxygen and fluids, as needed. 
 
Monitor vital signs (e.g., blood pressure, pulse, 
respiration, and temperature) every 15 ± 5 minutes until 
resolution. 
 
Medication such as antihistamines or corticosteroids 
should be given for symptomatic relief. 
Infusion Reaction Grade 4 
Life-threatening 
Urgent intervention indicated 
HEMATOLOGICAL TOXICITIES 
Thrombocytopenia 
Grade 1 (PLT 
- 75 × 109/L) 
Maintain dose level 
Grade 2 (PLT 75 - 50 × 109/L) 
Maintain dose level 
Grade 3 (PLT 
 - 25 × 109/L) 
 
 
 (
, then 
maintain dose level. 
 
If resolved in >7 days (>3 days in UK only), then reduce 
1 dose level. 
Grade 4 (PLT 
× 109/L) 
 Grade 1, then reduce 1 dose level. 
Neutropenia (ANC) 
Grade 1 (ANC
- 1.5 × 109/L)
Maintain dose level.
Grade 2 (ANC 
- 1.0 × 109/L) 
Maintain dose level. 
Grade 3 (ANC 
- 0.5 × 109/L) 
 
 
 
, then 
maintain dose level. 
 
If resolved in >7 days (>3 days in UK only), then reduce 
1 dose level. 
Grade 4 (ANC 
× 109/L) 
reduce 1 dose level 
and resume. 
Febrile neutropenia (decrease in neutrophils 
associated with fever, ANC 
× 109/L, fever 
[not CTCAE grade]) 
Omit dose until resolved, then reduce 1 dose level. 
Anemia 
Grade 4 (Hgb 
-threatening 
consequences, urgent intervention indicated) 
Grade 1, then reduce 1 dose level 
for all subsequent treatment cycles. 

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Table 11:
Management of Toxicities Defined as Study Treatment-Related Only
(Continued) 
Worst Toxicity CTCAE Grade Unless 
Otherwise Specified (Value) 
Dose Modification Guidelines 
NON-HEMATOLOGICAL TOXICITIES 
Renal 
Serum creatinine 
× ULN 
Maintain dose level. 
2-3 × ULN 
 
 
. 
 
If resolved in >7 days, then reduce 1 dose level for all 
subsequent treatment cycles. 
× ULN)
Omit dose and discontinue subject from study treatment.
Hepatic 
Total bilirubin 
In cases where total bilirubin is elevated (>ULN), direct and 
indirect bilirubin should also be assessed. 
× ULN 
Maintain dose level. 
2-3 × ULN 
 
 
. 
 
If resolved in >7 days, then reduce 1 dose level. 
Grade 3 (>3.0-10.0 × ULN) 
 
 
 days, reduce 1 dose level for all 
subsequent treatment cycles. 
 
If resolved in >7 days discontinue subject from study 
treatment. 
Grade 4 (>10.0 × ULN) 
Omit dose and discontinue subject from study treatment. 
Note: If Grade 3 or Grade 4 hyperbilirubinemia is due to the 
indirect (unconjugated) component only, and hemolysis as the 
etiology has been ruled out as per institutional guidelines (e.g., 
review of peripheral blood smear and haptoglobin 
determination), then reduce 1 dose level and continue treatment 
at the discretion of the Investigator. 
equivalent imaging procedure to exclude disease progression or 
potential other liver disease should be performed. 
AST or ALT 
Grade 1 (>ULN - 3.0 × ULN) 
Maintain dose level. 
Grade 2 (>3.0 - 5.0 × ULN) 
Maintain dose level. 

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Table 11:
Management of Toxicities Defined as Study Treatment-Related Only
(Continued) 
Worst Toxicity CTCAE Grade Unless 
Otherwise Specified (Value) 
Dose Modification Guidelines 
Hepatic (continued) 
Grade 3 (>5.0 - 20.0 × ULN) 
liver metastasis), then: 
 
. 
 
If resolved in >7 days, then reduce 1 dose level for all 
subsequent treatment cycles. 
Grade 4 (>20.0 × ULN) 
reduce 1 dose level. 
Drug-induced liver injury by Hy’s Law  
(AST or ALT >3 × ULN and total bilirubin 
>2 × ULN without other reason for liver injury 
than related to the study drug) 
Discontinue subject from study treatment. 
CARDIAC TOXICITIES 
Troponin I or T* 
Elevated cardiac troponin I or T level, ECG 
evaluations and LVEF measurements are 
within normal range 
Maintain dose level, and repeat LVEF measurement at 4-week 
intervals until troponin I or T level returns to baseline or until 
stabilization. 
Elevated cardiac troponin I or T level, LVEF 
measurement is abnormal 
Follow instructions below as appropriate. 
LVEF 
-
treatment values  
OR  
LVEF below institutional limits of normal and 
-
treatment values 
Omit dose for 4 weeks, then: 
 
If resolved (returns to normal limits and the absolute 
level. 
 
If not resolved, discontinue subject from study treatment. 
Left ventricular systolic dysfunction 
Grade 3 or 4  
Omit dose and discontinue subject from study treatment. 
Heart failure 
Grade 2 through Grade 4 
Omit dose and discontinue subject from study treatment. 
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS 
(excluding interstitial lung disease/pneumonitis; refer to Section 7.5.3) 
Grade 2 
Grade 1, then: 
 
. 
 
If resolved in >7 days, then reduce 1 dose level. 
Grade 3 
for all subsequent treatment cycles after discussion with the 
Sponsor. 

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Table 11:
Management of Toxicities Defined as Study Treatment-Related Only
(Continued) 
Worst Toxicity CTCAE Grade Unless 
Otherwise Specified (Value) 
Dose Modification Guidelines 
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
(excluding interstitial lung disease/pneumonitis; refer to Section 7.5.3) (continued) 
Grade 4
Omit dose and discontinue subject from study treatment.
Peripheral neuropathy
Peripheral neuropathy should be managed using a combination 
of dose delay and modification. For new or worsening Grade 2 
or 3 neuropathy, dosing should be held until neuropathy 
improves to Grade 1 or baseline and then restarted at next 
lower dose level. For Grade 4 peripheral neuropathy, 
MYTX-011 should be discontinued. 
Other Laboratory AEs 
Grade 3 
, then: 
 
ays from day of onset, maintain dose. 
 
If resolved in >7 days from day of onset, reduce 1 dose 
level for all subsequent treatment cycles. 
Grade 4 
Discontinue subject from study treatment 
Other Non-laboratory AEs 
Grade 3 
Delay dose until resolved to 
, then: 
 
ays from day of onset, maintain dose 
 
If resolved in >7 days from day of onset, reduce 1 dose 
level for all subsequent treatment cycles 
Grade 4 
Discontinue subject from study treatment 
AE = adverse event; ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate 
aminotransferase; CT = computed tomography; CTCAE = National Cancer Institute Common Terminology Criteria 
for Adverse Events Version 5.0; ECG = electrocardiogram; Hgb = hemoglobin; IRR = infusion-related reaction; 
IV = intravenous; LLN = lower limit of normal; LVEF = left ventricular ejection fraction; PLT = platelet count; UK 
= United Kingdom; ULN = upper limit of normal. 
* Troponin I or T levels are to be based on institutional guidelines. 
Note: Dose modification decisions due to hematopoietic toxicities should be discussed with the Mythic clinical team 
prior to the next dose administration. 
Note: All dose modifications should be based on the worst preceding toxicity (see Section 7.5). 
7.5.1. 
Management of Infusion-Related Reactions 
IRRs and hypersensitivity reactions/anaphylaxis may occur during the administration of 
MYTX-011. The infusion site should be properly equipped and staffed to manage IRRs and 
anaphylaxis should it occur. Medications for IRRs such as epinephrine and antihistamines should 
be available for immediate use and the subject should be managed appropriately according to 
institutional guidelines (please refer to Table 11). 

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Pre-medication may be used for subjects for subsequent infusions if they develop IRR (e.g., 
acetaminophen [650 mg orally] or equivalent, diphenhydramine [25-50 mg orally or 10-25 mg 
IV] or equivalent) and is to be administered 30-60 minutes prior to the infusion.  
7.5.2. 
Management of Ocular AEs 
Subjects should be advised to avoid using contact lenses while on MYTX-011 until EOT, unless 
otherwise directed by an eye care professional. Surgical interventions that involve the eye (e.g., 
cataract surgery) or orbital region must be performed at least 28-days before C1D1 and are 
prohibited while the patient is on study drug unless approved by the Sponsor Medical Monitor.  
If a subject has mild ocular surface disease (e.g., dry eye, punctate staining, decreased tear 
production), it is recommended the subjects’ ocular surface is treated/optimized prior to dosing 
by the eye care professional.  
All subjects should instill artificial tears to both eyes at least 4 times a day (sample schedule: 
breakfast, lunch, dinner, and bedtime), starting from C1D1 and continuing while the subject is on 
study treatment, including during dose break (if applicable). The use of temporary lower punctal 
plugs to increase lubrication of the eyes is optional if lubricating artificial tears are not sufficient. 
All subjects will receive prophylactic low-potency steroid eye drops (once daily on Days 1 3 of 
each treatment cycle) and alpha-adrenergic agonist eye drops (twice daily from Days 1 8 of each 
treatment cycle) to potentially reduce the incidence or severity of ocular adverse events, unless 
contraindicated. 
Study staff should instill one drop in each eye prior to infusion, then subject will administer 
prophylactic eyedrops as indicated. The recommended administration is to instill one drop of 
low-potency steroid eye drops 30 minutes prior to infusion, followed by one drop of alpha-
adrenergic eye drop to each eye 10-15 minutes later. Avoid use of artificial tear drops 30 minutes 
prior to infusion of steroid and alpha-adrenergic eye drops to prevent a wash out effect of the 
prophylaxis. 
The subject is responsible for following the remaining schedule of eyedrops after infusion and 
separate the use of eye drops by 10-15 minutes. Application of cold packs which cover both eyes 
during the entire infusion is also recommended.  
The choice of steroid, alpha-adrenergic agonist, and artificial tear eye drops are per the 
investigator or eye care professionals’ discretion. Preservative free eye drops are recommended. 
These prophylactic measures are summarized in Table 12. A version of the prophylactic 
measures mentioned above has been implemented for similar on-market ADC products 
(ELAHERE® [package insert] 2022; Kim et al. 2022; Matulonis et al. 2019; TIVDAK® [package 
insert] 2021). 
 

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Table 12:
Schedule of Prophylactic Measures for Ocular Adverse Events
Prophylaxis 
Day of Each Treatment Cycle 
1 
2 
3 
4 
5 
6 
7 
8 
9-21 
Dose- 
Break 
Artificial tears (QID + PRN) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Low potency steroid eyedrops 
(QD) 
X1 
X 
X 
 
 
 
 
Alpha-adrenergic agonist eye 
drop (BID) 
X2 
X 
X 
X 
X 
X 
X 
X 
 
 
Cold packs to eyes 
X3 
 
 
 
 
 
 
BID = twice daily; PRN = as needed; QID = 4 times a day; QD = once daily 
1 Recommend instilling one drop in each eye 30 minutes prior to infusion. 
2 Recommend instilling one drop in each eye 15 minutes prior to infusion. 
3 Applied during the entire infusion; ensure eye packs are cold throughout the duration of infusion. 
If new or worsening ocular symptoms occur (e.g., blurred vision, dry eyes, eye pain), an 
ophthalmic evaluation should be performed. A slit-lamp examination with fluorescein staining is 
recommended to assess corneal changes (e.g., distinguishing between staining and non-staining 
lesions such as pseudo-microcysts). For subjects with Grade 3 or higher ocular AEs (
vision change from baseline), more frequent ophthalmic monitoring is advised, with 
management and treatment guided by the eye care provider. Subjects with ongoing ocular AE at 
EOT visit should continue to undergo partial ophthalmic exams (full ophthalmic exams may 
replace partial exams per the eye care provider’s discretion) every 3-4 weeks (or shorter interval 
as clinically indicated) until resolution or return to baseline. Please refer to Table 13 for the 
management of ocular AEs. If autologous serum eye drops are planned for ocular AE 
management, subject serum should ideally be collected prior to Cycle 1 Day 1 (C1D1) or within 
3 days before study drug administration (for subjects who have already started treatment) to 
minimize potential MYTX-011 concentration in the serum eye drops.  
Subjects experiencing ocular adverse events that may affect their ability to perform tasks 
requiring full visual capacity (e.g., driving, operating machinery) should be advised to use 
caution or avoid such activities if clinically indicated.  
The benefit-risk profile for each subject should be carefully evaluated when considering 
MYTX 011 dose modifications. Any proposed deviations from the ocular AE management 
guidelines require discussion with the Sponsor Medical Monitor.  
Corneal AEs must be documented in the eCRF using preferred terms (e.g., keratitis, corneal 
erosion, keratopathy, or other relevant eye disorders) and graded per CTCAE v5.0 for consistent 
safety reporting. However, CTCAE grading alone should not guide clinical management 
decisions (e.g., dose modifications), as this scale was not designed to assess MYTX-011-specific 
ocular toxicities. Instead, management should follow the protocol-defined criteria in Table 13, 
which are tailored to capture clinically relevant corneal changes.  

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Table 13:
Dose Modification Recommendation for Ocular Adverse Events1
Ocular Symptoms and Signs
MYTX-011 
Recommended 
Modification
Blurred Vision or 
Reduced Visual Acuity 
(Measured by Best 
Corrected Visual 
Acuity (BCVA) 2
Eye Symptoms3
(e.g., discomfort, 
pain, 
photophobia)
Cornea4 (Eye Signs)
1 line decrease 
from baseline 
BCVA related to 
study drug, or
20/25 Snellen 
equivalent BCVA
Mild eye 
symptoms 
(1-3/10)
Non-confluent epitheliopathy 
Scattered staining/SPK
Continue at same 
dose and per 
protocol scheduled 
ophthalmic exams 
2-3 line decrease in 
baseline BCVA 
related to study 
drug, or
20/30-20/40 
Snellen equivalent 
BCVA
Moderate 
eye 
symptoms 
(4-6/10)
Confluent epitheliopathy
Diffuse staining/SPK
Continue at same 
dose or reduce by 1 
dose level per 
Investigators 
discretion
Recommend close 
ocular follow ups, if 
needed 
4-8 line decrease in 
baseline BCVA, or
20/50-20/150 
Snellen equivalent 
BCVA
Severe eye 
symptoms 
(7-9/10)
Epithelial defect
Corneal Ulcer
Delay dose until 
return to baseline or 
within 1-2 lines from 
baseline BCVA
If eye symptoms are 
present, delay dose 
until symptoms 
improve to mild or 
baseline , then 
consider dose 
reduction
>8 line decrease in 
baseline BCVA or
equivalent BCVA
Extreme eye 
symptoms 
(10/10)
Corneal perforation
Consider 
discontinuation
1 Modify dose using the worst assessment from blurred vision, eye symptoms, and corneal changes

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2 Best Corrected Visual Acuity (BCVA) should be measured with manifest refraction or pinhole with correction 
(current glasses) at distance 
3 Eye symptoms: Can be assessed using a 0-10 scale (0 meaning no ocular symptoms and 10 the worst symptoms) 
4 Corneal changes: For management of corneal AEs, eye care professionals are encouraged to treat using best 
present 
ADL = activities of daily living; AE = adverse event 
All dose modifications should be based on the worst preceding toxicity. 
For further guidance on dose modifications, see Section 7.5. 
7.5.3. 
Monitoring and Management of Suspected Interstitial Lung 
Disease/Pneumonitis 
If a subject develops an acute onset of new or worsening pulmonary or other related signs/ 
symptoms such as dyspnea, cough, or fever, rule out interstitial lung disease (ILD)/pneumonitis. 
Subjects with prior radiation therapy to the thorax (e.g., lung, mediastinum, chest wall) within 
6 months of study entry should be monitored closely, as they may have increased risk of 
developing ILD/pneumonitis during treatment. Subjects with newly developed shortness of 
breath, suspicious findings on CXR, or a decrease in SpO2 at rest of 2 4% for 1 3 days as 
measured as a continuous variable at home, or a decrease in SpO2 after exertion of 2 5% for 
1 7 days, should be evaluated for ILD/pneumonitis immediately.  
If the AE is confirmed to have an etiology other than ILD/pneumonitis, follow the management 
guidance outlined in Table 11. 
If the AE is suspected to be ILD/pneumonitis, treatment with study drug should be paused 
pending further evaluations.  
Further evaluations should include: 
 High-resolution CT 
 Pulmonologist consultation 
 One blood sample collection for PK analysis as soon as ILD/pneumonitis is suspected, if 
feasible 
Other evaluations could include: 
 Pulmonary function tests including diffusing capacity of the lungs for carbon monoxide, 
peripheral oxygen saturation, and arterial blood gases 
 Serum marker testing (e.g., KL-6, surfactant protein D) 
 Other tests as needed (e.g., infectious work-up, etc.) 
As soon as ILD/pneumonitis is suspected, corticosteroid treatment should be started promptly as 
per clinical treatment guidelines. Refer to drug-induced lung disease guidelines (Swain et al. 
2022; Tarantino et al. 2011). It is recommended that subjects with prior radiation therapy to the 
thorax within 6 months of study entry to be treated more aggressively, and high-dose IV 
corticosteroid should be initiated in such subjects with suspected Grade 2 (symptomatic) 

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ILD/pneumonitis. If the AE is confirmed to be ILD/pneumonitis, follow the management 
guidance as outlined in Table 14. 
 
Table 14: 
Management of Confirmed Interstitial Lung Disease/Pneumonitis 
Grade 1
Delay dose until resolved to Grade 0, then:
 
ays from day of onset, maintain dose 
 
If resolved in >28 days from day of onset, reduce 1 dose level for all subsequent cycles 
However, if the Grade 1 interstitial lung disease /pneumonitis occurs beyond Cycle Day 22 
and has not resolved within 49 days from the last infusion, the study treatment should be 
discontinued. 
For further management, see guidance from Swain et al. 2022. 
Grade 2, 3, or 4 
Discontinue subject from study treatment. 
For further management, see guidance by Swain et al. 2022. 
Source: Swain et al. 2022 
7.5.4. 
Management of Dermatological AEs 
Consider topical steroids and antihistamines as clinically indicated to manage dermatologic AEs. 
In case of suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) hold 
MYTX-011 and obtain dermatology consult and contact the medical monitor. MYTX-011 must 
be discontinued if SJS/TEN confirmed.  
7.5.5. 
Infusion Site Extravasation 
The infusion site should be monitored during MYTX-011 administration and the infusion 
interrupted if there is extravasation.  
7.6.
CONCOMITANT THERAPY AND PROHIBITED MEDICATIONS
Any medication or vaccine (including over-the-counter or prescription medications, recreational 
drugs, vitamins, and/or herbal supplements) that the subject is receiving at the time of enrollment 
or receives during the study must be recorded along with: 
 Reason for use 
 Dates of administration, including start and end dates 
 Dosage information including the dose and frequency 
The following medications are prohibited during the study:  
 Systemic anticancer therapy including cytotoxic agents, targeted agents, immunotherapy, 
and other investigational therapeutic agents

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 Radiation (except for palliative radiation to known metastatic sites). Palliative radiation 
to the thorax, including the lungs and chest wall, during the study is not allowed unless 
approved by the Sponsor Medical Monitor 
 Systemic chronic steroid therapy: prednisone 10 mg daily or equivalent. Short-term use 
of systemic steroid therapy as pre-medication, to manage IRRs or AEs, is permitted. 
Inhaled steroids or topical steroid use is permitted 
 IV antibiotics, antivirals, or antifungal medication within 1 week prior to first dose of 
study drug administration 
 Live/attenuated vaccine within 30 days before the first dose of study drug, during 
treatment with MYTX-011, and up to 30 days after EOT
The following medications should be used with caution and avoided, if possible:  
 Use of strong CYP3A4/5 inhibitors should be avoided since MMAE is a CYP3A4/5
substrate. If CYP3A4/5 inhibitor use is medically necessary, the subject should be closely 
monitored for adverse reactions 
 Use of strong CYP3A4/5 inducers or substrates may decrease unconjugated MMAE 
AUC and should be avoided if possible 
 MMAE is a substrate of P-glycoprotein (P-gp). Concomitant use of P-gp inhibitors may 
increase exposure to MMAE. If P-gp inhibitor use is medically necessary, the subject 
should be closely monitored for adverse reactions 
 A list of strong CYP3A4/5 inhibitors, inducers, and substrates and P-gp inhibitors
(FDA 2022) 
Palliative Radiation therapy cannot be administered on the same day IP is given throughout the 
course of the study. 
In addition, subjects will be advised that the consumption of grapefruit and grapefruit juice 
should be avoided due to its known inhibitory effect on CYP3A4/5. 
The Sponsor Medical Monitor should be contacted if there are any questions regarding 
concomitant or prior therapy.  
7.6.1. 
Supportive Care Guidelines 
Prophylactic hematopoietic growth factors should not be administered during Cycle 1 of the 
study in Part 1; subjects may receive growth factors if clinically indicated (e.g., development of 
neutropenia after administration of the first dose of MYTX-011). Prophylactic growth factors are 
allowed thereafter in subsequent cycles as clinically indicated. Subjects enrolled in Part 2 of the 
study may receive prophylactic growth factors in all cycles at the Investigator’s discretion; and 
for treatment of neutropenia as clinically indicated.  
See Section 7.5.2 (Table 13) for required steps for prevention and management of ocular AEs for 
all subjects enrolled. 

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Prophylactic anti-emetics may not be administered during Cycle 1 of the study in Part 1 dose 
escalation cohorts, but may be used in subsequent cycles for Part 1 dose escalation cohorts, and 
in all cycles for all other subjects. 
Febrile neutropenia should be managed according to institutional guidelines. 
Blood products may be used according to institutional guidelines during the study (excluding 
eligibility requirements; see Section 5.1). 

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8.
STATISTICAL CONSIDERATIONS
Details of the statistical analyses and data reporting will be provided in the Statistical Analysis 
Plan to be finalized prior to the database lock. Results will be presented by study part (Part 1: 
Dose Escalation and Part 2: Dose Expansion).  
Primary efficacy analysis will be completed per each expansion cohort when all subjects treated
in a cohort are evaluable for the evaluation of response. A final analysis is planned after all dose 
escalation and dose expansion cohorts have completed the study. 
8.1. 
ANALYSIS POPULATIONS
Safety Analysis Population: All subjects who receive at least 1 dose of MYTX-011. All safety 
analyses will be performed using this analysis population. 
DLT Evaluable Population: All subjects enrolled in Part 1 (dose escalation; not including the 
enrichment cohorts) who receive at least 1 dose of MYTX-011 and have either completed 
Cycle 1 or withdrawn during Cycle 1 due to a DLT. Analyses to determine the MTD will be 
performed using this analysis population.  
Efficacy Evaluable Population: All subjects who receive at least 1 dose of MYTX-011 have a 
measurable disease on the baseline tumor assessment, and either have at least 1 post-infusion 
disease assessment or have discontinued treatment for any reason prior to the first response 
assessment. 
Response Evaluable Population: All subjects who receive at least 1 dose of MYTX-011 have a 
measurable disease on the baseline tumor assessment and have at least one post-infusion tumor 
assessment. 
PK Analysis Population: All subjects who receive at least 1 dose of MYTX-011 and have 
evaluable PK data. This population will be used for summaries of PK parameters. 
Immunogenicity Analysis Population: All subjects who receive at least 1 dose of MYTX-011 
and have at least 1 post-infusion immunogenicity sample. This population will be used for 
summaries of ADAs. 
8.2. 
SAMPLE SIZE 
The sample size in Part 1, dose escalation depends on the observed safety profile, which will 
determine the total number of cohorts. The dose escalation scheme in Part 1 is based on a 
3 -subject cohort minimum BOIN design (Yuan et al. 2016) and will initially consider a series of 
7 escalating dose levels (plus dose “level -1” if needed), with no skipping of dose levels 
permitted. However, additional intermediate dose levels may be introduced based on a review of 
the cumulative safety data and upon recommendation by the SRC, provided that the intermediate 
dose is not higher than the next scheduled dose to be tested or that it does not exceed MTD if the 
MTD has already been determined. The intermediate dose can also be lower than the currently 
considered dose level. A minimum of 3 subjects will be treated in each cohort.  

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8.2.1.
Enrichment Cohorts
Additional subjects may be enrolled in enrichment cohorts, at dose levels that have previously 
been determined to be safe (including planned dose levels and intermediate dose levels), to better 
understand the safety, tolerability, PK, and preliminary anti-tumor activity of MYTX-011. 
No more than 10 subjects will be enrolled per enrichment cohort. For doses and/or dosing 
schedules where favorable benefit-risk has been demonstrated, up to 20 subjects may be enrolled 
for further dose optimization after approval by the SRC. Enrollment into enrichment cohorts may 
continue throughout the conduct of the study until all enrichment cohort slots are filled or it is 
determined that additional enrollment is not required. DLTs will not be assessed for subjects 
enrolled into enrichment cohorts. In addition, the Sponsor may enroll subjects with certain levels 
of cMET expression (i.e., high, intermediate, low, or ultra-low cMET expression as defined in 
Part 2) in enrichment cohorts or intermediate dose levels in which preliminary anti-tumor 
activity is observed. 
8.2.2. 
Sample Size for Part 2 
Eight disease cohorts (A, B, B2, C, D, E, E2 and F) will be initially considered in Part 2 of the 
study. Additional dosing cohorts may be added, as described in Section 4.2. 
Expansion Cohort A will be monitored for efficacy using the Bayesian Optimal Phase 2 (BOP2) 
design (Zhou et al. 2017). The BOP2 design is optimized to maximize power under the 
alternative hypothesis while controlling the Type I error rate at 0.10. The optimization is 
performed assuming the uninformative prior Beta (0.5, 0.5) distribution. In Cohort A, the 
reference (uninteresting) rate is 15% and the efficacy response rate is assumed to be 55%. 
Initially, 20 subjects will be randomized to 2 dose levels (10 subjects each). An interim analysis 
for futility will be performed after 10 subjects per dose level are available in the Response 
Evaluable Population; enrollment will be paused to assess futility. This number may be adjusted 
during the course of enrollment based on Sponsor discretion. Subjects will be randomized to 
2 dose levels. At the interim analysis, a dose will be deemed unacceptable if fewer than 
2 responses are observed, and the dose will be terminated. Following the interim analysis, an 
additional 10 subjects will be enrolled in each dose that is not terminated, for a total of up to 
40 enrolled in Cohort A. At the primary analysis, efficacy of a dose level will be declared if 6 or 
more responses are observed in 20 subjects. If the true response rate is greater than 40%, the 
study will have at least 80% power to reject the reference rate of 15%. 
Cohort B will be monitored for efficacy using the BOP2 design (Zhou et al. 2017). The BOP2 
design is optimized to maximize power under the alternative hypothesis while controlling the 
probability of Type I error, set at 0.10. The optimization is performed assuming a prior Beta (0.5, 
0.5) distribution. For Cohort B, the reference rate is 15% and the assumed efficacy rate is 35%. 
Initially, 15 subjects will be given MYTX-011 at the RP2D. The interim analysis for futility will 
be performed after 15 subjects are available in the Response Evaluable Population. At the 
interim analysis, futility criteria are met if there are 2 or fewer responders in 15 subjects. 

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If Cohort B passes the interim analysis for futility (i.e., if 3 or more responders are observed in 
the first 15 subjects [which may occur before all 15 subjects are enrolled]), a randomization 
cohort for subjects with intermediate cMET expression (Cohort B2) may be opened. In Cohort 
B2, up to 40 subjects will be randomized 1:1 into 2 dose levels (i.e., RP2D [which was used in 
Cohort B] and an alternative dose). Subjects will be randomized to 1 of 2 dose levels. 
At the primary analysis of RP2D in the subject population fulfilling inclusion into Cohort B and 
Cohort B2, efficacy of RP2D will be evaluated using all subjects receiving RP2D in Cohort B 
and Cohort B2. If 35 subjects received RP2D, efficacy will be declared if 9 or more ORRs are 
observed in the 35 subjects. 
Cohort B + Cohort B2 with a total of 
35 subjects will have approximately 88% power to reject the reference rate of 15% for RP2D and 
the estimated Type I error rate is 6.2% (based on 10,000 clinical trial simulations).  
Efficacy of the alternative dose will be declared if 6 or more ORRs are observed out of 
20 subjects enrolled in Cohort B2 receiving the alternative dose. The study will have 
approximately 75% power to reject the reference rate of 15% if the true rate is assumed to be 
35%, with the probability of Type I error of 6.7% based on the binomial distribution. 
Cohort C will be evaluated using the Bayesian efficacy monitoring with predictive probability 
approach (Lee and Liu 2008) and assumes a 91% threshold for declaring efficacy at the final 
analysis, with a 99% threshold for stopping for efficacy and a 10% threshold for early stopping 
for futility based on the evaluation of posterior probability at interim. A distribution of Beta (0.5, 
0.5) is used as prior distribution for the efficacy response rate. For Cohort C, the reference 
response rate is 15%, while the efficacy rate is assumed to be 35%. When the Response 
Evaluable Population contains 15 subjects interim analysis will be performed to evaluate for 
evidence of early efficacy or futility; enrollment will be paused to assess futility. Cohort C will 
be terminated for futility if 1 or fewer responses are observed among 15 evaluable subjects. 
Early efficacy will be declared if 7 or more responses are observed in 15 subjects. Enrollment 
may be continued after early efficacy is declared. A primary analysis will be performed when a 
total of 40 subjects are included in the Response Evaluable Population, and efficacy will be 
declared if there are 10 or more subjects among the 40 subjects with a response observed. 
Cohort D will be evaluated using the Bayesian efficacy monitoring with predictive probability 
approach (Lee and Liu 2008) in the same way as Cohort C. The approach assumes a 90% 
threshold for declaring efficacy at the final analysis, with a 95% threshold for early stopping for 
efficacy and a 10% threshold for early stopping for futility based on the evaluation of posterior 
probability at interim. A distribution of Beta (0.5, 0.5) is used as prior distribution for the 
efficacy response rate. For Cohort D, the reference response rate is 15%, while the efficacy rate 
is assumed to be 35%. When the Response Evaluable Population contains 15 subjects interim 
analysis will be performed to evaluate for evidence of early efficacy or futility; enrollment will 
be paused to assess futility. Cohort D will be terminated for futility if 1 or fewer responses are 
observed among 15 evaluable subjects. Early efficacy will be declared if 6 or more responses are 
observed in 15 subjects. Enrollment may be continued after early efficacy is declared. A primary 
analysis will be performed when a total 
 are included in the Response Evaluable 
Population, at which time the efficacy will be declared if there are 14 or more responses 

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observed. Cohort D will have approximately 97% power to reject the reference rate of 15% if the 
9.99%) based on 10,000 clinical trial simulations. 
Cohort E will be monitored for efficacy using the BOP2 design (Zhou et al. 2017) in the same 
way as Cohort B. For Cohort E, the reference rate is 15% and the assumed efficacy rate is 35%. 
Initially, 15 subjects will be given MYTX-011 at the RP2D. The interim analysis for futility will 
be performed when the Response Evaluable Population contains 15 subjects. At the interim 
analysis, futility criteria are met if there are 2 
 
If Cohort E passes the interim analysis for futility (i.e., if 3 or more responders are observed in 
the first 15 subjects, which may occur before all 15 subjects are enrolled), a randomization part, 
E2, may be opened, where up to 40 subjects will be randomized 1:1 into 2 dose levels (i.e., either 
RP2D [which was used in the first 15 subjects] or an alternative dose).  
At the primary analysis of RP2D in the subject population fulfilling inclusion into Cohorts E and 
E2, efficacy of RP2D will be evaluated using all subjects receiving RP2D (i.e. up to 35 subjects 
(initial 15 subjects [Cohort E] + 20 subjects in the randomized part [Cohort E2]). If 35 subjects 
received RP2D, efficacy will be declared if 9 or more ORRs are observed in the 35 subjects. 
If 
s E + E2 
88% power to reject the reference rate of 15% for RP2D and the estimated Type I error rate 
would be 6.2% (based on 10,000 clinical trial simulations).  
Efficacy of the alternative dose will be declared if 6 or more ORRs are observed out of 
2 receiving the alternative dose. The study will have 
approximately 75% power to reject the reference rate of 15% if the true rate is assumed to be 
 
Cohort F will be evaluated using the Bayesian efficacy monitoring with predictive probability 
approach (Lee and Liu 2008) in the same way as Cohort C using the same design, same response 
assumptions and the same decision rules. This assumes a 91% threshold for declaring efficacy at 
the final analysis, a 99% threshold for stopping for efficacy and a 10% threshold for early 
stopping for futility based on the evaluation of posterior probability at interim. A distribution of 
Beta (0.5, 0.5) is used as prior distribution for the efficacy response rate. For Cohort F, the 
reference response rate is 15%, while the efficacy rate is assumed to be 35%. When the Response 
Evaluable Population contains 15 subjects, an interim analysis will be performed to evaluate for 
evidence of early efficacy or futility; enrollment will be paused to assess futility. Cohort F will 
be terminated for futility if one or no response is observed among the 15 subjects. Early efficacy 
will be declared if 7 or more responses are observed in 15 subjects. Enrollment may be continued 
after early efficacy is declared. A primary analysis will be performed when a total of 40 subjects 
are included in the Response Evaluable Population, and efficacy will be declared if there are 
10 or more subjects among the 40 subjects with a response observed. 
When clinical safety and efficacy data are available for the subjects in expansion Cohorts A, B, 
B2, C, D, E, E2 and F, the DSMB will review and determine clinical merit and recommend 
continuing or discontinuing a cohort.  

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Based on ongoing review of the data from Parts 1 and 2 of the study, the sponsor may determine 
that one of the two dose regimens (RP2D or Alternative Dose) being administered in Part 2 
appears to show a better benefit:risk ratio than the other. In this case, the sponsor may decide to 
assign ongoing patients and all newly enrolled patients to the dose regimen that appears to have 
the more favorable benefit:risk ratio, and no longer assign doses via randomization. 
Additionally, the Sponsor may determine that one or more other doses (not the originally 
selected RP2D or Alternative dose) be evaluated in Part 2 (see Section 4.2). If other dose(s) are 
added as a substitute for the RP2D or Alternative dose, the interim and final cohort sizes and 
rules for futility and efficacy will be used as described above for the RP2D or Alternate dose in 
each cohort; enrollment will be re-initiated to account for full enrollment of the other dose. 
If the additional dose to be evaluated is not a substitute for the RP2D or Alternative dose, the 
rules above governing futility, interim and final cohort sizes, and declaration of efficacy will be 
based on those used for the RP2D above. 
Efficacy will be summarized by the point and interval estimate of ORR, accompanied by the 
posterior probability statements to further characterize the effect of treatment in this cohort.
8.2.3. 
Additional Enrollment 
If futility criteria are not met within a cohort for a dose level based on the rules outlined above, 
additional patients may be enrolled at that dose level for a total of up to approximately 
80 evaluable patients. This is in order to provide a more precise estimation of clinical benefit 
based on the ORR and associated 95% confidence interval (see Table 15) and to guide future 
development and potential regulatory interactions. 
 
Table 15: 
ORR and Associated 95% Confidence Interval for N=80 Subjects 
Responders 
ORR 
95% Confidence Interval 
20 
25% 
15.9, 35.9 
22 
28% 
18.1, 38.6 
24 
30% 
20.3, 41.3 
26 
33% 
22.5, 43.9 
28 
35% 
24.7, 46.5 
30 
38% 
26.9, 49.0 
32 
40% 
29.2, 51.6 
34 
43% 
31.5, 54.0 

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8.3.
SUBJECT DISPOSITION
A tabulation of subject disposition will be provided by dose level (Part 1) and by study cohort 
(Part 2), including the number screened, the number enrolled, the number included in each 
analysis population, the number that discontinued treatment and reasons for treatment 
discontinuation, and the number that withdrew from the study and reasons for withdrawal. 
8.4. 
SUBJECT DEMOGRAPHICS AND BASELINE CHARACTERISTICS 
Baseline demographic and other baseline data including height, weight, baseline ECOG status, 
LVEF, and medical history will be summarized. Disease characteristics including histological 
diagnosis, stage, prior therapies, cMET status, MET amplifications/exon 14 skipping mutations, 
presence of actionable mutations, etc., will be listed individually and by group using descriptive 
statistics. 
Extent of Exposure: The dose (mg) of study drug administered, the cumulative dose (mg) of 
study drug administered, and the duration of treatment (number of study cycles) will be 
summarized with descriptive statistics. The number and percentage of subjects whose dose is 
modified at any time will be summarized by each type of modification by cycle and overall. 
Discontinuations and reasons for discontinuation will be presented.  
8.5. 
STATISTICAL METHODOLOGY 
8.5.1. 
General Considerations 
Data will be summarized using descriptive statistics (continuous data) and/or contingency tables 
(categorical data) for demographic and baseline characteristics, efficacy measurements, safety 
measurements, and all relevant PK and immunogenicity parameters. When estimating 
proportions, the denominator to be used in the calculation will be the total number of subjects in 
the indicated analysis population for a specific dose level or cohort. Unless otherwise noted, 
estimation will be based on exact methods. Interval estimates will be based on the 90% 
confidence level. When summarizing time-to-event endpoints, censoring will be defined for each 
endpoint separately. Time-to-event endpoints will be analyzed using the Kaplan-Meier method to 
include point and interval estimates around the median and other percentiles as well as plots of 
survival curves by dose levels or cohorts. 
Tabular summaries will also be accompanied with by-subject listings. Subject data collected up 
to the time of study completion/withdrawal from study will be included in the analysis, 
regardless of the actual duration of treatment. Individual subject duration of follow-up will vary 
across subjects, depending on individual safety, efficacy, and tolerability.  
8.5.2. 
Dose Escalation for MTD: BOIN Design 
Part 1 dose escalation algorithm is based on a 3-subject cohort minimum BOIN design (Yuan et 
al. 2016), a model-assisted design that employs an escalation/de-escalation procedure, similarly 
implemented as a classical 3 + 3 design, but optimized to minimize the probability of making an 

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erroneous decision. DLTs occurring during Cycle 1 will be considered when implementing the 
dosing algorithm and decisions. The dose escalation/de-escalation scheme and its parameters are 
provided in Section 4.1. The design employs safety overdose control where a dose and higher 
dose levels will be eliminated from further consideration, if, given the number of observed DLTs 
at the current dose, there is a greater than 0.95 probability that the true DLT rate is higher than 
30%, and at least 3 subjects evaluable for DLT have been treated. This posterior probability is 
evaluated assuming Beta (1,1) prior probability of true DLT rate. When the lowest dose is 
eliminated, the study will be stopped for safety. Once all the enrolled subjects in Part 1 complete 
the DLT observation period and the study is not stopped early, the BOIN design applies an 
isotonic regression to select the MTD.  
8.5.3. 
Cohort Expansion Monitoring for Efficacy  
The decision rules in Section 8.2.2 are based on different methods and assumptions as described, 
together with their statistical properties (power to declare efficacy and Type I error rate).
Additional analyses, for the purposes of internal decision making, planning of future studies, or 
responding to requests by the regulatory authorities, may be performed at the discretion of the 
Sponsor.  
8.6. 
EFFICACY ANALYSES 
Efficacy endpoints will be based on RECIST 1.1 (Appendix C) by Investigator assessment for 
the primary analysis. Confirmation of Investigator-assessed ORR and DOR may be performed 
retrospectively through an Independent Review Committee. The following efficacy endpoints 
will be assessed in both Part 1 and Part 2 of the study: 
 Overall Response Rate  
ORR is defined as the proportion of subjects with the BoR of CR or PR. All response 
data will also be summarized over time for all subjects using all available scans.  
Note that CR and PR must be confirmed by 2 tumor imaging assessments conducted at 
least 4 weeks apart. 
 Duration of Response (for subjects who achieve CR or PR) 
DOR is defined as time from the date of first documented evidence of CR or PR until 
first documented disease progression or death, whichever comes first. For subjects 
without PD or death prior to analysis cutoff date, DOR will be censored at the date of last 
available tumor assessment.  
 Overall Survival 
OS is defined as the time from the date of first administration of MYTX-011 to the date 
of death due to any cause. OS will be censored at the last reported date of contact.  

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 Progression-Free Survival 
PFS is defined as the time from the date of first administration of MYTX-011 to the date 
of documented disease progression per RECIST 1.1, date of clinical progression if no 
imaging documenting progression is performed, date of starting subsequent anti-cancer 
therapy, or date of death (in the absence of progression), whichever comes first. For 
subjects who have not progressed, started subsequent anti-cancer therapy, or died before 
the analysis cutoff date, PFS will be censored at the date of the last available tumor 
assessment. 
 Disease Control Rate 
DCR is defined as the proportion of subjects who achieve a BoR of CR or PR or SD. 
 Best Observed Response 
A single BoR is defined per each subject as the best result obtained among all tumor 
assessment visits from baseline until determination of PD.  
 Time to Response 
Time to response (TTR) is defined as the time from the first administration of MYTX-
011 to the first documentation of CR or PR. TTR will only be calculated for subjects with 
BoR of CR or PR. 
Note:Details of anti-tumor activity endpoints are specified in the Statistical Analysis Plan 
(SAP). 
8.6.1. 
Pharmacokinetic and Immunogenicity Analyses 
PK data will be presented overall and by dose level and will include subjects who have received 
at least 1 dose of MYTX-011 and have evaluable PK data. Analyses to describe the relationship 
between MYTX-011 exposure (total antibody, total ADC, and MMAE) and clinical outcomes 
(e.g., safety and anti-tumor activity) may be performed. 
Immunogenicity analyses: ADAs will be reported at multiple timepoints during the study. Titers, 
relationship of antibodies to MYTX-011 dose level, PK, anti-tumor activity, and safety may be 
reported. 
8.6.1.1. 
Pharmacokinetics 
MYTX-011 (total antibody, total ADC, and MMAE) levels will be determined using blood 
samples collected before and after dosing through the EOT visit. These determinations will be 
used to calculate the single- and repeat-dose PK profiles for each evaluable subject at each dose 
level administered. Single-dose and multiple-dose MYTX-011 (total antibody, total ADC, and 
MMAE) PK parameters will be estimated using non-compartmental analysis in dose escalation 
and dose expansion if possible. PK parameters for dose escalation and dose expansion will 
include, but are not limited to, accumulation ratio, Cmax, Tmax, Clast, Tlast, AUC0-last 
(e.g., AUC504h), volume of distribution (Vd), CL, and t½. A compartmental method will also be 
used to explore the MYTX-011 PK profile if possible. 

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The MYTX-011 concentration will be listed and summarized in tabular formats using descriptive 
statistics. MYTX-011 (total antibody, total ADC, and MMAE) concentrations will be plotted 
against timepoints by cohort. Individual and summary PK parameters will be listed and 
summarized in tabular format using descriptive statistics.  
Timepoints for the collection of PK and ADA assessments are provided in Table 6 and Table 7 
for dose escalation and dose expansion, respectively. The presence of MYTX-011 (total 
antibody, total ADC, and MMAE) will be quantified by a validated assay. 
8.6.1.2. 
Immunogenicity  
Immunogenicity incidence and persistence to MYTX-011 will be assessed and summarized 
descriptively. 
8.6.2. 
Exploratory Analyses 
Correlation between anti-tumor activity and baseline subject and disease characteristics 
(e.g., oncogenic drivers) will be explored. The relationship between potential biomarkers and 
predictors of response and resistance of MYTX-011 in the tumor and blood and subject 
outcomes (e.g., anti-tumor activity) may be explored as well as any changes in biomarkers and 
predictors of response and resistance to MYTX-011 from baseline such as: 
 Biomarkers and predictors of response and resistance to MYTX-011 in tumor and blood 
(e.g., molecular, genetics, protein) 
Details of other secondary and exploratory endpoint analyses will be provided in the Statistical 
Analysis Plan (SAP). 
8.6.2.1. 
Exploratory Pharmacokinetic Exposure Response Analysis 
Exposure-Dose-Efficacy 
, if appropriate, 
evaluated by a mixed effects model to characterize the relationship between changes from 
baseline to maximal tumor shrinkage and the plasma concentration of MYTX-011. If 
appropriate, effects of covariates (e.g., age, sex assigned at birth, race, and concomitant 
medications) will be evaluated as well. This will be done in 2 steps. First, a descriptive analysis 
will be performed graphically between PK exposure values and major safety, efficacy, and 
biomarker parameters (either as categories or continuous variables). If any potential correlation 
is identified, further investigation will be performed using a mechanism-based modeling 
approach, as appropriate. 
Exposure-QT Prolongation 
a mixed effects model to characterize the relationship between changes from baseline in QTcF 
and the plasma concentration of MYTX-011. If appropriate, effects of covariates (e.g., age, sex 

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assigned at birth, race, presence of medications known to cause QT prolongation, and other 
concomitant medications) will be evaluated as well.
In addition, the potential correlation between MYTX-011 exposure and other endpoints (major 
safety, efficacy, and biomarker parameters) will be evaluated. This will be done in 2 steps. First, 
a descriptive analysis will be performed graphically between PK exposure values and major 
safety, efficacy, and biomarker parameters (either as categories or as continuous variables). 
If any potential correlation is identified, further investigation will be performed using a 
mechanism-based modeling approach, as appropriate. 
Immunogenicity-Exposure and/or Adverse Event Relationship
The concentration/AE-immunogenicity relationship will also be explored graphically and 
tabulated to characterize a relationship between the changes from screening immunogenicity 
presence and plasma concentration of MYTX-011. In addition, the potential correlation between 
immunogenicity and other endpoints (major safety, efficacy, and biomarker parameters) may be 
evaluated. This will be done in 2 steps. First, a descriptive analysis will be performed graphically 
between immunogenicity change from screening values and major safety, efficacy, and 
biomarker parameters (either as categories or continuous variables). If any potential correlation 
is identified, further investigation will be performed using a mechanism-based modeling 
approach, as appropriate.
8.7. 
SAFETY ANALYSES 
All subjects who receive at least 1 dose of MYTX-011 will be included in the Safety Analysis 
Population to be used in safety analyses. Safety analyses will be presented overall and by dose 
level (Part 1) and cohort (Part 2). Safety analyses will also include summaries of TEAEs, 
treatment-related AEs, SAEs, and DLTs during Cycle 1 in Part 1. The number and percentage of 
subjects reporting any TEAE will be summarized and reported by Preferred Term and System 
Organ Class according to the Medical Dictionary for Regulatory Activities and by relationship to 
MYTX-011.  
Safety endpoints will include: 
 Incidence and severity of TEAEs, Grade 3 or higher TEAEs, SAEs, and TEAEs leading 
to dose modification, dose hold, or dose discontinuation 
 Incidence and severity of Grade 3 or higher treatment-related AEs 
 Incidence of Grade 3 and 4 clinical laboratory abnormalities and changes from baseline 
 Changes in vital signs, clinical laboratory parameters, and ECG from baseline  
Safety analyses will be based primarily on the incidence, severity, and type of AEs, as well as on 
clinically meaningful laboratory results, physical examination, and vital signs as available. 
Safety variables will be tabulated and presented by the dose of study drug received. Exposure to 
study drug and reasons for discontinuation of study drug will also be tabulated. 

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Detailed information collected for each AE will be included in a listing: AE term, start/stop dates 
of the AE, seriousness, severity, relationship to study drug(s), action taken, and outcome. 
In addition, the number and percentage of subjects experiencing at least 1 TEAE will be 
tabulated by body system, Preferred Term, and CTCAE grade. TEAEs, treatment-related AEs, 
AESIs, SAEs, AEs with a fatal outcome, and AEs leading to discontinuation/dose modification 
will be further summarized. Summary statistics for actual values and for changes from baseline 
will be tabulated for clinical laboratory results by scheduled visit. Subjects with laboratory 
values outside of the normal reference range at any post-baseline assessment will be summarized 
and graded per NCI CTCAE Version 5.0 as applicable. Subject incidence of abnormal laboratory 
results will be summarized by treatment group and maximum grade for each abnormal laboratory 
finding. 
8.8. 
MISSING VALUE HANDLING PROCEDURES 
In general, other than for partial dates, missing data will not be imputed and will be treated as 
missing. Any exceptions will be provided in the SAP. 

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9.
ADVERSE EVENT REPORTING AND CRITERIA
9.1. 
DEFINITION OF ADVERSE EVENT
An AE is any untoward medical occurrence in a clinical investigation subject administered a 
pharmaceutical product. Any AE starting or worsening after first treatment of study drug and 
noted within 30 days of the last treatment of study drug will be considered a TEAE. An AE does 
not necessarily have to have a causal relationship with this treatment. An AE can therefore be 
any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease 
temporarily associated with the use of a medicinal product, whether or not considered related to 
the medicinal product. This includes any occurrence that is new in onset or aggravated in 
severity or frequency from the baseline condition. It is the responsibility of the Investigator, 
based on their knowledge and experience, to determine which untoward medical occurrences 
should be considered AEs. 
9.2. 
CRITERIA FOR SERIOUS ADVERSE EVENTS 
The definitions of SAEs are described below. The Investigator is responsible for ensuring that all 
staff involved in the study are familiar with the content of this section. 
An SAE or reaction is defined as any untoward medical occurrence that meets at least 1 of the 
following criteria: 
 Results in death 
In the case of deaths, the event(s) leading to the death should be recorded and reported as 
SAE(s) with the outcome “Fatal.” The death itself will not be reported as an SAE, unless 
the cause of the death is unknown (e.g., in case of unexplained or sudden death). 
 Is life-threatening 
The term “life-threatening” refers to an event in which the subject is at immediate risk of 
death at the time of the event; it does not refer to an event that hypothetically might cause 
death if it were more severe.
Requires inpatient hospitalization or prolongation of existing hospitalization
 Results in persistent or significant disability/incapacity
A disability is defined as any substantial disruption of a subject’s ability to conduct 
normal life functions.
Is a congenital anomaly/birth defect
Is medically important
Medical and scientific judgment must be exercised in deciding whether an AE is 
considered “medically important.” Medically important events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may 
require intervention to prevent 1 of the other outcomes listed in this definition.  
Progression of disease (including fatal outcomes) should not be reported as an SAE.

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9.2.1.
Situations Not Considered SAEs
Treatment within or admission to the following facilities is not considered to meet the criteria of 
“inpatient hospitalization” (although if any other SAE criteria are met, the event must still be 
treated as an SAE and immediately reported; i.e., could meet the definition of important medical 
event): 
 Emergency department or emergency room 
 Hospitalization for drug administration, diagnostic procedure, or social circumstances 
Outpatient or same-day surgery unit
Observation or short-stay unit
 Rehabilitation facility 
 Hospice or skilled nursing facility 
 Nursing home, custodial care, or respite care facility 
Hospitalization during the study for a pre-planned surgical or medical procedure (1 planned prior 
to entry in the study), does not require reporting as an SAE to the Sponsor, but if hospitalization 
is prolonged due to an event, then this would be reportable to Sponsor or designee.
9.2.2. 
Serious versus Severe AEs 
It is important to distinguish between “serious” and “severe” AEs, as the terms are not 
synonymous. Severity is a measure of intensity; however, an AE of severe intensity need not 
necessarily be considered serious. For example, nausea that persists for several hours may be 
considered severe nausea but may not be considered an SAE. On the other hand, a stroke that 
results in only a limited degree of disability may be considered only a mild stroke but would be 
considered an SAE. Severity and seriousness should be independently assessed when recording 
AEs and SAEs on the eCRF. 
9.2.3. 
Adverse Event/Serious Adverse Event Grading 
The NCI CTCAE Version 5.0 is to be used for the grading of severity of AEs. 
For AEs not covered by the NCI CTCAE grading system, the following definitions should be 
used: 
 Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 
 Grade 2: Moderate; minimal, local, or non-invasive intervention indicated; limiting age-
appropriate instrumental activities of daily living (ADL). Instrumental ADL refers to 
preparing meals, shopping for groceries or clothes, using the telephone, managing 
money, etc. 

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 Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
ADL. Self-care ADL refers to bathing, dressing and undressing, feeding self, using the 
toilet, taking medications, and not bedridden. 
 Grade 4: Life-threatening consequences; urgent intervention indicated. 
 Grade 5: Death related to AE. 
9.2.4. 
Adverse Events of Special Interest 
The following AESIs will be closely monitored during the study including: 
 IRRs 
Ocular AEs
Clinically significant pulmonary AEs (e.g., suspected pneumonitis/ILD)
Peripheral neuropathy
 Hyperglycemia (based on laboratory results) 
 Clinically significant neurological disorder 
In addition, the occurrence of Grade 3 and 4 neutropenia and thrombocytopenia (based on 
laboratory results) will be monitored during the study.  
9.2.5. 
Adverse Events/Serious Adverse Event Causality Assessment 
The Investigator must also assess the causal relationship of any AE to the study drug, based on 
available information, using the following guidelines: 
Not related/unrelated 
Exposure to study drug did not occur or the occurrence of the AE is not reasonably 
related in time to study drug administration.  
Unlikely related
AE with time to study drug administration that makes relationship improbable 
(but not impossible). Disease or other drugs provide plausible explanations. 
Possibly related* 
AE with reasonable time relationship to study drug administration. Could also be 
explained by disease or other drugs. Information on drug withdrawal may be lacking 
or unclear. 
Probably related* 
AE with reasonable time relationship to study drug administration. Unlikely 
attributed to disease or other drugs.  
Definitely related* 
AE with plausible time relationship to study drug administration. Cannot be 
explained by disease or other drugs. Response to withdrawal plausible. 
* If other necessary ICH E2A criteria are met, these causalities would qualify for expedited reporting. 
9.2.6. 
Adverse Event/Serious Adverse Event Recording 
All non-serious AEs regardless of severity or relationship to the study drugs are to be recorded in 
the electronic data capture (EDC) system on the appropriate eCRF from signing of informed 
consent until 30 days after documented date of discontinuation or completion of protocol-

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specific treatment. All AEs must include the Investigator’s assessment of the event’s seriousness, 
severity, and causality to study drug.
All SAEs, regardless of severity or relationship to the study drug(s), are to be recorded in the 
EDC system on the appropriate eCRF from signing of informed consent until 30 days after 
documented date of discontinuation or completion of protocol-specific treatment. All SAEs must 
include the Investigator’s assessment of the event’s seriousness, severity, and causal relationship 
to study drug. AESIs and SAEs considered related to MYTX-011 must be reported to the 
Sponsor even after the 30-day period has been completed.  
If an AE is deemed by the Investigator as serious, as per the SAE criteria, it should be reported 
as soon as possible and no later than 24 hours of awareness to the Sponsor or designee using 
the appropriate eCRF in the EDC system. If a non-serious AE is deemed by the Investigator as a 
potential or suspected pneumonitis or ILD, it should also be reported as soon as possible and no 
later than 24 hours of awareness to the Sponsor or designee using the appropriate eCRF in the 
EDC system. Follow-up information for SAEs and information on non-serious AEs that become 
serious should also be reported as soon as possible but no later than 24 hours to the Sponsor 
or designee using the appropriate eCRF in the EDC system. SAEs should be followed until 
resolution (including results of an autopsy report, if applicable). An electronic SAE form is 
available for use if the EDC is unavailable. If an electronic SAE form is needed, the data must be 
reviewed and the electronic SAE form signed by the Investigator or designee. 
If the EDC system is unavailable, electronic SAEs must be reported to: 
Pharmacovigilance Department 
Catalyst Clinical Research 
safety@catalystcr.com 
New information relating to a previously reported SAE must be reported to the Sponsor within 
24 hours following knowledge of the new information. The Investigator may be requested to 
provide additional follow-up information such as discharge summaries and extracts from medical 
records.  
The onset date of the SAE is defined as the date the event meets serious criteria. The resolution 
date is the date when the SAE no longer meets serious criteria.  
Symptoms of the disease under study should not be classed as AEs if they are within the normal 
day-to-day fluctuation or expected progression of the disease. However, unexpected and 
significant worsening of the symptoms should be recorded as an AE. 
Disease progression assessed by measurement of malignant lesions on radiographs or other 
methods should not be reported as an AE.  
Other untoward events occurring in the framework of the study are also to be recorded as AEs 
(i.e., AEs that occur prior to assignment of study drug that are related to a protocol mandated 
intervention, including invasive procedures such as biopsies).  

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Subjects who discontinue from the study for a study-related AE or an abnormal laboratory value 
must be followed until resolution 
or stabilization, or the event is 
considered to be chronic and/or irreversible, whichever comes first. 
All new AEs (non-serious and serious) occurring during the follow-up period must be reported 
and followed until resolution unless, in the Investigator’s judgment, these are not likely to 
improve due to the underlying disease.  
Investigators must report SAEs and follow-up information to their responsible Institutional 
IRB)/IEC according to the policies of the responsible IRB/IEC. 
Investigators should use correct medical terminology/concepts and avoid colloquialisms and 
abbreviations when recording AEs or SAEs on the eCRF and/or SAE Report Form. 
The outcome of the AE must be recorded on the eCRF: 
Fatal 
Not recovered/not resolved 
Recovered/resolved 
Recovered/resolved with sequelae 
Recovering 
 Unknown 
9.2.6.1. 
Abnormal Laboratory Values and Other Safety Evaluations 
Some laboratory values may be outside the normal range due to the underlying disease. 
Abnormalities or changes in laboratory values, vital signs, or ECG assessments may represent an 
AE if the change is clinically significant. Clinically significant values/changes are those that 
result in an intervention or alteration in medical care, meet the criteria for an SAE or DLT, those 
causing dose delays/modifications and those that indicate a reason for subject discontinuation 
from study drug. Clinical syndromes associated with laboratory values should be recorded as 
appropriate on the AE eCRF page. 
9.2.7. 
Persistent or Recurrent Adverse Events 
A persistent AE is one that extends continuously, without resolution, between subject evaluation 
timepoints. Such events should only be recorded once on the AE Report Form and/or the eCRF. 
If a persistent AE becomes more severe (changes from a Grade 1 or 2 AE to a Grade 3 or 4 AE) 
or lessens in severity (changes from a Grade 3 or 4 AE to a Grade 1 or 2 AE), it should be 
recorded on a separate AE Report Form and/or eCRF. 
A recurrent AE is one that occurs and resolves between subject evaluation timepoints, and 
subsequently recurs. All recurrent AEs should be recorded on an AE Report Form and/or eCRF 
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9.2.8.
Deaths
Deaths that occur during the protocol-specified AE reporting period and are attributed by the 
Investigator solely to progression of the subject’s disease for up to 30 days after the last dose of 
study drug will be recorded on the appropriate study eCRF page and will be exempt from SAE
reporting. The term “disease progression” should not be used. Death due to disease progression 
in the absence of signs and symptoms should be recorded as the primary malignancy (e.g., 
metastatic NSCLC) on the eCRF Death page.
All other on-study deaths (i.e., not solely attributed to disease progression) will be reported to the 
Sponsor or designee on an SAE Report Form and recorded on the AE page of the eCRF.
When recording the death as an SAE, the event or condition that caused or contributed to the 
fatal outcome should be recorded as the single medical concept on the AE page of the eCRF: 
only one SAE representing the primary cause of death should be reported with serious criteria 
"Death", severity "Grade 5" and outcome "Fatal.” If the cause of death is unknown and cannot be 
ascertained at the time of reporting, record “Death NOS” on the eCRF AE page. 
9.3. 
HOSPITALIZATION, PROLONGED HOSPITALIZATION, OR SURGERY 
Any AE that results in hospital admission or prolongs hospitalization should be documented and 
reported as an SAE. There are some hospitalization scenarios that do not require reporting as an 
SAE when there is no occurrence of an AE.  
9.4. 
STOPPING RULES 
Enrollment may be stopped if an interim risk-benefit assessment by the DSMB and/or SRC of all 
available data determines that potential risk outweighs demonstrated/anticipated benefits of the 
investigational agent. In this situation, review of alternative dosing, administration, prophylaxes, 
or other maneuvers to reduce risk will be performed, and will be endorsed by SRC or DSMB 
prior to any final decisions on re-initiation of enrollment.  
An ad-hoc DSMB meeting will be held to discuss the benefit:risk profile of MYTX-011 if either 
of the below criteria are met: 
 
-related deaths (other than PD or confounded by PD) at any time or 
 
-related deaths (other than PD or 
subjects dosed with MYTX-011 in the same dose cohort 
9.5. 
PRE-EXISTING MEDICAL CONDITIONS 
A pre-existing relevant medical condition is one that is present at the start of the study. 
Such conditions should be recorded on the study’s appropriate medical history eCRF. A pre-
existing medical condition should be recorded as an AE or SAE only if the frequency, severity, 
or character of the condition worsens during the study. When recording such events on the 
appropriate SAE Report Form and/or eCRF, it is important to convey the concept that the pre-
existing condition has changed by including applicable descriptors. 

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9.6.
PREGNANCY
During the study, all female subjects of childbearing potential (the definition of females of 
childbearing potential is given in Appendix A) must contact the treating Investigator 
immediately if they suspect that they may be pregnant (a missed or late menstrual period should 
be reported to the treating Investigator).  
If an Investigator suspects that a subject may be pregnant prior to administration of study 
drug(s), the study drug(s) must be withheld until the result of the pregnancy test is confirmed. 
If a pregnancy is confirmed, the subject must not receive any study drug(s) and must be 
discontinued from the study. 
If an Investigator suspects that a subject may be pregnant after the subject has been receiving 
study drug(s), the study drug(s) must immediately be withheld until the result of the pregnancy 
test is confirmed. If a pregnancy is confirmed, the study drug(s) must be immediately and 
permanently stopped, the subject must be discontinued from the study, and the Investigator must 
notify the Sponsor Medical Monitor within 24 hours of awareness. 
If a female partner of a male subject becomes pregnant during the male subject’s participation in 
the study, the pregnancy must be reported immediately.  
Pregnancy should be recorded on a Pregnancy Report Form and reported by the Investigator to 
the Sponsor or designee in the same timeframe (within 24 hours of awareness) as reporting an 
SAE.  
Every effort should be made to gather information regarding the pregnancy outcome and 
condition of the infant. The pregnancy should be followed up to 6 months after the end of the 
pregnancy, which can include birth, spontaneous abortion, or voluntary termination, to collect 
the outcome with details of the birth and the presence or absence of any birth defects, congenital 
abnormalities, or maternal and/or newborn complications, as applicable. Follow-up to a 
pregnancy should be recorded on a Pregnancy Report Form and should include an assessment of 
the causal relationship to the study drug and reported by the Investigator to the Sponsor or 
designee. Pregnancy outcomes must be reported for the female partners of any males who took 
study drug on the Pregnancy Report Form. Consent to report information regarding these 
pregnancy outcomes should be obtained from the mother.  
Any SAE experienced during pregnancy must be reported on the SAE Report Form. Pregnancy 
complications such as spontaneous abortion/miscarriage are considered an SAE. An elective 
abortion/termination of pregnancy is not considered an SAE. Congenital anomalies/birth defects 
always meet SAE criteria and should therefore be reported as an SAE using the previously 
described process for SAE reporting. 
9.7. 
MEDICATION ERRORS AND STUDY DRUG OVERDOSE 
Symptomatic and asymptomatic overdose must be reported in the appropriate eCRF. Any 
accidental or intentional overdose with any of the study drug(s), even if not fulfilling a 

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seriousness criterion, is to be reported to the Sponsor or designee immediately (within 24 hours 
of awareness) using the SAE Report Form and following the same process described for SAEs. 
A medication error is an error made in the prescribing, dispensing, administration, and/or use of 
the study drug. Medication errors including use of unassigned treatment, incorrect dosage, or 
expired product should be reported within 24 hours to the Sponsor.  
9.8. 
REFERENCE SAFETY INFORMATION 
The reference for safety information for this study is the MYTX-011 IB, which will be provided
to the Investigators by the Sponsor or designee. 
9.9. 
SAFETY REPORTING TO REGULATORY AGENCIES, ETHICS 
COMMITTEES, AND INVESTIGATORS  
The Sponsor or designee will notify the appropriate regulatory agencies and all participating 
Investigators on an expedited basis and in accordance with local regulations if there are 
suspected unexpected serious adverse drug reactions (SUSARs) associated with MYTX-011 
administration. The Investigator (or Sponsor where required) will report the SUSARs to the 
appropriate IRB/IEC. 

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10.
CLINICAL DATA COLLECTION AND MONITORING
10.1. 
SAFETY OVERSIGHT COMMITTEES 
10.1.1. 
Safety Review Committee 
Safety will be monitored throughout the study by an SRC established by the Sponsor and will 
consist of participating Investigators and the Sponsor Medical Monitor. The Sponsor’s 
biostatistician and clinical pharmacologist will be consulted and may attend the meetings. 
Representatives of the Sponsor Clinical Development Team may also attend the SRC meetings. 
At a minimum, the SRC will meet when subjects in each cohort have completed the DLT 
observation period in Part 1, at the end of dose escalation for all cohorts/determination of the 
RP2D, and at the time of any planned futility analysis. Ad hoc meetings will be scheduled if 
there are unexpected safety findings.  
All available data will be reviewed by the SRC. The data to be reviewed may be unqueried.
During Part 1, the SRC will make recommendations on dose escalation/de-escalation/cohort 
expansion, exploring intermediate dose cohorts or alternate dosing regimens, and recommend the 
RP2D. The SRC will also recommend the alternative dose to be selected for cohorts that involve 
dose randomization.  
After reviewing cumulative safety data, the SRC may make recommendations on the conduct of 
the study including dosing regimens, supportive care measures, and protocol amendments if 
needed. During dose expansion, in addition to the Data Safety Monitoring board, the SRC may 
be consulted to make recommendations on opening cohorts, cohort modifications including 
enrollment pause or resumption, expansion, or termination as appropriate.  
10.1.2. 
Independent Data Safety Monitoring Board 
To ensure subjects’ safety during Part 2 of the study (Dose Expansion), safety data will be 
reviewed by an independent Data Safety Monitoring Board (DSMB) on an ongoing basis. Based 
on the available safety data from the entire study, the DSMB will make recommendations on 
continuation, modification, or suspension of the study or of a particular expansion cohort in 
Part 2 of the study (Dose Expansion). The DSMB will meet at the following timepoints: 
6 months after the first patient is dosed in Part 2, and then every 6 months thereafter until the 
primary analysis for Part 2 has been conducted. The DSMB may increase the frequency of 
meetings if deemed appropriate during the course of the trial. The specific working procedures 
will be described in a DSMB charter, which will be established prior to the first data review 
meeting held by the DSMB. 
Recommendations made by the SRC and DSMB will be documented and maintained in the 
Sponsor’s Trial Master File.  

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10.2.
SITE MONITORING PLAN
A study initiation site visit, a teleconference, and/or a planned Investigator meeting will be 
performed to review Investigator responsibilities and protocol requirements. During the study, 
the Sponsor or Sponsor delegate will make visits to the sites or perform remote monitoring as 
defined in the monitoring plan to review protocol compliance, examine eCRFs, laboratory data, 
safety data, and individual subject medical records and to ensure that the study is being 
conducted according to the protocol and pertinent regulatory requirements.  
Site monitoring shall be conducted to ensure that the human subject protection, study procedures, 
laboratory, study intervention administration, and data collection processes are of high quality 
and meet the Sponsor, GCP/ICH, and, when appropriate, regulatory guidelines. The Site 
Monitoring Plan shall define aspects of the monitoring process. 
10.3.
CURRICULA VITAE AND FINANCIAL DISCLOSURES
All Principal Investigators will be required to submit to the Sponsor or its designee a current
signed curriculum vitae (CV), a completed FDA Form 1572 (or equivalent form), and financial 
disclosure statement. In addition, all sub-Investigators will be required to submit to the Sponsor 
or its designee a current signed CV and a completed financial disclosure statement. 
10.4. 
DATA OWNERSHIP AND PUBLICATION 
The results of and all data generated during the conduct of this study belong to the Sponsor, are 
considered Sponsor’s proprietary and confidential information, and are subject to the 
confidentiality provisions in the Clinical Trial Agreement (CTA) governing the participation of 
the Investigator in the study. Sponsor retains the sole and exclusive right to the first publication 
of the results of this study. Such publication is intended to be a multicenter publication, collected 
from all Investigators and institutions participating in the study rather than publication based on 
individual site data. Any manuscripts, abstracts, or other presentation materials generated by 
Investigator must be reviewed and approved by the Sponsor prior to submission as set forth in 
the CTA and must meet all other applicable conditions set forth in the CTA. 

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11.
ETHICAL, FINANCIAL, AND REGULATORY 
CONSIDERATIONS 
This study will be conducted in accordance with the protocol and with the following: 
 Applicable ICH GCP Guidelines.  
 Applicable laws and regulatory requirements. 
 Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
International Ethical Guidelines. 
The protocol, protocol amendments, ICF, IB, and other relevant documents (e.g., 
advertisements) must be submitted to an IRB/IEC by the Investigator and reviewed and 
approved by the IRB/IEC before the study is initiated.
The Investigator will be responsible for the following: 
 Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC. 
 Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
 Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 Code of Federal Regulations (CFR), ICH guidelines, the IRB/IEC, European 
regulation 536/2014 for clinical studies (if applicable), and all other applicable local 
regulations.  
11.1. 
IRB/IEC APPROVAL 
The study protocol and amendments, ICFs, subject-facing documents (e.g., study diary), 
advertisements), information about payments (i.e., Investigator payments) and compensation 
available to the subjects and documentation evidencing the Principal Investigator’s qualifications 
must be submitted to the IRB/IEC per their guidelines for ethical review and approval prior to 
the study start. The IRB/IEC will also be provided with a copy of the IB.  
The Investigator will not start the study, nor will study drug be shipped to the investigational site 
before the Sponsor has been provided evidence of the IRB/IEC approval.  
The Principal Investigator/Sponsor and/or designee will follow all necessary regulations to 
ensure initial and ongoing IRB/IEC study review. The Principal Investigator/Sponsor (as 
appropriate) must submit and, where necessary, obtain approval from the IRB/IEC for all 
subsequent protocol amendments and changes to the ICFs unless there is an emergent subject 
safety issue. 
If a study is prematurely terminated or discontinued, the Sponsor will promptly notify the 
Investigator. After notification, the Investigator must contact all participating subjects. 

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If applicable, the Investigator will notify the IRB/IEC at the end of the study, or if the study 
terminates early, the Investigator must notify the IRB/IEC of the termination. A reason for the 
early termination must be provided (as defined in Directive 2001/20/EC). 
11.2. 
REGULATORY APPROVAL 
As required by local regulations, the Sponsor will ensure approval of the appropriate regulatory 
bodies is obtained, prior to study initiation. If required, the Sponsor will also ensure that the 
implementation of any substantial amendment to the protocol and other relevant study 
documents happens only after approval by the relevant regulatory authorities.
Safety updates for MYTX-011 will be prepared by the Sponsor or its representative as required, 
for submission to the relevant regulatory authority. 
11.3. 
FINANCIAL DISCLOSURE 
The Investigator is required to provide financial disclosure information to allow the Sponsor to 
submit the complete and accurate certification or disclosure statements required under 
21 CFR Part 54. 
In addition, the Investigator must provide the Sponsor with a commitment to promptly update 
this information if any relevant changes occur during the course of the investigation and for 
1 year following the completion of the study. 
11.4. 
INSURANCE AND INDEMNITY 
Details of insurance and/or indemnity will be contained within the written agreement between 
the Investigator or site and the Sponsor. 
11.5. 
INFORMED CONSENT 
Informed consent is a process by which a subject voluntarily confirms his or her willingness to 
participate in a particular study, after having been informed of all aspects of the study that are 
relevant to the subject's decision to participate. Informed consent is documented by means of a 
written, signed, and dated ICF. It is the responsibility of the Investigator to obtain written 
informed consent. 
The ICF will be submitted for approval to the IRB/IEC that is responsible for review and 
approval of the study. Each consent form must include all the relevant elements currently 
required by the responsible regulatory authority, as well as local county authority or state 
regulations and national requirements. The copy of the IRB/IEC-approved ICF to be utilized in 
the study must be submitted to the Sponsor prior to study initiation. Before recruitment and 
enrollment into the study, each prospective subject will be given a full explanation of the study. 
Once the essential information has been provided to the prospective candidate, and the 
Investigator is sure that the individual subject understands the implications of participating in 
this study, the subject will be asked to give consent to participate in the study by signing an ICF. 
A notation that written informed consent has been obtained will be made in the subject’s medical 

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record. A copy of the ICF, to include the subject’s signature, will be provided by the Investigator 
to the subject. Written informed consent for participation in the study must be obtained from the 
subject or legally authorized representative before performing any study-specific screening tests 
or evaluations. 
If an amendment to the protocol substantially alters the study design or the potential risks to the 
subjects, the subject’s consent to continue participation in the study must be obtained. 
11.6. 
SUBJECT CONFIDENTIALITY 
Confidentiality of subject’s personal data will be protected in accordance with the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) and national data protection laws. 
To protect the personal data of subjects, the Sponsor will assign a unique study number to each 
subject, which will be used on the eCRF or other documents submitted to the Sponsor. This 
information, together with the subject’s date of birth, will be used in the database for subject 
identification. Participant names or other information that would make the participant 
identifiable will not be entered in the eCRF or database or transferred in other documents 
submitted to Sponsor. No material bearing a subject’s name will be kept on file by the Sponsor. 
Subjects will be informed of their rights within the ICF. HIPAA regulations require that, to 
participate in the study, the subject should be informed of the following: 
 What protected health information (PHI) will be collected from subjects in this study 
 Who will have access to that information and why 
 Who will use or disclose that information
 That health information may be further disclosed by the recipients of the information and 
that if the information is disclosed the information may no longer be protected by federal 
or state privacy laws 
 The information collected about the research study will be kept separate from the 
subject’s medical records, but the subject will be able to obtain the research records after 
the conclusion of the study 
 Whether the authorization contains an expiration date; and 
 The rights of a research subject to revoke his or her authorization 
If a subject revokes authorization to collect or use his or her PHI, the Investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization. 
For subjects that have revoked authorization to collect or use PHI, attempts should be made to 
obtain permission to collect at least vital status (i.e., that the subject is alive) at the end of their 
scheduled study period. 
In compliance with ICH GCP guidelines and applicable parts of 21 CFR, it is a requirement that 
the Investigator and institution permit authorized representatives of the Sponsor, the regulatory 
authorities, and the IRB/IEC direct access to review the subject’s original medical records at the 

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site for verification of study-related procedures and data. The subject must be informed about the 
potential for this type of monitoring and auditing access. 
CTR Compliant Data Protection in the European Economic Area 
Mythic Therapeutics, Inc., as Data Controller, ensures that all processing activities involving 
personal data performed in the scope of this Study are compliant with, but not limited to, the 
requirements set by EU General Data Protection Regulation (GDPR 679/2016), its subsequent 
amendments and any additional national laws on Data Protection, recommendations and 
guidelines as applicable. 
To comply with the applicable rules on the protection of personal data, specifically regarding the 
implementation of the organizational and technical arrangements aiming to avoid unauthorized 
access, disclosure, dissemination, alteration or loss of information and processed personal data, 
Mythic Therapeutics, Inc. has implemented and maintains the following measures: 
 Restriction and monitoring of physical access to the offices and information processing 
facilities to employees, personnel and approved visitors
 Ensuring appropriate and restricted user access relevant to the function and type of 
activity performed in relation to the clinical trial 
 Implementing the pseudonymization and encryption of personal data, as appropriate
 Implementing the ability to ensure the ongoing confidentiality, integrity, availability, and 
resilience of processing systems and services 
 Implementing network, application, and database security by means of firewalls and 
antivirus/anti-malware software; ensuring detection of malware purposed for 
unauthorized deletion, blocking, copying of information, and disabling of security 
measures and response to such attacks 
 Means to restore the availability and access to personal information in a timely manner in 
the event of a physical or technical incident 
 Logging of security events/incidents in information systems 
 Implementing procedures that cover reporting, analysis, monitoring, and resolution of 
security incidents 
 Ensuring that information systems, computers, and software involved in the performance 
of the services provided in the Study are backed up 
 A process for regularly testing, assessing, and evaluating the effectiveness of technical 
and organizational measures for ensuring the security of the processing 
Mythic Therapeutics, Inc. is currently implementing and will maintain the following measures: 
 Procedures to capture within reasonable time any personal data breach occurred 
 Procedures and practices for securing destruction of paper documents containing personal 
data 

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 Business continuity procedures ensuring that Mythic Therapeutics, Inc. can continue to 
provide services through operational interruption 
All locations, personnel, and information systems that are used to perform services for the Study 
will be covered. 
Mythic Therapeutics, Inc. will ensure that the technical and organizational security measures 
described above are regularly reviewed and updated to take into account any evolution of 
technological developments. 
Mythic Therapeutics, Inc. may apply additional specific statutory requirements, where applicable 
in the national laws, and will implement the necessary security measures even if they are not 
expressly listed above. 
Besides the foregoing technical and organizational measures, Mythic Therapeutics, Inc., by 
means of internal measures and imposed contractual clauses to the selected sub-contractors, 
ensures the confidentiality of records and personal data of subjects. 
With exception of the activities in the scope of the on-site monitoring, the name of the subject 
will neither be asked for nor recorded by the Mythic Therapeutics, Inc. An identification number 
will be allocated to each subject registered in the Study. This number will identify the subject 
and will be included on all case report forms and corresponding material and data associated 
with the subject. 
Monitors and auditors acting on behalf of the Mythic Therapeutics, Inc. will have access to fully 
identifiable information only in the scope of the on-site monitoring visits, and only for the source 
data verification mandatory under clinical trial framework, including the ICH-GCP obligations 
applicable to the conduct of the Study. Staff involved in the performance of this task are bound 
by any additional stricter confidentiality clauses imposed upon them, as compared to other staff 
members. 
Mythic Therapeutics, Inc. is establishing a functional process of reporting of any data breach 
occurring at Mythic Therapeutics, Inc.’s or its sub-contractor’s facilities and premises. In case of 
the occurrence of any data breach, Mythic Therapeutics, Inc. will immediately apply relevant 
measures to mitigate the risks to data subjects as appropriate in relation to the specific context of 
the data breach, including taking into account its source, underlying intentions, and possibilities 
of recovery. Any data breach presenting risks to the rights and freedoms of data subjects will be 
reported to the relevant supervisory data protection authority within 72 hours of Mythic 
Therapeutics, Inc.’s becoming aware of the data breach. In addition, in case of occurrence of a 
high-risk breach, data subjects will be informed by the Mythic Therapeutics (via clinical Study 
site). 
11.7. 
INVESTIGATOR AND STAFF INFORMATION 
Personal data of the Investigators and sub-Investigators may be included in the Sponsor database 
and shall be treated in compliance with all applicable laws and regulations. When archiving or 

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processing personal data pertaining to the Investigator or sub-Investigator, the Sponsor shall take 
all appropriate measures to safeguard and prevent access to these data by any unauthorized party. 
11.8. 
FINANCIAL INFORMATION 
The finances for this study will be subject to a separate written agreement between the Sponsor 
and applicable parties. Any Investigator financial disclosures applicable to 21 CFR Part 54 shall 
be appropriately provided. 

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12.
RECORD RETENTION AND DOCUMENTATION OF THE 
STUDY 
12.1. 
DOCUMENTATION REQUIRED TO INITIATE STUDY 
The Sponsor/Sponsor designee will ensure that documentation is required to be in place before 
the study may start, in accordance with FDA regulations and/or local regulatory authorities, 
ICH E6, and Sponsor Standard Operating Procedures will be available before any study sites are 
initiated.  
Documents at a minimum required to begin the study include, but are not limited to, the 
following: 
 A signature authorized protocol and contract 
A copy of the official IRB/IEC approval of the study and the IRB/IEC members list or 
assurance verification 
 Current CVs for the principal Investigator and any associate Investigator(s) who will be 
involved in the study 
 Indication of appropriate accreditation for any laboratories to be used in the study and a 
copy of the normal ranges for tests to be performed by that laboratory 
 FDA Form 1572 (Statement of Investigator), or equivalent, appropriately completed and 
signed
 A copy of the IRB/IEC-approved consent form  
Financial disclosure forms for all Investigators listed on FDA Form 1572
GCP certificates for study training
 Verification of Principal Investigator acceptability from local and/or national debarment 
list(s) 
12.2. 
STUDY DOCUMENTATION AND STORAGE 
The Investigator must maintain a list of appropriately qualified persons to whom he or she has 
delegated study duties and should ensure that all persons assisting in the conduct of the study are 
informed of their obligations. All persons authorized to make entries and/or corrections on the 
eCRFs are to be included on this document. All entries in the subject’s eCRF are to be supported 
by source documentation. 
Source documents are the original documents, data, records, and certified copies of original 
records of clinical findings, observations, and activities from which the subject’s eCRF data are 
obtained. These can include, but are not limited to, hospital records, clinical and office charts, 
laboratory, medico-technical department and pharmacy records, diaries, microfiches, ECG 
traces, copies or transcriptions certified after verification as being accurate and complete, 
photographic negatives, microfilm or magnetic media, scans, and correspondence.  

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The Investigator and study staff are responsible for maintaining a comprehensive and centralized 
filing system (Investigator Study File [ISF]/Site Study File [SSF]) of all study-related (essential) 
documentation, suitable for inspection at any time by representatives from the Sponsor and/or 
applicable regulatory authorities. The ISF/SSF must consist of those documents that individually 
or collectively permit evaluation of the conduct of the study and the quality of the data produced. 
The ISF/SSF should contain as a minimum all relevant documents and correspondence as 
outlined in ICH GCP and 8 CFR Part 312.57, including key documents such as the IB and any 
amendments, protocol, and any amendments, signed ICFs, IRB/IEC approval documents, 
Financial Disclosure forms, subject identification lists, enrollment logs, delegation of authority 
log, staff qualification documents, laboratory normal ranges, and records relating to the study 
drugs. In addition, all original source documents supporting entries in the eCRF must be 
maintained and be readily available. 
The Sponsor shall maintain adequate investigational product records and financial interest 
records as per 21 CFR Part 54.6 and Part 312.57 for: 
 No less than 2 years after the last marketing application has been approved in an ICH 
region; or 
 No less than 2 years in the event that the marketing application has not been approved in 
an ICH region; or 
 At least 2 years have elapsed since the formal discontinuation of clinical development of 
the investigational product.  
If this requirement differs from any local regulations, the local regulations will take precedence 
unless the local retention policy is less than 2 years. No study records should be destroyed 
without prior authorization from the Sponsor.  
The IRB/IEC shall maintain adequate documentation/records of IRB/IEC activities as per 
21 CFR Part 56.115 for at least 3 years after completion of the research.
The Investigator shall maintain adequate records of drug disposition, case histories, and any 
other study-related records as per 21 CFR Part 312.62 for no less than 2 years after the last 
marketing application has been approved by FDA; or, in the event that the marketing application 
has not been approved by FDA, for no less than 2 years after the last shipment/delivery of the 
drug for investigational use is discontinued and FDA has been notified of the discontinuation. 
To enable evaluations and/or audits from regulatory authorities or from the Sponsor or its 
representative, the Investigator additionally agrees to keep records, including the identity of all 
participating subjects (sufficient information to link records, e.g., medical records), all original, 
signed ICFs, and copies of all eCRFs, SAE Reporting forms, source documents, detailed records 
of treatment disposition, and related essential regulatory documents. The documents listed above 
must be retained by the Investigator for as long as needed to comply with national and 
international regulations (generally 2 years after discontinuing clinical development or after the 
last marketing approval). The Sponsor or its representative will notify the 
Investigator(s)/institutions(s) when the study-related records are no longer required. 

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If the Investigator relocates, retires, or for any reason withdraws from the study, either the 
Sponsor or its representative should be prospectively notified. The study records must be 
transferred to an acceptable designee, such as another Investigator, another institution, or another 
Sponsor. The Investigator must obtain the Sponsor’s written permission before disposing of any 
records, even if retention requirements have been met. All study files will be maintained by the 
Sponsor or its representative throughout the study and will be transferred to the Sponsor at the 
conclusion of the study. 
12.3. 
AMENDMENTS TO THE PROTOCOL 
If an amendment to the protocol is required, the amendment will be originated by the Sponsor 
and approved by the Sponsor. The written amendment must be submitted to the IRB/IEC at the 
Investigator’s facility for approval as per IRB/IEC requirements. 
The amendment will be submitted formally to the FDA or other regulatory authorities by the 
Sponsor as applicable. 
If an amendment to the protocol substantially alters the study design or the potential risks to the 
subjects, their consent to continue participation in the study should be obtained.
12.4. 
DATA COLLECTION
The study eCRF is the primary data collection instrument for the study. An eCRF will be utilized 
for the collection of all data and all data will be entered using the English language and should be 
kept current to enable the monitor to review the subjects’ status throughout the course of the 
study. 
To maintain confidentiality, only study number, subject number, and partial date of birth will 
identify the subject in the eCRF. The Investigator will maintain a personal subject identification 
list (subject numbers with corresponding subject identifiers) to enable records to be identified 
and verified as authentic. Subject data/information will be kept confidential and will be managed 
according to applicable local, state, and federal regulations. 
12.5. 
STUDY MONITORING, AUDITING, AND INSPECTING
The Investigator will permit study-related monitoring, quality audits, and inspections by 
government regulatory authorities, the Sponsor, or its representative(s) of all study-related 
documents (e.g., source documents, regulatory documents, data collection instruments, eCRFs). 
The Investigator will ensure the capability for inspections of applicable study-related facilities. 
The Investigator will ensure that the study monitor or any other compliance or quality assurance 
reviewer is given access to all study-related documents and study-related facilities. 
At the Sponsor’s discretion, Source Document Verification (SDV) may be performed on all data 
items or a percentage thereof. 

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12.6.
QUALITY ASSURANCE AND QUALITY CONTROL
Independent auditing may be conducted during the conduct of the study to assess compliance 
with GCP and applicable regulatory requirements. Data or documentation audited shall be 
assessed for compliance with the protocol, accuracy in relation to source documents, and 
compliance with GCP and applicable regulations. 
Each study site shall be required to have processes that enable compliant study conduct and 
Investigator oversight of data generation and collection, as well as recording and reporting of 
data/documentation according to the protocol, GCP, and any applicable local, national, or 
international regulations.
Accurate and reliable data collection will be ensured by SDV, and cross-checking of the eCRFs 
against the Investigator’s records will be performed by the study monitor. Collected data will be 
entered into a computer database and subject to electronic and manual quality assurance 
procedures. 
12.7. 
DISCLOSURE AND PUBLICATION POLICY
All information provided regarding the study, as well as all information collected/documented 
during the course of the study, will be regarded as confidential. By conducting this study, the 
Investigator affirms to the Sponsor that he or she will maintain, in strict confidence, information 
furnished by the Sponsor including the results of and data generated from this study, except as 
exempted for regulatory purposes.  
A clinical study report will be prepared upon completion of the study. The format of the clinical 
study report will comply with ICH E3 guidelines for structure and content of a clinical study 
report. The Sponsor will comply with any applicable local laws/regulations regarding the posting 
of study results.
The financial disclosure information will be provided to the Sponsor prior to study participation 
from all Principal Investigators and sub-Investigators who are involved in the study and named 
on FDA Form 1572. 
All data generated during the conduct of this study are owned by the Sponsor and may not be 
used by the Investigator or affiliates without the expressed written consent of the Sponsor. 
It is anticipated that the results of this study will be presented at scientific meetings and/or 
published in a peer-reviewed scientific or medical journal. The Sponsor will comply with 
applicable 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, and authorship will comply with International Committee of 
Medical Journal Editors standards. Furthermore, the Investigator agrees that any publication by 
the Investigator of the results of the study conducted at the study site shall not be made before 
the first multicenter publication.  

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All manuscripts, abstracts, or other presentation materials generated by site Investigators must be 
reviewed and approved by the Sponsor prior to submission as set forth in the CTA governing the 
Investigator or his or her institution’s participation in the study. These requirements include, but 
are not limited to, submitting proposed publications to Sponsor at the earliest practicable time 
prior to submission or presentation and otherwise within the time set forth in the CTA. 

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13.
REFERENCES
ADCETRIS® [package insert]. 2023. Seagen Inc. 
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Alexander, M., S. Y. Kim, and H. Cheng. 2020. 'Update 2020: Management of Non-Small Cell 
Lung Cancer', Lung, 198: 897-907. 
Camidge DR, Bar J, Horinouchi H, Goldman J, Moiseenko F, Filippova E, Cicin I, Ciuleanu T, 
Daaboul N, Liu C, Bradbury P, Moskovitz M, Katgi N, Tomasini P, Zer A, Girard N, Cuppens 
K, Han JY, Wu SY, Baijal S, Mansfield AS, Kuo CH, Nishino K, Lee SH, Planchard D, Baik C, 
Li M, Ansell P, Xia S, Bolotin E, Looman J, Ratajczak C, Lu S. Telisotuzumab Vedotin 
Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced 
Nonsquamous EGFR-Wildtype Non-Small Cell Lung Cancer in the Phase II LUMINOSITY 
Trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011. 
DeGeorge, J. J., C. H. Ahn, P. A. Andrews, M. E. Brower, D. W. Giorgio, M. A. Goheer, D. Y. 
Lee-Ham, W. D. McGuinn, W. Schmidt, C. J. Sun, and S. C. Tripathi. 1998. 'Regulatory 
Considerations for Preclinical Development of Anticancer Drugs', Cancer Chemother 
Pharmacol, 41: 173-85. 
De Miguel M, Yamamoto N, Raimbourg J, Cho BC, Gottfried M, et al. 2024. 1257MO ABBV-
400, a c-Met protein-targeting antibody-drug conjugate (ADC), in patients (Pts) with advanced 
EGFR wildtype (WT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from 
a phase I study. NSCLC, metastatic. 35:2;S805-S806. 
Eisenhauer, E. A., P. Therasse, J. Bogaerts, L. H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. 
Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, 
and J. Verweij. 2009. 'New Response Evaluation Criteria in Solid Tumours: Revised RECIST 
Guideline (Version 1.1)', Eur J Cancer, 45: 228-47. 
ELAHERE® [package insert]. 2022. ImmunoGen, Inc. 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761310s000lbl.pdf. 
FDA. 2022. 'Drug Development and Drug Interactions: Table of Substrates, Inhibitors and 
Inducers'. https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-
interactions-table-substrates-inhibitors-and-inducers. 
Fernandes, M., P. Jamme, A. B. Cortot, Z. Kherrouche, and D. Tulasne. 2021. 'When the MET 
Receptor Kicks in to Resist Targeted Therapies', Oncogene, 40: 4061-78. 
Fisher, J. E., Jr. 2021. 'Considerations for the Nonclinical Safety Evaluation of Antibody-Drug 
Conjugates', Antibodies (Basel, Switzerland), 10. 

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Johnson, M., T. F. Burns, J. Thompson, A. Spira, M. Alexander, G. R. Blumenschein, J. 
Michalski, S. Bilic, A. Teh, K. C. Lai, S. McGann, H. Chalk, L. Haystrand, T-H. Wu, G. Gallant, 
and R. S. Heist. 2024. Abstract 8558: 'MYTX-011 in patients with previously treated locally 
advanced or metastatic NSCLC: Initial dose escalation results in the phase 1 KisMET-01 study', 
2024 Annual ASCO Meeting, J Clin Oncol, 42 (16Suppl.): 8558. https://mythictx.com/wp-
content/uploads/2024/06/ASCO-2024-MYTX-011-01-poster.pdf 
Kim, S. K., P. Ursell, R. L. Coleman, B. J. Monk, and I. Vergote. 2022. 'Mitigation and 
Management Strategies for Ocular Events Associated with Tisotumab Vedotin', Gynecol Oncol, 
165: 385-92.
Lee, J. J., and D. D. Liu. 2008. 'A Predictive Probability Design for Phase II Cancer Clinical 
Trials', Clin Trials, 5: 93-106.
Masters, J. C., D. J. Nickens, D. Xuan, R. L. Shazer, and M. Amantea. 2018. 'Clinical Toxicity 
of Antibody Drug Conjugates: a Meta-analysis of Payloads', Invest New Drugs, 36: 121-35. 
Matulonis, U. A., M. J. Birrer, D. M. O'Malley, K. N. Moore, J. Konner, L. Gilbert, L. P. Martin, 
T. M. Bauer, A. M. Oza, K. Malek, J. Pinkas, and S. K. Kim. 2019. 'Evaluation of Prophylactic 
Corticosteroid Eye Drop Use in the Management of Corneal Abnormalities Induced by the 
Antibody-Drug Conjugate Mirvetuximab Soravtansine', Clin Cancer Res, 25: 1727-36. 
Mithoowani, H., and M. Febbraro. 2022. 'Non-Small-Cell Lung Cancer in 2022: A Review for 
General Practitioners in Oncology', Curr Oncol, 29: 1828-39. 
National Cancer Institute. 2023. 'Cancer Stat Facts: Lung and Bronchus Cancer', National Cancer 
Institute. https://seer.cancer.gov/statfacts/html/lungb.html.
PADCEV® [package insert]. 2021. Astellas Pharma US, Inc. 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761137s000lbl.pdf. 
POLIVY® [package insert]. 2023. Genentech, Inc. 
https://www.gene.com/download/pdf/polivy_prescribing.pdf.
Heist, R Shum E, Garcia E, Itchins M, Gao B, et al. 2025. MYTX-011, a cMET-targeting 
antibody-drug conjugate (ADC), in patients with previously treated, advanced NSCLC: Updated 
dose escalation results in the phase 1 KisMET-01 study. JCO 43, 8613-8613. 
Saber, H., and J. K. Leighton. 2015. 'An FDA Oncology Analysis of Antibody-Drug Conjugates', 
Regul Toxicol Pharmacol, 71: 444-52. 
Salgia, R. 2017. 'MET in Lung Cancer: Biomarker Selection Based on Scientific Rationale', Mol 
Cancer Ther, 16: 555-65. 
Sierra, J. R., and M. S. Tsao. 2011. 'c-MET as a Potential Therapeutic Target and Biomarker in 
Cancer', Ther Adv Med Oncol, 3: S21-35. 
Sung, H., J. Ferlay, R. L. Siegel, M. Laversanne, I. Soerjomataram, A. Jemal, and F. Bray. 2021. 
'Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide 
for 36 Cancers in 185 Countries', CA Cancer J Clin, 71: 209-49. 

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Swain, S. M., M. Nishino, L. H. Lancaster, B. T. Li, A. G. Nicholson, B. J. Bartholmai, J. 
Naidoo, E. Schumacher-Wulf, K. Shitara, J. Tsurutani, P. Conte, T. Kato, F. Andre, and C. A. 
Powell. 2022. 'Multidisciplinary Clinical Guidance on Trastuzumab Deruxtecan (T-DXd)-
Related Interstitial Lung Disease/Pneumonitis-Focus on Proactive Monitoring, Diagnosis, and 
Management', Cancer Treat Rev, 106: 102378. 
Tarantino, P., S. Modi, S. M. Tolaney, J. Cortes, E. P. Hamilton, S. B. Kim, M. Toi, F. Andre, 
and G. Curigliano. 2021. 'Interstitial Lung Disease Induced by Anti-ERBB2 Antibody-Drug 
Conjugates: A Review', JAMA Oncol, 7: 1873-81. 
TIVDAK® [package insert]. 2021. Seagen Inc. and Genmab US, Inc. 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761208Orig1s000lbledt.pdf. 
Yuan, Y., K. R. Hess, S. G. Hilsenbeck, and M. R. Gilbert. 2016. 'Bayesian Optimal Interval 
Design: A Simple and Well-Performing Design for Phase I Oncology Trials', Clin Cancer Res, 
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Zhou, H., J. J. Lee, and Y. Yuan. 2017. 'BOP2: Bayesian Optimal Design for Phase II Clinical 
Trials with Simple and Complex Endpoints', Stat Med, 36: 3302-14.

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APPENDIX A.
CONTRACEPTION GUIDELINES
Definition of Females Not of Childbearing Potential
A woman is considered of childbearing potential, i.e., fertile, following menarche and until 
becoming postmenopausal unless permanently sterile. Permanent sterilization methods include 
hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is 
defined as no menses for 12 months without an alternative medical cause. 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. However, in the absence of 12 months of amenorrhea, a single FSH measurement is 
insufficient. 
Definition of, and Contraception Guidelines for, Females of Childbearing Potential
Females of childbearing potential, defined as all females physiologically capable of becoming 
pregnant, must use a highly effective method of contraception for the duration of the study and 
for at least 6 months after the last dose of study drug.  
 hours prior to 
initiating treatment and a negative urine or serum pregnancy test prior to each administration of 
study drug in compliance with local requirements. 
Contraception Guidelines for Male Subjects 
Male subjects with partners of childbearing potential must use a highly effective method of 
contraception for the duration of the study and for at least 6 months after the last dose of study 
drug. 
Male subjects should not donate sperm starting at screening and until at least 6 months after the 
last dose of study drug. 
Definition of Highly Effective Contraception 
A highly effective method of contraception, as per Clinical Trials Facilitation and Coordination 
Group Recommendations Related to Contraception and Pregnancy Testing in Clinical Trials 
v1.1, is defined as any of the following: 
 Combined (estrogen and progesterone containing) hormonal contraception associated 
with inhibition of ovulation (oral, intravaginal, or transdermal)  
 Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, 
injectable, or implantable)  
 Intrauterine device 
 Intrauterine hormone-releasing system 
 Bilateral tubal ligation  
 Vasectomized partner 

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 Sexual abstinence 
Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with MYTX-011 treatment. The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the clinical trial and the preferred and usual 
lifestyle of the subject. 
The following are unacceptable forms of contraception:  
 Female condom 
 Natural family planning (rhythm method) or breastfeeding 
 Fertility awareness 
 Withdrawal 
 Cervical shield 
 

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APPENDIX B.
NEW YORK HEART ASSOCIATION CLASSIFICATIONS
New York Heart Association (NYHA) Classifications 
Class 
Functional Capacity 
Objective Assessment 
I
Subjects with cardiac disease but without resulting 
limitations of physical activity. Ordinary physical activity 
does not cause undue fatigue, palpitation, dyspnea, or 
anginal pain.
No objective evidence of 
cardiovascular disease. 
II 
Subjects with cardiac disease resulting in slight limitation 
of physical activity. They are comfortable at rest. Ordinary 
physical activity results in fatigue, palpitation, dyspnea, or 
anginal pain. 
Objective evidence of 
minimal cardiovascular 
disease. 
III 
Subjects with cardiac disease resulting in marked 
limitation of physical activity. They are comfortable at 
rest. Less than ordinary activity causes fatigue, palpitation, 
dyspnea, or anginal pain. 
Objective evidence of 
moderately severe 
cardiovascular disease. 
IV 
Subjects with cardiac disease resulting in inability to carry 
on any physical activity without discomfort. Symptoms of 
heart failure or anginal syndrome may be present even at 
rest. If any physical activity is undertaken, discomfort is 
increased. 
Objective evidence of 
severe cardiovascular 
disease. 
Source: The Criteria Committee of New York Heart Association. Nomenclature and Criteria for Diagnosis of 
Diseases of the Heart and Great Vessels. 9th ed. Boston, MA: Little, Brown & Co; 1994:253-256. 

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APPENDIX C.
RESPONSE EVALUATION CRITERIA IN SOLID 
TUMORS 1.1 (RECIST 1.1) 
Tumor response will be assessed according to RECIST 1.1 (Eisenhauer et al. 2009), as described 
below. 
Measurability of Tumor at Baseline 
At baseline, tumor lesions/lymph nodes will be categorized as measurable or nonmeasurable as 
follows:
Measurable 
Tumor lesions: Must be accurately measured in 1 dimension (longest diameter in the plane of 
measurement to be recorded) with a minimum size of:
10 mm by CT scan (CT scan slice thickness no greater than 5 mm) 
10 mm caliper measurement by clinical examination (lesions that cannot be accurately 
measured with calipers should be recorded as nonmeasurable)
20 mm by chest X-ray
Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node 
must be 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended 
to be no greater than 5 mm) 
Nonmeasurable 
 All other lesions (or disease sites), including small lesions (longest diameter 10 mm or 
pathological lymph nodes with 10 to 15 mm short axis) 
 Lesions considered truly nonmeasurable include the following: leptomeningeal disease, 
ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitic 
involvement of skin or lung, and abdominal masses/abdominal organomegaly, identified 
by physical examination, but not measurable by reproducible imaging techniques 
 Lesions in a previously irradiated area or in an area subjected to locoregional 
therapy are usually not considered measurable unless there has been demonstrated 
progression in the lesion 
Tumor Response Evaluation 
Baseline Documentation of Target and Nontarget Lesions 
Target Lesions 
 When >1 measurable lesion is present at baseline, all lesions up to a maximum of 
5 lesions total (and a maximum of 2 lesions per organ) representative of all involved 
organs should be identified as target lesions 
 It may be the case that, on occasion, the largest lesion that can be measured reproducibly 
should be selected 

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Nontarget Lesions
 All other lesions (or disease sites), including pathological lymph nodes, should be 
identified as nontarget lesions
 It is possible to record multiple nontarget lesions involving the same organ as a single 
item (e.g., “multiple enlarged pelvic lymph nodes” or “multiple liver metastases”) 
Evaluation of Target Lesions 
Target lesions will be evaluated, and response recorded as defined in Table 16.
Table 16: 
Response Based on Evaluation of Target Lesions at Each Assessment
Complete response (CR) 
Disappearance of all target lesions; if a pathologic lymph node, reduction in the 
shortest axis to 10 mma 
Partial response (PR)b 
30% decrease in the sum of the diameters of target lesions relative to the baseline 
sum diametersc
Stable disease (SD)b,d 
Neither a sufficient reduction to qualify as a PR nor a sufficient increase to qualify 
as progressionc 
Progressive disease 
(PD)b 
20% increase in the sum diameters relative to the smallest sum diameters recorded 
(including the baseline sum diameters) in conjunction with an increase of at least 
5 mm in the smallest sum diameters or the appearance of 1 or more new lesionsc,e
a For each pathologic lymph node considered a target lesion, the node must have a short axis measuring  10 mm to 
be considered as a CR. In such cases, the sum diameters may not be zero (as a normal lymph node can have a short 
axis of 10 mm). 
b For each pathologic lymph node considered a target lesion, the measurement of the short axis of the node is to be 
included in the sum diameters when determining PR, stable disease, and progression. 
c In this study, the “baseline sum diameter” is calculated based on the lesion measurements obtained at screening. 
d Duration of stable disease is measured from the date of the first dose of study drug until criteria for progressive 
disease are met based on the smallest sum diameters recorded (including the baseline sum diameters). 
e The finding of a new lesion should be unequivocal and not possibly attributable to a difference in imaging modality 
or scanning technique. Post-baseline, fluorodeoxyglucose positron emission tomography (FDG-PET) scan may be 
useful in assessing new lesions apparent on computed tomography (CT) scan. 

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Evaluation of Nontarget Lesions
Nontarget lesions will be evaluated and response recorded as defined in Table 17.
Table 17: 
Response Based on Evaluation of Nontarget Lesions at Each Assessment 
Complete response (CR) 
Disappearance of all nontarget lesions; all lymph nodes must be non-pathologic in 
size (i.e., 10 mm on the short axis) 
Not CR or not 
progressive disease (PD) 
Persistence of 1 or more nontarget lesions 
PD 
Unequivocal progressiona of any existing nontarget lesion or the appearance of 1 or 
more new lesionsb
a  The subject should stop investigational product, even in the presence of a PR or stable disease, based on an 
assessment of target lesions. 
b The finding of a new lesion should be unequivocal and not possibly attributable to a difference in imaging 
modality or scanning technique. Post-baseline, fluorodeoxyglucose positron emission tomography (FDG-PET) 
may be useful in assessing new lesions apparent on computed tomography (CT) scan. 
New Lesions 
The appearance of new malignant lesions denotes PD; therefore, some comments on detection of 
new lesions are important. There are no specific criteria for the identification of new 
radiographic lesions; however, the finding of a new lesion should be unequivocal, i.e., not 
attributable to differences in scanning technique, change in imaging modality, or findings 
thought to represent something other than tumor (e.g., some “new” bone lesions may be simply 
healing or flare of pre-existing lesions). This is particularly important when the subject’s baseline 
lesions show PR or CR. For example, necrosis of a liver lesion may be reported on a CT scan 
report as a “new” cystic lesion, which it is not.
Timepoint Response
Timepoint response based on the evaluation of target and nontarget lesions will be determined as 
shown in Table 18. 
 
Table 18: 
Evaluation of Timepoint Response
Target Lesions 
Nontarget Lesions 
New Lesions 
Overall Response 
Complete response 
Complete response 
No 
Complete response 
No target lesiona
Complete response 
No 
Complete response 
Complete response 
Not evaluableb 
No 
Partial response 
Complete response 
Not complete 
response/nonprogressive disease 
No 
Partial response 

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Table 18:
Evaluation of Timepoint Response (Continued)
Target Lesions
Nontarget Lesions
New Lesions
Overall Response
Partial response
Non-progressive disease and 
not evaluableb
No 
Partial response 
Stable disease 
Non-progressive disease and 
not evaluableb
No 
Stable disease 
Not all evaluated 
Non-progressive disease 
No 
Not evaluable 
No target lesiona
Not all evaluated 
No 
Not evaluable 
No target lesiona
Non-complete response/ 
non-progressive disease 
No 
Non-complete response/ 
non-progressive disease 
Progressive disease 
Any 
Yes or No 
Progressive disease 
Any 
Progressive disease 
Yes or No 
Progressive disease 
Any 
Any 
Yes 
Progressive disease 
No target lesiona
Unequivocal progressive disease 
Yes or No 
Progressive disease 
No target lesiona
Any 
Yes 
Progressive disease 
a Defined as no target lesions at baseline. 
b Not evaluable is defined as when either no lesion measurements or only a subset of lesion measurements are made 
at an assessment. 

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APPENDIX D.
ECOG PERFORMANCE STATUS
ECOG
Description
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out 
work of a light or sedentary nature (e.g., light house work, office work) 
2
Ambulatory and capable of all selfcare but unable to carry out any work 
activities; up and about more than 50% of waking hours 
3
Capable of only limited selfcare, confined to a bed or chair more than 50% of 
waking hours 
4 
Completely disabled; cannot carry out selfcare; totally confined to bed or chair 

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APPENDIX E.
CREATININE CLEARANCE BY MODIFIED 
COCKCROFT-GAULT FORMULA 
Conventional–Serum Creatinine in mg/dL 
Male 
CrCl (mL/min) =  
 
Female 
CrCl (mL/min) = 
 × 0.85 
International System of Units (SI)–Serum C
 
Male 
CrCl (mL/min) = 
Female 
CrCl (mL/min) = 
× 0.85 
Source: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 
1976;16:31-41. 
Online Calculator: The Calculator.co website. Creatinine Clearance Calculator. 
https://www.thecalculator.co/health/Creatinine-Clearance-Calculator-258.html 
72
 
 
mg/dL)
(in 
 
creatinine
 
serum
kg)
(in 
 weight 
  
years)]
(in 
 
age
 - 
[140
72
 
 
mg/dL)
(in 
 
creatinine
 
serum
kg)
(in 
 weight 
  
years)]
(in 
 
age
 - 
[140
0.0113
 
  
72
 
  
mol/L)
(in 
 
creatinine
 
serum
kg)
(in 
 weight 
  
years)]
(in 
 
age
 - 
[140
0.0113
 
  
72
 
  
mol/L)
(in 
 
creatinine
 
serum
kg)
(in 
 weight 
  
years)]
(in 
 
age
 - 
[140