A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the MYC Inhibitor OMO-103 Administered Intravenously in Patients With Advanced Solid Tumours
Phase: PHASE1
Conditions: Advanced Solid Tumors, Pancreatic Cancer, CRC
Sponsor: Peptomyc S.L.

MW006 Protocol Template: Version Final (05 February 2019) CONFIDENTIAL 
CLINICAL STUDY PROTOCOL AMENDMENT - CONFIDENTIAL 
Protocol Number: 
 
OMO-103-01 
EudraCT Number: 
 
2020-003802-30 
Investigational Product: 
 
OMO-103 
Title: 
 
A 
Phase 1/2 
Study 
to 
evaluate 
the 
Safety, 
Pharmacokinetics, and Anti-Tumour Activity of the Myc 
Inhibitor OMO-103 administered intravenously in 
Patients with Advanced Solid Tumours 
Version and Date: 
 
Amendment Final V1.0; 01 September 2021 
Sponsor: 
 
Peptomyc S.L. 
 
Carrer Natzaret 115-117 
 
08035 Barcelona 
 
Spain 
Sponsor’s Medical Contact: 
 
Dr. Manuela Niewel 
 
Chief Medical Officer  
 
e-mail address: mniewel@peptomyc.com 
 
Phone: +34 670327414 
 
Prepared by: 
 
 
Simbec-Orion 
7 Bath Road,  
Slough,  
Berkshire, 
SL1 3UA, UK 
 
Confidentiality Statement: 
The information contained in this protocol is confidential and is intended for the use of clinical 
investigators. It is the property of Peptomyc S.L. and should not be copied by or distributed to persons 
not involved in the clinical investigation of OMO-103, unless such persons are bound by a 
confidentiality agreement with Peptomyc S.L.

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SIGNATURE PAGE 
 
Title: A Phase 1/2 Study to evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity 
of the Myc Inhibitor OMO-103 administered intravenously in Patients with Advanced Solid 
Tumours 
Sponsor 
 
Dr. Manuela Niewel 
 
Chief Medical Officer 
Signature 
Peptomyc S.L. 
 
Tel: +34 670327414 
e-mail: mniewel@peptomyc.com 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
Statistician CRO 
 
Richard Morton 
 
Statistics Team Lead 
Signature 
Simbec-Orion 
 
Tel: +44 (0)1753 695146 
e-mail: richard.morton@simbecorion.com 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
Signing of this page of the protocol indicates that the protocol format and content has been agreed and 
approved by both parties, and that it is agreed that no further changes to the protocol are required at the time 
of signing. 

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PROTOCOL AGREEMENT PAGE 
I confirm that I have read and that I understand this protocol, the Investigator Brochure, and all 
other product information provided by Peptomyc S.L. I agree to conduct this study in 
conformity with this protocol and also in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki, the E6 International Council on Harmonization (ICH) 
Harmonized Tripartite Guideline for Good Clinical Practice (GCP), all applicable laws and 
regulations, including, without limitation, data privacy laws and regulations, and the regulatory 
requirements for reporting serious adverse events (SAEs) defined in Section Error! Reference 
source not found. of this protocol. 
 
Principal Investigator 
 
Title and Name: 
 
Position: 
 
 
 
Signature: 
 
Date: 
 
 

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SYNOPSIS 
Study title: 
A Phase 1/2 Study to evaluate the Safety, Pharmacokinetics, and Anti-
Tumour Activity of the Myc Inhibitor OMO-103 administered 
intravenously in Patients with Advanced Solid Tumours 
Protocol number: 
OMO-103-01 
Type of study: 
Phase 1/2 
Sponsor: 
Peptomyc S.L. 
Coordinating 
Investigator: 
Dr Elena Garralda 
Oncology Department 
Vall d’Hebron University Hospital (VHIO) 
P. Vall d’Hebron 119-129 
08035 Barcelona 
Spain 
e-mail: egarralda@vhio.net 
Study drug: 
OMO-103 
Dose to be studied: 
Part 1: Dose Escalation: 5 OMO-103 dose levels planned, including 
0.48 mg/kg, 1.44 mg/kg, 2.88 mg/kg, 4.32 mg/kg and 6.48 mg/kg. 
Part 2: Dose Expansion: OMO-103 at the RP2D found in the previous 
part of the study. 
Dosage form: 
OMO-103 solution for infusion presented in vials. 
Route: 
In both study parts, OMO-103 will be administered IV as a 30-45 min 
infusion once weekly. 
Study centres: 
Planned: Up to 15 centres in up to 5 countries 
Study objectives: 
Primary (Part 1: Dose Escalation): 
• To evaluate the safety and tolerability of OMO-103 in adult 
patients with advanced solid tumours. 
Secondary (Part 1: Dose Escalation): 
• To establish and confirm the RP2D and dosing regimen of 
OMO-103 for further development.  
• To characterise the PK of OMO-103.  
• To evaluate preliminary anti-tumour activity in the dose 
escalation part. 
• To assess the development of human ADA to OMO-103. 
Primary (Part 2: Dose Expansion): 
• To assess the preliminary anti-tumour activity of OMO-103 
monotherapy as measured by ORR according to standard 
criteria (RECIST v1.1 [Eisenhauer 2009]). 
 

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Secondary (Part 2: Dose Expansion): 
• To confirm the RP2D and dosing regimen of OMO-103 for 
further development.  
• To assess the type, incidence, severity, timing, seriousness, and 
relatedness of AEs and laboratory abnormalities.  
• To characterise the PK of OMO-103.  
• To assess other efficacy parameters in patients with advanced 
solid tumours including DCR, PFS, OS, TTP, TTR and DOR 
by RECIST v1.1.  
• To assess the development of human ADA to OMO-103. 
Exploratory (Both Parts 1 and 2): 
• Evaluation of biomarkers. 
• Myc expression levels. 
Study design: 
This study is an open label, two-part, FIH Phase 1/2 dose-finding study 
designed to determine the safety, tolerability, PK, PD and proof-of-
concept of OMO-103 in patients with advanced solid tumours. 
The study consists of two parts:  
• Part 1: Dose escalation in patients with advanced solid 
tumours, including 5 OMO-103 dose levels. 
Approximately 11 to 24 patients in total will be enrolled in 
Part 1, covering 5 dose levels with the primary objective of 
determining the safety and tolerability of OMO-103 and 
defining an appropriate dose for further evaluation in Part 2. 
The study will start with an accelerated-titration dose-
escalation scheme enrolling one evaluable patient per cohort 
for the first 2 dose levels followed by a classic 3+3 design. 
• Part 2: Dose expansion where at least 3 parallel groups of 
patients with advanced NSCLC, TNBC and CRC will be 
treated at the RP2D of OMO-103 to further characterise the 
safety, tolerability, PK, PD and anti-tumour activity of 
OMO-103. 
Approximately 18 patients will be enrolled in each of the 
3 parallel groups of patients (NSCLC, TNBC, CRC) in Part 2. 
Note: If an objective response is observed in a tumour group 
within Part 1, or a long period without disease progression is 
observed (in Part 1), additional tumour groups may be added in 
this Phase 1/2 study for further assessment. 
Diagnosis and main 
criteria for inclusion: 
Male or female patients, 18 years of age or older who sign the informed 
consent document, are willing and able to comply with the study 
protocol and have: 

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Part 1 (Dose Escalation): 
Histologically or cytologically proven advanced solid tumour for 
which there is no curative therapy and has progressed on SOC 
treatment or is intolerant to or has no available SOC or SOC 
unacceptable. 
Part 2 (Dose Expansion): 
Histologically or cytologically proven advanced NSCLC whose 
tumours are KRAS-mutated and where the disease has progressed after 
a chemotherapy and immunotherapy regimen (at least two prior lines 
of standard therapy), advanced TNBC where the disease has 
progressed after having received at least one line of prior systemic 
treatment for advanced disease and advanced CRC whose tumours are 
RAS mutated and where the disease has progressed after at least two 
prior lines of standard therapy. 
Parts 1 and 2: 
• Patient must have measurable disease as per RECIST v1.1 
criteria and documented by CT and/or MRI. NOTE: Lesions to 
be used as measurable disease for the purpose of response 
assessment must either:  
a. not reside in a field that has been subjected to prior 
radiotherapy, or  
b. have demonstrated clear evidence of radiographic 
progression since the completion of prior radiotherapy 
and prior to study enrolment.  
• Tumour biopsy (either from the primary tumour or from 
metastases) during Screening and during Treatment should be 
obtained from the patients. Discussion needed with Sponsor if 
considered not feasible. In Part 1, biopsy obtained only from 
the 3rd dose level onwards. 
Note: In case a patient has had a tumour biopsy in the previous 
6 months and a paraffin block is available, a new biopsy does 
not need to be done at Screening. 
• For each patient undergoing pre- and on-treatment biopsies, the 
identified lesion to be biopsied should not have been previously 
irradiated and should not be the only lesion being utilised as a 
measurable-disease target lesion for objective response 
assessment. Patients must have tumour lesions that can be 
accessed for biopsy with acceptable clinical risk in the 
judgement of the Investigator. 
• Documented progression on or following the last line of 
therapy. 
• ECOG performance status up to 1. 

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• Life expectancy of ≥12 weeks. 
• Resolution of all acute, reversible toxic effects of prior therapy 
or surgical procedure to Grade ≤1 (except alopecia and 
peripheral neuropathy to Grade ≤2). 
• Adequate organ function as defined by the following criteria: 
Haematological: 
a. Neutrophils ≥1,000μL 
b. Platelets ≥100,000/μL 
c. Haemoglobin ≥9 g/dL 
Renal: 
a. Creatinine Clearance (calculated via Cockcroft-Gault 
Equation) ≥40 mL/min 
Hepatic: 
a. Serum total bilirubin ≤1.5 ULN or 
b. Direct bilirubin ≤ULN for patients with total bilirubin 
>1.5 ULN 
c. AST/ SGOT and ALT/ SGPT ≤2.5 ULN or ≤5 ULN if 
liver metastases 
Coagulation: 
a. INR ≤1.5  
b. aPTT ≤1.5 ULN 
Chemistry: 
a. Albumin >25 g/L 
• If not postmenopausal or surgically sterile, female patients 
must be willing to practice at least one highly effective methods 
of birth control (defined as having a low failure rate) for at least 
a menstrual cycle before and for 4 months after last study drug 
administration.  
• Male patients and their sexual partners must use an appropriate 
contraceptive from Screening for 4 months after last study drug 
administration. 
Total sample size: 
In total, about 78 eligible patients will be enrolled. 
Number of planned 
visits: 
Part 1: Dose Escalation 
• Screening period: 28 days to 1 day prior 1st dose 
• Treatment period:  
- 
Cycle 1 (DLT period): C1D1, C1D2, C1D3, C1D4, C1D5, 
(Days 3 to 5 only from dose level 3 onwards for PK 
evaluation), C1D8, C1D15, C1D16 or C1D17 (Day 16 or 
Day 17 for biopsy and only from dose level 3 onwards) 
- 
Cycle 2: C2D1, C2D8, C2D15  

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- 
Cycle 3*: C3D1, C3D2, C3D3, C3D4, C3D5, (Days 3 to 5 
only from dose level 3 onwards for PK evaluation), C3D8, 
C3D15  
*NOTE: Assumed 3 cycles but these are unlimited. The 
planned visits of other cycles will occur on D1, D8 and 
D15, except for every 3 cycles from Cycle 3 (i.e., Cycle 6, 
Cycle 9, etc. as PD biomarkers for target validation will be 
sampled on D1, as well as on D2 during these cycles). 
- 
EOT visit 
• Follow-up period: 1-Month Follow-up visit 
Part 2: Dose Expansion 
• Screening period: 28 days to 1 day prior 1st dose 
• Treatment period:  
- 
Cycle 1: C1D1, C1D2, C1D8, C1D15 
- 
Cycle 2: C2D1, C2D8, C2D15, C2D16 or C2D17 (Day 16 
or Day 17 for biopsy) 
- 
Cycle 3: C3D1, C3D2, C3D8, C3D15,  
- 
Cycle 4: C4D1, C4D8, C4D15,  
- 
Cycle 5: C5D1, C5D8, C5D15,  
- 
Cycle 6*: C6D1, C6D2, C6D8, C6D15,  
*NOTE: Assumed 6 cycles but these are unlimited. The 
planned visits of all other cycles will occur on D1, D8 and 
D15, except for every 3 cycles from Cycle 3 (i.e., Cycle 6, 
Cycle 9, etc. as PD biomarkers for target validation will be 
sampled on D1, as well as on D2 during these cycles). 
- 
EOT visit 
• Follow-up period: 6-Month Follow-up period, including 
monthly visits if feasible. Telephone visits may be allowed if 
considered appropriate, e.g., hospice patients 
Safety parameters: 
Physical examinations; vital signs assessments; ECOG performance 
status; laboratory analyses; autoimmunity; 12-Lead ECG; reported 
AEs. 
Efficacy parameters: 
Tumour response:  
• ORR (primary efficacy endpoint);  
• DCR; PFS; OS; TTP; TTR; DOR (secondary efficacy 
endpoints) (only Part 2). 
Pharmacokinetic 
parameters: 
PK parameters of OMO-103: AUC; Cmin; Cmax; tmax; t1/2. 
PD parameters: 
Circulating human ADA to OMO-103; Ki67 and CC3 by IHC; 
Immune infiltration by IHC (CD3, CD4/CD8, PD-1/ PD-L1) and 
others to be determined; Multiplex assay from biopsies (e.g., MYC-

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expression levels); Cytokines and other PD biomarkers for the purpose 
of an optional genetic analysis and for target validation; PBMC and 
immune characterisation blood samples only during Part 2 (Dose 
Expansion). 
Statistical methods: 
Sample Size 
The sample size is determined based on clinical rather than statistical 
considerations. For the dose escalation part, up to 24 patients are 
anticipated to be recruited. The number of patients in this study is 
consistent with Phase 1 dose finding studies. In Part 2, at least 3 parallel 
groups of patients with advanced NSCLC, TNBC and CRC will be 
treated. Approximately 18 patients will be enrolled in each group in 
Part 2. 
General Considerations 
In general, all data will be summarised using appropriate descriptive 
statistics by per dose cohort and for the expansion groups where 
applicable. Summary tabulations will be presented that display the 
number of patients (N), number of observations, mean, SD, median, 
minimum, and maximum for continuous variables, and the number and 
percent (of non-missing values) per category for categorical data by 
absolute and relative frequencies. 
Unless indicated otherwise, summary statistics will be reported for 
observed data only. Missing data will not be imputed. If a baseline 
value is missing, no change from baseline will be calculated.  
Baseline is defined as the last assessment before the start of IMP 
administration. 
Safety data will be reviewed continuously and integrated with PK and 
PD data at the end of dose escalation in order to determine the dose to 
be administered during the dose expansion part of the study. The same 
data will be integrated at the conclusion of the study in order to 
determine the RP2D to be used in future trials of OMO-103. 
Interim Analysis 
An interim analysis is planned at the end of Part 1 (Dose Escalation) 
to provide an overview of available study results at that stage. Note: 
This interim analysis will not replace the role of the SMC and will not 
affect dose escalation rules, nor the decision to proceed to Part 2 (Dose 
Expansion).  
Another interim analysis is planned in the dose expansion part. After 
half of the patients in all groups (i.e., 9 patients per group) have been 
included and treated for 3 cycles, efficacy and safety will be analysed. 
If no response (as per RECIST v1.1) is seen during the interim analysis 
in at least one patient regardless of group, or for safety reasons, 
recruitment could be stopped (or the dose reduced) following 
discussion between the Investigator, the SMC and the Sponsor. 

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If there are no safety concerns and a response is seen, the study will 
continue until 18 patients have been recruited in each group. 
 

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