Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours

NCT04808362 | Terminated Phase 1 Results DMC

• 1 other identifier: OMO-103-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

This study is an open label, two-part, First in Human (FIH) Phase 1/2 dose-finding study designed to determine the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and proof-of-concept (POC) of OMO-103 in patients with advanced solid tumours.

Conditions

Advanced Solid Tumors; Pancreatic Cancer; CRC

Keywords

MYC-Inhibitor; First in human; solid tumor

Outcome Measures

Primary Outcomes (1)

• Phase 1: Safety and Tolerability

  Phase 1: Number of patients with a DLT; Number of patients with IRRs, AEs /SAEs according to NCI CTCAE v 5;

  DLT period was 3 weeks and AEs were assessed for each patient until progression which was in average 3 months;

Secondary Outcomes (1)

• Phase 1: Elimination Half Life (t1/2)

  0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion

Study Arms (1)

OMO-103

EXPERIMENTAL

OMO-103 will be administered intravenously as 30 min infusion once weekly

Biological: OMO-103

Interventions

OMO-103 BIOLOGICAL

OMO-103 will be administered intravenously as 30 min infusion once weekly

OMO-103

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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:
• Part 1 (Dose Escalation):
• \- Histologically or cytologically proven advanced solid tumour for which there is no curative therapy and has progressed on Standard of Care (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 anthracyclines and taxanes (at least two prior lines of standard therapy) 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
• Tumour biopsy (either from the primary tumour or from metastases) during Screening and during Treatment should be obtained from the patients, if feasible.
• Documented progression on or following the last line of therapy.
• ECOG performance status up to 1.
• Life expectancy of ≥12 weeks.
• Adequate organ function

You may not qualify if:

• Parts 1 and 2:
• Systemic anti-cancer therapy within 4 weeks prior to study entry.
• Radiation therapy within 4 weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed.
• Non-malignant systemic disease including cerebrovascular accident (CVA), unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last 6 months, New York Heart Association (NYHA) Class III or IV heart failure, coagulation abnormalities and clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use to maintain adequate oxygenation in the previous 6 months.
• Patients with a history of congenital or acquired immunodeficiency syndrome, or currently receiving immunosuppressive therapy \>10 mg prednisolone or equivalent. Patients receiving inhaled or topical corticosteroids are eligible.
• Patients with symptomatic or unstable central nervous system (CNS) primary tumour or metastases and/or carcinomatous meningitis. Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the Investigator.
• Patients with need of therapeutic anticoagulation.

Sponsors & Collaborators

• Peptomyc S.L.: lead

Study Sites (3)

University Hospital Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, 28050, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Related Publications (1)

• Garralda E, Beaulieu ME, Moreno V, Casacuberta-Serra S, Martinez-Martin S, Foradada L, Alonso G, Masso-Valles D, Lopez-Estevez S, Jauset T, Corral de la Fuente E, Doger B, Hernandez T, Perez-Lopez R, Arques O, Castillo Cano V, Morales J, Whitfield JR, Niewel M, Soucek L, Calvo E. MYC targeting by OMO-103 in solid tumors: a phase 1 trial. Nat Med. 2024 Mar;30(3):762-771. doi: 10.1038/s41591-024-02805-1. Epub 2024 Feb 6.

  PMID: 38321218 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr Niewel
• Organization: Peptomyc

mniewel@peptomyc.com

+34932543450

Study Officials

• Elena Garralda, MD, PhD

  University Hospital Vall d´Hebron; Oncology Department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: accelerated titration design

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: April 28, 2021
• Primary Completion: December 15, 2022
• Study Completion: January 11, 2023
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)