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A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients With Advanced High-Grade Osteosarcoma

NCT06650514 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-01-10

No results posted yet for this study

Summary

This is an open-label, unicentric, single-arm Phase 2 pilot study to serve as a proof-of-concept of OMO-103 safety and activity in patients with advanced high-grade osteosarcoma.

Patients will be treated at the RP2D (6.5 mg/kg as a weekly IV infusion) of OMO-103 to estimate anti-tumour activity and further characterise the safety, tolerability, PK, and PD of OMO-103 in advanced high-grade osteosarcoma patients. Ten (10) evaluable patients will be enrolled. At least 30% of patients will be \<18 years old. The first three patients 12-15 years of age will undergo additional safety monitoring.

Patients will be treated until progression by RECIST v1.1 or intolerable toxicity.

Conditions

Interventions

DRUG

OMO-103

OMO-103 administered at the recommended phase 2 dose (6.5 mg/kg as a weekly intravenous infusion in 28-day cycles).

Sponsors & Collaborators

  • Peptomyc S.L.

    collaborator INDUSTRY

  • Osteosarcoma Institute

    collaborator UNKNOWN

  • Curing Kids' Cancer Foundation

    collaborator OTHER

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • The Morgan Adams Foundation

    collaborator UNKNOWN

  • The Kristen Ann Carr Fund

    collaborator UNKNOWN

  • Vall d'Hebron Institute of Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-27
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650514 on ClinicalTrials.gov