RecruitingPhase 2NCT06650514

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

Sponsor

Vall d'Hebron Institute of Oncology

Enrollment

10 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma Osteosarcoma in Children

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a combination of regorafenib and nivolumab — a targeted drug plus an immunotherapy — in young people (age 12 and older) with advanced high-grade osteosarcoma (a bone cancer) that has stopped responding to standard chemotherapy. **You may be eligible if...** - You are 12 or older - You have confirmed high-grade osteosarcoma that has progressed after standard chemotherapy (containing cisplatin and an anthracycline) - You have received no more than 2 prior treatment lines - You have measurable disease on imaging (CT or MRI) - Your tumor cannot be treated with surgery or radiation with curative intent **You may NOT be eligible if...** - You have received more than 2 prior treatment lines - Your disease is not measurable on imaging - You have serious organ problems or uncontrolled conditions that could interfere with the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.