Osteomyc

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 (Osteomyc)

Agents: OMO-103
Phase II
Status Open, recruiting
Sponsor Vall d'Hebron Institute of Oncology

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.

Further information can be found here.

 

WHO is the trial for?

  • Patients ≥12 years with unresectable or metastatic high-grade osteosarcoma.

  • Disease progression confirmed by radiological report after at least one line of standard chemotherapy (cisplatin + anthracycline) and no more than 2 previous lines.

  • Measurable disease as per RECIST v1.1.

  • Provision of a newly obtained tumor biopsy (if applicable).

  • ECOG performance status 0-2.

  • Life expectancy ≥12 weeks.

WHAT is the key question that this trial is attempting to answer?

This Phase 2 pilot study aims to evaluate the safety, tolerability, and anti-tumor activity of the Myc inhibitor OMO-103 administered intravenously in patients with advanced high-grade osteosarcoma.

WHY patients might want to participate?

Participating in this study offers patients with advanced high-grade osteosarcoma access to a novel treatment option that may provide therapeutic benefits. Additionally, contributing to this research helps advance medical knowledge, potentially improving future treatments for others with similar conditions. It's important to note that while the study may offer potential benefits, there are also possible risks and uncertainties. For more information on the importance and potential benefits of joining clinical trials, please visit this link.

WHEN will the trial be open?

The study is open for participation (recruiting)

WHERE is the trial available?

The trial is available in Spain.

  1. Contact: Claudia M Valverde
    Phone Number:+34932746085
    Email Address: cvalverde@vhio.net

STUDY DESIGN: What does the study look like?

This Phase 2 pilot study is designed as an open-label, single-arm trial to evaluate the safety and anti-tumor activity of OMO-103, a Myc inhibitor, administered intravenously in patients with advanced high-grade osteosarcoma. The study will enroll 10 evaluable patients, with at least 30% of participants being under 18 years old. Patients will receive OMO-103 at a dose of 6.5 mg/kg as a weekly intravenous infusion in 28-day cycles until disease progression or intolerable toxicity occurs.

HOW do I get more information?

Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

SHARE your experience

  
You want to share your experience on this trial?
Send us an e-mail to: info@sarcoma-patients.org
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

 No results are available at this time. Future results will be linked here.

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken

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