RecruitingPhase 2

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

Spain10 participantsStarted 2024-12-27

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Provision of signed and dated informed consent form.
✓. Age ≥12 years at time of informed consent.
✓. Histologically proven, advanced high-grade osteosarcoma not suitable for local treatments with curative intent
✓. Confirmed disease progression by radiological report to at least one line of standard chemotherapy containing cisplatin and anthracycline, and no more than 2 previous lines.
✓. Measurable disease as per RECIST v1.1 criteria and documented by CT/MRI (Appendix 1 - RECIST Response Criteria). NOTE: Lesions to be used as measurable disease for the purpose of response assessment must either:
✓. not reside in a field that has been subjected to prior radiotherapy, or
✓. have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.
✓. Provision of a newly obtained tumour biopsy (either from the primary tumour or from metastases) during screening and on-treatment from all patients \>16 years of age. Notes:

Exclusion criteria

What they're measuring

Preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma

Timeframe: 16 weeks from start of treatment

Trial details

NCT IDNCT06650514

SponsorVall d'Hebron Institute of Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Claudia M Valverde

+34932746085 cvalverde@vhio.net

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