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OsteomycNCT06650514

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from Vall d'Hebron Institute of Oncology

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2026 to Jun 2027 Show 6 more changesShow less
    • Eligibility criteria expanded, about 30 words
    • Enrollment closed, study ongoing
    • Study completion pushed from Dec 2026 to Dec 2027
    • Secondary endpoints: details revised at 8 of 14 entries
    • Site details revised
    • Collaborators: details revised at 1 of 8 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2024 to Dec 27, 2024
    • Collaborators: 7 to 8
    v3
  3. Collaborators: 6 to 7v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Preliminary anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma
Timeframe: 16 weeks from start of treatment

Secondary (5)

Further evaluate the anti-tumour activity of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Safety and tolerability profile of OMO-103 monotherapy in patients with high-grade osteosarcoma.
Assess the benefit/risk ratio associated with OMO-103
To characterise the pharmacokinetics (PK) of OMO-103 monotherapy in patients with high-grade osteosarcoma (12-15 years of age).
Evaluate quality of life (QoL) in patients with high-grade osteosarcoma

Arms and interventions

OMO-103Experimental

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

Drugs: OMO-103

Sites

1 site in 1 country

  • Hospital Universitari Vall d'HebronBarcelona, Barcelona, Spain