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NCT07725380PHASE1, PHASE2Recruiting

Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma

H. Lee Moffitt Cancer Center and Research Institute

Start Date

7/15/2026

Completion Date

8/1/2031

Summary

This is a multicenter, open-label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma and osteosarcoma.

Eligibility Criteria

Age Range: 12 years to 40 years

Inclusion Criteria: * Age ≥12 and ≤40 years. * Histologically confirmed relapsed or refractory sarcoma (Phase 1) or osteosarcoma (Phase 2). * At least one prior standard systemic therapy regimen. * Not candidates for available therapies known to provide survival benefit. * Karnofsky/Lansky performance score ≥60. * Life expectancy ≥16 weeks. * Adequate organ function: ANC ≥1,000/mcL, Platelets ≥100,000/uL, Hemoglobin ≥8 g/dL, Adequate hepatic and renal function. * Ability to swallow tablets. * Negative pregnancy test for females of childbearing potential. * Agreement to use effective contraception. * Ability to provide informed consent/assent. Exclusion Criteria: * Receiving another investigational agent. * Receiving concurrent anticancer therapy. * Known hypersensitivity to domatinostat or sirolimus. * Bone marrow-only disease. * CNS metastatic disease. * Major surgery within 2 weeks prior to treatment. * Active malignancy within the previous 3 years (with protocol-specified exceptions). * History of solid organ transplantation. * Significant recent cardiac disease. * Concurrent prohibited CYP3A4/P-gp interacting medications. * Uncontrolled infection or other serious uncontrolled illness. * Pregnancy or breastfeeding. * HIV infection on antiretroviral therapy. * Weight \<40 kg. * Inability to comply with study requirements.

Interventions

DRUG

Domatinostat

DRUG

Sirolimus

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Conditions

SarcomaOsteosarcoma

Locations

Moffitt Cancer Center

Tampa, Florida 33612

United States

Washington University in St. Louis

St Louis, Missouri 63110

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States