Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma

Recruiting now · Phase 1/Phase 2

Conditions studied: Sarcoma, Osteosarcoma

In brief

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.

Key facts

Study ID

NCT07725380

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

74

Starts

2026-07-15

Expected to finish

2031-08-01

Last updated by the study team

2026-07-24

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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