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
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