NCT07725380RecruitingPhase 1/2
Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
Open-Label, Cohort-Sequential Dose-Escalation and Dose-Confirmation Phase 1/2 Clinical Trial to Evaluate the Safety and Efficacy of Domatinostat in Combination With Sirolimus in Adolescents and Adults With Relapsed, Refractory Sarcoma and Osteosarcoma
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 21 Jul 2026
- Start date
- 15 Jul 2026
- Primary completion date
- Aug 2031
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07725380
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 74
- From 15 Jul 2026 to the primary completion date, Aug 2031
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving another investigational agent.
- Receiving concurrent anticancer therapy.
- Major surgery within 2 weeks prior to treatment.
- Active malignancy within the previous 3 years (with protocol-specified exceptions).
- Concurrent prohibited CYP3A4/P-gp interacting medications.
Other illness
- Known hypersensitivity to domatinostat or sirolimus.
- Bone marrow-only disease.
- CNS metastatic disease.
- History of solid organ transplantation.
- Significant recent cardiac disease.
- Uncontrolled infection or other serious uncontrolled illness.
- HIV infection on antiretroviral therapy.
Other
- Pregnancy or breastfeeding.
- Weight \<40 kg.
- Inability to comply with study requirements.
Who the study is looking for
- 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.
Age in the registry: 12 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Not yet recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.