NCT07725380 Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
| NCT ID | NCT07725380 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2026-07-15 |
| Primary Completion | 2031-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 74 participants in total. It began in 2026-07-15 with a primary completion date of 2031-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Amy Armstrong, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07725380 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 40 Years, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07725380 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07725380 currently recruiting?
Yes, NCT07725380 is actively recruiting participants. Contact the research team at Jessica.Crimella@moffitt.org for enrollment information.
Where is the NCT07725380 trial being conducted?
This trial is being conducted at Tampa, United States, St Louis, United States, The Bronx, United States, Columbus, United States.
Who is sponsoring the NCT07725380 clinical trial?
NCT07725380 is sponsored by H. Lee Moffitt Cancer Center and Research Institute. The principal investigator is Amy Armstrong, MD at Washington University School of Medicine. The trial plans to enroll 74 participants.