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RECRUITING
NCT07725380
PHASE1/PHASE2

Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2026-07-15

Completion Date

2031-08

Last Updated

2026-07-24

Healthy Volunteers

No

Interventions

DRUG

Domatinostat

Tablet

DRUG

Sirolimus

Tablet

Locations (4)

Moffitt Cancer Center

Tampa, Florida, United States

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