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Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma

NCT07725380 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sirolimus

Tablet

DRUG

Domatinostat

Tablet

Sponsors & Collaborators

  • National Pediatric Cancer Foundation

    collaborator OTHER

  • Healx USA, Inc

    collaborator UNKNOWN

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Amy Armstrong, MD · Washington University School of Medicine

  • Jonathan Metts, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2031-08-31
Completion
2031-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725380 on ClinicalTrials.gov