Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07725380
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Osteosarcoma
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Domatinostat — DRUG
    Tablet
  • Sirolimus — DRUG
    Tablet

Study Details

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.

Key Dates

First listed
Jul 24, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation Cohort
    Participants with relapsed or refractory sarcoma will receive domatinostat plus sirolimus. Domatinostat dose levels will be escalated to determine the MTD and/or RP2D.
  • Experimental: Phase 2 Arm A (Surgical Complete Remission Osteosarcoma)
    Patients with relapsed/refractory osteosarcoma who achieve complete surgical remission before enrollment will receive domatinostat plus sirolimus at the RP2D.
  • Experimental: Phase 2 Arm B (Measurable Osteosarcoma)
    Patients with unresectable measurable relapsed/refractory osteosarcoma will receive domatinostat plus sirolimus at the RP2D.

Primary Outcome Measure

Phase 1: Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Jonathan Metts, MD (PRINCIPAL_INVESTIGATOR)
Andrew Brohl, MD (SUB_INVESTIGATOR)
Isabel Canizares, APRN (SUB_INVESTIGATOR)
Mihaela Druta, MD (SUB_INVESTIGATOR)
Anya Ibern, APRN (SUB_INVESTIGATOR)
Desiree Morales, APRN (SUB_INVESTIGATOR)
Mauricio Silva Almeida Ribeiro, MD (SUB_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63110
Amy Armstrong, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Alice Lee, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Bhuvana Setty, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLWashington University in St. Louis· St Louis, MOMontefiore Medical Center· The Bronx, NYNationwide Children's Hospital· Columbus, OH

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