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Can two drugs together fight Hard-to-Treat bone and Soft-Tissue cancers?

NCT ID NCT07725380

Disease control Sponsor: H. Lee Moffitt Cancer Center and Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This trial tests whether combining domatinostat with sirolimus can safely shrink or slow the growth of relapsed or refractory sarcoma and osteosarcoma in adolescents and adults aged 12 to 40. Participants must have already tried at least one standard therapy without success. The study first finds the best dose (phase 1) and then checks how well it works (phase 2).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
domatinostat combined with sirolimus
What this could lead to
If it works, this combination could offer a new treatment option for people with sarcoma or osteosarcoma that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the combination may not prove effective or may cause significant side effects. Success in phase 1/2 does not guarantee broader benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteosarcoma sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteosarcoma Sarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    NOT_YET_RECRUITING

    The Bronx, New York, 10467, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Washington University in St. Louis

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

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