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A Single-Center clinical study evaluating the safety and antitumor activity of entinostat in children with malignant soft tissue sarcoma harboring PAX-family gene abnormalities

NCT ID NCT07888114

Sponsor: Beijing Tongren Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time

Summary

Pediatric soft tissue sarcomas (STS) are a group of malignant tumors originating from primitive mesenchymal tissues and account for approximately 7% of childhood cancers. STS are broadly classified into rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). RMS accounts for approximately one half of pediatric STS. As reported, PAX fusion-positive RMS is more aggressive than fusion-negative RMS, with higher metastatic potential and poorer prognosis. Based on the unmet therapeutic need in pediatric sarcoma with PAX-family abnormalities, this study is intended to evaluate the preliminary safety and antitumor activity of entinostat with or without chemontherapy.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

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

Started

Mar 2025

Expected to finish

Mar 2027

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

1 year to 18 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: 1. Age \>1 year and ≤18 years. 2. Histologically confirmed malignant soft tissue sarcoma that is PAX3-FOXO1- or PAX7-FOXO1-fusion positive or has another PAX-family gene abnormality. 3. Clinical disease status: (a) monotherapy cohort: completion of standard backbone chemotherapy and/or radiotherapy with a favorable clinical response (CR or PR); (b) combination cohort: inadequate response following standard chemotherapy and/or radiotherapy, or recurrent/progressive disease. 4. Karnofsky Performance Status (KPS) ≥50 or Lansky Performance Status (LPS) ≥50. 5. Adequate bone marrow function: ANC ≥0.5 × 10\^9/L, platelet count ≥50 × 10\^9/L, hemoglobin ≥70 g/L, and WBC ≥1.5 × 10\^9/L, with values not exceeding the upper limit of normal. 6. Life expectancy of at least 6 months. 7. Written informed consent obtained. Exclusion Criteria: 1. Previous hematopoietic stem cell transplantation or organ transplantation. 2. Participation in another drug clinical trial within 2 months before enrollment. 3. Uncontrolled infection or body temperature ≥38°C. 4. Total bilirubin, ALT, and AST \>2.5 × the upper limit of normal. 5. Serum creatinine \>2.0 × the upper limit of normal. 6. Any other condition considered by the investigator to constitute a contraindication to study participation.

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Conditions

The condition(s) this trial relates to.

rhabdomyosarcoma sarcoma soft tissue sarcoma

As listed by the trial registrant

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

Soft tissue sarcoma

How to take part

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

  1. The places running it

    1 site. 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

  • Beijing Tongren Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

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