NCT07888114RecruitingPhase 1
Preliminary Clinical Study of Entinostat in Children With Malignant Soft Tissue Sarcoma Harboring PAX-family Gene Abnormalities
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 15 Oct 2026
- Start date
- 15 Mar 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Beijing Tongren Hospital
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07888114
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 16
- From 15 Mar 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hematopoietic stem cell transplantation or organ transplantation.
- Participation in another drug clinical trial within 2 months before enrollment.
Other illness
- Uncontrolled infection or body temperature ≥38°C.
- Any other condition considered by the investigator to constitute a contraindication to study participation.
Lab values
- Total bilirubin, ALT, and AST \>2.5 × the upper limit of normal.
- Serum creatinine \>2.0 × the upper limit of normal.
Who the study is looking for
- Age \>1 year and ≤18 years.
- Histologically confirmed malignant soft tissue sarcoma that is PAX3-FOXO1- or PAX7-FOXO1-fusion positive or has another PAX-family gene abnormality.
- 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.
- Karnofsky Performance Status (KPS) ≥50 or Lansky Performance Status (LPS) ≥50.
- 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.
- Life expectancy of at least 6 months.
- Written informed consent obtained.
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tongren Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.