NCT07888114 Preliminary Clinical Study of Entinostat in Children With Malignant Soft Tissue Sarcoma Harboring PAX-family Gene Abnormalities
| NCT ID | NCT07888114 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Beijing Tongren Hospital |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2025-03-15 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07888114 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07888114 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07888114 currently recruiting?
Yes, NCT07888114 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beijing Tongren Hospital to inquire about joining.
Where is the NCT07888114 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07888114 clinical trial?
NCT07888114 is sponsored by Beijing Tongren Hospital. The trial plans to enroll 16 participants.