OncoMatch/Clinical Trials/NCT07888114
Preliminary Clinical Study of Entinostat in Children With Malignant Soft Tissue Sarcoma Harboring PAX-family Gene Abnormalities
Official title: 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
Is NCT07888114 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including Entinostat and VAC/VTC chemotherapy for soft tissue sarcoma.
Treatment: Entinostat · VAC/VTC chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Sarcoma
Biomarker criteria
Required: FOXO1 pax3-foxo1 fusion
PAX3-FOXO1- or PAX7-FOXO1-fusion positive
Required: FOXO1 pax7-foxo1 fusion
PAX3-FOXO1- or PAX7-FOXO1-fusion positive
Required: PAX gene abnormality
another PAX-family gene abnormality
Demographics
Prior therapy
Must have received: chemotherapy and/or radiotherapy
completion of standard backbone chemotherapy and/or radiotherapy with a favorable clinical response (CR or PR); or inadequate response following standard chemotherapy and/or radiotherapy, or recurrent/progressive disease
Cannot have received: hematopoietic stem cell transplantation
Previous hematopoietic stem cell transplantation
Cannot have received: organ transplantation
Previous organ transplantation
Lab requirements
Blood counts
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
Kidney function
serum creatinine ≤2.0 × the upper limit of normal
Liver function
total bilirubin, alt, and ast ≤2.5 × the upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07888114 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hematopoietic stem cell transplantation, organ transplantation disqualifies patients from enrollment.
Does this trial require FOXO1?
Yes, FOXO1 pax3-foxo1 fusion is a required biomarker for enrollment.
Does this trial require FOXO1?
Yes, FOXO1 pax7-foxo1 fusion is a required biomarker for enrollment.
Does this trial require PAX?
Yes, PAX gene abnormality is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages