RecruitingPhase 1Phase 2NCT06456892

Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen

Phase I/II Clinical Study on the Safety and Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen as Neoadjuvant Therapy for Children and Adolescents With Intermediate/High-Risk Rhabdomyosarcoma

Sponsor

Sun Yat-sen University

Enrollment

82 participants

Start Date

Jun 6, 2024

Study Type

INTERVENTIONAL

Conditions

Pediatric Cancer Rhabdomyosarcoma

Summary

This study comprises both Phase I and Phase II research. This phase focuses on safety, tolerability, and pharmacokinetics using a "3+3" dose escalation design with three dose groups: 1 mg/kg, 3 mg/kg, and 6 mg/kg. The drug will be administered in combination with the standard regimen for intermediate/high-risk rhabdomyosarcoma once every three weeks (Q3W). In phase II study, all subjects will receive Pucotenlimab combined with the standard regimen for intermediate/high-risk rhabdomyosarcoma for 2-4 cycles of neoadjuvant therapy every 3 weeks (Q3W), followed by surgery.

Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding pucotenlimab (an immunotherapy drug) to standard chemotherapy improves outcomes in children and teenagers newly diagnosed with intermediate to high-risk rhabdomyosarcoma — a type of cancer that forms in muscle tissue. **You may be eligible if...** - You are between 1 and 18 years old - You have been newly diagnosed with intermediate or high-risk rhabdomyosarcoma, confirmed by pathology - Surgery has been assessed as very difficult - You have at least one tumor that can be measured on imaging - Your expected survival is at least 6 months - Your heart function is adequate (LVEF ≥ 50% on echocardiogram) **You may NOT be eligible if...** - You have already received treatment for this cancer - You have poor heart function - You do not meet the performance status or organ function requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.