NCT06456892

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhabdomyosarcoma
• Pediatric Cancer

Interventions

Type	Name	Description
DRUG	Pucotenlimab	Pucotenlimab Combined with Standard Chemotherapy Regimen

Timeline

• Start date: 2024-06-06
• Primary completion: 2026-06-06
• Completion: 2026-12-06
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: China