Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen

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.

Trial Details

NCT ID
NCT06456892
Phase
PHASE1 / PHASE2
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • Pucotenlimab
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Age: 1-18 years old;
  • ECOG PS score: 0-1 points;
  • Pathologically confirmed newly diagnosed children or adolescents with intermediate to high-risk rhabdomyosarcoma;
  • Patients evaluated by surgery as having a high degree of difficulty;

For full eligibility, visit ClinicalTrials.gov.

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