Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen

Sponsor
Sun Yat-sen University
Study ID
NCT06456892
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Pediatric Cancer
  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Pucotenlimab — DRUG
    Pucotenlimab Combined with Standard Chemotherapy Regimen

Study Details

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.

Key Dates

First listed
Jun 13, 2024
Start date
Jun 6, 2024
Status verified
Jun 2024
Primary completion
Jun 6, 2026
Completion
Dec 6, 2026

Study Design

Enrollment
82 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pucotenlimab Combined with Standard Chemotherapy Regimen
    In phase I, it 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, after establishing the recommended Phase II dose (RP2D), ll 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. The standard regimen for intermidiate/high-risk rhabdomyosarcoma refer to the SYSUCC-RMS-2017 in China.

Primary Outcome Measure

DLT [ Time Frame: within 28 days of the dose escalation phase. ]

Central Contacts

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