OncoMatch/Clinical Trials/NCT06456892
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
Is NCT06456892 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Pucotenlimab for rhabdomyosarcoma.
Treatment: Pucotenlimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Rhabdomyosarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Received anti-PD-1 or anti-PD-L1 monoclonal antibodies or targeted drugs related to these pathways
Cannot have received: anti-PD-L1 therapy
Received anti-PD-1 or anti-PD-L1 monoclonal antibodies or targeted drugs related to these pathways
Cannot have received: chemotherapy
Received chemotherapy, radiotherapy, or other treatments
Cannot have received: radiation therapy
Received chemotherapy, radiotherapy, or other treatments
Cannot have received: surgery
Exception: excluding biopsy
Previous surgical treatment (excluding biopsy)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L; Platelet count ≥ 100.0 × 10^9/L; Hemoglobin ≥ 90 g/L
Kidney function
Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 or serum creatinine (Cr) ≤ 1.5 × ULN
Liver function
Total bilirubin (conjugated + unconjugated) ≤ 2.5 × ULN corresponding to age, patients with confirmed Gilbert's syndrome may be enrolled based on the investigator's discretion; AST and ALT ≤ 2.5 × ULN
Cardiac function
Echocardiography shows LVEF ≥ 50%; EKG indicates no evidence of myocardial ischemia; No history of arrhythmia requiring pharmacological intervention before enrollment
Cardiac function: Echocardiography shows LVEF ≥ 50%; EKG indicates no evidence of myocardial ischemia; No history of arrhythmia requiring pharmacological intervention before enrollment. Liver and kidney functions need to meet the following criteria: Total bilirubin (conjugated + unconjugated) ≤ 2.5 × ULN corresponding to age, patients with confirmed Gilbert's syndrome may be enrolled based on the investigator's discretion; AST and ALT ≤ 2.5 × ULN; Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 or serum creatinine (Cr) ≤ 1.5 × ULN. For patients with known non-involvement of the bone marrow (BM): Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L; Platelet count ≥ 100.0 × 10^9/L; Hemoglobin ≥ 90 g/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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