OncoMatch/Clinical Trials/NCT06456892
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
Is NCT06456892 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Rhabdomyosarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06456892 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 18 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages