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Tests treatment safety and results for Rhabdomyosarcoma
Official title Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
ClinicalTrials.gov ID: NCT06456892
What this study is testing
What is Pucotenlimab?
Pucotenlimab is an investigational medicine, being studied as a potential treatment for rhabdomyosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- 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;
- Must have at least one measurable lesion defined by RECIST or WHO criteria;
You likely can't join if
- Received anti-PD-1 or anti-PD-L1 monoclonal antibodies or targeted drugs related to these pathways;
- Received chemotherapy, radiotherapy, or other treatments;
- Previous surgical treatment (excluding biopsy);
- Known allergy to PD-1 monoclonal antibodies or any of their excipients; known history of allergic diseases or severe allergies;
- Having other malignant tumor diseases besides the tumor being treated in this study, excluding: malignant tumors that have been cured and have not...
- Active central nervous system metastases (whether treated or not), including symptomatic brain metastases, meningeal metastases, or spinal cord...
See the full 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;
- Must have at least one measurable lesion defined by RECIST or WHO criteria;
- Expected survival time ≥ 6 months;
- Cardiac function:
- Echocardiography shows LVEF ≥ 50%;
- EKG indicates no evidence of myocardial ischemia;
- No history of arrhythmia requiring pharmacological intervention before enrollment;
- No history of severe immune-related adverse events (CTCAE V4.03 G3 or G4);
- For patients with known non-involvement of the bone marrow (BM):
- Absolute neutrophil count (ANC) ≥ 1.0 × 109/L;
- Platelet count ≥ 100.0 × 109/L;
- Hemoglobin ≥ 90 g/L;
- Liver and kidney functions need to meet the following criteria:
- Total bilirubin (conjugated + unconjugated) ≤ 2.5 × upper limit of normal (ULN) corresponding to age, patients with confirmed Gilbert's syndrome may be enrolled based on the investigator's discretion;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 or serum creatinine (Cr) ≤ 1.5 × ULN;
- Able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during the study;
- The parents/guardians of the child or adolescent participants have the ability to understand, consent to, and sign the informed consent form (ICF) and applicable child consent forms before initiating any...
- Received anti-PD-1 or anti-PD-L1 monoclonal antibodies or targeted drugs related to these pathways;
- Received chemotherapy, radiotherapy, or other treatments;
- Previous surgical treatment (excluding biopsy);
- Known allergy to PD-1 monoclonal antibodies or any of their excipients; known history of allergic diseases or severe allergies;
- Having other malignant tumor diseases besides the tumor being treated in this study, excluding: malignant tumors that have been cured and have not recurred within 3 years before enrollment, completely resected basal...
- Active central nervous system metastases (whether treated or not), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, etc. Excluding: asymptomatic brain metastases without...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Previous treatment toxicity still \> Grade 1 (CTCAE V4.03 criteria), excluding alopecia and neurotoxicity;
- History of mental disorders;
- History of drug abuse or substance abuse upon inquiry;
- History of idiopathic pulmonary fibrosis or idiopathic pneumonitis;
- Comorbidities requiring immunosuppressive drug treatment, or comorbidities requiring systemic or local use of corticosteroids at immunosuppressive doses (prednisone \> 10 mg/day or equivalent doses of similar drugs).
- History of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Excluding: Type I diabetes...
- Previous or current active tuberculosis infection;
- Active infections requiring systemic treatment;
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) or pulmonary hypertension or unstable angina pectoris; myocardial infarction or bypass surgery, stenting within 6...
- Concurrent severe medical conditions, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc.;
- Positive Anti-HIV, TP-Ab, HCV-Ab; HBV-Ag positive with HBV DNA copy number \> upper limit of normal value of the testing unit;
- Abnormal thyroid function test results (FT3, FT4, T3, T4);
- Expected to receive live or attenuated vaccines within 4 weeks before administration, during treatment, or within 5 months after the last dose;
- Participated in another clinical trial and received experimental drug treatment within 30 days before administration;
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.