Status:
RECRUITING
A Study of IBI363 in Subjects With Advanced Melanoma
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
Eligibility Criteria
Inclusion
- Histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th edition staging III-IV). Progression or recurrence after at least first-line systemic standard treatment.
- At least one measurable lesion (target lesion) per RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Life expectancy of 3 months or more.
- Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.
Exclusion
- Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug.
- Active or symptomatic central nervous system metastasis.
- At baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin\<90 g/L; Absolute neutrophil count (ANC)\<1.5 × 109/L; Platelet count\<100 × 109/L.
- At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin\>1.5 × ULN; AST or ALT\>3 × ULN; If it is tumor liver metastasis, AST or ALT\>5.0 × ULN; Serum creatinine\>1.5 × ULN or CCr\<45 mL/min, using the Cockcroft Fault formula to calculate CCr (using actual body weight); Albumin\<30 g/L.
- At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR\>1.5 × ULN (\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin time (aPTT))\>1.5 × ULN (\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN).
- History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational drug, unless sufficient treatment has been given and the investigator believes that the condition is stable.
- Uncontrolled bleeding or known tendency to bleed.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06081920
Start Date
October 19 2023
End Date
July 31 2026
Last Update
May 16 2025
Active Locations (12)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Peking University Cancer Hospital & Institute, Beijing, China,
Beijing, Beijing Municipality, China, 100142
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
4
The Third people's hospital of Zhengzhou
Zhengzhou, Henan, China, 450044