Tests IBI363 in adults with advanced melanoma
Tests the drug IBI363 in adults with advanced melanoma skin cancer.
Plain-language title generated from the registry record
Registry title: A Study of IBI363 in Subjects With Advanced Melanoma
Key facts
- Where
- Beijing, Changchun, Changsha, Fuzhou, Jinan, Kunming, Nanchang, Nanjing, Taiyuan, and Zhengzhou, ChinaSee the 12 sites
- Phase
- Phase 2
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- Peking University Cancer Hospital & Institute, Beijing, China,Beijing, ChinaTaking people
- Jilin Cancer HospitalChangchun, ChinaTaking people
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
- Hunan Cancer HospitalChangsha, ChinaTaking people
- Fujian Cancer HospitalFuzhou, ChinaTaking people
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- Yunan Cancer HospitalKunming, ChinaTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
- Nanjing Drum Tower hospitalNanjing, ChinaTaking people
- Shanxi Bethune HospitalTaiyuan, ChinaTaking people
- The Third People's Hospital of ZhengzhouZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Trial code
- NCT06081920
- Record updated
- 29 July 2026
- Original description
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patientsRead full original descriptionShow less
A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
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; 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; 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); Active or symptomatic central nervous system metastasis.