A Study of IBI363 in Subjects With Advanced Melanoma
- Registration Number
- NCT06081920
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IBI363 IBI363 -
- Primary Outcome Measures
Name Time Method AE（Adverse event） 2 years ORR（Objective response rate） 2 years DoR（duration of response） 2 years PFS (progression free survival) 2 years DCR (disease control rate) 2 years TTR (time to response) 2 years TTP (time to progression) 2 years
- Secondary Outcome Measures
Name Time Method OS（overall survival） 2 years PK concentration: IBI363 serum concentration 2 years ADA (Anti-drug antibody) 2 years Nab (Neutralizing antibody) 2 years
Trial Locations
- Locations (12)
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The Third people's hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
The first affiliated hospital of Nanchang university
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The first hospital of Jilin University
🇨🇳Changchun, Jilin, China
Qilu Hospital of Shandong university
🇨🇳Jinan, Shandong, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Yunan Cancer Hospital
🇨🇳Kunming, Yunan, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking University Cancer Hospital & Institute, Beijing, China,
🇨🇳Beijing, Beijing, China