A Study of IBI363 in Subjects With Advanced Melanoma

Study Overview
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Brief Summary
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This is an open-label, multicenter Phase Ib/II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients

Official Title
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A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Biological: IBI363


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI363<br> | Biological: IBI363<br>* RP2D of IBI363<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase Ⅰb: AE（Adverse event） |  | 2 year | 
| Phase Ⅰb: RP2D（Recommended phase 2 dose） |  | 2 year | 
| Phase Ⅱ：ORR（Objective response rate） |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DoR（duration of response） |  | 2 year | 
| PFS（progression free survival） |  | 2 year | 
| OS（overall survival） |  | 2 year | 
| DCR（disease control rate） |  | 2 year | 
| TTR（time to response） |  | 2 year | 
| TTP（time to progression） |  | 2 year |