A Study of IBI363 in Subjects With Advanced Melanoma
Study Details
Study Description
Brief Summary
This is an open-label, multicenter Phase Ib/II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IBI363
|
Biological: IBI363
RP2D of IBI363
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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.
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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.
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Active or symptomatic central nervous system metastasis.
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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).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Cancer Hospital | Beijing | Beijing | China | 100142 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI363A201