NCT06081920RecruitingPhase 2
A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma
Innovent Biologics (Suzhou) Co. Ltd.17 sites in 1 country180 target enrollmentStarted: October 19, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 180
- Locations
- 17
- Primary Endpoint
- PFS (progression free survival)
Study Overview
Brief Summary
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or
- •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.
Arms & Interventions
IBI363
Experimental
Intervention: IBI363 (Biological)
Outcomes
Primary Outcomes
PFS (progression free survival)
Time Frame: 2 years
DCR (disease control rate)
Time Frame: 2 years
TTR (time to response)
Time Frame: 2 years
DoR（duration of response）
Time Frame: 2 years
AE（Adverse event）
Time Frame: 2 years
ORR（Objective response rate）
Time Frame: 2 years
TTP (time to progression)
Time Frame: 2 years
Secondary Outcomes
- OS（overall survival）(2 years)
- PK concentration: IBI363 serum concentration(2 years)
- ADA (Anti-drug antibody)(2 years)
- Nab (Neutralizing antibody)(2 years)
Investigators
Study Sites (17)
Loading locations...
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