A Study of IBI363 in Subjects With Advanced Melanoma

Study Purpose

This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. At least one measurable lesion (target lesion) per RECIST v1.1. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. Life expectancy of 3 months or more. 5. 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:

1. Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug. 2. Active or symptomatic central nervous system metastasis. 3. 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. 4. 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. 5. 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). 6. 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. 7. Uncontrolled bleeding or known tendency to bleed.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06081920
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Innovent Biologics (Suzhou) Co. Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Arms & Interventions

Arms

Experimental: IBI363

Interventions

Biological: - IBI363

IBI363 monotherapy

Contact a Trial Team

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