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Recruiting
NCT06081920
A Study of IBI363 in Subjects With Advanced Melanoma
Conditions: Melanoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 180
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Location: Beijing Cancer Hospital Beijing Beijing Municipality
Summary
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
Eligibility 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\5.0 × ULN; Serum creatinine\>1.5 × ULN or CCr\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.
Source: ClinicalTrials.gov (NCT06081920). StuddyBuddy aggregates publicly available trial information.