OncoMatch

OncoMatch/Clinical Trials/NCT06081920

A Study of IBI363 in Subjects With Advanced Melanoma

Is NCT06081920 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies IBI363 for melanoma.

Phase 2RecruitingInnovent Biologics (Suzhou) Co. Ltd.NCT06081920Data as of May 2026

Treatment: IBI363This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic standard treatment — first-line

Progression or recurrence after at least first-line systemic standard treatment

Lab requirements

Blood counts

hemoglobin <90 g/L; ANC <1.5 × 10^9/L; Platelet count <100 × 10^9/L

Kidney function

Serum creatinine >1.5 × ULN or CCr <45 mL/min (Cockcroft Fault formula, actual body weight)

Liver function

Total bilirubin >1.5 × ULN; AST or ALT >3 × ULN; If tumor liver metastasis, AST or ALT >5.0 × ULN

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 × 10^9/L; Platelet count<100 × 10^9/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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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