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Recruiting Phase 2

A Study of IBI363 in Subjects With Advanced Melanoma

NCT06081920 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2023-10-19
Last updated
2026-07-29

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

IBI363 →

IBI363: IBI363 monotherapy

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • AE(Adverse event) — 2 years
  • ORR(Objective response rate) — 2 years
  • DoR(duration of response) — 2 years
  • PFS (progression free survival) — 2 years
  • DCR (disease control rate) — 2 years
  • TTR (time to response) — 2 years
  • TTP (time to progression) — 2 years

Trial sites (12)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Peking University Cancer Hospital & Institute, Beijing, China, Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
The Third people's hospital of Zhengzhou Zhengzhou Henan Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Recruiting
The first affiliated hospital of Nanchang university Nanchang Jiangxi Recruiting
Jilin Cancer Hospital Changchun Jilin Recruiting
The first hospital of Jilin University Changchun Jilin Recruiting
Qilu Hospital of Shandong university Jinan Shandong Recruiting
Shanxi Bethune Hospital Taiyuan Shanxi Recruiting
Yunan Cancer Hospital Kunming Yunan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06081920 on ClinicalTrials.gov ↗ ← All trials in China