Clinical Trials in China / NCT06081920
Recruiting
Phase 2
A Study of IBI363 in Subjects With Advanced Melanoma
NCT06081920 · tracked via the Priya Life Science China tracker
Condition(s) studied
Melanoma
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
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Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity
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A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
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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