Actively Recruiting
A Study of IBI363 in Subjects With Advanced Melanoma
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-05-16
150
Participants Needed
12
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
CONDITIONS
Official Title
A Study of IBI363 in Subjects With Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic melanoma (AJCC 8th edition stage III-IV) with progression or recurrence after at least first-line systemic treatment
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Life expectancy of 3 months or more
- Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Pregnant or breastfeeding, or planning to conceive before, during, or within 6 months after last dose
- Active or symptomatic central nervous system metastasis
- Hematological abnormalities at baseline: hemoglobin <90 g/L; ANC <1.5 × 10^9/L; platelet count <100 × 10^9/L
- Serum biochemical abnormalities at baseline: total bilirubin >1.5 × ULN; AST or ALT >3 × ULN (or >5 × ULN if liver metastasis); serum creatinine >1.5 × ULN or creatinine clearance <45 mL/min
- Albumin <30 g/L at baseline
- Coagulation abnormalities at baseline: INR >1.5 × ULN (or >3 if on stable anticoagulant therapy); PTT or aPTT >1.5 × ULN (or >3 if on stable anticoagulant therapy)
- History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to first dose unless stable
- Uncontrolled bleeding or known bleeding tendency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Peking University Cancer Hospital & Institute, Beijing, China,
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
4
The Third people's hospital of Zhengzhou
Zhengzhou, Henan, China, 450044
Actively Recruiting
5
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
6
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
7
The first affiliated hospital of Nanchang university
Nanchang, Jiangxi, China, 330052
Actively Recruiting
8
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Actively Recruiting
9
The first hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
10
Qilu Hospital of Shandong university
Jinan, Shandong, China, 250012
Actively Recruiting
11
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Actively Recruiting
12
Yunan Cancer Hospital
Kunming, Yunan, China, 650118
Actively Recruiting
Research Team
H
Haiyun Zuo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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