A Study of IBI363 in Subjects With Advanced Melanoma
A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma
1 other identifier
interventional
150
1 country
12
Brief Summary
This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2023
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedMay 16, 2025
May 1, 2025
1.6 years
October 7, 2023
May 14, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
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
Secondary Outcomes (4)
OS（overall survival）
2 years
PK concentration: IBI363 serum concentration
2 years
ADA (Anti-drug antibody)
2 years
Nab (Neutralizing antibody)
2 years
Study Arms (1)
IBI363
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
- At least one measurable lesion (target lesion) per 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 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.
You may not qualify if:
- Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug.
- Active or symptomatic central nervous system metastasis.
- 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.
- 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.
- 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).
- 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.
- Uncontrolled bleeding or known tendency to bleed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking University Cancer Hospital & Institute, Beijing, China,
Beijing, Beijing Municipality, 100142, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350000, China
The Third people's hospital of Zhengzhou
Zhengzhou, Henan, 450044, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
The first affiliated hospital of Nanchang university
Nanchang, Jiangxi, 330052, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The first hospital of Jilin University
Changchun, Jilin, 130021, China
Qilu Hospital of Shandong university
Jinan, Shandong, 250012, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Yunan Cancer Hospital
Kunming, Yunan, 650118, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2023
First Posted
October 13, 2023
Study Start
October 19, 2023
Primary Completion
June 6, 2025
Study Completion (Estimated)
July 31, 2026
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share