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)
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
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.
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