AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

A Study of IBI363 in Subjects With Advanced Melanoma

RecruitingPhase 2Ages 18 Years - anyAllInnovent Biologics (Suzhou) Co. Ltd.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ร— 109/L; Platelet count\<100 ร— 109/L. 4. At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin\>1.5 ร— ULN; AST or ALT\>3 ร— ULN; If it is tumor liver metastasis, AST or ALT\>5.0 ร— ULN; Serum creatinine\>1.5 ร— 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 ร— ULN (\>3 if receiving anticoagulant therapy with stabilizer dosage) ร— ULN); PTT (or activated partial thromboplastin time (aPTT))\>1.5 ร— ULN (\>3 if receiving anticoagulant therapy with stabilizer dosage) ร— 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.
๐Ÿ’Š

What it tests

  • IBI363
๐Ÿ“

Where

12 sites
Beijing Cancer Hospital
Beijing, China
Peking University Cancer Hospital & Institute, Beijing, China,
Beijing, China
Fujian Cancer Hospital
Fuzhou, China
The Third people's hospital of Zhengzhou
Zhengzhou, China
Hunan Cancer Hospital
Changsha, China
Nanjing Drum Tower Hospital
Nanjing, China
The first affiliated hospital of Nanchang university
Nanchang, China
Jilin Cancer Hospital
Changchun, China

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy