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New treatment option for Melanoma
Official title A Study of IBI363 in Subjects With Advanced Melanoma
ClinicalTrials.gov ID: NCT06081920
What this study is testing
What is IBI363?
IBI363 is an investigational medicine, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on...
- 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 people of childbearing age or male people whose partners are female people of childbearing age agree to strictly adopt effective contraceptive...
You likely can't join if
- Pregnant or lactating people, or people 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...
- At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin\>1.5 × ULN; AST...
- At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR\>1.5 × ULN (\>3 if...
- History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational...
See the full eligibility criteria
- 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...
- 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 people of childbearing age or male people whose partners are female people of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after...
- Pregnant or lactating people, or people 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...
- 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 ×...
- 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...
- 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...
- Uncontrolled bleeding or known tendency to bleed.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Jinan, Shandong, China
- Taiyuan, Shanxi, China
- Kunming, Yunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Zhengzhou, Henan, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Nanchang, Jiangxi, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.