Evaluating IBI363 for advanced melanoma treatment

A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma

This study is testing a new treatment called IBI363 to see if it can help people with advanced melanoma who haven't had success with other therapies.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 12 sites (Beijing, Beijing Municipality and 11 other locations)
• Trial ID: NCT06081920 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase II study aims to assess the safety, tolerability, and efficacy of IBI363 in patients with advanced melanoma. Participants must have unresectable, locally advanced, or metastatic melanoma that has progressed after at least one prior systemic treatment. The study will measure the response of at least one measurable lesion according to RECIST criteria. The trial is designed to provide insights into the potential benefits of IBI363 for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable, locally advanced or metastatic melanoma who have experienced progression after first-line treatment.

Not a fit: Patients with active central nervous system metastasis or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced melanoma.

How similar studies have performed: Other studies have explored treatments for advanced melanoma, but the specific approach with IBI363 is novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 11 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Cancer Hospital & Institute, Beijing, China, — Beijing, Beijing Municipality, China (Recruiting)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• The Third people's hospital of Zhengzhou — Zhengzhou, Henan, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• The first affiliated hospital of Nanchang university — Nanchang, Jiangxi, China (Recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Recruiting)
• The first hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Qilu Hospital of Shandong university — Jinan, Shandong, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
• Yunan Cancer Hospital — Kunming, Yunan, China (Recruiting)

Study contacts

• Study coordinator: Haiyun Zuo

Conditions Melanoma