Evaluating IBI363 for advanced solid tumors

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

This study is testing a new treatment called IBI363 to see if it can help adults with advanced solid tumors like melanoma and lung cancer who have run out of other options.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (San Francisco, California and 8 other locations)
• Trial ID: NCT06281678 on ClinicalTrials.gov

What this trial studies

This Phase 2, open-label, multicenter study aims to assess the efficacy, safety, and tolerability of IBI363 in patients with advanced, refractory solid malignancies such as melanoma, non-small cell lung cancer, colorectal cancer, and renal cell cancer. Participants must be at least 18 years old and have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity. The study will exclude individuals with inadequate organ function or those who have recently undergone certain anti-tumor therapies. The trial is designed to provide insights into the potential benefits of IBI363 for patients with limited treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid malignancies and a performance status of 0 or 1.

Not a fit: Patients with inadequate organ function or those who have recently received specific anti-cancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced solid tumors who have exhausted other therapies.

How similar studies have performed: Other studies evaluating similar therapies have shown promise, but the specific approach of IBI363 in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of ≥ 3 months;

Exclusion Criteria:

1. Inadequate bone marrow and organ function;
2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.

Where this trial is running

San Francisco, California and 8 other locations

• University of California, San Francisco (UCSF) — San Francisco, California, United States (RECRUITING)
• Ocala Oncology Center — Ocala, Florida, United States (RECRUITING)
• BRCR Medical Center — Plantation, Florida, United States (RECRUITING)
• University of Kansas Medical Center (KUMC) — Fairway, Kansas, United States (RECRUITING)
• Michigan Hematology & Oncology Consultants - MedOnc Dearborn — Dearborn, Michigan, United States (RECRUITING)
• Michigan Hematology & Oncology Consultants - MedOnc Troy — Troy, Michigan, United States (RECRUITING)
• MD Anderson Cancer Center-University of Texas — Houston, Texas, United States (RECRUITING)
• Oncology Consultants P.A. — Houston, Texas, United States (RECRUITING)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Amanda Guo

Conditions: Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer, Renal Cell Cancer