Evaluating IBI363 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Amanda Guo
• Email: amanda.guo@innoventbio.com
• Phone: 1-832-207-5244

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.