A Study of IBI363 in Subjects with Advanced Solid Malignancies

Recruiting now · Phase 2

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

In brief

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

Key facts

Study ID

NCT06281678

Run by

Innovent Biologics (Suzhou) Co. Ltd.

People needed

178

Starts

2024-04-08

Expected to finish

2026-12-31

Last updated by the study team

2024-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Male or female subjects ≥ 18 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
• Anticipated life expectancy of ≥ 3 months;

You may not qualify if…

• Inadequate bone marrow and organ function;
• 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
• Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
• 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;
• 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 is running

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

Full record on ClinicalTrials.gov

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