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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
178
IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.
University of California, San Francisco (UCSF)
San Francisco, California, United States
RECRUITINGOcala Oncology Center
Ocala, Florida, United States
RECRUITINGObjective response rate (ORR)
Time frame: up to 2 years
Adverse Event (AE)
Time frame: Up to 90 days post last dose
Dose-limiting Toxicity (DLT)
Time frame: The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W.
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BRCR Medical Center
Plantation, Florida, United States
RECRUITINGUniversity of Kansas Medical Center (KUMC)
Fairway, Kansas, United States
RECRUITINGMichigan Hematology & Oncology Consultants - MedOnc Dearborn
Dearborn, Michigan, United States
RECRUITINGMichigan Hematology & Oncology Consultants - MedOnc Troy
Troy, Michigan, United States
RECRUITINGMD Anderson Cancer Center-University of Texas
Houston, Texas, United States
RECRUITINGOncology Consultants P.A.
Houston, Texas, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, United States
RECRUITING