A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies
Summary
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.
Arms & interventions
- DrugIBI363
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.
Outcome measures
Primary
Objective response rate (ORR)
Time frame: up to 2 years
Secondary
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.
Eligibility criteria
Study locations (9)
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Ocala Oncology Center
Ocala, Florida, 34474
BRCR Medical Center
Plantation, Florida, 33322
University of Kansas Medical Center (KUMC)
Fairway, Kansas, 66205
Michigan Hematology & Oncology Consultants - MedOnc Dearborn
Dearborn, Michigan, 48126
Michigan Hematology & Oncology Consultants - MedOnc Troy
Troy, Michigan, 48098
MD Anderson Cancer Center-University of Texas
Houston, Texas, 77025
Oncology Consultants P.A.
Houston, Texas, 77030
Fred Hutchinson Cancer Center
Seattle, Washington, 98109