This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
The Angeles Clinic And Research Institute
Los Angeles, California, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
University Of Mississippi Medical Center
Jackson, Mississippi, United States
The University of Texas MD Anderson Cancer Center - Investigational Cancer Therapies
Houston, Texas, United States
Dose Limiting Toxicity (DLT)
Time frame: .Day 1 - Day 21
Treatment-related Adverse Events (TRAEs)
Time frame: Day 1 - 90 days after last administration
PK parameters
The area under the curve (AUC)
Time frame: Up to 90 days post last dose
PK parameters
Maximum concentration (Cmax)
Time frame: Up to 90 days post last dose
PK parameters
Time at which maximum concentration (Tmax)
Time frame: Up to 90 days post last dose
PK parameters
The half-life (t1/2)
Time frame: Up to 90 days post last dose
Positive rate of ADA and Nab
Time frame: Up to 90 days post last dose
Positive rate of Circulating Immune Complex
Time frame: Through study completion, an average of 1 year
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