This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
167
BA1302 administered intravenously
Beijing Cancer Hospital
Beijing, China
RECRUITINGNumber of participants with dose limiting toxicities
Time frame: Up to 21 days
adverse events
Time frame: Through 28 days after the last study treatment
Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)
Time frame: Up to approximately 1 years
AUC from time zero to infinity (AUC0-inf)
Time frame: Up to approximately 1 years
Maximum serum concentration (Cmax)
Time frame: Up to approximately 1 years
Elimination half-life (t1/2)
Time frame: Up to approximately 1 years
Area under the concentration-time curve (AUC) at steady state
Time frame: Up to approximately 1 years
Incidence of anti-drug antibodies (ADA)
Time frame: Up to approximately 1 years
Objective response rate (ORR)
Time frame: Up to approximately 1 years
Duration of objective response (DOR)
Time frame: Up to approximately 1 years
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