This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3902 in patients with mCRPC and other advanced solid tumours.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
HLX3902 will be administered as an intravenous (IV) infusion.
Dose-Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 4 weeks)
maximum tolerated dose (MTD)
Time frame: Up to approximately 2 years
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Objective response rate (ORR)
Time frame: Up to approximately 2 years
disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Prostate-specific antigen (PSA) response
Time frame: Up to approximately 2 years
PK parameters of HLX3902
Time frame: Up to approximately 2 years
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) against HLX3902
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Time frame: Up to approximately 2 years
PD biomarkers, including peripheral blood cytokines (e.g., IL-2, IL-6, TNF-α, and IFN-γ) and peripheral T-cell activation and proliferation.
Time frame: Up to approximately 2 years