This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
A Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody, HLX35 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle
Fudan University Shanghai Cancer Center
Shanghai, China
THE Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Incidence of Treatment-Related Adverse Events
Time frame: 2 years
The proportion of patients experiencing dose limiting toxicity (DLT) events
Time frame: from first dose to the end of Cycle 2 (each cycle is 14 days)
The maximum tolerated dose (MTD)
Time frame: from first dose to the end of Cycle 2 (each cycle is 14 days)
Recommended phase 2 dose (RP2D)
Time frame: from first dose to the end of Cycle 2 (each cycle is 14 days)
Peak plasma concentration (Cmax) of HLX35
Time frame: 2 years
Time to peak (Tmax) of HLX35
Time frame: 2 years
Area under the concentration-time curve (AUC) of HLX35
Time frame: 2 years
Elimination half-life (t1/2) of HLX35
Time frame: 2 years
Clearance (CL) of HLX35
Time frame: 2 years
Volume of distribution (Vz) of HLX35
Time frame: 2 years
Accumulation Index (Rac) of HLX35
Time frame: 2 years
4-1BB receptor occupancy on circulating T cells
Time frame: 2 years
The level of 4-1BB in serum
Time frame: 2 years
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.