This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
A Recombinant Humanized Anti-EGFR Monoclonal Antibody, HLX07 will be administered as a single intravenous (IV) infusion on Day 1 in each 3-week cycle
Fudan University shanghai cancer center
Shanghai, China
The 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 1 (each cycle is 21 days)
The maximum tolerated dose (MTD)
Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)
Peak plasma concentration (Cmax) of HLX07
Time frame: 2 years
Time to peak (Tmax) of HLX07
Time frame: 2 years
Area under the concentration-time curve (AUC) of HLX07
Time frame: 2 years
Elimination half-life (t1/2) of HLX07
Time frame: 2 years
Clearance (CL) of HLX07
Time frame: 2 years
Volume of distribution (Vz) of HLX07
Time frame: 2 years
Accumulation Index (Rac) of HLX07
Time frame: 2 years
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
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Disease control rate (DCR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years