A mutilpe-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX55 in patients with advanced solid tumors overexpressing/Mutation/Amplification cMET after failure of standard of care.
This study is an open-label and dose escalation study including dose finding stage and expansion stage. In dosing finding stage, the study will precede in two phases, (i) a modified accelerated titration design 2A (ATD 2A) phase and (ii) a traditional 3+3 dose escalation phase aimed at exploring the safety and MTD of HLX55. Four dose levels are designed for HLX55 in this stage: 2.5, 5, 15, and 25 mg/kg/3 weeks. The 5 mg/kg/3 weeks will serve as the starting dose. In the dose-expansion stage, three to five cohorts are planned, and different cohorts will evaluate the efficacy of HLX55 for potential indications. Maximum 20 patients will be accrued in each cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
A humanized IgG2 monoclonal antibody targeting tyrosine-protein kinase MET (c-MET)
National Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGTri-Service General Hospital
Taipei, Taiwan
RECRUITINGTaipei Minicipal Wangfang Hospital
Taipei, Taiwan
RECRUITINGDose finding stage-safety
Numbers and percentage of patients with adverse events (AEs).
Time frame: Up to 2 years
Dose finding stage-MTD or RP2D
The maximum tolerated dose and recommended phase 2 dose (RP2D) of HLX55.
Time frame: Up to 2 years
Dose expansion stage-safety
Numbers and percentage of patients with adverse events (AEs).
Time frame: Up to 2 years
Dose expansion stage-efficacy
Disease control rate (DCR).
Time frame: Up to 2 years
Dose expansion stage-efficacy
Overall response rate (ORR).
Time frame: Up to 2 years
Dose expansion stage-efficacy
Duration of response (DOR).
Time frame: Up to 2 years
Dose finding stage and dose expansion stage-PK profile
PK profile of HLX55 including maximum concentration (Cmax), minimum concentration (Cmin), area under concentration (AUC0-tau), half-life (T1/2), clearance (CL) rate and the volume of distribution at steady state (Vss) at different doses.
Time frame: Through study completion, up to 2 years.
Dose finding stage and dose expansion stage-serum HGF levels
Changes in serum HGF levels before and at different time-points after HLX55 treatment.
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Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
Taipei County, Taiwan
RECRUITINGTime frame: Cycle 1 to 3 (each cycle is 21 days)
Dose finding stage and dose expansion stage-immunogenicity
The presence and percentage of anti-HLX55 antibody-positive patients (immunogenicity) by measurement of anti-HLX55 antibodies in serum.
Time frame: Up to 2 years