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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04169178
Study type Interventional
Source Henlix, Inc
Contact PeiZhi Lu
Phone +886-2-792-7927
Email plu@henlix.com
Status Recruiting
Phase Phase 1
Start date March 3, 2020
Completion date December 2022

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