NCT04169178

Evaluate Safety, Tolerability and PK of HLX55 in Patients With Advanced Solid Tumors With Different cMET Status

A Phase 1 Dose Finding/Expansion Study of HLX55, A Monoclonal Antibody Targeting Tyrosine-Protein Kinase MET (C-MET) in Patients With Advanced Solide Tumors Refactory to Standard Therapy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Henlix, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	HLX55	A humanized IgG2 monoclonal antibody targeting tyrosine-protein kinase MET (c-MET)

Timeline

• Start date: 2020-03-03
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-11-19
• Last updated: 2020-05-01

Locations

4 sites across 1 country: Taiwan