CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 102 target
Drug / intervention
HLX42drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06210815
NCT06210815Phase 1RecruitingOn TrackUpdated 9mo ago

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX42 (Anti-EGFR ADC) in Patients With Advanced/Metastatic Solid Tumors

Shanghai Henlius Biotech·interventional·Posted Jan 18, 2024·Updated Sep 22, 2025

In Brief

A Phase 1 clinical trial evaluating HLX42 for Solid Tumor and NSCLC. Currently recruiting, targeting 102 participants across 1 site.

Detailed Summary

This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1Recruiting
2024202520262027
First PostedJan 18, 2024
Enrollment StartMar 14, 2024
Primary CompletionSep 2, 2026
Study CompletionJun 14, 2027
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 2.5 years agoPrimary completion in 2 months

Interventions

HLX42drug

HLX42 is an anti-EGFR monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.