NCT06210815

A Study of HLX42 in Advanced/Metastatic Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The first stage: This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42 with escalated doses in the treatment of patients with advanced/metastatic solid tumors. In this study, a 3 + 3 dose escalation method will be adopted, and the patients will be administered with HLX42 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first administration of HLX42. The second stage: This is a randimazation, open label, 2 arms, muticentral clinical study, about 30 patients in each arm, the total sample size is about 60. Eligible subjects will be randomized in a 1:1 ratio: Group A: HLX42 2.5 mg/kg; Group B: HLX42 2.0 mg/kg. Stratification: tumor tissue type(adenocarcinoma or squamous carcinoma), EGFR-sensitive mutation status (mutant or wild-type or missing).

Conditions

• Solid Tumor and NSCLC

Interventions

Type	Name	Description
DRUG	HLX42	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.

Timeline

• Start date: 2024-03-14
• Primary completion: 2026-09-02
• Completion: 2027-06-14
• First posted: 2024-01-18
• Last updated: 2025-09-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study