NCT07473726

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX48 (EGFR/c-MET Bispecific Antibody-Drug Conjugate) in Participants With Advanced/Metastatic Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (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, tolerability, and pharmacokinetic characteristics of HLX48 in patients with advanced/metastatic solid tumors.

Detailed description

This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX48 with escalated doses in the treatment of participants with advanced/metastatic solid tumors. In this study, a 3+3 dose escalation method will be adopted, and the participants will be administered HLX48 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first dose of HLX48. To ensure the safety of participants, the Safety Review Committee (SRC) will review all safety data from all participants in the current cohort before deciding to proceed to the next cohort to include more participants. The SRC will review all safety data collected in the cohort to confirm that there are no unexpected, significant, or unacceptable risks to participants. Based on the evaluation results, the SRC will make recommendations on participant eligibility and dose levels, and vote on whether to start enrollment and treatment for the next cohort. If necessary, the investigator and the sponsor will discuss the need to add a new dose group based on the available data on safety, tolerability, PK, immunogenicity, and efficacy. If a participant withdraws from the study within the DLT observation period due to reasons other than therapeutic toxicity, he/she will be replaced by a new participant.

Conditions

• Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	HLX48	EGFR/c-MET Bispecific Antibody-Drug Conjugate

Timeline

• Start date: 2026-05-17
• Primary completion: 2027-03-01
• Completion: 2028-08-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China