RecruitingPhase 1NCT06210815

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


Sponsor

Shanghai Henlius Biotech

Enrollment

102 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called HLX42 in patients with advanced or metastatic solid tumors (various cancer types) that have stopped responding to standard treatments. The trial first finds a safe dose, then evaluates effectiveness in specific tumor types. **You may be eligible if...** - You are between 18 and 75 years old with a confirmed advanced or metastatic solid tumor - Your cancer has progressed on or you cannot tolerate standard treatments - You are in adequate general health - You have measurable or evaluable tumor lesions **You may NOT be eligible if...** - You have active brain metastases that are uncontrolled - You have serious heart, liver, or immune conditions - You have received recent prior treatments that conflict with this drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX42

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.


Locations(1)

Guangdong Provincial People's Hospital

Guangdong, Guangzhou, China

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NCT06210815