New drug HLX48 enters first human trial for Hard-to-Treat cancers

NCT ID NCT07473726

Recruiting now Disease control Sponsor: Shanghai Henlius Biotech Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called HLX48 in 72 people with advanced or metastatic solid tumors that have not responded to standard treatments. HLX48 is designed to target two cancer-related proteins (EGFR and c-MET) and deliver a toxic payload directly to cancer cells. The main goals are to check safety, find the right dose, and see how the drug behaves in the body.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: HLX48 (a bispecific antibody-drug conjugate targeting EGFR and c-MET)
What this could lead to: If successful, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
What could go wrong: This is a very early Phase 1 trial with only 72 participants, focused on safety and dosing. It may not show strong anti-tumor effects, and side effects could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED/METASTATIC SOLID TUMORS

Contacts and locations

Locations

GenesisCare St.Leonards
NOT_YET_RECRUITING

Saint Leonards, New South Wales, 2065, Australia
Macquarie University
NOT_YET_RECRUITING

North Ryde, New South Wales, 2109, Australia
Peninsula and South Eastern Haematology and Oncology Group
NOT_YET_RECRUITING

Frankston, Victoria, 3199, Australia
Shanghai General Hospital
RECRUITING

Hongkou, Shanghai Municipality, 200080, China
Shanxi Provincial Cancer Hospital
NOT_YET_RECRUITING

Taiyuan, Shanxi, 030000, China
Sun Yat-Sen University Cancer Center
RECRUITING

Guangzhou, Guangzhou, 716099, China
Zhujiang Hospital of Southern Medical University
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510280, China

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