Clinical TrialAug 3, 2026, 08:07 AM
Adlai Nortye Gets Approval for Phase I Clinical Trial of AN4035 in Australia
AI Summary
Adlai Nortye Ltd. announced the submission of a Clinical Trial Notification (CTN) to Australia's TGA and received Human Research Ethics Committee (HREC) approval to begin a Phase I clinical trial for AN4035. AN4035 is a first-in-class CEACAM5-targeting, pan-RAS(ON) inhibitor-based antibody drug conjugate (ADC) designed for CEACAM5-enriched RAS-addicted solid tumors. The company is also preparing IND submissions for the U.S. FDA and China NMPA, with patient dosing anticipated to start in the second half of 2026.
Key Highlights
- Adlai Nortye received HREC approval for a Phase I clinical trial of AN4035 in Australia.
- AN4035 is a first-in-class CEACAM5-targeting, pan-RAS(ON) inhibitor-based antibody drug conjugate (ADC).
- The trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy.
- AN4035 targets CEACAM5-enriched, RAS-addicted solid tumors, including colorectal, pancreatic, and lung cancers.
- Investigational New Drug (IND) applications are in process for the U.S. FDA and China NMPA.
- Patient dosing for AN4035 is expected to commence in the second half of 2026.
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