Adlai Nortye signs trial deals with Lilly, Merck KGaA for AN4035-cetuximab study

Adlai Nortye Group Ltd. announced on October 15, 2026 that it had entered into clinical trial collaboration and supply agreements with Eli Lilly and Company and Merck KGaA, Darmstadt, Germany covering the anti-EGFR antibody cetuximab, marketed as ERBITUX.¹

The agreements back an existing Phase I study of AN4035, described as a pan-RAS(ON) inhibitor-based ADC being tested both alone and alongside cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors.¹ Adlai Nortye is the sponsor of the trial.¹

Under the supply terms, Lilly will provide cetuximab free of charge for the trial's U.S. sites¹, while Merck KGaA, Darmstadt, Germany will supply cetuximab at no cost for the Australia and China sites.¹

Dr. Archie Tse, the company's President and Head of Research & Development, said combining EGFR and RAS inhibition could be useful against RAS-driven cancers but noted that overlapping toxicities can limit systemic combinations, and that delivering the RAS(ON) inhibitor selectively through the ADC to CEACAM5-expressing tumors may widen the therapeutic window for the cetuximab pairing.¹

The ongoing global Phase I study is assessing AN4035's safety, tolerability, pharmacokinetics, pharmacodynamics, and early efficacy signals, both as a standalone treatment and combined with cetuximab, in tumors marked by high CEACAM5 levels and RAS pathway dependence.¹ The release noted that CEACAM5 tends to be elevated in colorectal, pancreatic, and lung cancers, cancer types where RAS mutations are common.¹ The monotherapy and combination arms will open on a staggered timeline.¹

The company describes AN4035 as a first-in-class ADC that targets CEACAM5 and carries a potent pan-RAS(ON) inhibitor payload.¹