Adlai Nortye (ANL) said it has submitted a clinical trial notification to Australia's Therapeutic Goods Administration and received approval from the Human Research Ethics Committee to begin a phase 1 trial of AN4035.

The global trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AN4035, both as a monotherapy and in combination with cetuximab, in patients with CEACAM5-enriched, RAS-addicted solid tumors.

AN4035 is a CEACAM5-targeting antibody-drug conjugate built around a pan-RAS(ON) inhibitor payload.

The company expects to begin dosing patients in the second half of the year.

Adlai Nortye also said it is filing investigational new drug applications for AN4035 with the US Food and Drug Administration and China's National Medical Products Administration.