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Adlai Nortye Doses First Patient in Phase I Trial for Solid Tumors

Adlai Nortye Doses First Patient in Phase I Trial for Solid Tumors

MT newswireMT newswire2026/09/08 11:53
07:53 AM EDT, 09/08/2026 (MT Newswires) -- Adlai Nortye (ANL) has dosed the first patient in Australia in a global Phase I trial of AN4035 as a potential treatment for CEACAM5-enriched, RAS-addicted solid tumors, the company said Tuesday. The company also received a "Study-May-Proceed" letter from the US Food and Drug Administration on its investigational new drug application for AN4035, clearing the way to expand the trial to the US, the company said. The Phase I trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AN4035 as both a monotherapy and in combination with cetuximab, the company said. Shares of the company were up 1.3% in recent premarket trading.
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