Clinical TrialAug 3, 2026, 07:03 AM
Adlai Nortye AN4035 Phase I Clinical Trial Approved in Australia
AI Summary
Adlai Nortye announced that its first-in-class pan-RAS(ON) ADC, AN4035, has received approval from Australia's Human Research Ethics Committee (HREC) and submitted a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration (TGA) to commence a Phase I clinical trial. This global trial will evaluate AN4035 for CEACAM5-enriched RAS-addicted solid tumors, both as monotherapy and in combination with cetuximab. The company is also filing Investigational New Drug (IND) applications with the U.S. FDA and China NMPA, with patient dosing expected to begin in the second half of 2026.
Key Highlights
- AN4035 Phase I clinical trial approved by Australia's HREC and CTN submitted to TGA.
- IND applications for AN4035 are in process with U.S. FDA and China NMPA.
- AN4035 is a first-in-class CEACAM5-targeting, pan-RAS(ON) inhibitor-based ADC.
- The trial targets CEACAM5-enriched RAS-addicted solid tumors.
- Patient dosing for AN4035 is expected to begin in the second half of 2026.
- AN4035 is the first pan-RAS(ON) ADC to enter the clinic globally.
- The drug demonstrates proof-of-concept for the company's RASiCA™ platform.
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