Adlai Nortye Doses First U.S. Patient in Phase 1 Pan-RAS Inhibitor Trial
Adlai Nortye dosed the first U.S. patient in its global Phase 1 study of AN9025, an oral pan-RAS(ON) inhibitor targeting advanced solid tumors with RAS mutations. The multicenter trial, conducted in collaboration with ASK Pharm under a regional license agreement, will assess safety, pharmacokinetics and anti-tumor activity.
1. U.S. Patient Dosing Milestone
In early February, Adlai Nortye administered the first dose of AN9025 to a U.S. patient as part of its global Phase 1 trial, marking the company’s entry into human testing for its oral pan-RAS(ON) inhibitor.
2. Phase 1 Trial Design
The first-in-human, open-label, multicenter study will enroll patients with advanced or metastatic solid tumors harboring RAS mutations and will evaluate safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of AN9025.
3. Collaboration and Licensing
The trial is being conducted as a multi-regional clinical trial under a license agreement with ASK Pharm, under which Adlai Nortye retains ex-China rights while ASK Pharm holds rights in mainland China, Hong Kong and Macao.
4. Next Steps and Timeline
Adlai Nortye plans to expand dosing cohorts across multiple centers worldwide, with initial safety and PK data expected later this year to guide dose escalation and future trial phases.