AN9025 for Advanced Solid Tumors with RAS Mutations

This study is testing a new oral medication called AN9025 for people with advanced or metastatic (spread) solid tumors that have a specific genetic change called a RAS mutation. AN9025 works by targeting RAS proteins in cancer cells. The main goals are to find a safe and tolerable dose of AN9025 and understand its side effects. To join, you must be at least 18 years old, have a good general health status (ECOG Performance Status of 0 or 1), and an estimated life expectancy of at least 12 weeks. Researchers are looking for people whose tumors have specific biomarkers like KRAS or NRAS mutations. You will take AN9025 by mouth daily or weekly until your cancer progresses or side effects become too severe.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves increasing doses of AN9025 to find the safest and most effective amount, and plans to enroll 118 participants.
What's involved
You will take AN9025 by mouth every day or once a week. You will continue taking the medication until your disease gets worse, you experience severe side effects, or you choose to stop.
Compensation
Not stated in the trial record.
Follow-up
The study will measure dose-limiting toxicities (severe side effects) for 21 days after your first dose.

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NCT07252479

Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations

Recruiting
PHASE1Ages 18+InterventionalTreatment
Adlai Nortye Biopharma Co., Ltd.
~118 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:AN9025 oral capsule

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
• Nature and frequency of dose limiting toxicities (DLTs)
Measured over 21 days after first dose
Solid Tumors (Phase 1)
RAS Mutation
3 sites across 2 states
Florida2
Texas1

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  • • Nature and frequency of dose limiting toxicities (DLTs)21 days after first dose

    • Incidence, nature, and severity of adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0