Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
The goal of this clinical trial is to learn determine if AN9025 is safe and tolerable to treat solid cancer tumors with specific genetic mutations. It will help identify doses for use in future testing and establish the safety profile of the drug. The main questions it aims to answer are: Which dose(s) of AN9025 are safe and tolerable for use in evaluating anti-tumor activity in participants with Rat Sarcoma oncogene (RAS) mutated solid tumors? What medical problems do participants have when taking AN9025? Participants will: Take AN9025 by mouth every day or once a week until their disease progresses, they experience severe ill side effects from taking the drug, or withdraw from the study due to their own choice or as recommended by their physician. Visit the clinic 3-4 times during the first 21 days of treatment for study testing, blood draws and tumor tissue sample collection (if needed). The blood draws will be used to check drug levels in the participants blood for research purposes. Visit the clinic every 21 days for checkups and tests and monitoring of participant progress. Return to the clinic at 14 and 30 days after AN9025 treatment is stopped. Participants will be contacted every 3 months to check on the participants disease status and general well being. Participants may also partake in a food effect study, where the effect of eating is studied to see if there is any effect on AN9025 in the body.
Sponsor: Adlai Nortye Biopharma Co., Ltd.
You may qualify if…
- ✓ 1. Aged ≥18 years old at the time of informed consent.
- ✓ 2. Able to provide informed consent voluntarily before any study-related activities and according to local guidelines.
- ✓ 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- ✓ 4. Have an estimated life expectancy ≥ 12 weeks, in the judgment of the Investigator.
- ✓ 5. Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
- ✓ 6. Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory.
- ✓ Note: Participants with melanoma who have documented loss-of-function NF1 mutation and wild type KRAS/NRAS/HRAS/BRAF are also eligible for the backfill of Part 1 cohorts QD, QW.
- ✓ 7. Have consented to provide archival tumor tissue collected within 5 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
You may not qualify if…
- ✕ Participants meeting any of the following criteria will not be eligible for participation in the study.
- ✕ 1. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- ✕ 2. Have tumors previously tested positive for Class I BRAF mutations i.e. V600X.
- ✕ 3. Prior treatment with a pan-RAS(ON) inhibitor, ) except for participants enrolled in the backfill cohorts who have experienced radiological or clinical disease progression on prior pan-RAS(ON) inhibitor therapy.
- ✕ 4. Gastrointestinal conditions that may interfere with drug absorption (e.g., malabsorption syndrome, chronic nausea/vomiting, active inflammatory bowel disease).
- ✕ 5. Have a serious concomitant systemic disorder that, in the judgment of the Investigator, would compromise the participant's ability to adhere to the protocol, such as the following:
- ✕ 1. Known human immunodeficiency virus (HIV) infection per HIV 1 and/or 2 antibodies.
- ✕ 2. Participants with evidence of active Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody)
Where it's recruiting
Source: ClinicalTrials.gov · NCT07252479 · last updated 2026-06-08