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

Exclusion Criteria

• •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.
• •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)
• •3. Active tuberculosis, fungal infection
• •4. Active infection requiring intravenous antibiotic therapy. Use of oral antibiotics for minor infections (e.g., uncomplicated UTI or URI) is permitted if clinically stable, at the Investigator's discretion
• •6. The participant has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including interstitial lung disease (ILD), severe dyspnea at rest, or requiring oxygen therapy.
• •7. Prior or second concurrent primary malignancies that, in the judgment of the Investigator, may affect the interpretation of results. Participants with carcinoma in situ of any origin and participants with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the Investigator, or malignancies that don't need treatment (i.e., small renal cell carcinoma \[RCC\] and localized prostate cancer) are eligible for this study.
• •8. Moderate or severe cardiovascular disease, such as the following:
• •1. congestive heart failure
• •2. New York Heart Association Class III/IV heart disease
• •3. unstable angina pectoris
• •4. myocardial infarction or cardiovascular event within the last 6 months before enrollment
• •5. valvulopathy that is severe, moderate, or deemed clinically significant
• •6. arrhythmias that are symptomatic or require treatment (not including Participants with rate-controlled supraventricular tachycardia)
• •7. a history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT syndrome)
• •8. require the use of concomitant medications that prolong the QT/QTc interval
• •9. Have symptomatic central nervous system (CNS) malignancy or metastasis.
• •10. Are pregnant or planning to become pregnant during the study or within 6 months following the last dose of AN9025. Plan to be breastfeeding from the initial dose of study treatment or within 6 months following the last dose of AN9025.
• •11. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
• •12. Use of other herbal supplements, traditional medicines, or prescription medications that are known or suspected to interact with the investigational product or effect disease treatment/side effect management, as determined by the study Investigator.
• •13. Known allergic reaction against any of the components of the study treatments.
• •14. Current use of drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4) including herbal medications.
• •15. Current use of drugs known to be of P-glycoprotein (P-gp) inhibitors.
• •16. Participants who are unable to discontinue proton pump inhibitors (PPIs) for at least 5 days prior to the first dose of AN9025, or unable to abstain from PPI use throughout the study treatment period.
• •17. Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and Investigator's knowledge.