Actively Recruiting
Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Led by Adlai Nortye Biopharma Co., Ltd. · Updated on 2026-02-11
91
Participants Needed
2
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of informed consent
- Able to voluntarily provide informed consent according to local guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Estimated life expectancy of at least 12 weeks as judged by the Investigator
- Histological or cytological confirmation of advanced or metastatic cancer with progression after standard treatments
- Documented KRAS, NRAS, or HRAS mutation by validated testing of tumor tissue or circulating free DNA
- Consent to provide archival tumor tissue collected within 5 years or a new biopsy of a tumor lesion not previously irradiated
- For Part 1 and Part 2: cancers including pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer, cutaneous melanoma, or biliary tract cancer
- For Part 3 Dose-Expansion Cohort 3A: histologically or cytologically confirmed advanced or metastatic RAS-mutated solid tumors without targetable oncogenic driver mutations (EGFR, ALK, BRAF, RET, ROS1)
- Prior 1 or 2 lines of systemic therapy including immune checkpoint inhibitors and platinum chemotherapy without prior docetaxel
- Refractory to anti-PD-1/PD-L1 therapy
- Adjuvant or multimodal therapy considered prior therapy if disease progression occurred or treatment completed within 6 months before first AN9025 dose
- No tumors positive for Class I BRAF mutations (V600X)
- Adequate organ function including ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9.0 g/dL, AST and ALT ≤ 2.5 x ULN (or higher if liver metastases), total bilirubin ≤ 1.5 x ULN, creatinine clearance ≥ 50 ml/min, and acceptable coagulation tests
- All prior cancer treatments discontinued with resolution of adverse events to Grade 1 or less (except alopecia and managed endocrinopathies) before enrollment
- Corrected QT interval ≤ 470 msec for females and ≤ 450 msec for males
- Able to swallow oral medication and comply with study requirements
- Left ventricular ejection fraction greater than 50%
- Fertile men and women of childbearing potential agree to use effective birth control during and for 180 days after treatment; women must have a negative pregnancy test within 14 days before first dose
You will not qualify if you...
- Currently enrolled in another clinical study with an investigational product or incompatible research
- Tumors previously tested positive for Class I BRAF mutations (V600X)
- Prior treatment with a pan-RAS(ON) inhibitor
- Gastrointestinal conditions that may affect drug absorption such as malabsorption syndrome, chronic nausea/vomiting, or active inflammatory bowel disease
- Serious systemic disorders that may compromise adherence including known HIV infection, active Hepatitis B or C, active tuberculosis or fungal infection, and active infections requiring IV antibiotics
- Serious pre-existing medical conditions including interstitial lung disease, severe dyspnea at rest, or need for oxygen therapy
- Prior or concurrent second primary malignancies that might affect study results, except certain low-risk or remitted cancers
- Moderate or severe cardiovascular disease including congestive heart failure, advanced heart disease, recent myocardial infarction, significant valvulopathy, symptomatic arrhythmias, risk factors for Torsades de Pointes, or use of medications that prolong QT interval
- Symptomatic central nervous system malignancy or metastasis
- Pregnant or planning pregnancy or breastfeeding during study or within 6 months after last dose
- Conditions, therapies, or lab abnormalities that may confound study results or interfere with participation
- Use of herbal supplements, traditional medicines, or prescription drugs that may interact with the study drug
- Known allergy to study treatment components
- Current use of drugs that strongly affect cytochrome P450 3A4 or P-glycoprotein
- Inability to stop proton pump inhibitors for at least 5 days before first dose or during study
- Likely inability to complete all study visits or comply with procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
C
Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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