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New treatment option for Solid Tumors (Phase 1)
Official title Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
ClinicalTrials.gov ID: NCT07252479
What this study is testing
What is AN9025 oral capsule?
AN9025 oral capsule is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for solid tumors (phase 1).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥18 years old at the time of informed consent.
- Able to provide informed consent voluntarily before any study-related activities and according to local guidelines.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have an estimated life expectancy ≥ 12 weeks, in the judgment of the Investigator.
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available...
You likely can't join if
- Participants meeting any of the following criteria will not be eligible for participation in the study.
- Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically...
- Have tumors previously tested positive for Class I BRAF mutations i.e. V600X.
- Prior treatment with a pan-RAS(ON) inhibitor, ) except for participants enrolled in the backfill cohorts who have experienced radiological or...
- Gastrointestinal conditions that may interfere with drug absorption (e.g., malabsorption syndrome, chronic nausea/vomiting, active inflammatory bowel...
- Have a serious concomitant systemic disorder that, in the judgment of the Investigator, would compromise the participant's ability to adhere to the...
See the full eligibility criteria
Who can join
- Aged ≥18 years old at the time of informed consent.
- Able to provide informed consent voluntarily before any study-related activities and according to local guidelines.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Have an estimated life expectancy ≥ 12 weeks, in the judgment of the Investigator.
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
- 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...
- 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.
- Part 1 Dose-Escalation and Part 2 Food Effect Assessment: cancers including, but not limited to:
- Pancreatic ductal adenocarcinoma (PDAC)
- Colorectal cancer (CRC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous melanoma
- Biliary tract cancer (BTC)
- Part 3 Dose-Expansion: Cohort 3A: RAS-mutated solid tumors (2L/3L)
- Histologically or cytologically confirmed advanced or metastatic disease
- Participants must not have tumors previously tested positive for targetable oncogenic driver mutations including Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), B-Rapidly Accelerated...
- Participants must have received 1 or 2 prior lines of systemic therapy which include prior immune checkpoint inhibitor and platinum chemotherapy administered either concurrently or sequentially, and have not received...
- Participants must be refractory to anti-PD-1/PD-L1 therapy.
- Adjuvant therapy or multimodal therapy with curative intent is considered prior therapy if disease progression occurred or treatment completion was within 6 months of first dose of AN9025.
- Participants must not have tumors previously tested positive for Class I BRAF mutations i.e. V600X.
- Have adequate organ functions prior to enrollment:
- ANC: \>= 1.5 x 10\^9/L
- Platelets: \>= 100x 10\^9/L
- Hemoglobin: \>= 9.0 g/dL
- AST and ALT: \<= 2.5 x Upper Limit of Normal (ULN) or ,+ x ULN if liver metastases are present
- Total bilirubin: \<= 1.5 x ULN
- Creatinine clearance (CrCl): CrCl \>= 50 ml/min as determined by Cockcroft-Gaulat formula
- International Normalized Ratio (INR) or prothrombin (PT) time or activated partial thromboplastin time (aPTT): PT or aPTT \<= 1.5 x ULN or INR \< 1.5
- Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1 (except for alopecia, and endocrinopathies that are managed with replacement therapy), and all clinically...
- Corrected QT interval (QTc) ≤ 470 msec for females and ≤ 450 msec for males per the Fridericia's Formula (QTcF).
- Able to swallow oral medication and comply with study requirements.
- Left ventricular ejection fraction (LVEF) greater than 50% on echocardiography or multiple gated acquisition (MUGA) scan.
- Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study treatment administration. Women of childbearing...
What rules you out
- Participants meeting any of the following criteria will not be eligible for participation in the study.
- 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.
- Have tumors previously tested positive for Class I BRAF mutations i.e. V600X.
- 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.
- Gastrointestinal conditions that may interfere with drug absorption (e.g., malabsorption syndrome, chronic nausea/vomiting, active inflammatory bowel disease).
- 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:
- Known human immunodeficiency virus (HIV) infection per HIV 1 and/or 2 antibodies.
- Participants with evidence of active Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody)
- Active tuberculosis, fungal infection
- 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
- 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...
- 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...
- Moderate or severe cardiovascular disease, such as the following:
- congestive heart failure
- New York Heart Association Class III/IV heart disease
- unstable angina pectoris
- myocardial infarction or cardiovascular event within the last 6 months before enrollment
- valvulopathy that is severe, moderate, or deemed clinically significant
- arrhythmias that are symptomatic or require treatment (not including Participants with rate-controlled supraventricular tachycardia)
- a history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT syndrome)
- require the use of concomitant medications that prolong the QT/QTc interval
- Have symptomatic central nervous system (CNS) malignancy or metastasis.
- 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...
- 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...
- 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...
- Known allergic reaction against any of the components of the study treatments.
- Current use of drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4) including herbal medications.
- Current use of drugs known to be of P-glycoprotein (P-gp) inhibitors.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Tampa, Florida, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Tampa, Florida, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.