Solid Tumors (Phase 1)Phase 1NCT07252479
Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
A Phase 1 study testing AN9025 oral capsule in people with Solid Tumors (Phase 1) and RAS Mutation, run by Adlai Nortye Biopharma Co., Ltd. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors (Phase 1), RAS Mutation
- What is being tested?
- AN9025 oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jan 2026to 1 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
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- 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.
- 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 Fibrosarcoma (BRAF), RET, and ROS1
- 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 docetaxel previously
- 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 significant toxicities from prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy to ≤ Grade 1 prior to enrollment.
- 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 potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 14 days prior to the first dose of the study treatment.
Who cannot join
- 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:
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- 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, or requiring oxygen therapy.
- 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.
- 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 dose of AN9025.
- 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.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Hong, MD, 8776326789, Toshiwa.Bryant@ergomedgroup.com
- Recruiting
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
Lead Study Coordinator, 904-380-2410, stephanie.davis@scri.com
- Not yet recruiting
H. Lee Moffit Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, 33612-9497
Kevin Executive Director, 848 230-7430, AN9025S0101@adlainortye.com
About this study
Official title: A Multi-center, Open-label, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AN9025 in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
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?
Read more
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.
Read the detailed description
This is a first-in-human, open label, multi-center, multiple-ascending dose escalation, phase I study consisting of three parts: Part 1 Dose-Escalation, Part 2 Food Effect Assessment and Part 3 Dose-Expansion (See Figure 1, Figure 2, Figure 3 and Figure 4). The study is designed to evaluate the safety, tolerability, PK, and preliminary efficacy of AN9025, an oral pan-RAS (ON) inhibitor, in participants with advanced or metastatic solid tumors that harbor RAS mutations. In addition, the effect of food intake on the PK of AN9025 will be preliminarily investigated. The study will be conducted in the United States and China.
Part 1 Dose-Escalation is designed to identify the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) in participants with advanced or metastatic RAS-mutant solid tumors. Participants will be evaluated for Dose-limiting Toxicities (DLTs) in escalating dose and back fill cohorts. Participants enrolled in escalating dose cohorts will receive AN9025 with continuous once daily (QD) dosing or once weekly (QW) dosing in 21-day cycles. Participants enrolled in back fill cohorts will start with a single lead-in dose of AN9025 at least 5 days prior to initiating continuous QD dosing to enable PK sampling during the Single-Dose Lead-in period (Cycle 0). Following the Lead-in period, back fill participants will begin Cycle 1 Day 1 of the standard QD or QW 21-day cycle treatment (Figure 3 A).
Part 2 Food Effect Assessment will employ a single-sequence, two-period crossover design in at least 6 participants. Participants will begin with a Food Effect Lead-in period (Cycle 0), receiving a single-dose of AN9025 (at a selected dose level lower than the MTD) under fasting condition, followed by PK sample collection and a washout period. A second single-dose will then be administered under fed conditions, with additional PK sampling and another washout period. Upon completing this lead-in period, participants will transition to the main study treatment, initiating QD dosing from Cycle 1 Day 1 in 21-day cycles (Figure 3 B).
Part 3 Dose-Expansion will evaluate the clinical activity of AN9025 in up to two RAS-mutated solid tumor indications using up to two dose levels selected based on the MTD/RDE established during dose escalation. This phase will further characterize the safety, tolerability, and PK of AN9025 in selected tumor types.
- Conditions
- Solid Tumors (Phase 1), RAS Mutation
- Being tested
- AN9025 oral capsule
- Keywords
- RAS, RAS (ON), RAS Solid Tumor, KRAS G12X(C/D/V), KRAS G13D, NRAS Q61X(L/K), Oral Pan RAS medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN9025 oral capsuleDrug
AN9025 is a novel, oral, small molecule pan-RAS (ON) inhibitor that binds cyclophilin A (CypA) with a slow dissociation rate, forming a tri-complex with guanosine triphosphate (GTP) bound state of both mutant and wild-type RAS proteins. AN9025 exhibits potent anti-proliferative activity in RAS-addicted cancer cell lines, demonstrates favorable pharmacokinetics (PK), pharmacodynamics and an acceptable tolerability profile in vivo.
| Study group | Role | What they receive |
|---|---|---|
| AN9025 Treatment | Experimental | Oral administration of AN9025 capsules Receives: Drug: AN9025 oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Nature and frequency of dose limiting toxicities (DLTs)
- Incidence, nature, and severity of adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 21 days after first dose
Secondary outcomes (9)
Preliminary anti-tumor activity:Objective response rate (ORR)
- Measure the Objective response rate (ORR)
Measured: Tumor assessments will occur at baseline and then every 6 weeks starting from Cycle 3, Day 1 up to Cycle 9, Day 1 and then every 12 weeks thereafter (± 1 week window), through study completion, for an average duration of 1 year
• Characterization of the PK profile of AN9025 following administration as an oral capsule formulation
- The assessment will include, but not limit to, the following PK parameters for AN9025
- AUC(inf) after single dose and AUC (0-τ) after single and multiple doses Maximum blood concentration (Cmax)
Measured: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
•Characterization of the PK profile of AN9025 following administration as an oral capsule formulation: steady state characterization
Accumulation ratio (AR) at steady-state
Measured: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of AN9025 following administration as an oral capsule formulation: drug level characterization in blood
Apparent clearance (CL/F) after single and multiple doses
Measured: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of AN9025 following administration as an oral capsule formulation
AN9025 apparent terminal half-life (t1/2)
Measured: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of PK profile of AN9025 following administration as an oral capsule formulation: blood concentration characteristics
Time to maximum blood concentration (Tmax)
Measured: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Preliminary anti-tumor activity: disease control rate (DCR)
measurement of the disease control rate (DCR)
Measured: Tumor assessments will occur at baseline and then every 6 weeks starting from Cycle 3, Day 1 up to Cycle 9, Day 1 and then every 12 weeks thereafter (± 1 week window), through study completion, for an average duration of 1 year
Preliminary anti-tumor activity for tumor response
meausrement of the duration of response (DoR)
Measured: Tumor assessments will occur at baseline and then every 6 weeks starting from Cycle 3, Day 1 up to Cycle 9, Day 1 and then every 12 weeks thereafter (± 1 week window), through study completion, for an average duration of 1 year
Preliminary anti-tumor activity: participant survival
Measurement of the participant's progression-free survival (PFS) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Measured: Tumor assessments will occur at baseline and then every 6 weeks starting from Cycle 3, Day 1 up to Cycle 9, Day 1 and then every 12 weeks thereafter (± 1 week window), through study completion, for an average duration of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start28 Jan 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors (Phase 1)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adlai Nortye Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252479
- Sponsor's protocol ID
- AN9025S0101
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AN9025 in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
- ClinicalTrials.gov ID
- NCT07252479
- Acronym / sponsor ID
- AN9025S0101
- Conditions
- Solid Tumors (Phase 1), RAS Mutation
- Keywords
- RAS, RAS (ON), RAS Solid Tumor, KRAS G12X(C/D/V), KRAS G13D, NRAS Q61X(L/K), Oral Pan RAS medication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Adlai Nortye Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a first-in-human, open label, multi-center, multiple-ascending dose escalation, phase I study consisting of three parts: Part 1 Dose-Escalation, Part 2 Food Effect Assessment and Part 3 Dose-Expansion (See Figure 1, Figure 2, Figure 3 and Figure 4). The study is designed to evaluate the safety, tolerability, PK, and preliminary efficacy of AN9025, an oral pan-RAS (ON) inhibitor, in participants with advanced or metastatic solid tumors that harbor RAS mutations. In addition, the effect of food intake on the PK of AN9025 will be preliminarily investigated. The study will be conducted in the United States and China.
Part 1 Dose-Escalation is designed to identify the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) in participants with advanced or metastatic RAS-mutant solid tumors. Participants will be evaluated for Dose-limiting Toxicities (DLTs) in escalating dose and back fill cohorts. Participants enrolled in escalating dose cohorts will receive AN9025 with continuous once daily (QD) dosing or once weekly (QW) dosing in 21-day cycles. Participants enrolled in back fill cohorts will start with a single lead-in dose of AN9025 at least 5 days prior to initiating continuous QD dosing to enable PK sampling during the Single-Dose Lead-in period (Cycle 0). Following the Lead-in period, back fill participants will begin Cycle 1 Day 1 of the standard QD or QW 21-day cycle treatment (Figure 3 A).
Part 2 Food Effect Assessment will employ a single-sequence, two-period crossover design in at least 6 participants. Participants will begin with a Food Effect Lead-in period (Cycle 0), receiving a single-dose of AN9025 (at a selected dose level lower than the MTD) under fasting condition, followed by PK sample collection and a washout period. A second single-dose will then be administered under fed conditions, with additional PK sampling and another washout period. Upon completing this lead-in period, participants will transition to the main study treatment, initiating QD dosing from Cycle 1 Day 1 in 21-day cycles (Figure 3 B).
Part 3 Dose-Expansion will evaluate the clinical activity of AN9025 in up to two RAS-mutated solid tumor indications using up to two dose levels selected based on the MTD/RDE established during dose escalation. This phase will further characterize the safety, tolerability, and PK of AN9025 in selected tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AN9025 Treatment | Experimental | Drug: AN9025 oral capsuleOral administration of AN9025 capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- 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.
Key exclusion criteria (30 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN9025 oral capsuleAN9025 is a novel, oral, small molecule pan-RAS (ON) inhibitor that binds cyclophilin A (CypA) with a slow dissociation rate, forming a tri-complex with guanosine triphosphate (GTP) bound state of both mutant and wild-type RAS proteins. AN9025 exhibits potent anti-proliferative activity in RAS-addicted cancer cell lines, demonstrates favorable pharmacokinetics (PK), pharmacodynamics and an acceptable tolerability profile in vivo. | Drug | AN9025 Treatment |
Primary outcome
• Nature and frequency of dose limiting toxicities (DLTs)
Time frame: 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
9 secondary outcomes
Preliminary anti-tumor activity:Objective response rate (ORR)
Time frame: Tumor assessments will occur at baseline and then every 6 weeks starting from Cycle 3, Day 1 up to Cycle 9, Day 1 and then every 12 weeks thereafter (± 1 week window), through study completion, for an average duration of 1 year
• Characterization of the PK profile of AN9025 following administration as an oral capsule formulation
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
•Characterization of the PK profile of AN9025 following administration as an oral capsule formulation: steady state characterization
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of AN9025 following administration as an oral capsule formulation: drug level characterization in blood
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of the PK profile of AN9025 following administration as an oral capsule formulation
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Characterization of PK profile of AN9025 following administration as an oral capsule formulation: blood concentration characteristics
Time frame: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
Preliminary anti-tumor activity: disease control rate (DCR)
Time frame: Tumor assessments will occur at baseline and then every 6 weeks starting from Cycle 3, Day 1 up to Cycle 9, Day 1 and then every 12 weeks thereafter (± 1 week window), through study completion, for an average duration of 1 year
Preliminary anti-tumor activity for tumor response
Time frame: Tumor assessments will occur at baseline and then every 6 weeks starting from Cycle 3, Day 1 up to Cycle 9, Day 1 and then every 12 weeks thereafter (± 1 week window), through study completion, for an average duration of 1 year
Preliminary anti-tumor activity: participant survival
Time frame: Tumor assessments will occur at baseline and then every 6 weeks starting from Cycle 3, Day 1 up to Cycle 9, Day 1 and then every 12 weeks thereafter (± 1 week window), through study completion, for an average duration of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AN9025 oral capsule in people with Solid Tumors (Phase 1) and RAS Mutation, run by Adlai Nortye Biopharma Co., Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager (848 230-7430, AN9025S0101@adlainortye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Nature and frequency of dose limiting toxicities (DLTs) (time frame: 21 days after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.