AN9025 for Cancer

Overseen By Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Adlai Nortye Biopharma Co., Ltd.

Must not be taking: CYP3A4 inhibitors, P-gp inhibitors, PPIs

Disqualifiers: HIV, Hepatitis B/C, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the drug AN9025 is safe and tolerable for treating certain solid tumors with specific genetic mutations. The researchers seek to find the proper dose and identify any side effects. The trial is recruiting individuals with advanced or metastatic cancer, such as pancreatic or colorectal cancer, who have specific RAS mutations and have not responded to standard treatments. Participants will take the drug daily and attend regular clinic visits for monitoring. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot use certain drugs that interact with the study drug, like proton pump inhibitors, strong CYP3A4 inhibitors or inducers, and P-glycoprotein inhibitors. It's best to discuss your current medications with the study team to see if any need to be stopped.

Is there any evidence suggesting that AN9025 is likely to be safe for humans?

Research shows that AN9025, a pill, may help treat certain types of cancer. Early lab studies demonstrated that AN9025 stopped these cancer cells from growing. However, since this trial is in the early stages, limited information exists about its safety for people. Researchers are still carefully monitoring how well participants tolerate it. Participants must visit the clinic regularly for checkups and tests to quickly address any side effects. While lab results are promising, testing in people is necessary to determine how the body responds to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AN9025 is unique because it offers a new approach to cancer treatment with its oral capsule format, which can be more convenient compared to traditional intravenous chemotherapy. Researchers are excited about AN9025 because it may target cancer cells differently, potentially with fewer side effects. This new treatment could provide a more accessible and patient-friendly option for those battling cancer.

What evidence suggests that AN9025 might be an effective treatment for cancer?

Research suggests that AN9025, the treatment under study in this trial, could effectively treat cancers with RAS mutations. Studies have shown it can stop the growth of cancer cells reliant on these mutations. AN9025 targets and blocks the RAS gene, a key factor in many cancers. The drug has demonstrated good behavior in the body, crucial for its effectiveness. These promising results mainly come from lab studies, so further research is needed to determine its effectiveness in people. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced or metastatic solid tumors that have RAS mutations. Participants will take the AN9025 oral capsule daily and attend regular clinic visits for tests and monitoring. They must be willing to provide blood and tumor samples, if needed.

Inclusion Criteria

Able to provide informed consent voluntarily before any study-related activities and according to local guidelines

Have an estimated life expectancy ≥ 12 weeks, in the judgment of the Investigator

Corrected QT interval (QTc) ≤ 470 msec for females and ≤ 450 msec for males per the Fridericia's Formula (QTcF)

Exclusion Criteria

Currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be compatible with this study

Have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol

Serious pre-existing medical conditions that would preclude participation in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Participants receive escalating doses of AN9025 to identify the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE).

21-day cycles

3-4 visits during the first 21 days

Food Effect Assessment

Participants undergo a single-sequence, two-period crossover design to assess the effect of food on AN9025 pharmacokinetics.

Cycle 0 (Lead-in period)

Dose-Expansion

Evaluation of the clinical activity of AN9025 in selected RAS-mutated solid tumor indications using dose levels established during dose escalation.

21-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment. Return visits at 14 and 30 days post-treatment, with follow-up every 3 months.

1 year

Return visits at 14 and 30 days, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• AN9025

Trial Overview The study is testing the safety and tolerability of different doses of AN9025 in patients with RAS-mutated solid tumors. It aims to establish a safe dosage range, understand side effects, and monitor how the drug affects tumor activity over time.

How Is the Trial Designed?

Group I: AN9025 Treatment Experimental Treatment 1 Intervention

Oral administration of AN9025 capsules

Who Is Running the Clinical Trial?

Adlai Nortye Biopharma Co., Ltd.

Lead Sponsor

Trials

8

Recruited

740+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07252479?lastUpdPost=2020-01-16_

Evaluation of a Rat Sarcoma Oncogene (RAS) Inhibitor in ... AN9025 exhibits potent anti-proliferative activity in RAS-addicted cancer cell lines, demonstrates favorable pharmacokinetics (PK), ...

2. ir.adlainortye.com ir.adlainortye.com/news-releases/news-release-details/adlai-nortye-announces-topline-results-phase-iii-buran-trial

Adlai Nortye Announces Topline Results of Phase III BURAN ... ... tumor types. Preclinical studies have demonstrated that AN9025 effectively inhibits RAS-mutant cancers with potent and durable efficacy ...

3. trial.medpath.com trial.medpath.com/news/2802f228ff956d1b/adlai-nortye-to-showcase-novel-cancer-immunotherapy-and-ras-inhibitor-at-aacr-2025

Adlai Nortye to Showcase Novel Cancer Immunotherapy and ... Preclinical studies have demonstrated that AN9025View drug details effectively inhibits RAS-mutant cancers with potent and durable efficacy, ...

4. synapse.patsnap.com synapse.patsnap.com/drug/2f483ac56888437380ac6c5e37fd24d4

AN-9025 - Drug Targets, Indications, Patents Clinical Results associated with AN-9025. Login to view more data. 100 ... Clinical Trial. Identify the latest clinical trials across global registries ...

5. adlainortye.com adlainortye.com/upload/2025/04/30/17460015476932hfxs1.pdf

AN9025 Poster_2025AACR_20250430 Shows potent anti-proliferative activity in RAS-addicted cancer cell lines (picomolar IC50 values). Demonstrates a favorable PK/PD and ...

6. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/4377/757610/Abstract-4377-AN9025-an-orally-bioavailable-pan

Abstract 4377: AN9025, an orally bioavailable pan-RAS(ON ... AN9025, an oral RAS (ON) inhibitor, with best-in-class potential, demonstrates picomolar potency against RAS-dependent tumor cell lines, showing ...

7. oncologynewscentral.com oncologynewscentral.com/drugs/info/recent-fda-cancer-drug-safety-warnings-and-updates

Recent FDA Cancer Drug Safety Warnings and Updates The U.S. Food and Drug Administration (FDA) has issued multiple safety updates affecting oncology drugs, including new labeling requirements ...