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AN9025

Phase 1

Solid Tumors (Phase 1) | Small molecule | Oncology |Adlai Nortye Ltd. American Depositary Shares|Last Updated: Jun 8, 2026

Target and mechanism

Molecular targetRAS
Target classProtein
ModalitySmall molecule

Also known as AN9025 oral capsule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment118

FDA Designations

No designations recorded

Clinical trial landscape

AN9025 · 1 trial · 2 indications

Phase 1 1
NCT07252479Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS MutationsSolid Tumors (Phase 1)
RECRUITING118 Analytics
PHASE1RECRUITING
Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Solid Tumors (Phase 1)Unlock trial analytics

Study Endpoints

Primary Endpoints

• Nature and frequency of dose limiting toxicities (DLTs)
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

Secondary Endpoints

Preliminary anti-tumor activity:Objective response rate (ORR)
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
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
At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AN9025 TreatmentEXPERIMENTALOral administration of AN9025 capsules

Interventions

NameTypeDescription
AN9025 oral capsuleDRUGAN9025 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Aged ≥18 years old at the time of informed consent. 2. Able to provide informed consent voluntarily before any study-related activities and according to local guidelines. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Have an estimated life expe...

Countries:United States
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Frequently asked questions about AN9025

What is AN9025 used for?

AN9025 is an investigational oral small molecule being developed for the treatment of advanced or metastatic solid tumors harboring RAS mutations. It is currently in Phase 1 clinical development and is not yet approved by the FDA.

What does AN9025 target?

AN9025 targets RAS, a protein that is frequently mutated in various cancers. By inhibiting RAS, the drug aims to interfere with signaling pathways that drive tumor growth, potentially offering a therapeutic option for patients with RAS-mutant solid tumors.

Who is developing AN9025?

AN9025 is being developed by Adlai Nortye Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ANL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is AN9025 in?

AN9025 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and preliminary efficacy in patients.

What clinical trials is AN9025 in?

AN9025 is being evaluated in a Phase 1 clinical trial with the identifier NCT07252479. This trial is recruiting participants with advanced or metastatic solid tumors harboring RAS mutations, with an enrollment target of 118 patients, and is being conducted in the United States.

Is AN9025 the same as AN9025 oral capsule?

Yes, AN9025 oral capsule is the formulation of the drug AN9025. The oral capsule is the dosage form being tested in clinical trials, and the drug is referred to by the same name, AN9025, in both contexts.