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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

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)
NCT07252479118
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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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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT07252479Enrollment: 91 → 118
LOWJun 8, 2026NCT07252479Enrollment: 91 → 118
LOWJun 8, 2026NCT07252479Enrollment: 91 → 118
LOWMay 26, 2026NCT07252479primaryCompletionDate: changed
LOWMay 24, 2026NCT07252479studyFirstPostDate: changed