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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment91
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07252479Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS MutationsPHASE1 RECRUITING 118Jan 28, 2026Jun 1, 2028Jun 8, 20263 United States
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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 — 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