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AN8025

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Adlai Nortye Ltd. American Depositary Shares|Trials Updated: Jun 10, 2026

AN8025 target and mechanism

Molecular targetPD-L1
Target classProtein
ModalitySmall molecule

Also known as AN8025 is a multifunctional antibody fusion protein

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

AN8025 clinical trials

AN8025 · 1 trial · 1 indication

Phase 1 1
NCT07639047An Initial Evaluation of AN8025 in Solid TumorsAdvanced Solid Tumor (Phase 1)
RECRUITING91 Analytics
PHASE1RECRUITING
An Initial Evaluation of AN8025 in Solid Tumors
Advanced Solid Tumor (Phase 1)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety of AN8025
24 months

Incidence, nature and severity of adverse events (AEs) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Minimum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE)
At the end of the DLT cycle, defined as 28 days from the first dose of study treatment (Cycle1 Day1) or from Cycle1 Day1 through Cycle2 Day7, whichever is longer. Note: Treatment cycles are 21 days in length and the DLT cycle is 28 days in length.

Nature and frequency of dose limiting toxicities (DLTs)

Secondary Endpoints

Determine the pharmacokinetics (PK) of AN8025
Days 1,2,3,8,15 during identified cycles (Cycles 1-5)
Preliminary anti-tumor activity of AN8025, Objective Response Rate (ORR)
24 months
Preliminary anti-tumor activity of AN8025, Disease Control Rate (DCR)
24 Months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AN2025 TreatmentEXPERIMENTALAN8025 is a tri-functional antibody that is a reconstituted liquid intravenously administered over the period of 60 mins.

Interventions

NameTypeDescription
AN8025 is a multifunctional antibody fusion proteinDRUGAN8025 is being developed for the treatment of advanced or metastatic solid tumors, which may include PD(L)-1 refractory advanced solid tumors
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Aged ≥18 years old. 2. Able to provide informed consent obtained 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 expectancy ≥ 12 weeks, in the judgment ...

Countries:Australia
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about AN8025

What is AN8025 used for?

AN8025 is being studied for the treatment of advanced solid tumors. It is an investigational therapy in Phase 1 clinical development and has not been approved for any indication. The ongoing trial enrolls adults with advanced solid tumors in Australia.

What does AN8025 target?

AN8025 targets PD-L1, a protein that tumors use to suppress immune responses. By binding PD-L1, AN8025 is designed to interfere with this immune evasion pathway. It is described as a multifunctional antibody fusion protein, combining antibody targeting with additional functional domains.

Who is developing AN8025?

AN8025 is being developed by Adlai Nortye Ltd., whose American Depositary Shares trade under the ticker ANL. The company is advancing the candidate through early clinical testing in oncology.

What phase is AN8025 in?

AN8025 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 program is evaluating the therapy in patients with advanced solid tumors.

What clinical trials is AN8025 in?

AN8025 is being evaluated in a single Phase 1 trial, NCT07639047, titled An Initial Evaluation of AN8025 in Solid Tumors. The study is currently recruiting approximately 91 participants aged 18 years and older in Australia. It is an uncontrolled, open-label trial without randomization or blinding.

Is AN8025 the same as a multifunctional antibody fusion protein?

Yes, AN8025 is described as a multifunctional antibody fusion protein. This designation reflects its molecular design, which combines antibody targeting with fusion protein components. It is distinct from conventional small molecule or simple antibody therapies.