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AN8025

Phase 1

Advanced Solid Tumor (Phase 1) | Small molecule | Oncology |Adlai Nortye Ltd. American Depositary Shares|Last Updated: Jun 10, 2026

Target and mechanism

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

UNCONTROLLEDDMC
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

Clinical trial landscape

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)
NCT0763904791
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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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