RecruitingPhase 1ACTRN12625001232426

Study of AN8025 in Patients With Unresectable Advanced or Metastatic Solid Tumors

A Phase I Open-label Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of AN8025 in Participants with Unresectable Advanced or Metastatic Solid Tumors

Sponsor

Adlai Nortye Biopharma Co., Ltd.

Enrollment

91 participants

Start Date

Dec 9, 2025

Study Type

Interventional

Conditions

Advanced or Metastatic Solid Tumors

Summary

This study will assess the safety and tolerability of a new anti-cancer drug, AN8025, to determine the safest dose that can be given to adults with advanced or metastatic solid tumours. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an advanced or metastatic cancer, this may be non-small cell lung cancer, melanoma (skin cancer) or another type of cancer that presents as solid tumours. Participants will also need to complete additional health checks by a doctor to determine if it is safe for them to enter this study. Study details All participants who choose to enrol in this study will be given AN8025 once every 3 weeks. Treatment will continue until the body can no longer tolerate the drug, the disease progresses, or the participant decides to stop taking part in the study. Different groups of participants will be enrolled to test higher doses of AN8025, once the starting dose has been determined to be safe. Participants will be asked to provide blood samples and keep a diary of any side effects that they experience after taking AN8025. It is hoped this research will determine that use of AN8025 is safe and tolerable for patients with advanced or metastatic cancer, and that this study will determine the highest safe dose for patients with cancer. Once the safest dose is determined, a larger study enrolling a greater number of cancer patients may go ahead.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This early-phase clinical trial is testing the safety and appropriate dosing of a new experimental cancer drug called AN8025 in adults with advanced or metastatic solid tumours — meaning cancers that have spread and have not responded to standard treatments. The study is especially interested in cancers like non-small cell lung cancer, melanoma, and other solid tumour types. Participants will receive AN8025 as an infusion once every three weeks. Different groups of participants will be tested at progressively higher doses, starting low and increasing only once the previous dose level has been found to be safe. The main goals are to determine how safe the drug is, what the maximum tolerable dose is, and how the body processes it. Participants will keep symptom diaries and have regular blood tests. You may be eligible if you are 18 or older, have advanced or metastatic cancer that has progressed despite standard treatments, are in reasonably good health (ECOG 0 or 1), and have a life expectancy of at least 12 weeks. People with active HIV, hepatitis, tuberculosis, serious heart conditions, or active infections requiring IV antibiotics are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a first-in-human phase I study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of AN8025 in participants with unresectable advanced or metastatic solid tumours. The maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) will also be investigated in this study. AN8025 is given 7.5 microgram (mg) as the starting dose, every 3 weeks by intravenous infusion until unacceptable toxicity or disease progression. When it’s safe, 25mg, 75mg, 250mg, 750mg, 1200mg, 1500mg will be studied separately in order to establish a safe and recommended dose for further study. AN8025 is given only under the supervision of study investigators.