An Initial Evaluation of AN8025 in Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor (Phase 1)

In brief

The goal of this clinical trial is to determine the appropriate dose of AN8025 for use in the treatment of advanced solid tumors. This study will be conducted in in adults \>18 years of age. The main questions to answer: 1. Determine which dose level of AN8025 is safe and tolerability in participants with advanced solid tumors 2. To determine the maximum tolerated of AN8025 for future testing. Participants will visit their study site in 3 week cycles, during which they will be under go treatment with AN8025 and visit their clinical site during each cycle for check ups and testing.

Key facts

Study ID

NCT07639047

Run by

Adlai Nortye Biopharma Co., Ltd.

People needed

91

Starts

2025-11-01

Expected to finish

2028-01-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥18 years old.
• Able to provide informed consent obtained before any study-related activities and according to local guidelines.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Have an estimated life expectancy ≥ 12 weeks, in the judgment of the investigator.
• Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies or are intolerant to or refuse standard therapies that are known to provide clinical benefit.
• Part A Dose Escalation only: Participants have unresectable advanced or metastatic solid tumors, with no preference of cancer type.
• Part B Dose Expansion only: Participants enrolled into tumor-specific cohorts have unresectable advanced metastatic disease. Participants must also have progressed after treatment with the appropriate targeted therapy. Participants must be primary refractory or non-responding to anti-PD-1 monotherapy as defined by:
• The participant has received at least 2 doses of an approved anti-PD-1/PD-L1 monoclonal antibody
• The participant has demonstrated progressive disease (PD) after anti-PD-1/PD-L1 therapy as defined by RECIST Version 1.1, which was subsequently confirmed by a second assessment no less than 4 weeks from the date of the first documented PD to rule out pseudo-progression.
• Participants who have received anti-PD-1/PD-L1 therapy as part of their adjuvant therapy but experienced recurrence with locally advanced or metastatic disease within 6 months after completing adjuvant therapy may be eligible for Part B.
• Part B Dose Expansion only: Participants enrolled into the expansion cohort must have documented PD-L1 tumor expression on ≥1% tumor cells (i.e. TPS or TC ≥1%) as assessed by validated immunohistochemistry (IHC) assay on archival or fresh tumor tissue.
• Participants have consented to provide archival tumor tissue collected within 5 years or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Archival tumor tissue can be formalin-fixed, paraffin embedded (FFPE) tissue blocks or at least 15 freshly-sectioned slides. Tissue should be obtained from surgical resection or core needle biopsy. Fine-needle aspiration (FNA), pleural effusion, or ascitic fluid samples are not acceptable. FFPE blocks are preferred to slides and newly obtained biopsies are preferred to archival tissue. For participants who have consented to provide newly obtained fresh biopsy of baseline tumor tissue, the biopsy is required to be collected during the screening period. Tissue requirements may be waived on a case-by-case basis after discussion with the sponsor if tissue or biopsy is not available or feasible.
• Have at least one measurable lesion as defined per RECIST v1.1. Bone metastases are not considered measurable. Participants who only have non-measurable lesion(s) may be eligible for Part A, except for "back-filled" cohorts.
• Have adequate hematologic function and major organ function, defined by laboratory assessment documented within 7 days prior to first dose of study treatment:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
• Hemoglobin ≥ 9 g/dL (which may be reached by transfusion).
• Platelets ≥ 100 x 109/L (which may be reached by transfusion).
• International normalized ratio (INR) ≤ 1.5.
• Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if liver metastases are present.
• Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN if Gilbert's syndrome is present.
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCL) > 50 mL/min.
• Thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal limits at baseline, the participant will still be eligible if total T3 or free T3 (FT3) and free T4 (FT4) are within the normal limits.
• Have discontinued previous cancer treatment and recovered from the acute toxicity of therapy. Participants must have discontinued from previous treatment with length of time prior to first dose of study treatment.
• Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study treatment administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of the study treatment.

You may not qualify if…

• Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have a serious concomitant systemic disorder that, in the judgment of the investigator, would compromise the participant's ability to adhere to the protocol.
• Known human immunodeficiency virus (HIV) infection per HIV 1 and/or 2 antibodies.
• Participants with evidence of Hepatitis B or Hepatitis C infections (positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody) must fulfill the following criteria in order to be eligible for the study:
• Hepatitis B virus (HBV) viral load ≤2500 copies or ≤500 IU/mL before study enrollment, and participants with active HBV need to be on anti-HBV suppression ≥3 months, throughout treatment and for 6 months after; and
• Hepatitis C virus (HCV) viral load ≤lower limits of detection, participants with curable or controllable HCV infection are eligible. Participants with detectable HCV RNA can remain on continuous, effective antiviral therapy during the study.
• Note: The necessity of conducting HBV DNA/HCV RNA quantitative testing is based on the local epidemiology and local clinical practice.
• Active tuberculosis.
• Active infection requiring intravenous therapy.
• Prior or second concurrent primary malignancies that, in the judgment of the investigator, may affect the interpretation of results. Participants with carcinoma in situ of any origin and participants with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the investigator, are eligible for this study.
• Have an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. This criterion does not apply to participants with:
• Resolved childhood asthma/atopy or who require intermittent use of bronchodilators or corticosteroid;
• Raynaud's syndrome; or
• Sjogren's syndrome. Use of topical, ophthalmic, inhaled, and intranasal corticosteroids are permitted.
• Evidence of (a) interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (for example, interstitial lung disease); (b) active, noninfectious pneumonitis; or (c) history of noninfectious pneumonitis that required corticosteroid therapy or immune related pneumonitis.
• Moderate or severe cardiovascular disease, including:
• A myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;
• Unstable angina pectoris;
• New York Heart Association Class III/IV congestive heart failure;
• Aneurysm of major vessels or heart;
• Left ventricular ejection fraction <50% (evaluation based on institutional lower limit of normal);
• Uncontrolled hypertension;
• Severe, moderate, or clinically significant valvulopathy;
• Documented major ECG abnormalities that, in the judgment of the investigator, are clinically significant (for example, arrhythmia requiring treatment)
• Mean QTc ≥470 ms calculated using Fridericia's correction and confirmed by triplicate ECG.

Where it is running

• Linear Clinical Research Ltd — Nedlands, Western Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.