AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

An Initial Evaluation of AN8025 in Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllAdlai Nortye Biopharma Co., Ltd.
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 of the investigator. 5. 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. 6. Part A Dose Escalation only: Participants have unresectable advanced or metastatic solid tumors, with no preference of cancer type. 7. 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: 1. The participant has received at least 2 doses of an approved anti-PD-1/PD-L1 monoclonal antibody 2. 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. 3. 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. 8. 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. 9. 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. 10. 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. 11. Have adequate hematologic function and major organ function, defined by laboratory assessment documented within 7 days prior to first dose of study treatment: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. 2. Hemoglobin ≥ 9 g/dL (which may be reached by transfusion). 3. Platelets ≥ 100 x 109/L (which may be reached by transfusion). 4. International normalized ratio (INR) ≤ 1.5. 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. 6. Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN if Gilbert's syndrome is present. 7. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCL) \> 50 mL/min. 8. 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. 12. 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. 13. 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. Exclusion Criteria: 1. 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. 2. Have a serious concomitant systemic disorder that, in the judgment of the investigator, would compromise the participant's ability to adhere to the protocol. 3. Known human immunodeficiency virus (HIV) infection per HIV 1 and/or 2 antibodies. 4. 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: 1. 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 2. 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. 5. Active tuberculosis. 6. Active infection requirin
💊

What it tests

  • AN8025 is a multifunctional antibody fusion protein
📍

Where

1 site
Linear Clinical Research Ltd
Nedlands, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy