An Initial Evaluation of AN8025 in Solid Tumors (NCT07639047) | Clinical Trial Compass
RecruitingPhase 1
An Initial Evaluation of AN8025 in Solid Tumors
Australia91 participantsStarted 2025-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of AN8025
Timeframe: 24 months
2
Minimum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE)
Timeframe: 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.
. 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
Exclusion criteria
. 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.