Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS (NCT06846606) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS
United States34 participantsStarted 2025-05-01
Plain-language summary
This Phase 1, multicenter, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of AUTX-703 administered orally in subjects with advanced hematologic malignancies.
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
. Participant must be ≥18 years of age
. Participant must have confirmed diagnosis as follows:
. Participant must be willing and able to comply with scheduled study visits and treatment plans.
. Participant must be willing to undergo all study procedures unless contraindicated due to medical risk.
. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2
. Participant must have adequate hepatic function
. Participant must have adequate renal function
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.
1Since this is a Phase 1 trial of AUTX-703, the main goal is figuring out a safe dose rather than proving it works — does that change whether this might be right for me compared to other options?
2The trial is listed as 'active but not recruiting,' which means they're no longer enrolling new patients — is there any way to find out if enrollment might reopen, or are there similar trials studying AUTX-703 or the same approach that I could look into instead?
3Because the primary thing being measured is how often serious side effects and dose-limiting toxicities occur, what are the specific risks we should discuss, and how would my current health handle potential serious adverse events?
4Given that this trial targets relapsed or refractory AML or MDS — meaning disease that has come back or stopped responding to treatment — how does my specific situation and prior treatments affect whether a trial like this, or a different salvage strategy, would make more sense for me?
5If I can't get into this trial, are there other Phase 1 or Phase 2 trials for relapsed or refractory AML or MDS that are currently enrolling and that you think would be worth exploring based on my disease profile?
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
Incidence of Adverse Events (AEs), Dose-Limiting Toxicities (DLTs), and Serious Adverse Events (SAEs)
Timeframe: From the first dose through 28 days after the last dose of study drug.
. Participant must have adequate cardiovascular function
Exclusion criteria
. Participant is unable to provide informed consent and/or to follow protocol requirements.
. Participant has undergone chimeric antigen receptor T cell therapy or HSCT within 60 days of the first dose of study treatment or has active clinically significant graft-versus-host disease (GVHD)
. Participant has another malignancy that may interfere with diagnosis and treatment of R/R AML or R/R MDS.
. Participant has an active severe infection that requires anti-infective therapy or has an unexplained temperature of \>38.5°C during screening visits or on their first day of study treatment.
. Participant has a known sensitivity to AUTX-703 or any of its components.
. Participant is taking systemic strong CYP3A4 inhibitors or inducers within 14 days of the first dose of study treatment.
. Participant who are taking proton pump inhibitors should be switched to another acid-reducing agent such as an antacid or H2 blocker
. Participant is taking P-gp and breast cancer resistance protein (BCRP) inhibitors or inducers within 14 days of first dose of study treatment.