Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combi… (NCT07723703) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combination in Participants With AML
54 participantsStarted 2026-09-01
Plain-language summary
The purpose of the study is to assess the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS) and in combination with anticancer agents in participants with AML.
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:
* Participants with relapsed or refractory AML who have failed all available standard therapies or relapsed or refractory high-risk MDS with BM blasts 10-19%
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Adequate washout from prior therapies
* Adequate kidney and liver function
* Female participants of childbearing potential must use highly effective contraception, and male participants must agree to use barrier contraception and avoid sperm donation for at least 120 days after last dose
* If enrolled in M1B: Participant must have no documented contraindication to treatment with posaconazole before start of treatment
Exclusion Criteria:
* Diagnosis of acute promyelocytic leukaemia or chronic myelogenous leukaemia in blast crisis
* Clinically active central nervous system (CNS) leukaemia
* Receiving immunosuppressive therapy post HSCT
* History of another malignancy that is active, progressing, or has required systemic treatment within the past 2 years
* Presence of \>Grade 1 active graft versus host disease within 4 weeks prior to C1D1
* Significant cardiovascular disease
* Family history of sudden cardiac death before 40 years of age or a family history of long QT syndrome
* Clinically significant electrolyte imbalances (e.g., hypokalaemia, hypomagnesaemia, hypocalcaemia) that may contribute to QT interval prolongation
* Clinically significant bradycardia (\<50 beats per minute) that is symptomatic or causes haemodynamic insta…
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
Number of participants with adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interests (AESIs) and serious adverse events (SAEs)
Timeframe: Until 30 days after last dose (Approximately 2 years 8 months)
2
Number of participants with dose limiting toxicities (DLTs)
Timeframe: During Cycle 1 (each cycle will be 28 days)