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NCT07723703
Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combination in Participants With AML
Conditions: Acute Myeloid Leukaemia, High Risk Myelodysplastic Syndrome
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 54
Sponsor: Amphista Therapeutics Ltd
Location: NEXT Oncology Virginia Fairfax Virginia
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.
Eligibility Criteria
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 for at least 120 days, or 27 weeks (applicable to the United Kingdom \[UK\] only), after last dose, 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 (\
Source: ClinicalTrials.gov (NCT07723703). StuddyBuddy aggregates publicly available trial information.