Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combination in Participants With AML

Study acronym: BRAMLIE
StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Start date changed from estimate of Oct 16, 2026 to Sep 16, 2026
  2. Start date pushed from Sep 30, 2026 to Oct 16, 2026
    • Eligibility criteria expanded, about 99 words
  3. Recruitment opened Show 4 more changesShow less
    • Start date: Sep 1, 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 11 of 34 entries
    • Study description expanded, about 2 words
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07723703
Lead Sponsor Amphista Therapeutics Ltd
Conditions
(from sponsor)		 Acute Myeloid Leukaemia, High Risk Myelodysplastic Syndrome
Related terms Leukemia, Myeloid, Acute
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov