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

Part of paid clinical trials in Fairfax, Virginia.

Sponsor
Amphista Therapeutics Ltd
Study ID
NCT07723703
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukaemia
  • High Risk Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AMX-883 — DRUG
    AMX-883 will be administered orally.
  • Posaconazole — DRUG
    Posaconazole tablets will be administered orally.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Dec 4, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 Part A (M1A): AMX-883 monotherapy dose escalation cohort
    Participants will receive escalating dose levels of AMX-883 administered as monotherapy.
  • Experimental: Module 1 Part A (M1A): AMX-883 monotherapy food effect cohort
    Participants will receive a selected dose of AMX-883 from the M1A dose escalation cohort, administered as monotherapy, under fed and fasted conditions.
  • Experimental: Module 1 Part B (M1B): AMX-883 + posaconazole
    Participants will receive a selected dose level for at least two escalating dose levels of AMX-883 selected from the M1A dose escalation cohort, administered in combination with posaconazole.

Primary Outcome Measure

Number of participants with adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interests (AESIs) and serious adverse events (SAEs) [ Time Frame: Until 30 days after last dose (Approximately 2 years 8 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NEXT Oncology VirginiaFairfaxVirginia22031-

Find similar trials in Fairfax, VA

By research site
NEXT Oncology Virginia· Fairfax, VA

Related Studies