Recruiting
Phase 1

AMX-883

Sponsor:

Amphista Therapeutics Ltd

Code:

NCT07723703

Conditions

Acute Myeloid Leukaemia

High Risk Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AMX-883

Posaconazole

Study Details

Brief 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.

Conditions

Acute Myeloid Leukaemia

High Risk Myelodysplastic Syndrome

Study ID

NCT07723703

Start date

Sep 30, 2026

Status verified date

Sep, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Dec 4, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 instability
  • Major surgery within 4 weeks prior to C1D1 or inadequate recovery from prior surgery
  • Uncontrolled intercurrent illness
  • Inability to fast, swallow, ingest, or absorb oral medication due to a pre-existing condition
  • History of interstitial lung disease or pneumonitis requiring systemic corticosteroid treatment
  • Requirement for medications with a known risk of Torsades de Pointes that cannot be discontinued prior to study treatment
  • Detectable human immunodeficiency virus (HIV) viral load
  • Known serologic status reflecting active hepatitis B or C infection
  • Active uncontrolled systemic fungal, bacterial, viral, or other infection or a condition predisposing to severe infection

Study Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

AMX-883

AMX-883 will be administered orally.

Posaconazole

Posaconazole tablets will be administered orally.

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) ]
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: During Cycle 1 (each cycle will be 28 days) ]

Central Contacts and Locations

Central contacts

Amphista Medical Monitor

mm@amphista.com

Locations

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Amphista Therapeutics Ltd

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Pharmacokinetics
  • Dose escalation
  • Bayesian Optimal INterval (BoIN)
  • Bromodomain-Containing Protein 9 (BRD9)
  • Monotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Amphista Therapeutics Ltd on 2026-09-15.