Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Los Angeles, California.

Sponsor
Lomond Therapeutics Holdings, Inc.
Study ID
NCT06366789
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • AML With Gene Mutations

Eligibility Criteria

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

Interventions

  • ZE46-0134 — DRUG
    oral capsules QD

Study Details

This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia

Key Dates

Start date
May 29, 2024
Status verified
Dec 2025
Primary completion
Jan 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ZE46-0134 Dose Level -1
    Optional and would only be performed Dose Level 1 is poorly tolerated
  • Experimental: ZE46-0134 Dose Level 1
  • Experimental: ZE46-0134 Dose Level 2
  • Experimental: ZE46-0134 Dose Level 3
  • Experimental: ZE46-0134 Dose Level 4
  • Experimental: ZE46-0134 Dose Level 5
  • Experimental: ZE46-0134 Selected dose 1
    The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study and will not exceed a loading dose of 150 mg x 2 days and maintenance dose of 50 mg QD
  • Experimental: ZE46-0134 Selected dose 2
    The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study and will not exceed a loading dose of 150 mg x 2 days and maintenance dose of 50 mg QD
  • Experimental: ZE46-0134 Dose Level 6
  • Experimental: ZE46-0134 Dose Level 7
  • Experimental: ZE46-0134 Dose Level 8
  • Experimental: ZE50-0134 (Group 2) Dose Level -1
    Optional and would only be performed Dose Level 1 is poorly tolerated
  • Experimental: ZE50-0134 (Group 2) Dose Level 1
  • Experimental: ZE50-0134 (Group 2) Dose Level 2
  • Experimental: ZE50-0134 (Group 2) Dose Level 3
  • Experimental: ZE50-0134 (Group 2) Dose Level 4
  • Experimental: ZE50-0134 (Group 2) Selected dose 1
    The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study.
  • Experimental: ZE50-0134 (Group 2) Selected dose 2
    The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study.

Primary Outcome Measure

The incidence of DLTs [ Time Frame: From baseline to the End of Treatment (EOT) (Max 24 cycles, 28 days each) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Schiller
University of California, San FranciscoSan FranciscoCalifornia94143
Olin
Emory UniversityAtlantaGeorgia30322
Blum
The University of ChicagoChicagoIllinois60637
Stock
University of KansasLawrenceKansas66160
Lin
University of MarylandCollege ParkMaryland20742
Baer
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Stein
University of North CarolinaChapel HillNorth Carolina27514
Zeidner
University of CincinnatiCincinnatiOhio45219
Curran
The Ohio State UniversityColumbusOhio43210
Handa
Oregon Health & Science UniversityPortlandOregon97239
Swords
The University of Texas Southwestern Medical CenterDallasTexas75390
Madanat

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University of California, Los Angeles· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAEmory University· Atlanta, GAThe University of Chicago· Chicago, ILUniversity of Kansas· Lawrence, KSUniversity of Maryland· College Park, MD

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