A Phase 1b Study of Lonitoclax + Azacitidine in Acute Myeloid Leukemia Patients
NCT07303660 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2025-12-26
Summary
This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory Acute Myeloid Leukemia patients.
Conditions
Interventions
- DRUG
-
ZE50-0134
Oral capsules BID
- DRUG
-
Azacitidine Days 1-7
75 mg/m2 daily, days 1-7
- DRUG
-
ZE 50-0134
Oral capsules QD
Sponsors & Collaborators
-
Lomond Therapeutics Holdings, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-10
- Primary Completion
- 2026-09-30
- Completion
- 2027-11-30
- FDA Drug
- Yes
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