Actively Recruiting
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
Led by Lomond Therapeutics Holdings, Inc. · Updated on 2025-12-31
150
Participants Needed
23
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent before study procedures
- Must be 18 years of age or older
- Have relapsed or refractory AML after first-line therapy, with or without stem cell transplant
- Group 1: Confirmed FLT3-ITD or FLT3-TKD mutation by central lab
- Group 2: Documented SF3B1, SRSF2, U2AF1, or ZRSR2 mutation by local lab sequencing
- For Group 1: Prior treatment with Gilteritinib with disease progression, not eligible for Gilteritinib, or declined for social reasons
- Life expectancy of at least 3 months as judged by investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Meet clinical lab test criteria: AST and ALT ≤2.5 times upper limit of normal, total bilirubin ≤1.5 times upper limit unless Gilbert's disease, estimated glomerular filtration rate >50 mL/min
- Female patients of non-childbearing potential or if childbearing potential, negative pregnancy tests and agree to use contraception until 45 days after last dose
- Male patients and female partners of childbearing potential must agree to use two forms of contraception and males must not donate sperm during and 45 days after study
You will not qualify if you...
- Diagnosis of isolated myeloid sarcoma without blood or marrow involvement
- Acute promyelocytic leukemia (FAB M3)
- Active central nervous system involvement by AML
- Clinical signs or symptoms of leukostasis needing urgent therapy
- Known active infection with HIV, hepatitis B or C unless virus PCR test is negative
- Disseminated intravascular coagulation with active bleeding or thrombosis
- Received investigational agent within 5 half-lives or unknown half-life within 1 week prior to study
- Systemic antineoplastic therapy within 5 half-lives or radiation therapy within 1 week, except hydroxyurea
- Pregnant or lactating female patients
- Psychological, social, or medical conditions that prevent informed consent or study compliance
- Uncontrolled illnesses including serious heart conditions, recent myocardial infarction, severe arrhythmias, or other comorbidities precluding safety evaluations
- Uncontrolled active infection not under control by investigator's judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 23 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
5
University of Kansas
Lawrence, Kansas, United States, 66160
Actively Recruiting
6
University of Maryland
College Park, Maryland, United States, 20742
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
9
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
10
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
11
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
12
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
13
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
14
Eastern Health - Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Actively Recruiting
15
Linear Clinical Research Ltd
Perth, Western Australia, Australia, 6009
Actively Recruiting
16
Gachon University Gil Medical Center
Incheon, Gyeonggi-do, South Korea, 21565
Not Yet Recruiting
17
Korea University Anam Hospital
Seoul, South Korea, 02841
Not Yet Recruiting
18
Seoul National University Hospital
Seoul, South Korea, 03080
Not Yet Recruiting
19
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Not Yet Recruiting
20
Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan, 235041
Not Yet Recruiting
21
China Medical University Hospital
Taichung, Taiwan, 404327
Not Yet Recruiting
22
National Cheng Kung University Hospital
Tainan, Taiwan, 704302
Not Yet Recruiting
23
Taichung Veterans General Hospital
Xitun, Taiwan, 407219
Not Yet Recruiting
Research Team
K
Kate Dokukina, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
18
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