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Tests treatment safety and results for AML With Gene Mutations
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
ClinicalTrials.gov ID: NCT06366789
What this study is testing
What is ZE46-0134?
ZE46-0134 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for aml with gene mutations.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including...
- Patient is ≥18 years of age at the time of obtaining informed consent.
- Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).
- Group 1: Patient must have a confirmed FLT3-ITD or FLT3-TKD mutation by central laboratory testing. Group 2: Patient must have a documented SF3B1...
- For Group 1 only: Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for...
You likely can't join if
- Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including...
- Patient is ≥18 years of age at the time of obtaining informed consent.
- Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).
- Patient must have a confirmed FLT3 ITD, TKD or ITD-F691L mutation documented within the past 90 days in absence of therapy or within the Screening...
- Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with...
- Patients have a life expectancy of at least 3 months in the opinion of the Investigator.
See the full eligibility criteria
Who can join
- Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- Patient is ≥18 years of age at the time of obtaining informed consent.
- Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).
- Group 1: Patient must have a confirmed FLT3-ITD or FLT3-TKD mutation by central laboratory testing. Group 2: Patient must have a documented SF3B1, SRSF2, U2AF1, or ZRSR2 pathogenic mutation by local lab sequencing.
- For Group 1 only: Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator, or...
- Patients have a life expectancy of at least 3 months in the opinion of the Investigator.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Patient must meet the following criteria as indicated on the clinical laboratory tests:
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN)
- Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease
- Estimated glomerular filtration (eGFR) rate of \>50 mL/min as calculated by the Modification of Diet in Renal Disease equation.
- Female patients:
- If of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit or postmenopausal (where postmenopausal is defined...
- If of childbearing potential, must: i. Have a negative serum pregnancy test at the Screening visit and urine pregnancy test on admission to the clinic on Day-1. ii. Agree not to attempt to become pregnant or donate ova...
- Male patients and their female spouse/partners who are of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (at least 1of which must be a barrier method)...
What rules you out
- Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- Patient is ≥18 years of age at the time of obtaining informed consent.
- Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).
- Patient must have a confirmed FLT3 ITD, TKD or ITD-F691L mutation documented within the past 90 days in absence of therapy or within the Screening period 28 days) prior to study drug administration on C1D1 if therapy...
- Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator, or chosen not to have...
- Patients have a life expectancy of at least 3 months in the opinion of the Investigator.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Patient must meet the following criteria as indicated on the clinical laboratory tests:
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN)
- Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease
- Estimated glomerular filtration (eGFR) rate of \>50 mL/min as calculated by the Modification of Diet in Renal Disease equation.
- Female patients:
- If of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit or postmenopausal (where postmenopausal is defined...
- If of childbearing potential, must: i. Have a negative serum pregnancy test at the Screening visit and urine pregnancy test on admission to the clinic on Day-1. ii. Agree not to attempt to become pregnant or donate ova...
- Male patients and their female spouse/partners who are of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (at least 1of which must be a barrier method)...
- Diagnosis of isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML)
- Acute promyelocytic leukemia (FAB M3)
- Active central nervous system (CNS) involvement by AML
- Clinical signs/symptoms of leukostasis requiring urgent therapy
- Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for...
- Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.
- Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An...
- Systemic antineoplastic therapy within 5 half-lives or radiation therapy within 1 week prior to starting protocol with the exception of hydroxyurea, which is allowed to control white blood cell counts.
- Female patients who are pregnant or lactating
- Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol...
- Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial...
- Infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control in the opinion of the Investigator. Patients with uncontrolled infection shall...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lawrence, Kansas, United States
- College Park, Maryland, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Incheon, Gyeonggi-do, South Korea
- Seoul, South Korea
- New Taipei City, Taiwan
- Taichung, Taiwan
- Tainan, Taiwan
- Xitun, Taiwan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Lawrence, Kansas, United States; College Park, Maryland, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.