NCT06366789 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
| NCT ID | NCT06366789 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Lomond Therapeutics Holdings, Inc. |
| Condition | AML With Gene Mutations |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2026-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. 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). 2. Patient is ≥18 years of age at the time of obtaining informed consent. 3. Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT). 4. 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. 5. 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 chosen not to have treatment with Gilteritinib for social reasons. 6. Patients have a life expectancy of at least 3 months in the opinion of the Investigator. 7. Patient has a