An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With KRT-232 in Patients With Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)
Description
Brief Summary
This study evaluates TL-895, a potent, orally available and highly selective irreversible
tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule
inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia.
Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible
for this study.
Phase
N/AInclusion and Exclusion Criteria
- TP53 wildtype AML
- Relapsed/Refractory to at least one prior therapy, one of which must have included a FLT-3 inhibitor
- FLT3 mutation (FLT3-TKD or FLT3-ITD)
- ECOG 0-2
- Adequate hematologic, hepatic, and renal functions
- AML subtype 3
- Prior treatment with MDM2 antagonist therapies
- Eligible for HSCT
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.