TL-895 and KRT-232 Study in Acute Myeloid Leukemia
Sponsored by Telios Pharma, Inc.
About this trial
Last updated 2 years ago
Study ID
TL-895-203
Status
Active, not recruiting
Type
Interventional
Phase
Phase 1/Phase 2
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 4 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion 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
Exclusion Criteria
- AML subtype 3
- Prior treatment with MDM2 antagonist therapies
- Eligible for HSCT