Overview

TL-895 and KRT-232 Study in Acute Myeloid Leukemia

Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with 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:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Telios Pharma, Inc.
Collaborator:
Kartos Therapeutics, Inc.
Criteria
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