Clinical trial · Interventional
TL-895 and KRT-232 Study in Acute Myeloid Leukemia
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KRT-232 | Drug | Navtemadlin | ALIAS |
| TL-895 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Phase 1b - Dose Level 1
- description
- KRT-232 240mg QD, orally administered on days 1 through 7 of each 28-day cycle in combination with TL-895 150mg BID continuously for each 28-day cycle.
- interventionNames
- Drug: TL-895
- Drug: KRT-232
- type
- EXPERIMENTAL
- label
- Phase 1b - Dose Level 2
- description
- KRT-232 300mg QD, orally administered on days 1 through 7 of each 28-day cycle in combination with TL-895 150mg BID continuously for each 28-day cycle.
- interventionNames
- Drug: TL-895
- Drug: KRT-232
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available