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Clinical trial

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)

ID
Name
TL-895-203
Description
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.
Trial arms
Trial start
2021-03-31
Estimated PCD
2024-11-01
Trial end
2025-11-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Arms:
Phase 1b - Dose Level 1, Phase 1b - Dose Level 2, Phase 1b - Dose Level 3, Phase 1b - Dose Level 4, Phase 1b - Dose Level 5, Phase 2 - Dose Expansion
KRT-232
KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
Arms:
Phase 1b - Dose Level 1, Phase 1b - Dose Level 2, Phase 1b - Dose Level 3, Phase 1b - Dose Level 4, Phase 1b - Dose Level 5, Phase 2 - Dose Expansion
Size
18
Primary endpoint
Primary Objective, Phase 1b: To determine the MTD/MAD and recommended Phase 2 dose (RP2D) of TL-895 in combination with KRT-232
13 months
Primary Objective, Phase 2: To determine the rates of complete remission (CR) and complete remission with partial hematologic recovery (CRh)
41 months
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}
Updated at
2023-02-17

1 organization

2 products

1 indication

Organization
Telios Pharma
Product
KRT-232
Indication
Acute Myeloid Leukemia
Product
TL-895