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

T

Telios Pharma

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: TL-895
Drug: KRT-232

Study type

Interventional

Funder types

Industry

Identifiers

NCT04669067
TL-895-203

Details and patient eligibility

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 6 patient groups

Phase 1b - Dose Level 1
Experimental group
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.
Treatment:
Drug: KRT-232
Drug: TL-895
Phase 1b - Dose Level 2
Experimental group
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.
Treatment:
Drug: KRT-232
Drug: TL-895
Phase 1b - Dose Level 3
Experimental group
Description:
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 150 mg BID continuously for the first 28-day cycle Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 150 mg BID continuously for each 28-day cycle.
Treatment:
Drug: KRT-232
Drug: TL-895
Phase 1b - Dose Level 4
Experimental group
Description:
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 300 mg BID continuously for the first 28-day cycle. Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 300 mg BID continuously for each 28-day cycle.
Treatment:
Drug: KRT-232
Drug: TL-895
Phase 1b - Dose Level 5
Experimental group
Description:
Cycle 1 only: KRT-232 360 mg QD orally administered on Days 1 through 7 of the first 28-day cycle in combination with TL-895 450 mg BID continuously for the first 28-day cycle. Cycle 2 and beyond: KRT-232 300 mg QD orally administered on Days 1 through 7 of each 28-day cycle in combination with TL-895 450 mg BID continuously for each 28-day cycle.
Treatment:
Drug: KRT-232
Drug: TL-895
Phase 2 - Dose Expansion
Experimental group
Description:
Dose expansion of the recommended phase 2 dose of TL-895 in combination with KRT-232 as determined in Phase 1b.
Treatment:
Drug: KRT-232
Drug: TL-895

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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