NCT04669067

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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Telios Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	TL-895	TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
DRUG	KRT-232	KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.

Timeline

• Start date: 2021-03-31
• Primary completion: 2024-11-01
• Completion: 2025-11-01
• First posted: 2020-12-16
• Last updated: 2023-02-17

Locations

35 sites across 8 countries: United States, Australia, Austria, France, Germany, Italy, South Korea, Spain

Regulatory

• FDA-regulated drug study