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Closed (no longer recruiting)Last updated: 2 February 2024

This phase Ib/II trial is trying to understand how safe and effective a combined treatment of two targeted therapies (TL-895 and KRT-232) is in adults with FLT3 mutated Acute Myeloid LeukaemiaAn 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)

Clinical summary

Summary

This is a non-randomised, open-label trial with one experimental arm. Participants will receive TL-895, administered orally, twice daily, continuously starting on Day 1 in a 28-day cycle, in combination with KRT-232, administered orally, once daily, on days 1-7 in a 28-day cycle.

Conditions

This trial is treating patients with acute myeloid leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

Telios Pharma, Inc.

Scientific Title

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)

Eligibility

Inclusion

  • 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

  • AML subtype 3
  • Prior treatment with MDM2 antagonist therapies
  • Eligible for HSCT

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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