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No longer recruiting (closed or complete)Last updated: 22 October 2024

TL-895-203: 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

TL-895-203

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 people with acute myeloid leukaemia

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

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, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

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)

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