Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

Official Title

A Phase 1 Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

Summary:

This is an open-label, multi-centre Phase 1 study of LY3410738, an oral, covalent IDH inhibitor, in patients with IDH1 or IDH2-mutant advanced hematologic malignancies who have received standard therapy

Trial Description

Primary Outcome:

  • To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
  • To assess the activity of LY3410738 as measured by the overall response rate (ORR) per the investigator assessment
Secondary Outcome:
  • To determine the safety profile and tolerability of LY3410738 including acute and chronic toxicities by collecting and evaluating adverse events and treatment emergent adverse events
  • To characterize the pharmacokinetics (PK) properties of LY3410738 by collecting and evaluating serum at protocol specified time points
  • To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma
  • To assess the activity of LY3410738 as measured by the overall response rate (ORR) per investigator assessment
  • To assess the activity of LY3410738 as measured by Best Overall Response per investigator assessment
  • To assess the activity of LY3410738 by Complete Response Rate plus partial hematologic recovery (AML patients)
  • To assess the activity of LY3410738 by Duration of Response
  • To assess the activity of LY3410738 by Hematologic improvement in patients with MDS
  • To determine the safety profile and tolerability of LY3410738 including acute and chronic toxicities by collecting and evaluating Adverse events and treatment emergent adverse events
  • To characterize the pharmacokinetics (PK) properties of LY3410738 by collecting and evaluating serum at protocol specified time points
  • To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma.
This study includes 2 parts: dose escalation and dose expansion. The dose escalation will enroll eligible patients with select IDH-mutant advanced hematologic malignancies. Once the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of LY3410738 is established, the dose expansion will begin and enroll into 4 cohorts to further evaluate safety and clinical activity

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society