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 and/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