NCT04603001

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

Detailed description

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 5 cohorts to further evaluate safety and clinical activity

Conditions

• Acute Myeloid Leukemia (AML)
• Myelodysplastic Syndrome (MDS)
• Chronic Myelomonocytic Leukemia (CMML)
• Myeloproliferative Neoplasms (MPNs)

Interventions

Type	Name	Description
DRUG	LY3410738	Oral LY3410738
DRUG	Venetoclax	Oral venetoclax
DRUG	Azacitidine	Subcutaneous or intravenous azacitidine

Timeline

• Start date: 2020-11-19
• Primary completion: 2023-07-03
• Completion: 2026-05-01
• First posted: 2020-10-26
• Last updated: 2025-06-27

Locations

37 sites across 12 countries: United States, Australia, Belgium, Canada, Finland, France, Germany, Israel, Singapore, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study