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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

NCT04603001•Eli Lilly and Company

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Advanced IDH mutant hematologic malignancy including:
•\-- For Dose Escalation Arm C and Dose Expansion Cohort 5:
•* Patients with newly diagnosed AML who are 75 years or older or have comorbidities that preclude the use of intensive chemotherapy
•* Patients with R/R AML (US only)
•Patients must have received prior therapy
•Blasts at least 5% in bone marrow.
•Patients must have a qualifying IDH1 R132, IDH2 R140 or IDH2 R172 mutation
•Eastern Cooperative Oncology Group (ECOG) 0 to 2
•Adequate organ function
•Ability to swallow capsules or tablets
+2 more criteria

Exclusion Criteria

•Investigational agent or anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter; or investigational monoclonal antibody within 4 weeks prior to planned start of LY3410738
•For Dose Escalation Arm C and Dose Expansion Cohort 5:
•* Prior venetoclax treatment is not allowed.
•* Patients are allowed to receive up to 1 cycle of single agent azacitidine or azacitidine plus venetoclax while waiting for results of locally obtained molecular profiling, including IDH1/IDH2 mutational status, prior to starting on study.
•Major surgery within 4 weeks prior to planned start of LY3410738.
•Active, uncontrolled clinically significant systemic bacterial, viral, fungal or parasitic infection or an unexplained fever \> 38.5ºC during Screening or on the first day of study drug administration.
•Another concurrent malignancy requiring active therapy.
•Active central nervous system involvement
•Any unresolved toxicities from prior therapy greater than CTCAE v5.0 Grade 2 at the time of starting study treatment except for alopecia.
•History of hematopoietic stem cell transplant (HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 60 days of the first dose of LY3410738.
+10 more criteria

Locations (37)

City of Hope National Medical Center

Duarte, California, United States

UCLA Medical Center

Los Angeles, California, United States

University of California, Davis - Health Systems

Sacramento, California, United States

H Lee Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago Hospital

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Key Dates

Start Date

November 19, 2020

Primary Completion Date

July 3, 2023

Completion Date

May 1, 2026

Last Updated

June 27, 2025

Enrollment

260

ESTIMATED participants

Conditions

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

Interventions

LY3410738

DRUG

Venetoclax

DRUG

Azacitidine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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