Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
NCT ID: NCT04603001
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
260 participants
INTERVENTIONAL
2020-11-19
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Escalation Arm A (Monotherapy)
Patients not requiring a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
LY3410738
Oral LY3410738
Dose Escalation Arm B (Monotherapy)
Patients requiring a strong CYP3A4 inhibitor for active management or prevention of a lifethreatening condition, such as an azole administered to prevent invasive fungal infection.
LY3410738
Oral LY3410738
Dose Escalation Arm C (LY3410738, Venetoclax, and Azacitidine)
Patients with no prior venetoclax therapy and not requiring a strong CYP3A4 inhibitor for active treatment within 7 days of starting LY3410738.
LY3410738
Oral LY3410738
Venetoclax
Oral venetoclax
Azacitidine
Subcutaneous or intravenous azacitidine
Cohort 1
Patients with relapsed/refractory (R/R) AML harboring an IDH1 R132 mutation who have received a prior IDH inhibitor.
LY3410738
Oral LY3410738
Cohort 2
Patients with R/R AML harboring an IDH1 R132 mutation who have not received a prior IDH inhibitor.
LY3410738
Oral LY3410738
Cohort 3
Patients with R/R MDS, chronic myelomonocytic leukemia (CMML) or other advanced hematologic malignancy harboring an IDH1 R132 mutation.
LY3410738
Oral LY3410738
Cohort 4
Patients with R/R AML, MDS, CMML or other advanced hematologic malignancy harboring IDH2 mutations.
LY3410738
Oral LY3410738
Cohort 5
Patients with newly diagnosed AML, R/R AML, or other advanced hematologic malignancy harboring IDH1 and/or IDH2 mutations with no prior venetoclax therapy. Strong CYP3A4 inhibitor allowed but not required.
LY3410738
Oral LY3410738
Venetoclax
Oral venetoclax
Azacitidine
Subcutaneous or intravenous azacitidine
Interventions
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LY3410738
Oral LY3410738
Venetoclax
Oral venetoclax
Azacitidine
Subcutaneous or intravenous azacitidine
Eligibility Criteria
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Inclusion Criteria
\-- 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
* Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
* Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment.
Exclusion Criteria
* 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.
* Clinically significant cardiovascular disease
* Active hepatitis B virus (HBV)
* Active hepatitis C virus (HCV)
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug
* Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or P- glycoprotein (P-gp) inhibitor, with the exception of patients being treated with allowed antifungal inhibitors of CYP3A4
* Treatment with proton pump inhibitor (PPIs) within 7 days of starting LY3410738
* Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the Investigator would contraindicate the patient's participation in the study or confound the results of the study
* Known human immunodeficiency virus (HIV), excluded due to potential drug-drug interactions between antiretroviral medications and LY3410738
* Pregnancy, lactation or plan to breastfeeding during the study or within 90 days of the last dose of study intervention
* Known hypersensitivity to any of the components of LY3410738 or its formulation
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Cliniques universitaires Saint-Luc
Brussels, , Belgium
BC Cancer Vancouver
Vancouver, British Columbia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, , Finland
Institut Paoli-Calmettes
Marseille, , France
Hopital Saint Louis
Paris, , France
Centre hospitalier universitaire de Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Claudius Regaud
Toulouse, , France
Medizinische Hochschule Hanover
Hanover, Lower Saxony, Germany
Rambam Medical Center
Haifa, , Israel
National University Cancer Institute
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Seoul National University Hospital
Seoul, , South Korea
Clinico Y Provincial Barcelona
Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Fe de Valencia
Valencia, , Spain
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Related Links
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Study of LY3410738 in Patients with Advanced Blood Cancers with a Change in the IDH1 or IDH2 Gene
Other Identifiers
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2020-002830-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
I9Y-OX-JDHB
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-IDH-20001
Identifier Type: OTHER
Identifier Source: secondary_id
18076
Identifier Type: -
Identifier Source: org_study_id
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