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Clinical Trials in China / NCT04603001
Active, not recruiting Phase 1

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

NCT04603001 · tracked via the Priya Life Science China tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2020-11-19
Last updated
2026-07-22

Condition(s) studied

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

Investigational drug(s) / intervention(s)

LY3410738VenetoclaxAzacitidine

LY3410738: Oral LY3410738

Venetoclax: Oral venetoclax

Azacitidine: Subcutaneous or intravenous azacitidine

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 * 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: * 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. * 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

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California
UCLA Medical Center Los Angeles California
University of California, Davis - Health Systems Sacramento California
H Lee Moffitt Cancer Center Tampa Florida
Northwestern University Chicago Illinois
University of Chicago Hospital Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Roswell Park Cancer Institute Buffalo New York
Memorial Sloan Kettering Cancer Center New York New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Vanderbilt University Medical Center Nashville Tennessee
University of Texas MD Anderson Cancer Center Houston Texas
Peter MacCallum Cancer Centre Melbourne Victoria
The Alfred Hospital Melbourne Victoria
Linear Clinical Research Nedlands Western Australia
Cliniques universitaires Saint-Luc Brussels Belgium
BC Cancer Vancouver Vancouver British Columbia
Princess Margaret Hospital Toronto Ontario
Jewish General Hospital Montreal Quebec
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
Rambam Medical Center Haifa Israel
National University Cancer Institute Singapore Singapore
Singapore General Hospital Singapore Singapore
Asan Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul]
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

On this site

📄 Venclexta (venetoclax) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04603001 on ClinicalTrials.gov ↗ ← All trials in China