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

  • STATUS
    Recruiting
  • End date
    Sep 22, 2023
  • participants needed
    220
  • sponsor
    Eli Lilly and Company
Updated on 22 July 2021
hematologic malignancy
blast cells
IDH2

Summary

This is an open-label, multi-center 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

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 4 cohorts to further evaluate safety and clinical activity

Details
Condition Bone marrow disorder, Chronic myelomonocytic leukemia, Juvenile Myelomonocytic Leukemia, Preleukemia, Acute myeloid leukemia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Myeloproliferative Neoplasms, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, myelodysplastic syndrome (mds), acute myelogenous leukemia, anll, acute myeloblastic leukemia, chronic myelomonocytic leukaemia, cmml
Treatment LY3410738
Clinical Study IdentifierNCT04603001
SponsorEli Lilly and Company
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Advanced IDH mutant hematologic malignancy
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) 0-2
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
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 > 38.5C 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 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-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 anti-retroviral 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
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