Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 1  | ENROLLING

NCT04603001

Advanced Hematologic Malignancies

IDH1 Inhibitor


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

NCT04603001
Key Inclusion Criteria
  • ≥18 years of age or age of majority if higher per local regulations
  • Advanced IDH-mutant hematologic malignancy, including acute myeloid leukemia (AML) according to the World Health Organization (WHO) 2016 criteria, myelodysplastic syndrome (MDS) with excess blasts (subtype MDS-EB-1 or MDS-EB-2) or considered high or very high risk by the Revised International Prognostic Scoring System (IPSS R), or other relapsed and/or primary refractory (R/R) hematologic cancers (eg, chronic myelomonocytic leukemia or myeloproliferative neoplasms [myelofibrosis, essential thrombocythemia, or polycythemia vera])
  • Blasts at least 5% in bone marrow
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate organ function
  • Able to swallow capsules
  • Able to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation
  • Males and females of reproductive potential must be willing to use conventional and effective birth control
Key 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 study treatment with the exception of hydroxyurea, which is allowed throughout the study for the control of peripheral leukemia blasts in patients with white blood cell counts >30,000/μL
  • Major surgery within 4 weeks prior to planned start of study treatment
  • Active, uncontrolled clinically significant systemic bacterial, viral, fungal, or parasitic infection, or an unexplained fever >101.3°F during screening or on the first day of study treatment
  • Another concurrent malignancy requiring active therapy
  • Active central nervous system involvement
  • Any unresolved toxicities from prior therapy > grade 2 as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 at the time of starting study treatment, except for alopecia
  • History of hematopoietic stem cell transplant, or CAR-T therapy within 60 days of the first dose of study treatment, or with any of the following:
    • Ongoing immunosuppressive therapy post-HSCT or CAR-T therapy at the time of screening with the exception of use of low-dose corticosteroids ≤10 mg prednisone or equivalent and topical steroids for ongoing skin graft-versus-host disease (GVHD), or clinically significant GVHD, or need for anticytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > grade 1 from CAR-T therapy
  • Clinically significant cardiovascular disease with history of myocardial infarction within 6 months prior to planned start of study treatment; New York Heart Association (NYHA) class III or IV congestive heart failure; unstable angina; LVEF <40% by echocardiogram (ECG) or multigated acquisition scan within 28 days of C1D1; known history of severe and/or uncontrolled ventricular arrhythmia within 6 months prior to planned start of study drug; prolongation of the QT interval corrected for heart rate (QTcF) >470 ms on at least two out of three consecutive ECGs, and mean QTcF >470 ms on all three ECGs, during screening
  • Active HIV and/or hepatitis B or C virus (patients with controlled hepatitis B or successfully treated hepatitis C >4 weeks between achieving sustained viral response and starting study drug are eligible)
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
  • Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitor with the exception of patients being treated with allowed antifungal inhibitors of CYP3A4 who are being evaluated for arm B
  • Treatment with proton pump inhibitor within 7 days of starting study drug
  • Any serious underlying medical or psychiatric condition, 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
  • Pregnancy, lactation, or plan to breastfeed during the study or within 30 days of the last dose of study treatment
  • Known hypersensitivity to any components of the study drug or its formulation
*
This clinical trial is being conducted in the United States.
Additional criteria not shown here may exist for individual parts of the study.
LY3410738 is administered PO.
Contact the Loxo Oncology at Lilly Clinical Trial Team

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.