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

NCT04521686

Advanced Solid Tumors

IDH1 Inhibitor


A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 Mutations*

NCT04521686
Key Inclusion Criteria
  • Evidence of IDH1 R132 mutation in tumor tissue (any solid tumor) or circulating tumor DNA (cholangiocarcinoma, chondrosarcoma, and glioma) as determined by molecular testing routinely performed at a certified laboratory
  • Availability of an archived tumor tissue sample
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • ≥18 years of age
  • 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
  • Adequate biliary drainage (per investigator's discretion) with no evidence of ongoing infection for cholangiocarcinoma patients
  • Males and females of reproductive potential must be willing to use conventional and effective birth control
  • Primary central nervous system (CNS) tumors with no leptomeningeal disease and are on a stable or decreasing steroid dose for 7 days prior to screening
Key Exclusion Criteria
  • Investigational agent or anticancer therapy within 2 weeks; or investigational monoclonal antibody within 4 weeks prior to planned start of study treatment
  • Major surgery within 4 weeks prior to planned start of study treatment
  • Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving whole-brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment
  • Cholangiocarcinoma that underwent hepatic radiation, chemoembolization and radiofrequency ablation, radioembolization, or other locoregional therapy <4 weeks; history of hepatic encephalopathy of any grade; ascites requiring intervention such as diuretics or paracentesis; ongoing cholangitis; or mixed hepatocellular biliary tract cancer histology
  • Active CNS metastases or suspected or confirmed leptomeningeal disease (patients with asymptomatic and treated brain metastases may participate provided that they are stable and are not requiring steroid treatment)
  • Evidence of intracranial hemorrhage either by MRI or CT
  • 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
  • Clinically significant, uncontrolled cardiac or cardiovascular disease, or prolongation of the QT interval corrected for heart rate (QTcF) >470 ms on at least two out of three consecutive electrocardiograms (ECGs), and mean QTcF >470 ms on all three ECGs, during screening; or history of myocardial infarction within 6 months prior to planned start of study treatment
  • Active, uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process
  • Known HIV infection and/or active hepatitis B or C infection (patients with controlled hepatitis B or successfully treated hepatitis C >4 weeks between achieving sustained viral response and starting study drug are eligible)
  • Treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitor
  • Treatment with proton pump inhibitor within 7 days of starting study drug
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study treatment
  • Active second malignancy unless in remission and with life expectancy >2 years
  • Pregnancy, lactation, or plan to breastfeed during the study or within 30 days of the last dose of study treatment
  • Hypersensitivity to any component 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.
§
Cisplatin is administered intravenously (IV).
Gemcitabine is administered IV.
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.