Phase 1  | 
Enrolling
 | Investigational Drug

NCT04521686

Advanced Solid Tumors

IDH1/2 Inhibitor


A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations*

show modal icon NCT04521686
Key Inclusion Criteria
  • Evidence of IDH1 R132 mutation (any solid tumor) or circulating tumor DNA IDH2 R140 or IDH2 R172 mutation (cholangiocarcinoma only) as determined by molecular testing routinely performed at a CLIA, ISO/IEC, CAP, or other similarly certified laboratory. For cholangiocarcinoma, chondrosarcoma, and glioma, molecular testing can be performed on tumor tissue or circulating tumor DNA. For all other solid tumor types, molecular testing must be performed on tumor tissue
  • 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 or tablets
  • 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
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 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 >10,000 μL
  • 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, 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 or history of liver transplant
  • Active central nervous system (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/cardiovascular disease 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 P-gp inhibitors
  • 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 3 months of the last dose of study treatment
  • Hypersensitivity to any component of the study drug or its formulation
*
This clinical trial is being conducted globally. 
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.
Patients who received adjuvant chemotherapy at least 6 months prior to the development of advanced or metastatic disease are eligible. Patients who are receiving the first cycle of cisplatin plus gemcitabine while waiting for results of molecule profiling are eligible, provided that a radiographic assessment demonstrates no interval disease progression since chemotherapy initiation. Per protocol amendment v7, patients can receive up to 2 cycles of cisplatin plus gemcitabine prior to enrollment.
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.