Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

Inclusion Criteria: 1. 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 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. 2. Availability of an archived tumor tissue sample. Patients without an available archival tumor tissue sample must be discussed with the sponsor's Medical Monitor prior to enrollment. 3. Eastern Cooperative Oncology Group (ECOG) 0-1. 4. At least 18 years of age. 5. Adequate organ function. 6. Ability to swallow capsules or tablets. 7. Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation. 8. For cholangiocarcinoma patients, must have adequate biliary drainage (per investigator's discretion), with no evidence of ongoing infection. 9. 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. Patients enrolled to Dose Expansion Cohort 4 shall also follow cisplatin/gemcitabine contraception duration requirements as determined by labels and/or local guidelines. Patients enrolled in dose expansion Cohort 5 should follow durvalumab contraception duration requirements as determined by the durvalumab label and/or local guidelines. Monotherapy Dose Escalation: 10. A locally advanced or metastatic solid tumor, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator. 11. Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate by tumor type. 12. Prior IDH1 inhibitor treatment is permitted. Monotherapy Dose Expansion Cohort 1: 13. Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma, following 1 to 2 lines of prior systemic treatment for advanced disease. Prior IDH1 inhibitor treatment is not permitted. 14. Measurable disease as determined by RECIST 1.1. Monotherapy Dose Expansion Cohort 2: 15. A locally advanced or metastatic solid tumor (except for cholangiocarcinoma), where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator. 16. Measurable disease as determined by RECIST 1.1 or RANO as appropriate by tumor types. Monotherapy Dose Expansion Cohort 3: 17. A locally advanced or metastatic solid tumor, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator. 18. Non-measurable disease only as determined by RECIST 1.1 or RANO as appropriate by tumor type. Combination Dose Expansion Cohort 4: 19. Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma, not eligible for curative resection. 20. No prior systemic therapy for advanced or metastatic disease with the following exceptions: * Patients who received adjuvant chemotherapy are eligible, if the adjuvant therapy was completed at least 6 months prior to the development of advanced or metastatic disease. * Patients who are receiving up to two cycles of cisplatin plus gemcitabine as the first line systemic therapy while waiting for results of molecule profiling including IDH1/IDH2 mutational status, are eligible, provided that a radiographic assessment during screening demonstrates the absence of interval disease progression since initiation of chemotherapy treatment, and all other eligibility criteria are met. 21. Measurable disease as determined by RECIST 1.1. Combination Dose Expansion Cohort 5: 22. Cholangiocarcinoma patients with IDH1 R132, IDH2 R140, or IDH2 R172 mutations 23. Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma, following 1 or more lines of prior systemic treatment for advanced disease. 24. Measurable disease as determined by RECIST 1.1 Exclusion Criteria: 1. Had an investigational agent or anticancer therapy within 2 weeks; or investigational monoclonal antibody within 4 weeks prior to planned start of LY3410738. 2. Had major surgery within 4 weeks prior to planned start of LY3410738. 3. Had 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. 4. Patients with cholangiocarcinoma: underwent hepatic radiation, chemoembolization and radiofrequency ablation, radioembolization or other locoregional therapy \<4 weeks, have history of hepatic encephalopathy of any grade, have ascites requiring intervention such as diuretics or paracentesis, have ongoing cholangitis, have mixed hepatocellular biliary tract cancer histology or history of liver transplant. 5. Have active CNS metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate provided that they are stable and are not requiring steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible even if treated. 6. Have primary CNS tumors are eligible provided that they do not have leptomeningeal disease and are on a stable or decreasing steroid dose for 7 days prior to screening. Patients with evidence of intracranial hemorrhage either by MRI or CT are not eligible 7. Any unresolved toxicities from prior therapy greater than CTCAE (version 5.0) Grade 2 at the time of starting study treatment except for alopecia. 8. Have clinically significant, uncontrolled car…

Reproduced word-for-word from the public registry record — the study team can answer questions about it.