Last updated on October 2020

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


Brief description of study

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with IDH1 R132-mutant advanced solid tumor types, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma.

Detailed Study Description

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with IDH1 R132-mutant advanced solid tumor types, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma.

This study includes 2 parts, Phase 1 dose escalation and Phase 1 dose expansion. The Phase 1 dose escalation monotherapy cohort will enroll any eligible patient with IDH1 R132-mutant advanced solid tumor. Once the LY3410738 monotherapy RP2D is established, Phase 1 dose expansion will begin and will include 4 cohorts to further evaluate safety and clinical activity - three cohorts will be administered LY3410738 monotherapy and the fourth cohort wiil administer LY3410738 to patients in combination with gemcitabine and cisplatin.

IDH1 R132 mutations will be identified through standard of care testing as routinely performed at each participating site utilizing material collected prior to patient consent . Molecular assays utilized for enrollment are required to be performed in CLIA, ISO/IEC, CAP, or other similarly certified laboratory. Enrollment of patients with cholangiocarcinoma, chondrosarcoma or glioma may be made based on molecular tests performed in either tumor or blood. Enrollment of patients with other tumor types is limited to testing performed in tumor tissue.

Clinical Study Identifier: NCT04521686

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Recruitment Status: Open


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