Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
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|ClinicalTrials.gov Identifier: NCT04521686|
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : June 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma Chondrosarcoma Glioma Any Solid Tumor||Drug: LY3410738||Phase 1|
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 tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or IDH2 R140 or R172 mutant cholangiocarcinoma.
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 or IDH1 or IDH2 mutant cholangiocarcinoma. The Phase 1 dose expansion will include 4 cohorts to further evaluate safety and clinical activity - three cohorts will be administered LY3410738 monotherapy and the fourth cohort will administer LY3410738 at or below the monotherapy RP2D to patients in combination with gemcitabine and cisplatin.
IDH1 R132, IDH2 R140, or IDH2 R172 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations|
|Actual Study Start Date :||October 16, 2020|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||September 2023|
Phase 1 dose escalation - Multiple doses of LY3410738 Phase 1 dose expansion - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
- Recommended Phase 2 dose (RP2D) [ Time Frame: Up to 24 months ]
- Objective Response Rate [ Time Frame: Up to 24 months ]
- Assess the safety and tolerability of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine. [ Time Frame: Up to 24 months ]
- To assess the preliminary anti-tumor activity of LY3410738 monotherapy and in combination with cisplatin plus gemcitabine [ Time Frame: Up to 24 months ]
- Characterize PK properties of LY3410738 when administered alone or in combination with cisplatin plus gemcitabine. [ Time Frame: Up to 24 months ]
- To characterize the pharmacodynamic properties of LY3410738 as expressed by change in 2-HG oncometabolite levels in plasma. [ Time Frame: Up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521686
|Contact: Patient Advocacy||833-LOXO-IDHfirstname.lastname@example.org|
|Study Director:||Nikhil Shukla||Medical Monitor|