Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04521686
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2020-08-13
Brief Title:
Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicenter Phase 1 study to evaluate safety tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 IDH1 arginine 132 R132-mutant advanced solid tumors including but not limited to cholangiocarcinoma chondrosarcoma and glioma or isocitrate dehydrogenase 2 IDH2 arginine 140 R140 or arginine 172 R172 mutant cholangiocarcinoma
Detailed 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 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 5 cohorts to further evaluate safety and clinical activity Three cohorts will be administered LY3410738 monotherapy The fourth cohort will administer LY3410738 at or below the monotherapy RP2D in combination with gemcitabine and cisplatin The fifth cohort US only will administer LY3410738 at or below the monotherapy RP2D in combination with durvalumab
IDH1 R132 IDH2 R140 or IDH2 R172 mutations will be identified through genomic testing utilizing material collected prior to patient consent Molecular assays utilized for enrollment are required to be performed in CLIA ISOIEC 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
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 5 cohorts to further evaluate safety and clinical activity Three cohorts will be administered LY3410738 monotherapy The fourth cohort will administer LY3410738 at or below the monotherapy RP2D in combination with gemcitabine and cisplatin The fifth cohort US only will administer LY3410738 at or below the monotherapy RP2D in combination with durvalumab
IDH1 R132 IDH2 R140 or IDH2 R172 mutations will be identified through genomic testing utilizing material collected prior to patient consent Molecular assays utilized for enrollment are required to be performed in CLIA ISOIEC 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I9Y-OX-JDHC | OTHER | Eli Lilly and Company | None |
| 2020-002863-77 | EUDRACT_NUMBER | None | None |