Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-03-22
Brief Title:
ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer
Sponsor:
MEI Pharma Inc
Organization:
MEI Pharma Inc
Study Overview
Official Title:
A Phase 1b Study of the OxPhos Inhibitor ME-344 Combined With Bevacizumab in Previously Treated Metastatic Colorectal Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 a Phase 1b open-label multiple doseschedule sequential study to determine the safety and efficacy of the oxidative phosphorylation OxPhos pathway inhibitor ME-344 in combination with bevacizumab in subjects with recurrent mCRC
Detailed Description:
This is a Phase 1b open-label multiple doseschedule sequential study to determine the safety and efficacy of the oxidative phosphorylation OxPhos pathway inhibitor ME-344 in combination with bevacizumab in subjects with recurrent mCRC
This study will enroll subjects with metastatic CRC including but not limited to subjects with RAS wild-type or mutant tumors MSI-HpMMR and BRAF V600E who have progressed or demonstrated intolerability to standard approved therapies which include fluoropyrimidine oxaliplatin irinotecan-based chemotherapies cetuximabpanitumumab PD-1 inhibitors or BRAF inhibitors if clinically indicated andor other checkpoint inhibitors Approximately 40 subjects will be enrolled in the study in 2 cohorts of 20 subjects each
Subjects will continue treatment with ME-344 and bevacizumab until radiological progressive disease unacceptable AEs withdrawal of consent start of new anticancer therapy or death
This study will enroll subjects with metastatic CRC including but not limited to subjects with RAS wild-type or mutant tumors MSI-HpMMR and BRAF V600E who have progressed or demonstrated intolerability to standard approved therapies which include fluoropyrimidine oxaliplatin irinotecan-based chemotherapies cetuximabpanitumumab PD-1 inhibitors or BRAF inhibitors if clinically indicated andor other checkpoint inhibitors Approximately 40 subjects will be enrolled in the study in 2 cohorts of 20 subjects each
Subjects will continue treatment with ME-344 and bevacizumab until radiological progressive disease unacceptable AEs withdrawal of consent start of new anticancer therapy or death
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