Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509906
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
M9466 in Combination With Topoisomerase 1 Inhibitors-based Regimens in Advanced Solid Tumors and Colorectal Cancer DDRiver 511
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Label Multicenter Phase 1 Study to Evaluate the Safety Tolerability and PharmacokineticPharmacodynamic Profile of the PARP1 Inhibitor M9466 in Combination With Topoisomerase 1 Inhibitor-based Regimens in Advanced Solid Tumors and Colorectal Cancer DDRiver 511
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens As such the combination with FOLFIRI folinic acid fluorouracil irinotecan and Bevacizumab will be evaluated in participants with colorectal cancer to establish the M9466 maximum tolerated dose if observed and the recommended dose for expansion
Study Duration After a Screening period of up to 28 days enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent are lost to follow-up or die
Visit Frequency The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle After end of study intervention period the participants will come for an End of Treatment Visit and a Safety Follow-up Visit
Study Duration After a Screening period of up to 28 days enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent are lost to follow-up or die
Visit Frequency The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle After end of study intervention period the participants will come for an End of Treatment Visit and a Safety Follow-up Visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None