Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308263
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-03-06
Brief Title:
M1774 Human Mass Balance Study DDRIVER Solid Tumors 303
Sponsor:
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
Organization:
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany
Study Overview
Official Title:
Phase 1 Study to Evaluate the Mass Balance Pharmacokinetics Metabolism and Excretion of M1774 Containing Microtracer 14C M1774 in Participants With Advanced Solid Tumors DDRIVER Solid Tumors 303
Status:
RECRUITING
Status Verified Date:
2024-07
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 single sequence 2-period open label study in participants with advanced solid tumors The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors Thereafter participants may enter an optional extension phase Period 2 where participants will receive M1774 until disease progression or other criteria for study intervention discontinuation are met
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 2022-502940-10-00 | OTHER | EU trial number | None |