Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504916
Status:
TERMINATED
Last Update Posted:
2023-06-29
First Post:
2020-08-04
Brief Title:
A Study of Zilovertamab Vedotin MK-2140VLS-101 in Participants With Solid Tumors MK-2140-002
Sponsor:
VelosBio Inc a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
VelosBio Inc a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
A Phase 2 Study of VLS-101 in Patients With Solid Tumors
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study evaluating the efficacy safety and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer TNBC non-TNBC human epidermal growth factor receptor 2 HER2-negative breast cancer non-squamous non-small-cell lung cancer NSCLC gastric cancer pancreatic cancer and platinum-resistant ovarian cancer The study will evaluate a null hypothesis that the objective response rate ORR is 5 against the alternative hypothesis that it is 20
Detailed Description:
Participants enrolled prior to Amendment 3 will receive zilovertamab vedotin at 25 mgkg given intravenously on Day 1 of repeated 21-day cycles Participants enrolled after Amendment 3 will receive zilovertamab vedotin at 175 mgkg given intravenously on Day 1 and Day 8 of repeated 21-day cycles Treatment will continue until progressive disease or discontinuation
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 |
|---|---|---|---|
| VLS-101-0003 | OTHER | None | None |
| MK-2140-002 | OTHER | Merck | None |