Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03119428
Status:
TERMINATED
Last Update Posted:
2020-08-11
First Post:
2017-03-29
Brief Title:
A Study of OMP-313M32 in Subjects With Locally Advanced or Metastatic Solid Tumors
Sponsor:
OncoMed Pharmaceuticals Inc
Organization:
Mereo BioPharma
Study Overview
Official Title:
A Phase 1ab Open-Label Dose-Escalation Study of the Safety and Pharmacokinetics of OMP-313M32 Administered as a Single Agent or in Combination With Nivolumab to Subjects With Locally Advanced or Metastatic Solid Tumors
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
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 tolerability of OMP-31M32 as a single agent or in combination with nivolumab OMP-313M32 is an experimental anti-TIGIT antibody that was developed to block TIGIT from binding PVR allowing the bodys T-cells to destroy cancer cells
Detailed Description:
This is an open-label Phase 1ab dose escalation study of OMP-31M32 administered as a single agent or in combination with nivolumab to evaluate the safety tolerability pharmacokinetics and pharmacodynamics in patients with locally advanced or metastatic solid tumors This study consists of a screening period a treatment period and a post-treatment follow-up period in which patients will be followed for survival for up to 2 years Subjects will be enrolled in two stages in the Phase 1a dose escalation and expansion and one stage in the Phase 1b dose escalation
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