Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05378425
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2022-05-12
Brief Title:
A Study of NTX-1088 a Monoclonal Antibody Targeting the Poliovirus Receptor PVR CD155 as Monotherapy and Combined With Pembrolizumab
Sponsor:
Nectin Therapeutics Ltd
Organization:
Nectin Therapeutics Ltd
Study Overview
Official Title:
A Phase 1 First-in-Human Study of NTX-1088 a Monoclonal Antibody Targeting the Poliovirus Receptor PVR CD155 as Monotherapy and Combined With Pembrolizumab in Patients With Advanced Solid Malignancies
Status:
RECRUITING
Status Verified Date:
2023-02
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 1open-label multi-center first-in-human 2-part Part 1 dose escalation and Part 2 expansion study evaluating multiple doses and schedules of intravenously IV administered NTX-1088 with or without pembrolizumab in patients with advanced solid malignancies ie locally advanced or metastatic
Detailed Description:
This is a Phase 1 open-label multi-center study whose principal Part 1 stage objective is to determine the recommended Phase 2 dose RP2D of the anti-PVR monoclonal antibody mAb as a single agent and combined with the anti-PD-1 mAb pembrolizumab in patients with advanced solid malignancies
In the Part 2 stage the antitumor activity of NTX-1088 alone or combined with pembrolizumab will be evaluated in patients with malignancies known to express PVR
In the Part 2 stage the antitumor activity of NTX-1088 alone or combined with pembrolizumab will be evaluated in patients with malignancies known to express PVR
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 |
|---|---|---|---|
| KEYNOTE-E92 | OTHER | None | None |
| MK-3475-E92 | OTHER | Merck Sharp Dohme LLC | None |