Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2025-12-17 @ 5:10 PM
Study NCT ID:
NCT05996445
Status:
None
Last Update Posted:
2024-08-23 00:00:00
First Post:
2023-06-23 00:00:00
Brief Title:
A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
Sponsor:
Xencor Inc
Organization:
Xencor, Inc.
Study Overview
Official Title:
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors
Status:
None
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor made a business decision to end the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human (FIH), Phase 1, open-label, multicenter dose escalation study with cohort expansion at one or more recommended dose(s) (RDs), designed to evaluate the safety and tolerability of XmAb662 monotherapy or in combination with pembrolizumab in subjects with selected solid tumors that have progressed after standard/approved therapies, or for which there are no effective available therapies. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2), and subdivided into arms for XmAb662 monotherapy and XmAb662+pembrolizumab combination.
Detailed Description:
This is a first-in-human FIH Phase 1 open-label multicenter dose escalation study with cohort expansion at one or more recommended doses RDs designed to evaluate the safety and tolerability of XmAb662 monotherapy or in combination with pembrolizumab in subjects with selected solid tumors that have progressed after standardapproved therapies or for which there are no effective available therapies This study will be conducted in 2 parts dose escalation Part 1 and dose expansion Part 2 and subdivided into arms for XmAb662 monotherapy and XmAb662pembrolizumab combination
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