NCT05996445

A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous administration of XmAb662 monotherapy or in combination with pembrolizumab in subjects with advanced solid tumors and to identify the recommended dose regimen that is safe and biologically effective for XmAb662.

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 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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	XmAb662	Intravenous (IV) administration
BIOLOGICAL	Keytruda® (pembrolizumab)	Intravenous (IV) administration

Timeline

• Start date: 2023-07-28
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2023-08-18
• Last updated: 2024-08-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study