NCT05585034

Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (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 (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.

Detailed description

This is a Phase 1, open-label, first-in-human (FIH), multiple-dose, dose escalation study with cohort expansion at the RD, designed to evaluate the safety and tolerability of XmAb808 in combination with pembrolizumab. This study will be conducted in 2 parts: Part A (dose escalation) and Part B (cohort expansion).

Conditions

• Head and Neck Squamous Cell Carcinoma
• Melanoma Excluding Uveal Melanoma
• Non-small Cell Lung Cancer, Squamous or Non-squamous
• Urothelial Carcinoma
• Renal Cell Carcinoma, Clear Cell
• Castration-resistant Prostate Cancer
• Ovarian Cancer, Epithelial
• TNBC - Triple-Negative Breast Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	XmAb®808	Monoclonal bispecific antibody
BIOLOGICAL	Keytruda® (pembrolizumab)	Monoclonal antibody

Timeline

• Start date: 2022-12-14
• Primary completion: 2025-05-20
• Completion: 2025-05-20
• First posted: 2022-10-18
• Last updated: 2025-08-07

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study