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

Active:	Yes
Cancer Type:	Colon/Rectal Cancer Melanoma Ovarian Cancer	NCT ID:	NCT05585034
Trial Phases:	Phase I	Protocol IDs:	XmAb808-01 (primary) NCI-2023-00610
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Xencor, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05585034

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.

Objectives

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).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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