Study of XB010 in Subjects With Solid Tumors

Active:	Yes
Cancer Type:	Breast Cancer Esophogeal Cancer Head and Neck Cancer Lung Cancer Solid Tumor	NCT ID:	NCT06545331
Trial Phases:	Phase I	Protocol IDs:	XB010-101 (primary) NCI-2024-09409
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Exelixis Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT06545331

Summary

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and
preliminary antitumor activity of XB010 as a single agent and in combination with
pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom
alternative therapies do not exist or available therapies are intolerable or no longer
effective.

Objectives

This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation
Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended
dosage(s) for expansion (RDE[s]) of XB010 as a single agent, and to evaluate XB010
monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is
designed to explore the clinical activity and further characterize the safety and
tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.

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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