Study of XB010 in Subjects With Solid Tumors
Breast Cancer
Esophogeal Cancer
Head and Neck Cancer
Lung Cancer
Solid Tumor
18 Years and older, Male and Female
XB010-101 (primary)
NCI-2024-09409
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.
Eligibility
- - Age 18 years or older on the day of consent. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. - Adequate organ and marrow function. - Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent. - The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer). - Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
Treatment Sites in Georgia
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