Spots Global Cancer Trial Database for Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors
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Trial Identification
Brief Title: Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors
Official Title: A Phase I Multicenter, Open Label Study of Enadenotucirev Combined With PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors
Study ID: NCT02636036
Study Description
Brief Summary: This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.
Detailed Description: To characterise the safety and tolerability of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumours. A dose escalation phase is conducted in subjects with solid tumors of epithelial origin not responding to standard therapy to establish the MTD/MFD and optimum dosing schedule of the enadenotucirev and nivolumab combination treatment. A dose expansion phase will further outline the dose level and schedule of enadenotucirev and nivolumab combination treatment and investigate signals of efficacy in three cohorts of subjects with specific epithelial tumour types.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, 1515 North Campbell Ave., Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center, 1500 E Duarte Str., Duarte, California, United States
UCLA Medical Center, 10945 Le Conte Ave, Ste. 3360, Santa Monica, California, United States
Horizon Oncology Research, 1345 Unity Place, Suite 365, Lafayette, Indiana, United States
Henry Ford Hospital, 2799 West Grand Blvd., Detroit, Michigan, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Contact Details
Name: Tom Lillie, MD
Affiliation: Psioxus Theraputics
Role: STUDY_DIRECTOR
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