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Brief Title: First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector
Official Title: A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)
Study ID: NCT04053283
Brief Summary: To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.
Detailed Description: To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours. The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous (IV) infusion in a range of tumour types. The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types (Dose Expansion Cohorts A, B and C).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Southern California (USC) - Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA, Santa Barbara, California, United States
Moffitt-Advent Health Clinical Research Unit, Celebration, Florida, United States
Ochsner Medical Center (OMC) - The Gayle and Tom Benson Cancer Center, New Orleans, Louisiana, United States
Washington University Medical School, Saint Louis, Missouri, United States
MD Anderson, Houston, Texas, United States