Spots Global Cancer Trial Database for Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
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Trial Identification
Brief Title: Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
Official Title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies
Study ID: NCT04561362
Study Description
Brief Summary: This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Part B), Safety and tolerability (Part C), and characterization of the pharmacokinetics (Part D).
Detailed Description: This study will assess the safety and tolerability of BT8009 alone and in combination with pembrolizumab in patients with select advanced solid tumors. BT8009 will be given as a single agent in 3 different dosing schedules- weekly (28 day cycle), biweekly (28 day cycle) or dosing on day 1 and day 8 of a 3-weekly (21 day cycle) and in combination with pembrolizumab. There are three parts to this study. Part A is a dose escalation in patients with select advanced solid tumors primarily designed to evaluate safety and tolerability of BT8009 as monotherapy or in combination with pembrolizumab and to determine a recommended Phase II dose (RP2D). Following a selection of an RP2D, Part B, a dose expansion portion, will be initiated with the primary objective of clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab in patients with select advanced solid tumors. Part C will evaluate safety and tolerability of RP2D in patients with renal insufficiency. Part D will further characterize the pharmacokinetics of BT8009 and MMAE.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Ocala Oncology Center, Ocala, Florida, United States
Advent Health, Orlando, Florida, United States
Horizon Oncology Research, Lafayette, Indiana, United States
Norton Cancer Institute, Downtown, Louisville, Kentucky, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Institut Bergonie, Bordeaux, , France
Centre Leon Berard, Lyon, , France
Institut Paoli-Calmettes, Marseille, , France
Centre Eugene Marquis, Rennes, , France
Institut Gustave Roussy, Villejuif, , France
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, MI, Italy
Ospedale San Raffaele, Milan, , Italy
Vall d'Hebron Institute of Oncology, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
START Madrid Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Next Oncology - Hospital Quironsalud Madrid, Pozuelo de Alarcon, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Sarah Cannon Research Institute UK, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Meredith McKean, MD, MPH
Affiliation: Tennessee Oncology, PLLC
Role: STUDY_CHAIR
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