329
Participants
Start Date
July 17, 2020
Primary Completion Date
March 31, 2026
Study Completion Date
December 31, 2026
BT8009
Bicyclic Toxin Conjugate (BTC) administered either weekly (i.e., on Days 1, 8, 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle for participants in A-1. Participants in Cohorts A-2 and B-7 will receive BT8009 weekly on 21-day cycle. Participants in Parts B-1-B-6 will receive BT8009 weekly either on a 21-day or 28-day cycle. Participants in Parts B-8 and B-9 will receive BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive BT8009 once weekly (i.e., on Days 1, 8, 15, and 22) on a 28-day cycle. Participants in Part D will receive BT8009 once weekly on a 28-day cycle.
Pembrolizumab
Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each Q3W.
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
RECRUITING
Institut Paoli-Calmettes, Marseille
RECRUITING
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia
RECRUITING
Ospedale San Raffaele, Milan
RECRUITING
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
RECRUITING
START Madrid Fundacion Jimenez Diaz, Madrid
WITHDRAWN
Hospital Universitario La Paz, Madrid
RECRUITING
Next Oncology - Hospital Quironsalud Madrid, Pozuelo de Alarcón
RECRUITING
Institut Bergonie, Bordeaux
RECRUITING
Ocala Oncology Center, Ocala
RECRUITING
Advent Health, Orlando
RECRUITING
Centre Eugene Marquis, Rennes
RECRUITING
Tennessee Oncology, PLLC, Nashville
RECRUITING
Hospital Universitario Marques de Valdecilla, Santander
WITHDRAWN
Norton Cancer Institute, Downtown, Louisville
RECRUITING
University Hospitals Cleveland Medical Center, Cleveland
WITHDRAWN
Horizon Oncology Research, Lafayette
RECRUITING
Centre Leon Berard, Lyon
RECRUITING
Mary Crowley Cancer Research Center, Dallas
RECRUITING
The University of Texas MD Anderson Cancer Center, Houston
RECRUITING
Sarah Cannon Research Institute at HealthONE, Denver
WITHDRAWN
Comprehensive Cancer Centers of Nevada, Las Vegas
RECRUITING
Institut Gustave Roussy, Villejuif
WITHDRAWN
Cross Cancer Institute, Edmonton
RECRUITING
University Health Network, Princess Margaret Cancer Centre, Toronto
RECRUITING
Vall d'Hebron Institute of Oncology, Barcelona
RECRUITING
Hospital Clinic de Barcelona, Barcelona
RECRUITING
Sarah Cannon Research Institute UK, London
RECRUITING
The Christie NHS Foundation Trust, Manchester
BicycleTx Limited
INDUSTRY