Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative Neoplasms, Hormone Receptor Positive, HER2-low Neoplasms, Breast Neoplasms, Non-Small-Cell Lung Neoplasms, Ovarian Neoplasm, Advanced Solid Tumor
In brief
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 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).
Key facts
- Study ID
- NCT04561362
- Run by
- BicycleTx Limited
- People needed
- 329
- Starts
- 2020-07-17
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
- Ocala Oncology Center — Ocala, Florida, United States
- Advent Health — Orlando, Florida, 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
- 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 — Milan, 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
- Next Oncology - Hospital Quironsalud Madrid — Pozuelo de Alarcón, Spain
- Hospital Universitario Marques de Valdecilla — Santander, Spain
- Sarah Cannon Research Institute UK — London, United Kingdom
- The Christie NHS Foundation Trust — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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