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).
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
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).
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
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Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218
Ocala Oncology Center, Ocala, Florida, United States, 34474
Advent Health, Orlando, Florida, United States, 34747
Horizon Oncology Research, Lafayette, Indiana, United States, 47905
Norton Cancer Institute, Downtown, Louisville, Kentucky, United States, 40207
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States, 89169
Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States, 19107
Tennessee Oncology, PLLC, Nashville, Tennessee, United States, 37203
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
BicycleTx Limited,
Meredith McKean, MD, MPH, STUDY_CHAIR, Tennessee Oncology, PLLC
2026-12