Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies (NCT04561362)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Sarah Cannon Research Institute at HealthONE — Denver, Colorado
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado
- Ocala Oncology Center — Ocala, Florida
- Advent Health — Orlando, Florida
- Icahn School of Medicine at Mount Sinai — New York, New York
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
- Tennessee Oncology, PLLC — Nashville, Tennessee
- Mary Crowley Cancer Research Center — Dallas, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario
- Institut Bergonie — Bordeaux,
- Centre Leon Berard — Lyon,
- Institut Paoli-Calmettes — Marseille,
- Centre Eugene Marquis — Rennes,
- Institut Gustave Roussy — Villejuif,
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, MI
- Ospedale San Raffaele — Milan,
- Vall d'Hebron Institute of Oncology — Barcelona,
- Hospital Clinic de Barcelona — Barcelona,
- START Madrid Fundacion Jimenez Diaz — Madrid,
- Next Oncology - Hospital Quironsalud Madrid — Pozuelo de Alarcón,
- Hospital Universitario Marques de Valdecilla — Santander,
- Sarah Cannon Research Institute UK — London,
- The Christie NHS Foundation Trust — Manchester,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.