Spots Global Cancer Trial Database for A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
Official Title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT03071757
Conditions
Study Description
Brief Summary: The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer \[TNBC\] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.
Detailed Description: Recruitment is closed in Part 1A; subjects are in maintenance
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moores Cancer Center at UC San Diego /ID# 201334, La Jolla, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 201342, Sacramento, California, United States
Stanford University /ID# 206949, Stanford, California, United States
Yale University /ID# 207895, New Haven, Connecticut, United States
Carolina BioOncology Institute /ID# 160786, Huntersville, North Carolina, United States
Greenville Hospital System /ID# 160785, Greenville, South Carolina, United States
University of Texas Southwestern Medical Center /ID# 201934, Dallas, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 160788, San Antonio, Texas, United States
University of Virginia /ID# 212895, Charlottesville, Virginia, United States
Virginia Cancer Specialists - Fairfax /ID# 160787, Fairfax, Virginia, United States
AP-HM - Hopital de la Timone /ID# 165036, Marseille CEDEX 05, Bouches-du-Rhone, France
Institut Curie /ID# 165038, Paris CEDEX 05, Ile-de-France, France
Centre Leon Berard /ID# 165037, Lyon CEDEX 08, Rhone, France
Institut Gustave Roussy /ID# 165035, Villejuif Cedex, Val-de-Marne, France
National Cancer Center Hospital East /ID# 214530, Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital /ID# 214531, Chuo-ku, Tokyo, Japan
Pan American Center for Oncology Trials, LLC /ID# 213809, Rio Piedras, , Puerto Rico
Hospital Duran i Reynals /ID# 205997, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 206973, Majadahonda, Madrid, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 208879, Pamplona, Navarra, Spain
Hospital General Universitario Gregorio Maranon /ID# 205999, Madrid, , Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 205996, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 211500, Madrid, , Spain
Hospital Clinico Universitario de Valencia /ID# 211499, Valencia, , Spain
National Cheng Kung University Hospital /ID# 164002, Tainan, , Taiwan
National Taiwan University Hospital /ID# 164000, Taipei City, , Taiwan
Taipei Medical University Hospital /ID# 164001, Taipei City, , Taiwan
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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