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Brief Title: A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer
Official Title: A Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer
Study ID: NCT03639194
Brief Summary: This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham - Main /ID# 207295, Birmingham, Alabama, United States
Highlands Oncology Group, PA /ID# 207176, Springdale, Arkansas, United States
University of California, Davis Comprehensive Cancer Center /ID# 207548, Sacramento, California, United States
Yale School of Medicine /ID# 207559, New Haven, Connecticut, United States
University of Iowa Hospitals and Clinics /ID# 207560, Iowa City, Iowa, United States
University of Kentucky Chandler Medical Center /ID# 208217, Lexington, Kentucky, United States
Massachusetts General Hospital /ID# 207549, Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 213032, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center /ID# 207177, Ann Arbor, Michigan, United States
Henry Ford Hospital /ID# 233539, Detroit, Michigan, United States
Washington University-School of Medicine /ID# 207168, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 208216, New York, New York, United States
Duke Cancer Center /ID# 207547, Durham, North Carolina, United States
UH Cleveland Medical Center /ID# 207561, Cleveland, Ohio, United States
The Ohio State University /ID# 207552, Columbus, Ohio, United States
Tennessee Oncology, PLLC /ID# 207175, Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center /ID# 207551, Nashville, Tennessee, United States
NEXT Oncology /ID# 207167, San Antonio, Texas, United States
University of Utah /ID# 207553, Salt Lake City, Utah, United States
University of Washington /ID# 207557, Seattle, Washington, United States
Univ of Wisconsin Hosp/Clinics /ID# 207556, Madison, Wisconsin, United States
National Cancer Center Hospital East /ID# 230943, Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 229737, Matsuyama-shi, Ehime, Japan
Hokkaido Cancer Center /ID# 229101, Sapporo-shi, Hokkaido, Japan
Shizuoka Cancer Center /ID# 230911, Sunto-gun, Shizuoka, Japan
Wakayama Medical University Hospital /ID# 229111, Wakayama-shi, Wakayama, Japan
National Cancer Center /ID# 240169, Goyang, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital /ID# 234274, Seongnam, Gyeonggido, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 239515, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 234272, Seoul, , Korea, Republic of
Asan Medical Center /ID# 234273, Seoul, , Korea, Republic of
National Cheng Kung University Hospital /ID# 234267, Tainan, , Taiwan
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR