Spots Global Cancer Trial Database for A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies
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Trial Identification
Brief Title: A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies
Official Title: An Open-Label, Phase 1, First-In-Human Study of TRAIL Receptor Agonist ABBV-621 in Subjects With Previously-Treated Solid Tumors and Hematologic Malignancies
Study ID: NCT03082209
Study Description
Brief Summary: This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignancies. Only chemotherapy combination (ABBV-621 + FOLFIRI) enrolling participants with RAS-mutant CRC who have received one prior line of therapy is open for enrollment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale University /ID# 158029, New Haven, Connecticut, United States
The University of Chicago Medical Center /ID# 158030, Chicago, Illinois, United States
Ingalls Memorial Hosp /ID# 171221, Harvey, Illinois, United States
Univ Michigan Med Ctr /ID# 207134, Ann Arbor, Michigan, United States
Rhode Island Hospital /ID# 171157, Providence, Rhode Island, United States
Vanderbilt University Medical Center /ID# 215000, Nashville, Tennessee, United States
MD Anderson Cancer Center /ID# 202187, Houston, Texas, United States
Millennium Oncology /ID# 214981, Houston, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 160574, San Antonio, Texas, United States
Medical College of Wisconsin /ID# 171152, Milwaukee, Wisconsin, United States
National Cancer Center Hospital East /ID# 160596, Kashiwa-shi, Chiba, Japan
Yamagata University Hospital /ID# 200681, Yamagata-shi, Yamagata, Japan
Erasmus Medisch Centrum /ID# 160869, Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 169748, Groningen, , Netherlands
Maastricht Universitair Medisch Centrum /ID# 214935, Maastricht, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 169747, Utrecht, , Netherlands
Hospital Universitario Vall d'Hebron /ID# 170809, Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 200106, Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 165136, Madrid, , Spain
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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