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Brief Title: A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
Official Title: An Open Label Phase 1 Study of SC-006 as a Single Agent and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
Study ID: NCT03035279
Brief Summary: This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006 dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part A (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part B (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be expanded.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group /ID# 201182, Fayetteville, Arkansas, United States
University of California, Los Angeles /ID# 160882, Los Angeles, California, United States
University of Michigan Hospitals /ID# 167101, Ann Arbor, Michigan, United States
Mayo Clinic - Rochester /ID# 160884, Rochester, Minnesota, United States
Washington University-School of Medicine /ID# 160883, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center /ID# 160881, New York, New York, United States
Carolina BioOncology Institute /ID# 202712, Huntersville, North Carolina, United States
Oklahoma University /ID# 202713, Oklahoma City, Oklahoma, United States
Tennessee Oncology-Nashville Centennial /ID# 160880, Nashville, Tennessee, United States
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR