A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer

Stopped early · Phase 1

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT03035279

Run by

AbbVie

People needed

29

Starts

2017-03-08

Expected to finish

2019-03-28

Last updated by the study team

2020-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with histologically or cytologically confirmed advanced metastatic or unresectable colorectal cancer (CRC) that is relapsed, refractory, or progressive following at least 2 prior systemic regimens in the metastatic setting.
• Participants with an Eastern Cooperative Oncology Group (ECOG) of 0 - 1.
• Participants with adequate hematologic, hepatic, and renal function.

You may not qualify if…

• Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
• Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:
• History of inflammatory bowel disease
• Active autoimmune disease, with exception of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism
• History of primary immunodeficiency, allogenic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis
• History of immune-mediated pneumonitis
• Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment

Where it is running

• 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 — St 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

Full record on ClinicalTrials.gov

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