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

Study Identifier
M16-312
CT.gov Identifier
NCT03035279
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Colorectal Cancer
    • Study Drug
  • SC-006
  • ABBV-181
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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.
    Exclusion Criteria:
    * 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Highlands Oncology Group /ID# 201182
    Fayetteville, Arkansas, United States, 72703-4005
    Status
    Not applicable
    Location
    University of California, Los Angeles /ID# 160882
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    University of Michigan Hospitals /ID# 167101
    Ann Arbor, Michigan, United States, 48109-5008
    Status
    Not applicable
    Location
    Mayo Clinic - Rochester /ID# 160884
    Rochester, Minnesota, United States, 55905-0001
    Status
    Not applicable
    Location
    Washington University-School of Medicine /ID# 160883
    St Louis, Missouri, United States, 63110
    Status
    Not applicable
    Location
    Memorial Sloan Kettering Cancer Center /ID# 160881
    New York, New York, United States, 10065-6007
    Status
    Not applicable
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