A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/31/2019 |
| Start Date: | March 8, 2017 |
| End Date: | December 22, 2020 |
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
This is a multicenter, open-label, Phase 1 study of SC-006 given s 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.
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.
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
We found this trial at
13
sites
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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