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
660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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