Clinical trial · Interventional
A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic considerations
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-181 | Drug | — | UNRESOLVED |
| SC-006 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- SC-006 Dose regimen finding
- interventionNames
- Drug: SC-006
- type
- EXPERIMENTAL
- label
- Arm B
- description
- SC-006 Dose expansion
- interventionNames
- Drug: SC-006
- type
- EXPERIMENTAL
- label
- Arm C
- description
- SC-006 and ABBV-181 Combination escalation and expansion
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available