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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: SC-006
* Drug: ABBV-181


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>SC-006 Dose regimen finding | Drug: SC-006<br>* Intravenous<br>|
| Experimental: Arm B<br>SC-006 Dose expansion | Drug: SC-006<br>* Intravenous<br>|
| Experimental: Arm C<br>SC-006 and ABBV-181 Combination escalation and expansion | Drug: SC-006<br>* Intravenous<br>Drug: ABBV-181<br>* Intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with dose-limiting toxicities (DLT) | DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. | Minimum first cycle of dosing (21-day cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from the participant's first dose date to death due to any cause. | Approximately 2 years | 
| Progression Free Survival (PFS) | PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death due to any cause. | Approximately 2 years | 
| Time to Cmax (Tmax) of SC-006 | Time to Cmax of SC-006 | Approximately 1 year | 
| Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006 | Area under the plasma concentration-time curve within a dosing interval of SC-006 | Approximately 1 year | 
| Duration of Clinical Benefit (DOCB) | DOCB is defined as the time from the initial partial response (PR), complete response (CR), or stable disease to disease progression. | Approximately 2 years | 
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR), as determined by Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Approximately 2 years | 
| Terminal half life (T1/2) of SC-006 | Terminal half life (T1/2) of SC-006 | Approximately 1 year | 
| Duration of response (DOR) | DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression or death, whichever occurs first. | Approximately 2 years | 
| Observed plasma concentrations at trough (Ctrough) of SC-006 | Observed plasma concentrations at trough of SC-006 | Approximately 1 year | 
| Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD) | CBR is defined as the percentage of participants who achieve a best response of CR, PR, or stable disease (SD). | Approximately 2 years | 
| Maximum observed serum concentration (Cmax) of SC-006 | Maximum observed serum concentration of SC-006 | Approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Advanced colorectal cancer, Metastatic colorectal cancer, Unresectable colorectal cancer, Maximum tolerated dose, Pharmacokinetics