Clinical trial NCT03035279: A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Cancer
Keywords: Advanced colorectal cancer
Cancer
Metastatic colorectal cancer
Unresectable colorectal cancer
Maximum tolerated dose
Pharmacokinetics
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-01-30
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Number of participants with dose-limiting toxicities (DLT)
timeFrame: Minimum first cycle of dosing (21-day cycles)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 2 years
measure: Progression Free Survival (PFS)
timeFrame: Approximately 2 years
measure: Time to Cmax (Tmax) of SC-006
timeFrame: Approximately 1 year
measure: Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006
timeFrame: Approximately 1 year
measure: Duration of Clinical Benefit (DOCB)
timeFrame: Approximately 2 years
measure: Objective Response Rate (ORR)
timeFrame: Approximately 2 years
measure: Terminal half life (T1/2) of SC-006
timeFrame: Approximately 1 year
measure: Duration of response (DOR)
timeFrame: Approximately 2 years
measure: Observed plasma concentrations at trough (Ctrough) of SC-006
timeFrame: Approximately 1 year
measure: Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)
timeFrame: Approximately 2 years
measure: Maximum observed serum concentration (Cmax) of SC-006
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group /ID# 201182
state: Arkansas
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 160882
state: California
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals /ID# 167101
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 160884
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 160883
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center /ID# 160881
state: New York
city: Huntersville
country: United States
facility: Carolina BioOncology Institute /ID# 202712
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma University /ID# 202713
state: Oklahoma
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville Centennial /ID# 160880
state: Tennessee
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: