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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03035279
• Other study ID #: M16-312
• Status: Terminated
• Phase: Phase 1
• Start date: March 8, 2017
• Est. completion date: March 28, 2019

Study information

• Verified date: February 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• SC-006
Intravenous
• ABBV-181
Intravenous

Locations

Country	Name	City	State
United States	University of Michigan Hospitals /ID# 167101	Ann Arbor	Michigan
United States	Highlands Oncology Group /ID# 201182	Fayetteville	Arkansas
United States	Carolina BioOncology Institute /ID# 202712	Huntersville	North Carolina
United States	University of California, Los Angeles /ID# 160882	Los Angeles	California
United States	Tennessee Oncology-Nashville Centennial /ID# 160880	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center /ID# 160881	New York	New York
United States	Oklahoma University /ID# 202713	Oklahoma City	Oklahoma
United States	Mayo Clinic - Rochester /ID# 160884	Rochester	Minnesota
United States	Washington University-School of Medicine /ID# 160883	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Time to Cmax (Tmax) of SC-006	Time to Cmax of SC-006	Approximately 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Terminal half life (T1/2) of SC-006	Terminal half life (T1/2) of SC-006	Approximately 1 year
Secondary	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
Secondary	Observed plasma concentrations at trough (Ctrough) of SC-006	Observed plasma concentrations at trough of SC-006	Approximately 1 year
Secondary	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
Secondary	Maximum observed serum concentration (Cmax) of SC-006	Maximum observed serum concentration of SC-006	Approximately 1 year