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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: SC-006; Drug: ABBV-181

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703-4005
      • Highlands Oncology Group /ID# 201182
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 160882
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5008
      • University of Michigan Hospitals /ID# 167101
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 160884
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 160883
  • New York
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center /ID# 160881
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute /ID# 202712
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University /ID# 202713
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1632
      • Tennessee Oncology-Nashville Centennial /ID# 160880

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Pharmacokinetics; Maximum tolerated dose; Metastatic colorectal cancer; Unresectable colorectal cancer; Advanced colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: M16-312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No