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

Phase 1

Terminated

• Conditions: Colorectal Cancer
• Interventions: Drug: SC-006; Drug: ABBV-181

• Registration Number: NCT03035279
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-30
• Study Start: 2017-03-08
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm A	SC-006	SC-006 Dose regimen finding
Arm B	SC-006	SC-006 Dose expansion
Arm C	SC-006	SC-006 and ABBV-181 Combination escalation and expansion
Arm C	ABBV-181	SC-006 and ABBV-181 Combination escalation and expansion

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax) of SC-006	Approximately 1 year	Time to Cmax of SC-006
Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006	Approximately 1 year	Area under the plasma concentration-time curve within a dosing interval of SC-006
Duration of Clinical Benefit (DOCB)	Approximately 2 years	DOCB is defined as the time from the initial partial response (PR), complete response (CR), or stable disease to disease progression.
Objective Response Rate (ORR)	Approximately 2 years	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
Terminal half life (T1/2) of SC-006	Approximately 1 year	Terminal half life (T1/2) of SC-006
Observed plasma concentrations at trough (Ctrough) of SC-006	Approximately 1 year	Observed plasma concentrations at trough of SC-006
Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)	Approximately 2 years	CBR is defined as the percentage of participants who achieve a best response of CR, PR, or stable disease (SD).
Maximum observed serum concentration (Cmax) of SC-006	Approximately 1 year	Maximum observed serum concentration of SC-006
Overall Survival (OS)	Approximately 2 years	OS is defined as the time from the participant's first dose date to death due to any cause.
Progression Free Survival (PFS)	Approximately 2 years	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.
Duration of response (DOR)	Approximately 2 years	DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression or death, whichever occurs first.

Trial Locations

Locations (9)

University of Michigan Hospitals /ID# 167101; 🇺🇸 Ann Arbor, Michigan, United States

Memorial Sloan Kettering Cancer Center /ID# 160881; 🇺🇸 New York, New York, United States

Mayo Clinic - Rochester /ID# 160884; 🇺🇸 Rochester, Minnesota, United States

Highlands Oncology Group /ID# 201182; 🇺🇸 Fayetteville, Arkansas, United States

Washington University-School of Medicine /ID# 160883; 🇺🇸 Saint Louis, Missouri, United States

Oklahoma University /ID# 202713; 🇺🇸 Oklahoma City, Oklahoma, 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