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

February 18, 2020 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with dose-limiting toxicities (DLT)
Time Frame: 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.
Minimum first cycle of dosing (21-day cycles)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Approximately 2 years
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)
Time Frame: 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.
Approximately 2 years
Time to Cmax (Tmax) of SC-006
Time Frame: Approximately 1 year
Time to Cmax of SC-006
Approximately 1 year
Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006
Time Frame: Approximately 1 year
Area under the plasma concentration-time curve within a dosing interval of SC-006
Approximately 1 year
Duration of Clinical Benefit (DOCB)
Time Frame: Approximately 2 years
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)
Time Frame: 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
Approximately 2 years
Terminal half life (T1/2) of SC-006
Time Frame: Approximately 1 year
Terminal half life (T1/2) of SC-006
Approximately 1 year
Duration of response (DOR)
Time Frame: 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.
Approximately 2 years
Observed plasma concentrations at trough (Ctrough) of SC-006
Time Frame: Approximately 1 year
Observed plasma concentrations at trough of SC-006
Approximately 1 year
Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)
Time Frame: Approximately 2 years
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
Time Frame: Approximately 1 year
Maximum observed serum concentration of SC-006
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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