search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SC-006
ABBV-181
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Advanced colorectal cancer, Cancer, Metastatic colorectal cancer, Unresectable colorectal cancer, Maximum tolerated dose, Pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Highlands Oncology Group /ID# 201182
  • University of California, Los Angeles /ID# 160882
  • University of Michigan Hospitals /ID# 167101
  • Mayo Clinic - Rochester /ID# 160884
  • Washington University-School of Medicine /ID# 160883
  • Memorial Sloan Kettering Cancer Center /ID# 160881
  • Carolina BioOncology Institute /ID# 202712
  • Oklahoma University /ID# 202713
  • Tennessee Oncology-Nashville Centennial /ID# 160880

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

SC-006 Dose regimen finding

SC-006 Dose expansion

SC-006 and ABBV-181 Combination escalation and expansion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from the participant's first dose date to death due to any cause.
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.
Time to Cmax (Tmax) of SC-006
Time to Cmax of SC-006
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
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.
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
Terminal half life (T1/2) of SC-006
Terminal half life (T1/2) of SC-006
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.
Observed plasma concentrations at trough (Ctrough) of SC-006
Observed plasma concentrations at trough of SC-006
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).
Maximum observed serum concentration (Cmax) of SC-006
Maximum observed serum concentration of SC-006

Full Information

First Posted
January 23, 2017
Last Updated
February 18, 2020
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT03035279
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Strategic considerations
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Advanced colorectal cancer, Cancer, Metastatic colorectal cancer, Unresectable colorectal cancer, Maximum tolerated dose, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
SC-006 Dose regimen finding
Arm Title
Arm B
Arm Type
Experimental
Arm Description
SC-006 Dose expansion
Arm Title
Arm C
Arm Type
Experimental
Arm Description
SC-006 and ABBV-181 Combination escalation and expansion
Intervention Type
Drug
Intervention Name(s)
SC-006
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
ABBV-181
Intervention Description
Intravenous
Primary Outcome Measure Information:
Title
Number of participants with dose-limiting toxicities (DLT)
Description
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time Frame
Minimum first cycle of dosing (21-day cycles)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the participant's first dose date to death due to any cause.
Time Frame
Approximately 2 years
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Approximately 2 years
Title
Time to Cmax (Tmax) of SC-006
Description
Time to Cmax of SC-006
Time Frame
Approximately 1 year
Title
Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006
Description
Area under the plasma concentration-time curve within a dosing interval of SC-006
Time Frame
Approximately 1 year
Title
Duration of Clinical Benefit (DOCB)
Description
DOCB is defined as the time from the initial partial response (PR), complete response (CR), or stable disease to disease progression.
Time Frame
Approximately 2 years
Title
Objective Response Rate (ORR)
Description
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
Time Frame
Approximately 2 years
Title
Terminal half life (T1/2) of SC-006
Description
Terminal half life (T1/2) of SC-006
Time Frame
Approximately 1 year
Title
Duration of response (DOR)
Description
DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression or death, whichever occurs first.
Time Frame
Approximately 2 years
Title
Observed plasma concentrations at trough (Ctrough) of SC-006
Description
Observed plasma concentrations at trough of SC-006
Time Frame
Approximately 1 year
Title
Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)
Description
CBR is defined as the percentage of participants who achieve a best response of CR, PR, or stable disease (SD).
Time Frame
Approximately 2 years
Title
Maximum observed serum concentration (Cmax) of SC-006
Description
Maximum observed serum concentration of SC-006
Time Frame
Approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group /ID# 201182
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703-4005
Country
United States
Facility Name
University of California, Los Angeles /ID# 160882
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Michigan Hospitals /ID# 167101
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5008
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 160884
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Washington University-School of Medicine /ID# 160883
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center /ID# 160881
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Facility Name
Carolina BioOncology Institute /ID# 202712
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Oklahoma University /ID# 202713
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 160880
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs