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

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ClinicalTrials.gov Identifier: NCT03035279
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a multicenter, open-label, Phase 1 study of SC-006 given s 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: SC-006 Drug: ABBV-181 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 22, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Time to Cmax (Tmax) of SC-006 [ Time Frame: Approximately 1 year ]
    Time to Cmax of SC-006

  4. 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

  5. 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.

  6. 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

  7. Terminal half life (T1/2) of SC-006 [ Time Frame: Approximately 1 year ]
    Terminal half life (T1/2) of SC-006

  8. 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.

  9. Observed plasma concentrations at trough (Ctrough) of SC-006 [ Time Frame: Approximately 1 year ]
    Observed plasma concentrations at trough of SC-006

  10. 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).

  11. Maximum observed serum concentration (Cmax) of SC-006 [ Time Frame: Approximately 1 year ]
    Maximum observed serum concentration of SC-006



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035279


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
United States, Arkansas
Highlands Oncology Group /ID# 201182 Recruiting
Fayetteville, Arkansas, United States, 72703-4005
United States, California
University of California, Los Angeles /ID# 160882 Recruiting
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado /ID# 202708 Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Michigan
University of Michigan Hospitals /ID# 167101 Recruiting
Ann Arbor, Michigan, United States, 48109-5008
United States, Minnesota
Mayo Clinic - Rochester /ID# 160884 Recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Missouri
Washington University-School of Medicine /ID# 160883 Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Roswell Park /ID# 201178 Not yet recruiting
Buffalo, New York, United States, 14263
Icahn School of Med Mt. Sinai /ID# 201659 Not yet recruiting
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center /ID# 160881 Recruiting
New York, New York, United States, 10065-6007
United States, North Carolina
Carolina BioOncology Institute /ID# 202712 Recruiting
Huntersville, North Carolina, United States, 28078
United States, Oklahoma
Oklahoma University /ID# 202713 Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University /ID# 201176 Not yet recruiting
Portland, Oregon, United States, 97239-3098
United States, Tennessee
Tennessee Oncology-Sarah Cannon Research Institute /ID# 160880 Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03035279     History of Changes
Other Study ID Numbers: M16-312
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie:
Advanced colorectal cancer
Cancer
Metastatic colorectal cancer
Unresectable colorectal cancer
Maximum tolerated dose
Pharmacokinetics

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases