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A Study of SC-007 in Subjects With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT03253185
Recruitment Status : Terminated (Benefit/Risk Imbalance)
First Posted : August 17, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer (CRC) Gastric Cancer Drug: SC-007 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of SC-007 in Subjects With Advanced Cancer
Actual Study Start Date : September 13, 2017
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SC-007
SC-007 intravenous (IV) (various doses and dose regimens)
Drug: SC-007
intravenous




Primary Outcome Measures :
  1. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Minimum first cycle of dosing (Up to 21 days) ]
    DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.


Secondary Outcome Measures :
  1. Clinical Benefit Rate (CBR) [ Time Frame: Approximately 4 years ]
    CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD).

  2. Progression Free Survival (PFS) [ Time Frame: Approximately 4 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. Observed plasma concentrations at trough (Ctrough) of SC-007 [ Time Frame: Approximately 1 year ]
    Observed plasma concentrations at trough of SC-007

  4. Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007 [ Time Frame: Approximately 4 years ]
    Incidence of ATAs against SC-007

  5. Overall Survival (OS) [ Time Frame: Approximately 4 years ]
    OS is defined as the time from the participant's first dose date to death due to any cause.

  6. Terminal half life (T1/2) of SC-007 [ Time Frame: Approximately 1 year ]
    Terminal half life of SC-007

  7. Objective Response Rate (ORR) [ Time Frame: Approximately 4 years ]
    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

  8. Duration of Response (DOR) [ Time Frame: Approximately 4 years ]
    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

  9. Time to Cmax (Tmax) of SC-007 [ Time Frame: Approximately 1 year ]
    Time to Cmax of SC-007

  10. Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007 [ Time Frame: Approximately 1 year ]
    Area under the plasma concentration-time curve within a dosing interval of SC-007

  11. QTcF Change from Baseline [ Time Frame: Up to 9 weeks based on 3 cycles of dosing (21-day cycles) ]
    QT interval measurement corrected by Fridericia's formula (QTcF)

  12. Maximum observed serum concentration (Cmax) of SC-007 [ Time Frame: Approximately 1 year ]
    Maximum observed serum concentration of SC-007



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive after:
  • CRC: at least 2 prior systemic regimens in the metastatic setting, and as appropriate in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as well.
  • Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (HER2) targeted agent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

  • Any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study.
  • Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc) evaluation difficult.
  • Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.

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): NCT03253185


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905-0001
United States, Missouri
Washington University-School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
United States, Tennessee
Tennessee Oncology-Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03253185    
Other Study ID Numbers: M16-310
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: Yes
Keywords provided by AbbVie:
Cancer
Advanced cancer
Esophagogastric junction (EGJ) cancers
Maximum tolerated dose (MTD)
Maximum Tolerated Dose
Pharmacokinetics
Additional relevant MeSH terms:
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Colorectal Neoplasms
Stomach Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases