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A Study of SC‑004 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03138408
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a multicenter, first-in-human study of SC-004 in participants with advanced solid cancers. This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A will involve dose escalation to define the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and schedule. Part B will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Cancers Drug: SC-004 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase 1 Study of SC-004 in Subjects With Advanced Solid Tumors
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SC-004
SC-004 intravenous (IV) (various doses and dose regimens)
Drug: SC-004
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. Observed plasma concentrations at trough (Ctrough) of SC-004 [ Time Frame: Approximately 1 year ]
    Observed plasma concentrations at trough of SC-004

  2. Overall Survival (OS) [ Time Frame: Approximately 2 years ]
    OS is defined as the time from the subject's first dose date to death due to any cause.

  3. Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]
    ORR is defined as the proportion of subjects with complete response or partial response (CR+PR)

  4. Terminal half life (T1/2) of SC-004 [ Time Frame: Approximately 1 year ]
    Terminal half life (T1/2) of SC-004

  5. Maximum observed serum concentration (Cmax) of SC-004 [ Time Frame: Approximately 1 year ]
    Maximum observed serum concentration of SC-004

  6. Time to Cmax (Tmax) of SC-004 [ Time Frame: Approximately 1 year ]
    Time to Cmax of SC-004

  7. Clinical Benefit Rate (CBR) [ Time Frame: Approximately 2 years ]
    CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD).

  8. Progression Free Survival (PFS) [ Time Frame: Approximately 2 years ]
    PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression or death due to any cause, whichever occurs first. Under the situation that neither event occurs, the PFS time will be censored at the date of last tumor assessment. Subjects lacking an evaluation of tumor response after their first dose of study treatment will have their event time censored at Day 1.

  9. Duration of Response (DOR) [ Time Frame: Approximately 2 years ]
    DOR is defined as the time from the subject's initial objective response (CR or PR) to study drug therapy to disease progression or death due to any cause, whichever occurs first. If the dates of disease progression or death are not available, the DOR will be censored at the date of last valid tumor assessment.

  10. Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-004 [ Time Frame: Approximately 1 year ]
    Area under the plasma concentration-time curve within a dosing interval of SC-004

  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)



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

Inclusion Criteria:

  • Histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator:

    • High-grade serous ovarian epithelial cancer, including epithelial ovarian cancer, fallopian tubal cancer or peritoneal cancer of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least 1 platinum-based chemotherapeutic regimen
    • Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen
  • Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

- Participants with 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): NCT03138408


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

Locations
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic - Mayo Clinic -Methodist Campus -Pharmacy Research Support Not yet recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Missouri
Washington University School Recruiting
Saint Louis, Missouri, United States, 63108
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Tennessee Oncology-Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03138408     History of Changes
Other Study ID Numbers: M16-553
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 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:
Cancer
Solid tumor cancers
Ovarian cancer
Endometrial cancer
SC-004
Maximum tolerated dose (MTD)