A Study of SC-007 in Subjects With Advanced Cancer

Study Identifier
M16-310
CT.gov Identifier
NCT03253185
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Colorectal Cancer
  • Gastrointestinal Cancer - General
    • Study Drug
  • SC-007
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    University of California, Los Angeles
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    Mayo Clinic
    Rochester, Minnesota, United States, 55905-0001
    Status
    Not applicable
    Location
    Washington University-School of Medicine
    St Louis, Missouri, United States, 63110
    Status
    Not applicable
    Location
    Gabrail Cancer Center Research
    Canton, Ohio, United States, 44718
    Status
    Not applicable
    Location
    Tennessee Oncology-Sarah Cannon Research Institute
    Nashville, Tennessee, United States, 37203
    Status
    Not applicable
    Location
    MD Anderson Cancer Center
    Houston, Texas, United States, 77030
    Status
    Not applicable
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