A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)



Status:Terminated
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/19/2018
Start Date:January 4, 2018
End Date:October 5, 2018

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An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)

This is a multicenter, open-label study in participants with triple negative breast cancer
(TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of
SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B
(dose expansion).


Inclusion Criteria:

- Histologically or cytologically confirmed advanced TNBC that is relapsed, refractory,
or progressive and not eligible for another standard therapy that would confer
clinical benefit to the subject.

- Advanced disease is defined as metastatic disease or locally advanced disease
that is not amenable to surgery or radiotherapy with curative intent

- TNBC is defined as:

- <1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR)
receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR

- Negative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

- Any significant medical condition including any suggested by Screening laboratory
findings that, in the opinion of the Investigator or Sponsor, may place the subject at
undue risk from the study.

- Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult
(e.g., severe morphologic abnormalities).

- Prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or
known hypersensitivity or contraindication to SC-005 or excipient contained in the
drug formulation.
We found this trial at
8
sites
Saint Louis, Missouri 63108
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Saint Louis, MO
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4875 Higbee Avenue Northwest
Canton, Ohio 44718
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Canton, OH
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Chicago, Illinois 60637
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Chicago, IL
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Houston, Texas 77030
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Houston, TX
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Houston, TX
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Nashville, TN
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New York, New York 10065
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New York, NY
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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