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 |
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).
(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
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