A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
Stopped early · Phase 1
Conditions studied: Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT03316794
- Run by
- AbbVie
- People needed
- 2
- Starts
- 2018-01-04
- Expected to finish
- 2018-10-05
- Last updated by the study team
- 2018-12-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Chicago /ID# 169231 — Chicago, Illinois, United States
- Washington University School /ID# 169177 — St Louis, Missouri, United States
- Memorial Sloan Kettering /ID# 201016 — New York, New York, United States
- Gabrail Cancer Center Research /ID# 168756 — Canton, Ohio, United States
- Oklahoma University /ID# 200937 — Oklahoma City, Oklahoma, United States
- Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233 — Nashville, Tennessee, United States
- Baylor University /ID# 169860 — Houston, Texas, United States
- MD Anderson Cancer Center /ID# 169232 — Houston, Texas, United States
Full record on ClinicalTrials.gov
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