Overview

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

Status:
Terminated
Trial end date:
2018-10-05
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Criteria
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.