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

NCT ID: NCT03316794

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2018-10-05

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Triple Negative Breast Cancer Cancer Breast Cancer Maximum tolerated dose (MTD) Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SC-005

SC-005 intravenous (IV) (various doses and dose regimens)

Group Type EXPERIMENTAL

SC-005

Intervention Type DRUG

intravenous

Interventions

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SC-005

intravenous

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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University of Chicago /ID# 169231

Chicago, Illinois, United States

Site Status

Washington University School /ID# 169177

St Louis, Missouri, United States

Site Status

Memorial Sloan Kettering /ID# 201016

New York, New York, United States

Site Status

Gabrail Cancer Center Research /ID# 168756

Canton, Ohio, United States

Site Status

Oklahoma University /ID# 200937

Oklahoma City, Oklahoma, United States

Site Status

Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233

Nashville, Tennessee, United States

Site Status

Baylor University /ID# 169860

Houston, Texas, United States

Site Status

MD Anderson Cancer Center /ID# 169232

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M16-735

Identifier Type: -

Identifier Source: org_study_id