NCT03316794

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

October 18, 2017

Last Update Submit

December 14, 2018

Conditions

Breast Cancer

Keywords

Triple Negative Breast CancerCancerBreast CancerMaximum tolerated dose (MTD)Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Dose-limiting Toxicities (DLTs)

    DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

    Minimum 21 days

Secondary Outcomes (11)

  • QTcF Change from Baseline

    Up to approximately 9 weeks

  • Area Under the Plasma Concentration-time Curve (AUC)

    Up to approximately 9 weeks

  • Clinical benefit rate (CBR)

    Up to approximately 4 years

  • Maximum plasma concentration observed (Cmax)

    Up to approximately 9 weeks

  • Overall Survival (OS)

    Up to approximately 4 years

  • +6 more secondary outcomes

Study Arms (1)

SC-005

EXPERIMENTAL

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

Drug: SC-005

Interventions

SC-005DRUG

intravenous

SC-005

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Chicago /ID# 169231

Chicago, Illinois, 60637-1443, United States

Location

Washington University School /ID# 169177

St Louis, Missouri, 63108, United States

Location

Memorial Sloan Kettering /ID# 201016

New York, New York, 10065, United States

Location

Gabrail Cancer Center Research /ID# 168756

Canton, Ohio, 44718, United States

Location

Oklahoma University /ID# 200937

Oklahoma City, Oklahoma, 73104, United States

Location

Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233

Nashville, Tennessee, 37203, United States

Location

Baylor University /ID# 169860

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center /ID# 169232

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 20, 2017

Study Start

January 4, 2018

Primary Completion

October 5, 2018

Study Completion

October 5, 2018

Last Updated

December 17, 2018

Record last verified: 2018-12

Locations

US(8)