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

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).

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: SC-005

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637-1443
      • University of Chicago /ID# 169231
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School /ID# 169177
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering /ID# 201016
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research /ID# 168756
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University /ID# 200937
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor University /ID# 169860
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center /ID# 169232

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SC-005; SC-005 intravenous (IV) (various doses and dose regimens)	Drug: SC-005; intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
QTcF Change from Baseline	QT interval measurement corrected by Fridericia's formula (QTcF)	Up to approximately 9 weeks
Area Under the Plasma Concentration-time Curve (AUC)	Area under the plasma concentration-time curve (AUC) of SC-005.	Up to approximately 9 weeks
Clinical benefit rate (CBR)	CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR +SD).	Up to approximately 4 years
Maximum plasma concentration observed (Cmax)	Maximum plasma concentration observed (Cmax) of SC-005	Up to approximately 9 weeks
Overall Survival (OS)	OS is defined as the time from the participant's first dose date to death due to any cause.	Up to approximately 4 years
Observed Plasma Concentrations at Trough	Observed plasma concentrations at trough of SC-005.	Up to approximately 9 weeks
Duration of Clinical Benefit (DOCB)	DOCB is defined as the time from the participant's initial observation of clinical benefit (CR or PR or stable disease [SD]) to PD or death due to any cause, whichever occurs first.	Up to approximately 4 years
Objective Response Rate (ORR)Up to approximately 4 years	Objective response rate is defined as the proportion of participants with complete response (CR) or partial response (PR) based on RECIST version 1.1.	Up to approximately 4 years
Time of Cmax (Tmax)	Time of Cmax (Tmax) of SC-005.	Up to approximately 9 weeks
Progression Free Survival (PFS)	PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death due to any cause.	Up to approximately 4 years
Duration of Response (DOR)	DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression (PD) or death due to any cause, whichever occurs first.	Up to approximately 4 years

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2018
• Primary Completion (ACTUAL): October 5, 2018
• Study Completion (ACTUAL): October 5, 2018

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (ACTUAL): October 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer; Cancer; Pharmacokinetics; Triple Negative Breast Cancer; Maximum tolerated dose (MTD)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: M16-735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No