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

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: SC-005

• Registration Number: NCT03316794
• Lead Sponsor: AbbVie

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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-20
• Study Start: 2018-01-04
• Primary Completion: 2018-10-05
• Study Completion: 2018-10-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Dose-limiting Toxicities (DLTs)	Minimum 21 days	DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Secondary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve (AUC)	Up to approximately 9 weeks	Area under the plasma concentration-time curve (AUC) of SC-005.
Clinical benefit rate (CBR)	Up to approximately 4 years	CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR +SD).
Observed Plasma Concentrations at Trough	Up to approximately 9 weeks	Observed plasma concentrations at trough of SC-005.
Duration of Clinical Benefit (DOCB)	Up to approximately 4 years	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.
Time of Cmax (Tmax)	Up to approximately 9 weeks	Time of Cmax (Tmax) of SC-005.
Progression Free Survival (PFS)	Up to approximately 4 years	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.
QTcF Change from Baseline	Up to approximately 9 weeks	QT interval measurement corrected by Fridericia's formula (QTcF)
Maximum plasma concentration observed (Cmax)	Up to approximately 9 weeks	Maximum plasma concentration observed (Cmax) of SC-005
Overall Survival (OS)	Up to approximately 4 years	OS is defined as the time from the participant's first dose date to death due to any cause.
Objective Response Rate (ORR)Up to approximately 4 years	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.
Duration of Response (DOR)	Up to approximately 4 years	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.

Trial Locations

Locations (8)

Memorial Sloan Kettering /ID# 201016; 🇺🇸 New York, New York, United States

University of Chicago /ID# 169231; 🇺🇸 Chicago, Illinois, United States

Washington University School /ID# 169177; 🇺🇸 Saint Louis, Missouri, United States

Baylor University /ID# 169860; 🇺🇸 Houston, Texas, United States

MD Anderson Cancer Center /ID# 169232; 🇺🇸 Houston, Texas, United States

Oklahoma University /ID# 200937; 🇺🇸 Oklahoma City, Oklahoma, United States

Gabrail Cancer Center Research /ID# 168756; 🇺🇸 Canton, Ohio, United States

Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233; 🇺🇸 Nashville, Tennessee, United States