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

Breast Cancer Clinical Trial

Official title:

An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03316794
• Other study ID #: M16-735
• Status: Terminated
• Phase: Phase 1
• Start date: January 4, 2018
• Est. completion date: October 5, 2018

Study information

• Verified date: December 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• SC-005
intravenous

Locations

Country	Name	City	State
United States	Gabrail Cancer Center Research /ID# 168756	Canton	Ohio
United States	University of Chicago /ID# 169231	Chicago	Illinois
United States	Baylor University /ID# 169860	Houston	Texas
United States	MD Anderson Cancer Center /ID# 169232	Houston	Texas
United States	Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233	Nashville	Tennessee
United States	Memorial Sloan Kettering /ID# 201016	New York	New York
United States	Oklahoma University /ID# 200937	Oklahoma City	Oklahoma
United States	Washington University School /ID# 169177	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	QTcF Change from Baseline	QT interval measurement corrected by Fridericia's formula (QTcF)	Up to approximately 9 weeks
Secondary	Area Under the Plasma Concentration-time Curve (AUC)	Area under the plasma concentration-time curve (AUC) of SC-005.	Up to approximately 9 weeks
Secondary	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
Secondary	Maximum plasma concentration observed (Cmax)	Maximum plasma concentration observed (Cmax) of SC-005	Up to approximately 9 weeks
Secondary	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
Secondary	Observed Plasma Concentrations at Trough	Observed plasma concentrations at trough of SC-005.	Up to approximately 9 weeks
Secondary	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
Secondary	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
Secondary	Time of Cmax (Tmax)	Time of Cmax (Tmax) of SC-005.	Up to approximately 9 weeks
Secondary	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
Secondary	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