Clinical Trials /

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

NCT03316794

Description:

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).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
  • Official Title: An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)

Clinical Trial IDs

  • ORG STUDY ID: M16-735
  • NCT ID: NCT03316794

Conditions

  • Cancer - Breast

Interventions

DrugSynonymsArms
SC-005SC-005

Purpose

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 Arms

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

Eligibility Criteria

        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.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

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

Last Updated

March 30, 2018