Clinical trial NCT03316794: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Triple Negative Breast Cancer
Cancer
Breast Cancer
Maximum tolerated dose (MTD)
Pharmacokinetics
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of Participants with Dose-limiting Toxicities (DLTs)
timeFrame: Minimum 21 days
Secondary outcomes:
measure: QTcF Change from Baseline
timeFrame: Up to approximately 9 weeks
measure: Area Under the Plasma Concentration-time Curve (AUC)
timeFrame: Up to approximately 9 weeks
measure: Clinical benefit rate (CBR)
timeFrame: Up to approximately 4 years
measure: Maximum plasma concentration observed (Cmax)
timeFrame: Up to approximately 9 weeks
measure: Overall Survival (OS)
timeFrame: Up to approximately 4 years
measure: Observed Plasma Concentrations at Trough
timeFrame: Up to approximately 9 weeks
measure: Duration of Clinical Benefit (DOCB)
timeFrame: Up to approximately 4 years
measure: Objective Response Rate (ORR)Up to approximately 4 years
timeFrame: Up to approximately 4 years
measure: Time of Cmax (Tmax)
timeFrame: Up to approximately 9 weeks
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 4 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago /ID# 169231
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School /ID# 169177
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering /ID# 201016
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 168756
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University /ID# 200937
state: Oklahoma
city: Nashville
country: United States
facility: Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233
state: Tennessee
city: Houston
country: United States
facility: Baylor University /ID# 169860
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center /ID# 169232
state: Texas
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: