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).
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
Interventions
Drug | Synonyms | Arms |
---|
SC-005 | | SC-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
Name | Type | Description | Interventions |
---|
SC-005 | Experimental | SC-005 intravenous (IV) (various doses and dose regimens) | |
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: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
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: | Terminated |
Lead Sponsor: | AbbVie |
Trial Keywords
- Triple Negative Breast Cancer
- Cancer
- Breast Cancer
- Maximum tolerated dose (MTD)
- Pharmacokinetics
Last Updated
December 17, 2018