Breast Cancer
Conditions
Keywords
Triple Negative Breast Cancer, Cancer, Breast Cancer, Maximum tolerated dose (MTD), Pharmacokinetics
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).
Interventions
DRUGSC-005
intravenous
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| Observed Plasma Concentrations at Trough | Up to approximately 9 weeks | Observed plasma concentrations at trough of SC-005. |
| QTcF Change from Baseline | Up to approximately 9 weeks | QT interval measurement corrected by Fridericia's formula (QTcF) |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed