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

Study Overview
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Brief Summary
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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).

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: SC-005


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SC-005<br>SC-005 intravenous (IV) (various doses and dose regimens) | Drug: SC-005<br>* intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triple Negative Breast Cancer, Cancer, Breast Cancer, Maximum tolerated dose (MTD), Pharmacokinetics