A Study of SC-007 in Subjects With Advanced Cancer

Study Overview
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Brief Summary
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This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.

Official Title
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An Open Label Study of SC-007 in Subjects With Advanced Cancer

Conditions
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Colorectal Cancer (CRC), Gastric Cancer

Intervention / Treatment
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* Drug: SC-007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive after: CRC: at least 2 prior systemic regimens in the metastatic setting, and as appropriate in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as well. Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (HER2) targeted agent. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate hematologic, hepatic, and renal function. Exclusion Criteria: Any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study. Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc) evaluation difficult. Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.

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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Accepts Healthy Volunteers

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-007<br>SC-007 intravenous (IV) (various doses and dose regimens) | Drug: SC-007<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 first cycle of dosing (Up to 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Rate (CBR) | CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD). | Approximately 4 years | 
| 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. | Approximately 4 years | 
| Observed plasma concentrations at trough (Ctrough) of SC-007 | Observed plasma concentrations at trough of SC-007 | Approximately 1 year | 
| Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007 | Incidence of ATAs against SC-007 | Approximately 4 years | 
| Overall Survival (OS) | OS is defined as the time from the participant's first dose date to death due to any cause. | Approximately 4 years | 
| Terminal half life (T1/2) of SC-007 | Terminal half life of SC-007 | Approximately 1 year | 
| Objective Response Rate (ORR) | ORR is defined as the proportion of participants with complete response or partial response (CR+PR) | Approximately 4 years | 
| Duration of Response (DOR) | DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. | Approximately 4 years | 
| Time to Cmax (Tmax) of SC-007 | Time to Cmax of SC-007 | Approximately 1 year | 
| Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007 | Area under the plasma concentration-time curve within a dosing interval of SC-007 | Approximately 1 year | 
| QTcF Change from Baseline | QT interval measurement corrected by Fridericia's formula (QTcF) | Up to 9 weeks based on 3 cycles of dosing (21-day cycles) | 
| Maximum observed serum concentration (Cmax) of SC-007 | Maximum observed serum concentration of SC-007 | Approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced cancer, Maximum tolerated dose (MTD), Maximum Tolerated Dose, Pharmacokinetics, Esophagogastric junction (EGJ) cancers, Cancer