A Study of SC-007 in Subjects With Advanced Cancer

Phase 1

Terminated

• Conditions: Colorectal Cancer (CRC); Gastric Cancer
• Interventions: Drug: SC-007

• Registration Number: NCT03253185
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-17
• Study Start: 2017-09-13
• Primary Completion: 2018-03-20
• Status Verified: 2018-04
• Study Completion: 2018-04-02
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SC-007	SC-007	SC-007 intravenous (IV) (various doses and dose regimens)

Primary Outcome Measures

Name	Time	Method
Number of participants with dose-limiting toxicities (DLTs)	Minimum first cycle of dosing (Up to 21 days)	DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University-School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Gabrail Cancer Center Research; 🇺🇸 Canton, Ohio, United States

Tennessee Oncology-Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States