A Study of SC-007 in Subjects With Advanced Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03253185
• Other study ID #: M16-310
• Status: Terminated
• Phase: Phase 1
• First received: August 14, 2017
• Last updated: April 25, 2018
• Start date: September 13, 2017
• Est. completion date: April 2, 2018

Study information

• Verified date: April 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer (CRC)
• Colorectal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• SC-007
intravenous

Locations

Country	Name	City	State
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of California, Los Angeles	Los Angeles	California
United States	Tennessee Oncology-Sarah Cannon Research Institute	Nashville	Tennessee
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University-School of Medicine	Saint Louis	Missouri
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Observed plasma concentrations at trough (Ctrough) of SC-007	Observed plasma concentrations at trough of SC-007	Approximately 1 year
Secondary	Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007	Incidence of ATAs against SC-007	Approximately 4 years
Secondary	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
Secondary	Terminal half life (T1/2) of SC-007	Terminal half life of SC-007	Approximately 1 year
Secondary	Objective Response Rate (ORR)	ORR is defined as the proportion of participants with complete response or partial response (CR+PR)	Approximately 4 years
Secondary	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
Secondary	Time to Cmax (Tmax) of SC-007	Time to Cmax of SC-007	Approximately 1 year
Secondary	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
Secondary	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)
Secondary	Maximum observed serum concentration (Cmax) of SC-007	Maximum observed serum concentration of SC-007	Approximately 1 year