A Study of SC-007 in Subjects With Advanced Cancer

Sponsor

AbbVie (Industry)

Overall Status

Terminated

CT.gov ID

NCT03253185

Collaborator

(none)

Enrollment

Locations

Arm

6.6

Actual Duration (Months)

Patient Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer (CRC) Gastric Cancer	Drug: SC-007	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 13, 2017

Actual Primary Completion Date :

Mar 20, 2018

Actual Study Completion Date :

Apr 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SC-007 SC-007 intravenous (IV) (various doses and dose regimens)	Drug: SC-007 intravenous

Arm

Intervention/Treatment

Experimental: SC-007

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

Drug: SC-007

intravenous

Outcome Measures

Primary Outcome Measures

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

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
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	Mayo Clinic	Rochester	Minnesota	United States	55905-0001
3	Washington University-School of Medicine	Saint Louis	Missouri	United States	63110
4	Gabrail Cancer Center Research	Canton	Ohio	United States	44718
5	Tennessee Oncology-Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
6	MD Anderson Cancer Center	Houston	Texas	United States	77030
7	South Texas Accelerated Research Therapeutics	San Antonio	Texas	United States	78229