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A Study of SC-007 in Subjects With Advanced Cancer

Primary Purpose

Colorectal Cancer (CRC), Gastric Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SC-007
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer (CRC) focused on measuring Cancer, Advanced cancer, Esophagogastric junction (EGJ) cancers, Maximum tolerated dose (MTD), Maximum Tolerated Dose, Pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, Los Angeles
  • Mayo Clinic
  • Washington University-School of Medicine
  • Gabrail Cancer Center Research
  • Tennessee Oncology-Sarah Cannon Research Institute
  • MD Anderson Cancer Center
  • South Texas Accelerated Research Therapeutics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SC-007

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD).
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.
Observed plasma concentrations at trough (Ctrough) of SC-007
Observed plasma concentrations at trough of SC-007
Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007
Incidence of ATAs against SC-007
Overall Survival (OS)
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
Terminal half life of SC-007
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
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.
Time to Cmax (Tmax) of SC-007
Time to Cmax of SC-007
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
QTcF Change from Baseline
QT interval measurement corrected by Fridericia's formula (QTcF)
Maximum observed serum concentration (Cmax) of SC-007
Maximum observed serum concentration of SC-007

Full Information

First Posted
August 14, 2017
Last Updated
April 25, 2018
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03253185
Brief Title
A Study of SC-007 in Subjects With Advanced Cancer
Official Title
An Open Label Study of SC-007 in Subjects With Advanced Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Benefit/Risk Imbalance
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
April 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer (CRC), Gastric Cancer
Keywords
Cancer, Advanced cancer, Esophagogastric junction (EGJ) cancers, Maximum tolerated dose (MTD), Maximum Tolerated Dose, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SC-007
Arm Type
Experimental
Arm Description
SC-007 intravenous (IV) (various doses and dose regimens)
Intervention Type
Drug
Intervention Name(s)
SC-007
Intervention Description
intravenous
Primary Outcome Measure Information:
Title
Number of participants with dose-limiting toxicities (DLTs)
Description
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time Frame
Minimum first cycle of dosing (Up to 21 days)
Secondary Outcome Measure Information:
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD).
Time Frame
Approximately 4 years
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Approximately 4 years
Title
Observed plasma concentrations at trough (Ctrough) of SC-007
Description
Observed plasma concentrations at trough of SC-007
Time Frame
Approximately 1 year
Title
Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007
Description
Incidence of ATAs against SC-007
Time Frame
Approximately 4 years
Title
Overall Survival (OS)
Description
OS is defined as the time from the participant's first dose date to death due to any cause.
Time Frame
Approximately 4 years
Title
Terminal half life (T1/2) of SC-007
Description
Terminal half life of SC-007
Time Frame
Approximately 1 year
Title
Objective Response Rate (ORR)
Description
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Time Frame
Approximately 4 years
Title
Duration of Response (DOR)
Description
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 Frame
Approximately 4 years
Title
Time to Cmax (Tmax) of SC-007
Description
Time to Cmax of SC-007
Time Frame
Approximately 1 year
Title
Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007
Description
Area under the plasma concentration-time curve within a dosing interval of SC-007
Time Frame
Approximately 1 year
Title
QTcF Change from Baseline
Description
QT interval measurement corrected by Fridericia's formula (QTcF)
Time Frame
Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
Title
Maximum observed serum concentration (Cmax) of SC-007
Description
Maximum observed serum concentration of SC-007
Time Frame
Approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Washington University-School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Tennessee Oncology-Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of SC-007 in Subjects With Advanced Cancer

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