A Study of SC-007 in Subjects With Advanced Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Gastric Cancer; Colorectal Cancer (CRC)
• Intervention / Treatment: Drug: SC-007

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology-Sarah Cannon Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): April 2, 2018

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cancer; Pharmacokinetics; Advanced cancer; Maximum Tolerated Dose; Maximum tolerated dose (MTD); Esophagogastric junction (EGJ) cancers
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Stomach Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: M16-310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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