NCT03253185

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

September 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2018

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

August 14, 2017

Last Update Submit

April 25, 2018

Conditions

Colorectal Cancer (CRC)Gastric Cancer

Keywords

CancerAdvanced cancerEsophagogastric junction (EGJ) cancersMaximum tolerated dose (MTD)Maximum Tolerated DosePharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Clinical Benefit Rate (CBR)

    Approximately 4 years

  • Progression Free Survival (PFS)

    Approximately 4 years

  • Observed plasma concentrations at trough (Ctrough) of SC-007

    Approximately 1 year

  • Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007

    Approximately 4 years

  • Overall Survival (OS)

    Approximately 4 years

  • +7 more secondary outcomes

Study Arms (1)

SC-007

EXPERIMENTAL

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

Drug: SC-007

Interventions

SC-007DRUG

intravenous

SC-007

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

Location

Washington University-School of Medicine

St Louis, Missouri, 63110, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Tennessee Oncology-Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsStomach NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 17, 2017

Study Start

September 13, 2017

Primary Completion

March 20, 2018

Study Completion

April 2, 2018

Last Updated

April 27, 2018

Record last verified: 2018-04

Locations

US(7)