Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer

January 22, 2024 updated by: Gilead Sciences

A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer

The goal of this clinical study is to determine the dosing and safety of labetuzumab govitecan (formerly known as IMMU-130; hMN-14-SN38, antibody-drug conjugate) in participants with colorectal cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • UCLA Jonsson Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F. Graham Cancer Center-Christiana Care
    • Indiana
      • Goshen, Indiana, United States, 46526
        • IUHealth Goshen Center for Cancer Care
    • Ohio
      • Columbus, Ohio, United States, 43202
        • The Ohio State University Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed colorectal adenocarcinoma.
  • Stage IV (metastatic) disease.
  • Previously treated with at least one prior irinotecan-containing regimen for colorectal cancer.
  • Adequate performance status (Eastern Cooperative Oncology Group (ECOG) 0 or 1).
  • Expected survival > 6 months.
  • Carcinoembryonic antigen (CEA) plasma levels > 5 ng/mL.
  • Measurable disease by computed tomography (CT) or Magnetic resonance imaging (MRI).
  • At least 4 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
  • At least 2 weeks beyond corticosteroids.
  • Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
  • Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
  • Otherwise, all toxicity at study entry ≤ Grade 1 by National cancer institute common terminology criteria for adverse events (NCI CTC) v4.0.

Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
  • Individuals with Gilbert's disease or known central nervous system (CNS) metastatic disease.
  • Individuals with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
  • Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension).
  • Individuals with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while individuals with other prior malignancies must have had at least a 3-year disease-free interval.
  • Individuals known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
  • Known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
  • Known history of clinically significant active chronic obstructive pulmonary disease (COPD), or other moderate-to-severe chronic respiratory illness present within 6 months.
  • Infection requiring intravenous antibiotic use within 1 week.
  • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase1: Dose-escalation Phase: Labetuzumab Govitecan (LG) Once Weekly Dosing
Participants will receive 8, 12 and 16 mg/dose of LG once weekly dosing until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to up to 8 cycles, with a contingency to examine intermediate dose levels of 10 or 14 mg/kg, or if necessary to a lower dose level of 6 mg/kg.
Drug: Labetuzumab Govitecan (LG)
Administered as a slow intravenous (IV) infusion.
Other Names:
  • hMN14-SN38
  • Labetuzumab-SN38
  • Antibody-Drug Conjugate
  • IMMU-0130
  • GS-0130
Experimental: Phase1: Dose-escalation Phase: LG Twice Weekly Dosing
Participants will receive 6 and 9 mg/kg per dose twice weekly dose of LG until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to up to 8 cycles. A lower dose level of 4 mg/kg may be added if > 1 out of 3 or 2 out of 6 participants are unable to tolerate all 4 doses without dose delay or reduction.
Drug: Labetuzumab Govitecan (LG)
Administered as a slow intravenous (IV) infusion.
Other Names:
  • hMN14-SN38
  • Labetuzumab-SN38
  • Antibody-Drug Conjugate
  • IMMU-0130
  • GS-0130
Experimental: Phase 2: Dose-expansion Phase: LG Once or Twice Weekly Dosing
Participants will receive selected doses of LG once or twice weekly until unacceptable toxicity, progressive disease or death whichever occurs first, for each 21-day cycle for up to 8 cycles.
Drug: Labetuzumab Govitecan (LG)
Administered as a slow intravenous (IV) infusion.
Other Names:
  • hMN14-SN38
  • Labetuzumab-SN38
  • Antibody-Drug Conjugate
  • IMMU-0130
  • GS-0130

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Adverse Events and Serious Adverse Events (SAEs)
Time Frame: From first dose date up to approximately 2 years after the last dose or until disease progression
From first dose date up to approximately 2 years after the last dose or until disease progression
Percentage of Participants With Laboratory Abnormalities
Time Frame: From first dose date up to approximately 2 years after the last dose or until disease progression
From first dose date up to approximately 2 years after the last dose or until disease progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response
Time Frame: From first documentation of PR or CR to the earlier of the first documentation of PD or death from any cause (Up to approximately 2 years after the last dose or until disease progression)
Duration of response (DOR) is defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression (PD) or death from any cause.
From first documentation of PR or CR to the earlier of the first documentation of PD or death from any cause (Up to approximately 2 years after the last dose or until disease progression)
Progression-free Survival
Time Frame: From first dose date up to 12 weeks post treatment (Up to approximately 2 years after the last dose or until disease progression)
Progression free survival (PFS) is defined as the interval from the start of study drug treatment to the earlier of the first documentation of disease progression or death from any cause.
From first dose date up to 12 weeks post treatment (Up to approximately 2 years after the last dose or until disease progression)
Time to Progression
Time Frame: From first dose of study treatment up to PD (Up to approximately 2 years after the last dose or until disease progression)
Time to progression is defined as the interval from the first dose of treatment to the first documentation of disease progression (PD).
From first dose of study treatment up to PD (Up to approximately 2 years after the last dose or until disease progression)
Overall Survival
Time Frame: From first dose date up to approximately 2 years
Overall survival is defined as the time from start of study drug treatment to death from any cause.
From first dose date up to approximately 2 years
Time-to-treatment Failure
Time Frame: From first dose date up to 8 treatment cycles (each cycle = 21 days) (Up to approximately 24 weeks)
Time to treatment failure (TTF) is defined as the interval from the start of treatment to the earlier of the first documentation of disease progression or death due to any cause, the permanent cessation of LG therapy due to all reasons except progressive disease, participant died or lost to follow up.
From first dose date up to 8 treatment cycles (each cycle = 21 days) (Up to approximately 24 weeks)
Change from Baseline in Carcinoembryonic Antigen (CEA) Serum Levels
Time Frame: From first dose date up to approximately 2 years after the last dose or until disease progression
From first dose date up to approximately 2 years after the last dose or until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2013

Primary Completion (Actual)

January 3, 2017

Study Completion (Actual)

January 3, 2017

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimated)

May 24, 2012

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMMU-130-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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