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Dose Finding Study of Once or Twice Weekly IMMU-130 in Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01605318
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : April 8, 2019
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:
This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles, once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen. The study is being done to evaluate whether the study drug is safe and tolerable at different dose levels with these dosing schedules and to obtain preliminary information on its efficacy.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Colon Cancer Rectal Cancer Drug: IMMU-130 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer.
Study Start Date : September 2012
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IMMU-130
All patients receive IMMU-130 administered in 21-day treatment cycles consisting of once or twice weekly for 2 consecutive weeks followed by a 1-week rest period. Treatment can be continued in the absence of unacceptable toxicity for a period of up to 8 cycles until the first documentation of Progressive Disease by CT (physician discretion), but must terminate study treatment upon the second documentation of Progressive Disease.
Drug: IMMU-130
This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles, once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen.
Other Names:
  • hMN14-SN38
  • Labetuzumab-SN38
  • Antibody-Drug Conjugate

Primary Outcome Measures :
  1. Safety [ Time Frame: Safety during treatment and every 3 months after treatment ]
    Safety and tolerability will be evaluated from adverse events, standard safety laboratories (CBC with differential and platelet count, serum chemistries, urinalysis), physical examination, vital signs, and EKG. Adverse events will be classified according to the MedDRA system of preferred terms and system organ class, and all adverse events and abnormal laboratories will be classified for severity using NCI CTCAE v4.0 toxicity grades. Descriptive statistics will be used to characterize adverse events, cytopenias, and other abnormal laboratories.

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: measured every 8 weeks during treatement & every 3 months after treatment ]
    CT (chest, abdomen, pelvis; other if needed) and serum CEA are done every 8 weeks after first dose until the end of treatment or progression of disease and then every 3 months during follow up. CT may be obtained more frequently at the physician discretion to assess disease status.for up to 2 years or until progression of disease.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients, ≥ 18 years of age, able to understand and give written informed consent.
  • 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 (ECOG 0 or 1). (Appendix 1)
  • Expected survival > 6 months.
  • CEA plasma levels > 5 ng/mL.
  • Measurable disease by CT or 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, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
  • Adequate renal and hepatic function (creatinine ≤ 1.5 x IULN, bilirubin ≤ IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
  • Otherwise, all toxicity at study entry ≤ Grade 1 by 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.
  • Patients with Gilbert's disease or known CNS metastatic disease.
  • Patients with CEA plasma levels > 1000 ng/mL are excluded during dose escalation, but may be included after the MTD is determined.
  • Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension).
  • Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
  • Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
  • Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
  • Known history of clinically significant active 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01605318

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

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Responsible Party: Immunomedics, Inc. Identifier: NCT01605318    
Other Study ID Numbers: IM-T-IMMU-130-02
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Keywords provided by Immunomedics, Inc.:
metastatic colorectal cancer
colon cancer
rectal cancer
previously treated
Additional relevant MeSH terms:
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Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents