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Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers

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: NCT01631552
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : September 9, 2020
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:
The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles until unacceptable progression or toxicity, in previously treated patients with advanced epithelial cancer. In Phase II, the primary objective is the evaluation of the safety and efficacy of IMMU-132 administered in 3-week treatment cycles at a dose selected in Phase I, while the secondary objectives include pharmacokinetics and immunogenicity.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Esophageal Cancer Hepatocellular Carcinoma Non-small Cell Lung Cancer Small Cell Lung Cancer Ovarian Epithelial Cancer Carcinoma Breast Stage IV Hormone-refractory Prostate Cancer Head and Neck Cancers- Squamous Cell Renal Cell Cancer Urinary Bladder Neoplasms Cervical Cancer Endometrial Cancer Follicular Thyroid Cancer Glioblastoma Multiforme Triple Negative Breast Cancer Pancreatic Cancer Drug: IMMU-132 Phase 1 Phase 2

Detailed Description:
This is a Phase I/II, open-label study of IMMU-132 in previously treated patients with advanced epithelial cancers. Patients receive IMMU-132 administered once-weekly for the first 2 weeks of 3-week treatment cycles. Treatment cycles will continue until unacceptable toxicity or progression of disease. Both safety and efficacy will be assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 515 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers
Actual Study Start Date : February 2013
Actual Primary Completion Date : August 13, 2020
Actual Study Completion Date : August 13, 2020

Arm Intervention/treatment
Experimental: IMMU-132
IMMU-132 (hRS7-SN38) is an Antibody Drug Conjugate where the antibody, hRS7 is attached to SN38. SN38 is the active metabolite of irinotecan (CPT-11).
Drug: IMMU-132
IMMU-132 is administered on days 1 & 8 of 3 week treatment cycles.
Other Names:
  • hRS7-SN38
  • Sacituzumab Govitecan

Primary Outcome Measures :
  1. Safety (adverse events, change in lab values) [ Time Frame: During treatment, at the final evaluation and at follow up after treatment ]
    Safety will be assessed by monitoring the patient for adverse events, monitoring the change in lab values during and after treatment compared to baseline.

Secondary Outcome Measures :
  1. Efficacy (change in tumor measurements) [ Time Frame: Efficacy will be assessed every 8 weeks during treatment and then every 12 weeks after treatment ]
    Efficacy will be evaluated from CT scans (or MRI studies), using RECIST 1.1 to classify tumor response, time to onset of objective response, duration of objective response, and time to progression. Efficacy will be assessed every 8 weeks until the end of treatment or progression of disease and every 12 weeks at the follow up, over an average of 6 months.

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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 epithelial cancer of one of the following types:
  • Gastric adenocarcinoma (GC)
  • Esophageal cancer (EC)
  • Hepatocellular carcinoma (HCC)
  • Non-small-cell lung cancer (NSCLC)
  • Small-cell lung cancer (SCLC)
  • Epithelial ovarian cancer (EOC)
  • Cervical Cancer
  • Endometrial Cancer
  • Triple-negative breast cancer [With Amendment 10, these patients need to have unequivocal TNBC histology (ER-/PR-/HER2-) per ASCO/CAP guidelines, based on most recently analyzed biopsy, and must have had at least 2 prior therapies for metastatic disease, including prior taxane (any setting). Chemotherapy, biological or targeted or immunotherapy agents will count as qualifying prior therapies, but not hormonal or anti-HER2 agents (either given prior to achieving triple negative status or for any other reason).]
  • Non-triple-negative breast cancer
  • Follicular thyroid cancer
  • Glioblastoma multiforme (GBM)
  • Hormone-refractory prostate cancer (HRPC)
  • Head and neck cancers- squamous cell (SCCHN)
  • Renal cell cancer (clear cell) (RCC)
  • Urothelial cancer

(Note: Confirmation of Trop-2 expression by immunohistology or other means is not required, but the Sponsor will request tissue specimens from archived materials for determination of Trop-2 expression.)

  • Stage IV (metastatic) disease (except for patients with GBM).
  • Refractory to or relapsed after at least one prior standard therapeutic regimen
  • Adequate performance status (ECOG 0 or 1)
  • Expected survival ≥ 6 months.
  • Measurable disease by CT or MRI.
  • At least 2 weeks beyond treatment (chemotherapy, investigational drugs including small molecular inhibitors, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities to Grade 1 or less (except alopecia).
  • At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
  • 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 ≤ 2.0 x IULN, bilirubin ≤ 1.5 IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
  • Otherwise, all toxicity at study entry ≤ Grade 1.

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.
  • Patients with brain metastases can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks.
  • Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension). Patients with a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.
  • 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.
  • Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of study treatment.
  • Infection requiring intravenous antibiotic use within 1 week.
  • history of an anaphylactic reaction to irinotecan or ≥ Grade 3 GI toxicity to prior irinotecan,
  • 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): NCT01631552

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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 080045
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
United States, Florida
MD Anderson Cancer Center Orlando (UF Health Cancer Center)
Orlando, Florida, United States, 32806
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Indiana
IU Health Goshen Cancer Center
Goshen, Indiana, United States, 46526
United States, Massachusetts
Massachusettes General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Weill Cornell/New York Presbyterian Hospital
New York, New York, United States, 10021
Columbia University Herbert Irving Cancer Center
New York, New York, United States, 10032
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37212
United States, Texas
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States, 75246
United States, Washington
Virginia Mason Cancer Center
Seattle, Washington, United States, 98111
Sponsors and Collaborators
Immunomedics, Inc.
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Study Chair: Aditya Bardia, MD Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Immunomedics, Inc. Identifier: NCT01631552    
Other Study ID Numbers: IM-T-IMMU-132-01
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immunomedics, Inc.:
Gastric adenocarcinoma (GC)
Esophageal cancer (EC)
Hepatocellular carcinoma (HCC)
Non-small cell lung cancer (NSCLC)
Small cell lung cancer (SCLC)
Ovarian epithelial cancer (OEC)
Triple-negative breast cancer (TNBC)
Hormone-refractory prostate cancer (HRPC)
Head and neck cancers- squamous cell (SCCHN)
Renal cell cancer -clear cell (RCC)
Bladder cancer
Endometrial Cancer
Cervical Cancer
Metastatic non-triple negative breast cancer
Glioblastoma multiforme
Follicular thyroid cancer
pancreatic cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Carcinoma, Hepatocellular
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Esophageal Neoplasms
Small Cell Lung Carcinoma
Endometrial Neoplasms
Thyroid Neoplasms
Triple Negative Breast Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma, Renal Cell
Urinary Bladder Neoplasms
Adenocarcinoma, Follicular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases