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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Immunomedics, Inc.
Information provided by (Responsible Party):
Immunomedics, Inc. Identifier:
First received: June 26, 2012
Last updated: October 20, 2015
Last verified: October 2015
The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated patients with advanced epithelial cancer.The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers. The antibody, RS7, is attached to SN38, which is the active metabolite of irinotecan. This is planned as a multi-center study. In Phase II, up to 130 patients (assessable) in triple-negative breast cancer, up to 100 patients (assessable) in non-small cell and small-cell lung cancer and up to 50 patients (assessable) per other cancer types included in the protocol will be studied at the 10 mg/kg dose.

Condition Intervention Phase
Colorectal Cancer
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
Pancreatic Ductal Adenocarcinoma
Head and Neck Cancers- Squamous Cell
Renal Cell Cancer
Urinary Bladder Neoplasms
Cervical Cancer
Endometrial Cancer
Follicular Thyroid Cancer
Glioblastoma Multiforme
Drug: IMMU-132
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Immunomedics, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: During treatment, at the final evaluation and at follow up after treatment ] [ Designated as safety issue: Yes ]
    Safety will be assessed by monitoring the patient for adverse events, monitoring the change in lab values during and after treatment compared to baseline over an average of 6 months.

Secondary Outcome Measures:
  • Efficacy [ Time Frame: Efficacy will be assessed every 8 weeks during treatment and then every 12 weeks after treatment ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 250
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. Up to 8 cycles will be given.
Other Names:
  • hRS7-SN38
  • Sacituzumab Govitecan

Detailed Description:
This is a Phase I/II, open-label study of IMMU-132 in previously treated patients with advanced epithelial cancers, including ovarian, breast, prostate (hormone refractory), lung (non-small cell and small cell), head & neck (squamous cell), esophageal, gastric, colorectal, pancreatic, hepatocellular, renal (clear cell), endometrial, cervical, urothelial, thyroid cancers and glioblastoma multiforme. Patients receive IMMU-132 administered once-weekly for the first 2 weeks of 3-week treatment cycles. Patients may receive up to a maximum total of 8 cycles (16 doses), but patients with a partial response or stable disease at that time, or patients who had achieved an objective response but relapsed after discontinuing treatment, may continue to be treated based on physician discretion. Treatment will continue until unacceptable toxicity or progression of disease. Both safety and efficacy will be assessed.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:
  • Colorectal
  • Gastric adenocarcinoma
  • Esophageal cancer
  • Hepatocellular carcinoma
  • Non-small cell lung cancer
  • Small cell lung cancer
  • Ovarian epithelial cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Breast cancer
  • Hormone-refractory prostate cancer
  • Pancreatic ductal adenocarcinoma
  • Head and neck cancers- squamous cell
  • Renal cell cancer (clear cell)
  • Urothelial cancers
  • Glioblastoma multiforme
  • Follicular thyroid 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.
  • Refractory to or relapsed after at least one prior standard therapeutic regimen (Appendix 1 lists approved or standard chemotherapeutic agents for each cancer type. Patients who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving IMMU-132 are available prior to consenting to participate in this trial.)
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01631552

Contact: Pius Maliakal, PhD 973-605-8200
Contact: Finn Augensen 973-605-8200

United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Auora, Colorado, United States, 080045
Contact: MARK MORROW, MSc    720-848-0600   
Principal Investigator: Wells Messersmith, MD         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Contact: LISA BAKER    203-785-6398   
Principal Investigator: ALESSANDRO SANTIN, MD, PHD         
United States, Delaware
Helen F. Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Kathy Combs, RN   
Principal Investigator: Michael Guarino, MD         
United States, Florida
MD Anderson Cancer Center Orlando (UF Health Cancer Center) Recruiting
Orlando, Florida, United States, 32806
Contact: Georgina Hollenbach, RN   
Principal Investigator: REBECCA MOROOSE, MD         
United States, Indiana
IU Health Goshen Cancer Center Recruiting
Goshen, Indiana, United States, 46526
Contact: Tracy Thorne, RN   
Principal Investigator: Alexander Starodub, MD         
United States, Massachusetts
Massachusettes General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dennise Greensmith    617-724-0695   
Contact: Christopher Caldwell   
Principal Investigator: Aditya Bardia, MD         
United States, New York
Columbia University Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Ruby P Wu    212-304-5601   
Principal Investigator: KEVIN KALINSKY, MD,PHD         
Weill Cornell/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: Amanda De Laurentiis    646-962-9349   
Principal Investigator: Allyson Ocean, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Pamela Williams, RN    615-936-5621   
Principal Investigator: Jordan Berlin, MD         
Sub-Investigator: Ingrid Mayer, MD         
United States, Texas
Texas Oncology Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: STEPHANIE CANNON       Stephanie.Cannon@USONCOLOGY.COM   
Principal Investigator: JOYCE O'SHAUGHNESSY, MD         
United States, Washington
Virginia Mason Cancer Center Recruiting
Seattle, Washington, United States, 98111
Contact: Ann Chancellor, RN   
Principal Investigator: Vincent Picozzi, MD         
Sponsors and Collaborators
Immunomedics, Inc.
Study Director: Pius Maliakal, PhD Immunomedics, Inc.
Study Chair: Francois Wilhelm, MD, PhD Immunomedics, Inc.
  More Information

No publications provided by Immunomedics, Inc.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Immunomedics, Inc. Identifier: NCT01631552     History of Changes
Other Study ID Numbers: IM-T-IMMU-132-01
Study First Received: June 26, 2012
Last Updated: October 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Immunomedics, Inc.:
Colorectal (CRC)
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)
Pancreatic ductal adenocarcinoma (PDC)
Head and neck cancers- squamous cell (SCCHN)
Renal cell cancer -clear cell (RCC)
Bladder cancer
Endometrial Cancer
Cervical Cancer
Breast cancer
Metastatic non-triple negative breast cancer
Glioblastoma multiforme
Follicular thyroid cancer

Additional relevant MeSH terms:
Adenocarcinoma, Follicular
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Hepatocellular
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Ovarian Neoplasms
Prostatic Neoplasms
Small Cell Lung Carcinoma
Thyroid Neoplasms
Urinary Bladder Neoplasms
Uterine Cervical Neoplasms
Adnexal Diseases
Breast Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Carcinoma, Ductal
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases processed this record on November 24, 2015