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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Immunomedics, Inc.
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT01631552
First received: June 26, 2012
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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. 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. Depending on toxicity, 3-6 patients per dose cohort may be enrolled in up to 4 planned dose levels during Phase I dose escalation, for a maximum total enrollment of 24 patients. In Phase II, up to 15 patients per cancer type will be studied in up to 2 dose levels at or below the maximum acceptable dose determined in Phase I.


Condition Intervention Phase
Colorectal Cancer
Gastric Adenocarcinoma
Esophageal Cancer
Hepatocellular Carcinoma
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Ovarian Epithelial Cancer
Breast Cancer
Hormone-refractory Prostate Cancer
Pancreatic Ductal Adenocarcinoma
Head and Neck Cancers- Squamous Cell
Renal Cell Cancer
Bladder Cancer
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 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: 219
Study Start Date: February 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (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
  • IMMU-132

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 (triple negative), prostate (hormone refractory), lung (non-small cell and small cell), head & neck (squamous cell), esophageal, gastric, colorectal, pancreatic, hepatocellular, renal (clear cell) and bladder cancers. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, >18 years of age, able to understand and give written informed consent.
  • Histologically or cytologically confirmed epithelial adenocarcinoma of one of the following types:
  • 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

(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.
  • Previously treated with at least one prior therapeutic regimen
  • Adequate performance status (ECOG 0 or 1) (Appendix 1)
  • Expected survival > 6 months.
  • Measurable disease by CT or MRI.
  • At least 2 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
  • At least 2 weeks beyond corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
  • Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 2,000 per mm3, platelets > 150,000 per mm3).
  • Adequate renal and hepatic function (creatinine ≤ 2.0 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.
  • Known CNS metastatic disease.
  • Presence of bulky disease (defined as any single mass >5 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.
  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 ClinicalTrials.gov identifier: NCT01631552

Contacts
Contact: Pius Maliakal, PhD 973-605-8200 pmaliakal@immunomedics.com
Contact: Finn Augensen 973-605-8200 faugensen@Immunomedics.com

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Auora, Colorado, United States, 080045
Contact: Jamie Bendrick-Peart, MSc    720-848-0600    Jamie.Bendrick-Peart@ucdenver.edu   
Principal Investigator: Wells Messersmith, MD         
United States, Delaware
Helen F. Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Kathy Combs, RN       kcombs@christianacare.org   
Principal Investigator: Michael Guarino, MD         
United States, Florida
MD Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Kristine Moore, RN       KristineMDAResearch.Moore@orlandohealth.com   
Principal Investigator: Sajeve Thomas, MD         
United States, Indiana
IU Health Goshen Cancer Center Recruiting
Goshen, Indiana, United States, 46526
Contact: Tracy Thorne, RN       tthorne@iuhealth.org   
Principal Investigator: Alexander Starodub, MD         
United States, Massachusetts
Massachusettes General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dennise Greensmith    617-724-0695    dgreensmith@mgh.harvard.edu   
Contact: Christopher Caldwell       CCALDWELL3@mgh.harvard.edu   
Principal Investigator: Aditya Bardia, MD         
United States, New York
Weill Cornell/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: Romae Palmer    646-962-9349    rop2017@med.cornell.edu   
Principal Investigator: Allyson Ocean, MD         
United States, Washington
Virginia Mason Cancer Center Recruiting
Seattle, Washington, United States, 98111
Contact: Ann Chancellor, RN       Ann.Chancellor@vmmc.org   
Principal Investigator: Vincent Picozzi, MD         
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
  More Information

No publications provided

Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT01631552     History of Changes
Other Study ID Numbers: IM-T-IMMU-132-01
Study First Received: June 26, 2012
Last Updated: March 7, 2014
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

Additional relevant MeSH terms:
Adenocarcinoma
Breast Neoplasms
Carcinoma
Carcinoma, Ductal, Breast
Carcinoma, Hepatocellular
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Colorectal Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Ovarian Neoplasms
Prostatic Neoplasms
Small Cell Lung Carcinoma
Urinary Bladder Neoplasms
Adnexal Diseases
Breast Diseases
Bronchial Neoplasms
Carcinoma, Bronchogenic
Carcinoma, Ductal
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014