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BRIEF TITLE: Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers

A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers


  • Org Study ID: IM-T-IMMU-132-01
  • Secondary ID:
  • NCT ID: NCT01631552
  • NCT Alias:
  • Sponsor: Immunomedics, Inc. - Industry
  • Source: 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 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.

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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: February 2013 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Safety

Primary Outcome 1 - Time Frame: During treatment, at the final evaluation and at follow up after treatment

Condition:

  • 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
  • Triple Negative Breast Cancer

Eligibility

Criteria:
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:r/>
- 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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: William Wegener, MD, PhD

Role: Study Chair

Affiliation: Immunomedics, Inc.

Overall Contact

Name: Heather Horne

Phone: 973-605-8200

Email: hhorne@immunomedics.com

Locations

Facility Status Contact
University of Colorado Anschutz Medical Campus
Aurora, Colorado 080045
United States
Recruiting MARK MORROW, MSc
720-848-0600
Mark.Morrow@ucdenver.edu
Yale University School of Medicine
New Haven, Connecticut 06511
United States
Recruiting LISA BAKER
203-785-6398
lisa.baker@yale.edu
Helen F. Graham Cancer Center
Newark, Delaware 19713
United States
Recruiting Kathy Combs, RN

kcombs@christianacare.org
MD Anderson Cancer Center Orlando (UF Health Cancer Center)
Orlando, Florida 32806
United States
Recruiting Georgina Hollenbach, RN

Georgina.Hollenbach@orlandohealth.com
Moffitt Cancer Center
Tampa, Florida 33612
United States
Recruiting KELLY PARKER
813-745-8350
kelly.parker@moffitt.org
IU Health Goshen Cancer Center
Goshen, Indiana 46526
United States
Recruiting Vanessa Depue, RN

Massachusettes General Hospital
Boston, Massachusetts 02114
United States
Recruiting Aditya Bardia, MD
617-724-4000
Bardia.Aditya@mgh.harvard.edu
Weill Cornell/New York Presbyterian Hospital
New York, New York 10021
United States
Recruiting Amanda De Laurentiis
646-962-9349
amd9041@med.cornell.edu
Columbia University Herbert Irving Cancer Center
New York, New York 10032
United States
Recruiting Ruby P Wu
212-304-5601
rw2518@columbia.edu
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37212
United States
Recruiting Wendy VerMeulen, RN
615-936-5621
wendy.vermeulen@Vanderbilt.Edu
Texas Oncology Sammons Cancer Center
Dallas, Texas 75246
United States
Recruiting Rita Lopez

Rita.Lopez2@USONCOLOGY.COM
Virginia Mason Cancer Center
Seattle, Washington 98111
United States
Recruiting Ann Chancellor, RN

Ann.Chancellor@vmmc.org