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

Phase 1
18 Years
Open (Enrolling)
Advanced Epithelial Cancers, Ovarian Cancer, Prostate Cancer, Lung Cancer, Breast Cancer, Gastric Cancer, Colorectal Cancer, Pancreatic Cancer, Hepatocellular Cancer

Thank you

Trial Information

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

IMMU-132 will be administered on days 1 & 8 of a 21-day treatment cycle and up to 8 cycles
may be administered. Treatment will continue until unacceptable toxicity or progression of
disease. Both safety and efficacy will be assessed.

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:

- Breast cancer (BC)

- Colorectal (CRC)

- Gastric adenocarcinoma (GC)

- Hepatocellular carcinoma (HCC)

- Non-small cell lung cancer (NSCLC)

- Ovarian epithelial cancer (OEC)

- Pancreatic ductal adenocarcinoma (PDC)

- Prostate adenocarcinoma (PC) (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, but no more than 3
prior chemotherapy regimens.

- 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

- Patients with Gilbert's disease.

- Known CNS metastatic disease.

- Presence of bulky disease (defined as any single mass >5 cm in its greatest

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

during treatment and the change at the final evaluation after treatment

Safety Issue:


Principal Investigator

William Wegener, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

June 2015

Related Keywords:

  • Advanced Epithelial Cancers
  • Ovarian Cancer
  • Prostate Cancer
  • Lung Cancer
  • Breast Cancer
  • Gastric Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Hepatocellular Cancer
  • advanced epithelial cancers
  • including ovarian
  • prostate
  • lung
  • breast
  • gastric
  • colorectal
  • pancreatic
  • hepatocellular cancers
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms



MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Helen F. Graham Cancer CenterNewark, Delaware  19713
Virginia Mason Cancer CenterSeattle, Washington  98101
Weill Cornell/New York Presbyterian HospitalNew York, New York  10021
IU Health Goshen Cancer CenterGoshen, Indiana  46526