Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers
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 - Cervical Cancer - Endometrial Cancer
Conditions: official terms
Adenocarcinoma - 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 - Urinary Bladder Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
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
Study Type
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: IMMU-132
Type: Drug
Overall Status
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 50 evaluable patients per select cancer types will be studied at up to 2 dose levels at or below the maximum acceptable dose determined in Phase I.
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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:

- 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)

- 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.

- 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 4 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 > 150,000 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.

- Known (prior and current) CNS metastatic disease. Patients who have received adequate treatment for CNS metastases and who have been disease/symptom free with no evidence of progression for at least 3 months may be considered for enrollment after discussion and approval with the medical monitor.

- 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.

- Patients with a 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.
University of Colorado Anschutz Medical Campus
Auora, Colorado, United States
Status: Recruiting
Contact: Jamie Bendrick-Peart, MSc - 720-848-0600 -
Helen F. Graham Cancer Center
Newark, Delaware, United States
Status: Recruiting
Contact: Kathy Combs, RN -
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
Status: Recruiting
Contact: Kristine Moore, RN -
IU Health Goshen Cancer Center
Goshen, Indiana, United States
Status: Recruiting
Contact: Tracy Thorne, RN -
Massachusettes General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Dennise Greensmith - 617-724-0695 -
Weill Cornell/New York Presbyterian Hospital
New York, New York, United States
Status: Recruiting
Contact: Romae Palmer - 646-962-9349 -
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Pamela Williams, RN - 615-936-5621 -
Virginia Mason Cancer Center
Seattle, Washington, United States
Status: Recruiting
Contact: Ann Chancellor, RN -
Start Date
February 2013
Completion Date
June 2015
Immunomedics, Inc.
Immunomedics, Inc.
Record processing date processed this data on July 28, 2015 page