Clinical Trial VICCPHI1394
A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients with Epithelial Cancer
- Protocol No. VICCPHI1394
- Open Date: 04/17/2014
- Staging: Phase I/II
- Age Group: Adults
- Scope: National
- Objective: 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.
- Disease Sites: Breast; Phase I; Prostate; Ovarian; Pancreatic; Colon; Rectal; Lung
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: IMMU-132
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01631552
- Secondary Protocol No: IMMU-132-01
Patients are being asked to take part in this research study because they have some form of epithelial cancer. Standard treatments for epithelial cancers involving the stomach, ovaries, pancreas, large intestines and rectum, lung, breast, prostate and liver may use forms of chemotherapy. In some cases, external radiation therapy may be used as well. These treatments may slow the cancer for some patients, but the cancer will continue to worsen for many patients. Patients are being invited to take part in a research study to test an investigational drug called IMMU-132. This is the first study to use IMMU-132 in humans. IMMU-132 is composed of a drug attached to an antibody. The drug is the active ingredient in irinotecan, which has shown activity in epithelial cancers. Antibodies are proteins normally made by the immune system. They bind to substances that don-t belong in the body to prevent harm to the body. The antibody in this study was designed to bind to epithelial cancer tumors. The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies. This study will investigate how IMMU-132 acts for the treatment of epithelial cancers. The study is mainly being done to see if IMMU-132 is safe. The purpose of this study is to test the safety of IMMU-132 at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their advanced epithelial cancer. In the early part of the study, patients in groups of about 3-6 patients at different study sites will receive increasingly higher doses of IMMU-132. This will identify the highest dose of the IMMU-132 study drug that does not cause unacceptable side effects, known as the Maximum Tolerated Dose (MTD). Later in the study, groups of patients with specific cancers will be enrolled to further study the MTD.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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:
• 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.
-•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.