Phase I Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients with Epithelial Cancer
Open to Enrollment
This clinical research trial is for men and women with 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 may also be used. These treatments may slow the cancer for some people, but the cancer will continue to progress in many people.
This research study is evaluating a new, experimental therapy called IMMU-132. IMU-132 is composed of a drug attached to an antibody. The drug is the active ingredient irinotecan, which has shown activity in epithelial cancers. Antibodies are proteins that bind to substances that don’t belong in the body. The antibody used in this study was designed to bind to epithelial cancer tumors.
The purpose of the study is to evaluate the safety of IMU-132 at different dose levels. The study will also investigate the effects of IMMU-132 on advanced epithelial cancer.
Study participants will receive IMU-132 via infusion in 3-week treatment cycles: treatment once a week for 2 consecutive weeks with a 1 week rest period. If the drug is tolerated well without major side effects, participants will repeat the treatment schedule for up to 8 cycles, or 24 weeks. After completing the last dose of IMMU-132, participants will be followed every 3 months for up to 2 years.
Disease Status and/or Stage
Metastatic Epithelial Cancer
- Men and women, age 18 and older
- Diagnosed with epithelial cancer of one of the following types:
- Colorectal cancer
- Gastric cancer
- Hepatocellular (liver) cancer
- Non-small cell lung cancer
- Ovarian epithelial cancer
- Triple-negative breast cancer
- Hormone-refractory prostate cancer
- Pancreatic ductal adenocarcinoma (pancreatic cancer)
- Stage IV (metastatic disease)
- Refractory to or relapsed after at least 1 prior standard therapeutic regimen
- Detailed eligibility reviewed when you contact the study team
- Alice Mercado, RN
- (646) 962-3080
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