Ph I Dose Escalation Study of Antibody-drug Conjugate IMMU-132 in Patients With Advanced Epithelial Cancers

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 period.
• Patients with Gilbert's disease.
• Known CNS metastatic disease.
• Presence of bulky disease (defined as any single mass >5 cm in its greatest dimension).
• 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.