Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers

This is a Phase I/II, open-label study of IMMU-132 in previously treated patients with
advanced epithelial cancers. Patients receive IMMU-132 administered once-weekly for the first
2 weeks of 3-week treatment cycles. Treatment cycles 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 cancer of one of the following
types:

- Gastric adenocarcinoma (GC)

- Esophageal cancer (EC)

- Hepatocellular carcinoma (HCC)

- Non-small-cell lung cancer (NSCLC)

- Small-cell lung cancer (SCLC)

- Epithelial ovarian cancer (EOC)

- Cervical Cancer

- Endometrial Cancer

- Triple-negative breast cancer [With Amendment 10, these patients need to have
unequivocal TNBC histology (ER-/PR-/HER2-) per ASCO/CAP guidelines, based on most
recently analyzed biopsy, and must have had at least 2 prior therapies for metastatic
disease, including prior taxane (any setting). Chemotherapy, biological or targeted or
immunotherapy agents will count as qualifying prior therapies, but not hormonal or
anti-HER2 agents (either given prior to achieving triple negative status or for any
other reason).]

- Non-triple-negative breast cancer

- Follicular thyroid cancer

- Glioblastoma multiforme (GBM)

- Hormone-refractory prostate cancer (HRPC)

- Head and neck cancers- squamous cell (SCCHN)

- Renal cell cancer (clear cell) (RCC)

- Urothelial 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 (except for patients with GBM).

- Refractory to or relapsed after at least one prior standard therapeutic regimen

- Adequate performance status (ECOG 0 or 1)

- Expected survival ≥ 6 months.

- Measurable disease by CT or MRI.

- At least 2 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 > 100,000 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.

- Patients with brain metastases can be enrolled only if treated, non-progressive brain
metastases and off high-dose steroids (>20 mg prednisone or equivalent) for at least 4
weeks.

- 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.

- 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.