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



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Women's Studies, Gastrointestinal, Endometrial Cancer, Pancreatic Cancer, Bladder Cancer, Thyroid Cancer
Therapuetic Areas:Gastroenterology, Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:12/1/2018
Start Date:February 2013
End Date:September 2019

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A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers

The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single
agent administered in 3-week treatment cycles until unacceptable progression or toxicity, in
previously treated patients with advanced epithelial cancer. In Phase II, the primary
objective is the evaluation of the safety and efficacy of IMMU-132 administered in 3-week
treatment cycles at a dose selected in Phase I, while the secondary objectives include
pharmacokinetics and immunogenicity.

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.
We found this trial at
12
sites
Dallas, Texas 75246
Principal Investigator: JOYCE O'SHAUGHNESSY, MD
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Jordan Berlin, MD
Phone: 615-936-5621
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
Principal Investigator: Wells Messersmith, MD
Phone: 720-848-0600
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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Aurora, CO
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Boston, Massachusetts 02114
Principal Investigator: Aditya Bardia, MD
Phone: 617-724-4000
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Boston, MA
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Goshen, Indiana 46526
Principal Investigator: Alexander Starodub, MD
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Goshen, IN
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: ALESSANDRO SANTIN, MD, PHD
Phone: 203-785-6398
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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New York, New York 10002
Principal Investigator: Allyson Ocean, MD
Phone: 646-962-9349
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New York, New York 10032
Principal Investigator: KEVIN KALINSKY, MD,PHD
Phone: 212-304-5601
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New York, NY
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Newark, Delaware 19713
Principal Investigator: Michael Guarino, MD
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Newark, DE
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Orlando, Florida 32806
Principal Investigator: REBECCA MOROOSE, MD
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Orlando, FL
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Seattle, Washington 98111
Principal Investigator: Vincent Picozzi, MD
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Tampa, Florida 33612
Principal Investigator: Jhanelle Gray, MD
Phone: 813-745-8350
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