Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
Public ClinicalTrials.gov record NCT01631552. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I. Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).
Study identification
- NCT ID
- NCT01631552
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 515 participants
Conditions and interventions
Conditions
- Gastric Adenocarcinoma
- Esophageal Cancer
- Hepatocellular Carcinoma
- Non-small Cell Lung Cancer
- Small Cell Lung Cancer
- Ovarian Epithelial Cancer
- Carcinoma Breast Stage IV
- Hormone-refractory Prostate Cancer
- Head and Neck Cancers- Squamous Cell
- Renal Cell Cancer
- Urinary Bladder Neoplasms
- Cervical Cancer
- Endometrial Cancer
- Glioblastoma Multiforme
- Triple Negative Breast Cancer
- Pancreatic Cancer
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 16, 2012
- Primary completion
- Feb 28, 2019
- Completion
- Aug 12, 2020
- Last update posted
- Aug 11, 2021
2012 – 2020
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 080045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | — |
| Helen F. Graham Cancer Center | Newark | Delaware | 19713 | — |
| MD Anderson Cancer Center Orlando (UF Health Cancer Center) | Orlando | Florida | 32806 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| IU Health Goshen Cancer Center | Goshen | Indiana | 46526 | — |
| Massachusettes General Hospital | Boston | Massachusetts | 02114 | — |
| Weill Cornell/New York Presbyterian Hospital | New York | New York | 10021 | — |
| Columbia University Herbert Irving Cancer Center | New York | New York | 10032 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37212 | — |
| Texas Oncology Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Virginia Mason Cancer Center | Seattle | Washington | 98111 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01631552, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2021 · Synced Sep 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01631552 live on ClinicalTrials.gov.