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Completed Phase 1Phase 2 Interventional Results available

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer

ClinicalTrials.gov ID: NCT01631552

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.

ClinicalTrials.gov public records Last synced Nov 7, 2026, 1:38 PM EST

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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
Lead sponsor
Gilead Sciences
Industry
Enrollment
515 participants

Conditions and interventions

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 17, 2012 (Actual)
Primary completion
Mar 1, 2019 (Actual)
Completion
Aug 13, 2020 (Actual)
Last update posted
Aug 12, 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 12, 2021 · Synced Nov 7, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01631552 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →