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Last Updated: August 11, 2020

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CLINICAL TRIALS PROFILE FOR SACITUZUMAB GOVITECAN

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All Clinical Trials for sacituzumab govitecan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01631552 Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers Recruiting Immunomedics, Inc. Phase 1/Phase 2 2013-02-01 The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated patients with advanced epithelial cancer.The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers. The antibody, RS7, is attached to SN38, which is the active metabolite of irinotecan. This is planned as a multi-center study. In Phase II, up to 130 patients (assessable) in triple-negative breast cancer, up to 100 patients (assessable) in non-small cell and small-cell lung cancer and up to 50 patients (assessable) per other cancer types included in the protocol will be studied at the 10 mg/kg dose.
NCT02574455 Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer Not yet recruiting Immunomedics, Inc. Phase 3 2016-12-01 This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs to be selected prior to randomization from one of the 4 allowed regimens. Randomization will be stratified by number of prior chemotherapies for advanced disease (2-3 vs > 3) and geographical location (North America vs Europe). Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor progression leading to treatment withdrawal will be assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or TPC, CT scans (or MRI if contrast allergic) will be obtained at least every 8 weeks until the occurrence of progression of disease requiring discontinuation of further treatment.All patients, including those prematurely terminating study participation, will be followed every 4 weeks during the first year and every 8 weeks thereafter for survival follow-up.
NCT03547973 Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer Not yet recruiting Immunomedics, Inc. Phase 2 2018-06-15 This is an international, multi-center, open-label, phase II study in patients with metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 /PD-L1 based immunotherapy. Approximately 140 patients are anticipated to be enrolled across approximately 50 sites from North America and Europe.
NCT03725761 IMMU-132 in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy Not yet recruiting Immunomedics, Inc. Phase 2 2018-10-22 This study will investigate the safety and efficacy of IMMU-132 in patients with metastatic castration-resistant prostate cancer progressing on abiraterone or enzalutamide.
NCT03725761 IMMU-132 in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy Not yet recruiting National Cancer Institute (NCI) Phase 2 2018-10-22 This study will investigate the safety and efficacy of IMMU-132 in patients with metastatic castration-resistant prostate cancer progressing on abiraterone or enzalutamide.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for sacituzumab govitecan

Condition Name

Condition Name for sacituzumab govitecan
Intervention Trials
Invasive Breast Cancer 2
Solid Tumor 2
HER2-negative Breast Cancer 2
Breast Cancer 2
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Condition MeSH

Condition MeSH for sacituzumab govitecan
Intervention Trials
Breast Neoplasms 6
Triple Negative Breast Neoplasms 4
Glioblastoma 2
Prostatic Neoplasms 2
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Clinical Trial Locations for sacituzumab govitecan

Trials by Country

Trials by Country for sacituzumab govitecan
Location Trials
United States 20
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Trials by US State

Trials by US State for sacituzumab govitecan
Location Trials
Massachusetts 4
Texas 2
Tennessee 2
New York 2
Connecticut 2
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Clinical Trial Progress for sacituzumab govitecan

Clinical Trial Phase

Clinical Trial Phase for sacituzumab govitecan
Clinical Trial Phase Trials
Phase 3 3
Phase 2 5
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for sacituzumab govitecan
Clinical Trial Phase Trials
Not yet recruiting 10
Recruiting 2
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Clinical Trial Sponsors for sacituzumab govitecan

Sponsor Name

Sponsor Name for sacituzumab govitecan
Sponsor Trials
Immunomedics, Inc. 11
Massachusetts General Hospital 1
Pfizer 1
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Sponsor Type

Sponsor Type for sacituzumab govitecan
Sponsor Trials
Industry 14
Other 6
NIH 1
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