Rollover Study in Subjects With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan
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|ClinicalTrials.gov Identifier: NCT04319198|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Rollover study designed to evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continued treatment with sacituzumab govitecan.
Patients currently receiving, clinically benefiting from, and tolerating sacituzumab govitecan in an Immunomedics-sponsored parent study planned for closure will be considered for enrollment.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Metastatic Cancer||Drug: Sacituzumab Govitecan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Rollover Study to Evaluate Long-Term Safety in Subjects With Metastatic Solid Tumors That Are Benefiting From Continuation of Therapy With Sacituzumab Govitecan|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2024|
Experimental: Sacituzumab Govitecan
Sacituzumab govitecan is a Trop-2-directed Antibody Drug Conjugate where the antibody, hRS7, is attached to SN-38. SN-38 is the active metabolite of irinotecan (CPT-11).
Drug: Sacituzumab Govitecan
intravenous infusion administered on Days 1 and 8 of 21-day treatment cycles
Other Name: IMMU-132
- Long-term Safety [ Time Frame: Through study completion, an average of 3 years ]Number of participants with treatment-related AEs as assessed by CTCAE v 5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319198
|Contact: Medical Informationfirstname.lastname@example.org|
|Study Director:||Trishna Goswami, MD||Immunomedics, Inc.|