Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy

Phase 4

Completed

Brief Summary: The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and how safe it is in participants with metastatic cancer (cancer that has spread).

Detailed Description: This is a rollover study. Only participants who continue to receive clinical benefit from continuation of SG therapy and are tolerating therapy at the time of enrollment are eligible for this study. Participants enrolled may continue to receive SG at the dose that they were receiving in the Gilead parent study at the time of consenting to participate in this rollover study.

Recruitment & Eligibility

Inclusion Criteria

Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study.
Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy.

Key

Exclusion Criteria

Females who are pregnant or lactating.
Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the parent study in which they participated.
Experienced a toxicity from sacituzumab govitecan-hziy that resulted in permanent discontinuation of therapy.
Have 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)	Sacituzumab Govitecan-hiy	All participants who previously received SG in the parent study (IMMU-132-01) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)	Sacituzumab Govitecan-hiy	All participants who previously received SG in the parent study (IMMU-132-05) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.
Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)	Sacituzumab Govitecan-hiy	All participants who previously received SG in the parent study (IMMU-132-15) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Any Adverse Events	First dose date up to 30 days post last dose (Up to 3.9 years)	An adverse event was defined as any untoward medical occurrence in a participant administered a medicinal product that does not necessarily have a causal relationship with this treatment.
Percentage of Participants Experiencing Any Serious Adverse Events	First dose date up to 30 days post last dose (Up to 3.9 years)	A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, was fatal (resulting in death), was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities	First dose date up to 30 days post last dose (Up to 3.9 years)	The percentage of participants experiencing any clinically significant laboratory abnormality was summarized.

Secondary Outcome Measures

Name	Time	Method

Locations (21): University of California San Francisco
🇺🇸
San Francisco, California, United States
Rocky Mountain Cancer Center
🇺🇸
Aurora, Colorado, United States
Christiana Care Health Services, Christiana Hospital
🇺🇸
Newark, Delaware, United States
Florida Cancer Specialists & Research Institute
🇺🇸
Fort Myers, Florida, United States
Baptist Health - Miami Cancer Institute
🇺🇸
Miami, Florida, United States
Illinois Cancer Specialists
🇺🇸
Arlington Heights, Illinois, United States
University of Chicago
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Chicago, Illinois, United States
University of MD Greenebaum Comprehensive Cancer Center
🇺🇸
Baltimore, Maryland, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
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University of California San Francisco
🇺🇸San Francisco, California, United States