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

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, 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 sacituzumab govitecan-hziy therapy and are tolerating therapy at the time of enrollment are eligible for this study. Participants enrolled may continue to receive sacituzumab govitecan-hziy at the dose that they were receiving in the Gilead parent study at the time of consenting to participate in this rollover study.

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

Conditions
-----------------
Metastatic Solid Tumor

Intervention / Treatment
-----------------
* Drug: Sacituzumab Govitecan-hiy


Participation Criteria
=================
Eligibility Criteria
-----------------
Key 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacituzumab Govitecan-hziy<br>Participants will receive sacituzumab govitecan-hziy at the dose that they were receiving in the parent study until they experience toxicity, disease progression, loss of clinical benefit, withdrawal of consent, lost to follow-up, or Sponsor termination of the study is documented. Participants who continued to receive sacituzumab govitecan-hziy in the Gilead sponsored parent study after disease progression (PD), may continue to receive sacituzumab govitecan-hziy until there is no clinical benefit as determined by the treating physician. No participant will receive more than 10 mg/kg dose of sacituzumab govitecan-hziy. | Drug: Sacituzumab Govitecan-hiy<br>* Administered intravenously<br>* Other names: GS-0132;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing any Adverse Events |  | First dose date up to last dose date plus 30 days (approximately 3 years) | 
| Percentage of Participants Experiencing any Serious Adverse Events |  | First dose date up to last dose date plus 30 days (approximately 3 years) | 
| Percentage of Participants Experiencing Laboratory Abnormalities | The percentage of participants experiencing any clinically significant laboratory abnormality will be summarized. | First dose date up to last dose date plus 30 days (approximately 3 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADC, Antibody-Drug Conjugate, Trop-2, SN-38