Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy
- Interventional
- Recruiting
- NCT04319198
Contact Information
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
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 that has spread) urothelial cancer (mUC).
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.
- Metastatic Cancer
- Solid Tumors