This study is accepting new patients by invitation only

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

a study on Solid Tumor Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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 that has spread) urothelial cancer (mUC).

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

Details

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.

Keywords

Metastatic Solid Tumor, ADC, Antibody-Drug Conjugate, Trop-2, SN-38, Neoplasms, Sacituzumab govitecan, Sacituzumab Govitecan-hiy, Sacituzumab Govitecan-hziy

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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.

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • Rocky Mountain Cancer Center
    Aurora Colorado 80012 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT04319198
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated