Summary

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

Description

Summary

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.

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 an open-label, longitudinal cohort, rollover study. Eligible participants will receive sacituzumab govitecan therapy at the dose they were receiving in the parent study. No participant will receive more than 10 mg/kg dose of sacituzumab govitecan. Treatment with sacituzumab govitecan will be uninterrupted as eligible participants rollover/transition from the parent study to the rollover study. Participants may continue to receive sacituzumab govitecan until they experience toxicity, disease progression, loss of clinical benefit, lost to follow-up, or upon participant withdrawal of consent or Sponsor termination of the study.

Keywords

Solid Tumor Metastatic Cancer Sacituzumab Govitecan IMMU-132 ADC Antibody-Drug Conjugate Trop-2 SN-38 Neoplasm Metastasis

Eligibility

You can join if…

Open to people ages 18 years and up

  • Receiving ongoing treatment with sacituzumab govitecan in an Immunomedics-sponsored study that is closing
  • Continuing to receive clinical benefit from sacituzumab govitecan therapy

You CAN'T join if...

  • Women who are pregnant or lactating
  • Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the Immunomedics-sponsored study in which they participated
  • Experienced a toxicity from sacituzumab govitecan 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.

Locations

  • University of California, San Francisco Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94158 United States
  • Rocky Mountain Cancer Centers
    Aurora Colorado 80012 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Immunomedics, Inc.
ID
NCT04319198
Phase
Phase 3
Study Type
Interventional
Last Updated