Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
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