Phase 4
Completed N=25
Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy
Source: ClinicalTrials.gov NCT04319198 ↗Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Sep 2025
Primary outcomePrimary: Percentage of Participants Experiencing Any Adverse Events — 66.7; 100.0; 91.7 percentage of participants
◆ Published Evidence
Emerging
6citations · ~2 / year
Sacituzumab Govitecan-hziy in Breast Cancer.
Summary
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and how safe it is in participants with metastatic cancer (cancer that has spread).
Linked Publications
-
Sacituzumab Govitecan-hziy in Breast Cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Any Adverse Events |
66.7; 100.0; 91.7 | — |
| PRIMARY Percentage of Participants Experiencing Any Serious Adverse Events |
0; 40.0; 8.3 | — |
| PRIMARY Percentage of Participants Experiencing Any Grade and Grade 3 or 4 Laboratory Abnormalities |
100.0; 88.9; 81.8; 33.3; 44.4; 72.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04319198) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.