Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
← catalyst calendarNCT04617522 · readout ≤ 134 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
30estimated
Sites
15
Countries
France, Italy, Spain +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-04-06 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2020-11-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced or Metastatic Solid Tumor
- Liver Failure
Intervention
- Drug: Sacituzumab Govitecan-hziy — also filed as IMMU-132, GS-0132
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants experiencing Treatment Emergent Adverse Events (TEAEs) and Serious AEs
measured First dose date up to Day 38
Percentage of Participants Experiencing Any Dose Limiting Toxicities (DLTs)
measured Up to Day 22 (for participants receiving SG on Day 1); Up to Day 28 (for participants receiving SG on Day 8)
Percentage of Participants Experiencing Any Clinically Significant Laboratory Abnormalities
measured First dose date up to Day 38
Pharmacokinetic (PK) Parameter: Cmax of Free SN-38 and Sacituzumab Govitecan-hziy
measured Days 1 and 8
PK Parameter: AUC 0-168 of Free SN-38 and Sacituzumab Govitecan-hziy
measured Days 1 and 8
Percentage of Participants who Develop Anti-Sacituzumab Govitecan-hziy Antibodies
measured Day 1 (Predose) and Day 22
Publications
- PMID 21372224 — cited as background
- PMID 25915780 — cited as background
- PMID 28069724 — cited as background
- PMID 26101915 — cited as background
- PMID 1244564 — cited as background
- PMID 35728046 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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