Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
← catalyst calendarNCT05101096 · readout ≤ 284 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
135actual
Sites
36
Country
Japan
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 | 2021-10-20 | actual | When the study began enrolling |
| Primary completion | May 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Solid Tumor
- Metastatic Triple-Negative Breast Cancer
- HR+/HER2- Metastatic Breast Cancer
- Metastatic Urothelial Cancer
Intervention
- Drug: Sacituzumab Govitecan-hziy — also filed as IMMU-132, Trodelvy™, GS-0132
Primary outcomes
what the primary-completion date above is the date OFPhase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
measured First dose date to last dose date (Up to 15 weeks) plus 30 days
Phase 1: Percentage of Participants Experiencing Laboratory Abnormalities Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
measured First dose date to last dose date (Up to 15 weeks) plus 30 days
Phase 1: Percentage of Participants Experiencing Dose-limiting toxicity (DLTs) per Dose level
measured First dose date up to 21 days
Phase 2:(Metastatic Triple-negative Breast Cancer (mTNBC);Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Metastatic Breast Cancer (HR+/HER2- mBC) Cohorts):Objective Response Rate (ORR) as Assessed by IRC
measured Up to 17 months
Phase 2 (Metastatic Urothelial Cancer (mUC) Cohort): ORR as Assessed by Investigator
measured Up to 17 months
Publications
- PMID 39302614 — 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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