Trials / Active Not Recruiting
Active Not RecruitingNCT05101096
Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
A Phase 1/2 Open-Label Study of Sacituzumab Govitecan in Japanese Patients With Advanced Solid Tumors (ASCENT-J02)
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose (RP2D) of SG in Japanese participants with advance solid tumors. Phase 2: Evaluate the safety and efficacy of SG in Japanese participants with metastatic triple-negative breast cancer (mTNBC), hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC), and metastatic urothelial cancer (mUC).
Conditions
- Advanced Solid Tumor
- Metastatic Triple-Negative Breast Cancer
- HR+/HER2- Metastatic Breast Cancer
- Metastatic Urothelial Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sacituzumab Govitecan-hziy | Administered intravenously (IV) |
Timeline
- Start date
- 2021-10-20
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2021-11-01
- Last updated
- 2025-03-25
Locations
36 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05101096. Inclusion in this directory is not an endorsement.