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Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors — ASCENT-J02  

Advanced Solid Tumor Clinical Trial

Official title:
A Phase 1/2 Open-Label Study of Sacituzumab Govitecan in Japanese Patients With Advanced Solid Tumors (ASCENT-J02)

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05101096
Study type Interventional
Source Gilead Sciences
Contact Gilead Clinical Study Information Center
Phone 1-833-445-3230 (GILEAD-0)
Email GileadClinicalTrials@gilead.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 20, 2021
Completion date May 2026
View Details
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