OncRef

Clinical Trial: NCT05101096

Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Gilead Sciences
Information Provided By:Gilead Sciences
Last Update Posted:2026-07-10

Study Overview

Brief 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).

Official Title

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

Conditions

Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer, HR+/HER2- Metastatic Breast Cancer, Metastatic Urothelial Cancer

Intervention / Treatment

  • Drug: Sacituzumab Govitecan-hziy

Other Study ID Numbers

  • GS-US-569-6172
  • jRCT2031210346

Start Date (Actual)

2021-10-20

Primary Completion Date (Estimated)

2027-05

Study Completion Date (Estimated)

2027-05

Enrollment (Actual)

135

Study Type

Interventional

Phase

Phase 1, Phase 2