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ACTIVE NOT RECRUITING
NCT04707248
PHASE1

A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This clinical trial will evaluate raludotatug deruxtecan (R-DXd; DS-6000a) in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main goals of this study will be to investigate the recommended dose of R-DXd that can be given safely to participants, assess the adverse events of R-DXd, and evaluate the effectiveness of R-DXd.

Official title: Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

179

Start Date

2020-12-22

Completion Date

2026-06-30

Last Updated

2025-07-28

Healthy Volunteers

No

Interventions

DRUG

DS-6000a

Intravenous administration at doses starting at 1.6 mg/kg on Day 1 of Cycle 1

DRUG

DS-6000a

Intravenous administration at RDE on Day 1 of Cycle 1

Locations (13)

Arizona Oncology Associates, PC HOPE (A)A HOPE)

Tucson, Arizona, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Florida Cancer Lake Mary

Lake Mary, Florida, United States

Oklahoma University

Oklahoma City, Oklahoma, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

National Cancer Center Hospital East

Kashiwa-shi, Tokyo, Japan

National Hospital Organization Kyusyu Cancer Center

Fukuoka, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Kōtoku, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

Shizuoka Cancer Center

Nakatogari, Japan

Saitama Medical University International Medical Center

Saitama, Japan