NCT04707248

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

R-DXd is an antibody drug conjugate that specifically binds to CDH6 on the cell surface of target cells, which leads to the internalization of R-DXd into the cells. MAAA-1181a that is released from R-DXd in the target cells inhibits cell replication and induces cell apoptosis. This study will evaluate R-DXd given as a single agent once every 21 days. The dose escalation phase will enroll participants with OVC and RCC, and is designed to assess the safety and tolerability of R-DXd and to determine the maximum tolerated dose (MTD)/recommended dose for expansion (RDE). Following the selection of the RDE, the dose expansion phase will be initiated to evaluate clinical activity of R-DXd.

Conditions

• Renal Cell Carcinoma
• Ovarian Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-22
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2021-01-13
• Last updated: 2025-07-28

Locations

13 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study