NCT05394675

A Study of DS-9606a in Patients With Advanced Solid Tumors

A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.

Detailed description

This is a first-in-human, phase 1, dose escalation study of the anti-CLDN6 ADC, DS-9606a, given as a single agent to patients with solid tumors. The primary objectives are to investigate the safety and tolerability of DS-9606a and to determine the maximum tolerated dose (MTD) and recommended doses for expansion (RDE/RDEs) in advanced solid tumors. The secondary objectives of the study are to assess the pharmacokinetic properties and immunogenicity of DS-9606a, investigate the objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR) and progression free survival (PFS) of DS-9606a, according to RECIST v1.1.

Conditions

• Advanced Cancer
• Metastatic Cancer
• Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	DS-9606a	Intravenous infusion

Timeline

• Start date: 2022-05-31
• Primary completion: 2026-02-06
• Completion: 2026-02-06
• First posted: 2022-05-27
• Last updated: 2026-03-20

Locations

7 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study