NCT06174987

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

Detailed description

This Master Rollover Study includes sub-protocols with different study drugs. This Master Rollover Protocol describes core study elements that are applicable to all study drugs that will be provided under the Rollover Study.

Conditions

• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	T-DXd	T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens

Timeline

• Start date: 2024-01-05
• Primary completion: 2026-08-03
• Completion: 2028-01-17
• First posted: 2023-12-18
• Last updated: 2025-10-15

Locations

28 sites across 12 countries: United States, Australia, Belgium, Brazil, France, Israel, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study