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

• Status: Recruiting
• Trial end date: 2026-08-03
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo
• Collaborator: AstraZeneca
• Treatments: Trastuzumab deruxtecan

Criteria

Inclusion Criteria:

• Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements.

• Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.

• No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).

Exclusion Criteria:

• Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria

• Participant who has been off T-DXd therapy for >18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study