A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Cancer,Metastatic Cancer
Age
18+
Phase
PHASE3
Participants Needed
50
Est. Completion Date
Aug 3, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Daiichi Sankyo
ClinicalTrials.gov NCT Identifier
NCT06174987
Study Number
ROMast-001
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