A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
NCT06174987 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-10-15
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).
Conditions
Interventions
- DRUG
-
T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Global Clinical Leader · Daiichi Sankyo
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-05
- Primary Completion
- 2026-08-03
- Completion
- 2028-01-17
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Brazil
- France
- Israel
- Italy
- Japan
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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