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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Cancer, Metastatic Cancer

Intervention / Treatment
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* Drug: T-DXd


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-DXd<br>Participants who choose to continue treatment with T-DXd may be enrolled. Participants who were on the comparator arm in the parent study will be provided the option to access the drug through standard of care (SoC) or other available options. Participants will remain on their current dosage regimen of T-DXd as the last dose administered in the parent study, unless they experience an AE that requires dose reduction at the EOT of the parent study, in which case the starting dose in this study will be the next lower dose-level. | Drug: T-DXd<br>* T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens<br>* Other names: DS8201a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Treatment-emergent Adverse Events Leading to Study Drug discontinuation and/or Dose Reduction, Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (AESIs) |  | Baseline until disease progression, loss of clinical benefit, death, adverse event, pregnancy, withdrawal of consent, access to commercial supply, physician decision, or study closure, whichever occurs first, up to approximately 2 years 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced cancer, Metastatic cancer, T-DXd, DS8201a