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

Phase 3

Recruiting

• Conditions: Advanced Cancer; Metastatic Cancer
• Interventions: Drug: T-DXd

• Registration Number: NCT06174987
• Lead Sponsor: Daiichi Sankyo

Brief 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.

Study Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Study Start: 2024-01-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-08-03
• Study Completion: 2026-08-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T-DXd	T-DXd	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (28)

Miami Cancer Institute; 🇺🇸 Miami, Florida, United States

Duke University - Trent Center; 🇺🇸 Durham, North Carolina, United States

Flinders Medical Center; 🇦🇺 Bedford Park, Australia

Monash Medical Center; 🇦🇺 Melbourne, Australia

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Belgium

Instituto Aericas; 🇧🇷 Rio de Janeiro, Brazil

A.C. Camargo Cancer Center; 🇧🇷 Sao Paulo, Brazil

IBCC Nucleo de Pequisa e Ensino; 🇧🇷 Sao Paulo, Brazil

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

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