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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Advanced Cancer
• Intervention / Treatment: Drug: T-DXd

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Daiichi Sankyo Contact for Clinical Trial Information; Phone Number: 908-992-6400; Email: CTRinfo@dsi.com

Study Locations

• Australia
  • Bedford Park, Australia, 5042
    • Active, not recruiting
    • Flinders Medical Center
  • Melbourne, Australia, 3168
    • Withdrawn
    • Monash Medical Center
• Belgium
  • Charleroi, Belgium, 6000
    • Recruiting
    • Grand Hopital De Charleroi
• Brazil
  • Rio de Janeiro, Brazil
    • Not yet recruiting
    • Instituto Aericas
  • São Paulo, Brazil
    • Not yet recruiting
    • A.C. Camargo Câncer Center
  • São Paulo, Brazil
    • Not yet recruiting
    • IBCC Nucleo de Pequisa e Ensino
• France
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Israel
  • Petah Tikva, Israel
    • Active, not recruiting
    • Rabin Medical Center
• Italy
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Napoli, Italy, 80131
    • Withdrawn
    • Istituto Nazionale Tumori Fondazione G. Pascale
• Japan
  • Chūō, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital
• South Korea
  • Daegu, South Korea, 41404
    • Recruiting
    • Kyungpook National University Chilgok Hospital
  • Gyeonggi-do, South Korea, 10408
    • Recruiting
    • National Cancer Center
  • Gyeonggi-do, South Korea, 13620
    • Withdrawn
    • Seoul National University Bundang Hospital
  • Jongno-gu, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital, Yonsei University
• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Distrito de Les Corts, Spain, 08028
    • Not yet recruiting
    • Hospital Universitari Dexeus
  • L'Hospitalet de Llobregat, Spain, 08908
    • Recruiting
    • ICO l'Hospitalet - Hospital Duran i Reynals
  • Madrid, Spain, 28034
    • Withdrawn
    • Hospital Ruber Internacional
• Taiwan
  • Tainan City, Taiwan, 704
    • Withdrawn
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • Withdrawn
    • National Taiwan University Hospital
• United Kingdom
  • Guildford, United Kingdom, GU2 7XX
    • Withdrawn
    • Royal Surrey County Hospital
• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Cancer Institute
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University - Trent Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: T-DXd; T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens; Other Names: DS8201a

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Collaborators: AstraZeneca
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): January 17, 2028

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Advanced cancer; Metastatic cancer; T-DXd; DS8201a
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; trastuzumab deruxtecan
• Other Study ID Numbers: ROMast-001; 2023-506330-73-00 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No