Recruiting
Phase 3

Observational Study

Sponsor:

Daiichi Sankyo

Code:

NCT06174987

Conditions

Advanced Cancer

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

T-DXd

Study Details

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).

Conditions

Advanced Cancer

Metastatic Cancer

Study ID

NCT06174987

Start date

Jan 5, 2024

Status verified date

Oct, 2025

Completion date

Jan 17, 2028

Anticipated

Primary completion date

Aug 3, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • 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) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Daiichi Sankyo Contact for Clinical Trial Information

908-992-6400CTRinfo@dsi.com

Locations

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Duke University - Trent Center

Recruiting

Durham, North Carolina, United States, 27710

More Information

Sponsor

Daiichi Sankyo

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Keywords

  • Advanced cancer
  • Metastatic cancer
  • T-DXd
  • DS8201a

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Daiichi Sankyo on 2025-10-15.