Ireland
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Recruiting Phase 3

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

NCT06174987 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2024-01-05
Last updated
2026-10-26

Condition(s) studied

Advanced CancerMetastatic Cancer

Investigational drug(s) / intervention(s)

T-DXd →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for enrollment into the study: 1. Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition. 2. No evidence of progressive disease at screening and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s). 3. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. a. If the participant is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug. 4. Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration. 5. Female subjects must not donate, or retrieve for their own use, ova from the time of Screening, and throughout the Treatment Period in the compound-specific sub-protocol and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: 1. Participants who permanently discontinued from the study drug in the parent study. 2. Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject. 3. Local access to commercially available drug at no cost to the subject as permitted by local/country regulation.

Primary outcome measure(s)

  • 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 sites (34)

FacilityCityRegionStatus
Research Facility Miami Florida Active Not Recruiting
Research Facility Durham North Carolina Active Not Recruiting
Research Facility Bedford Park Australia Active Not Recruiting
Research Facility Itajaí Brazil Active Not Recruiting
Research Facility Rio de Janeiro Brazil Active Not Recruiting
Research Facility São Paulo Brazil Active Not Recruiting
Research Facility Changchun China Active Not Recruiting
Research Facility Harbin China Active Not Recruiting
Research Facility Hefei China Recruiting
Research Facility Lille France Active Not Recruiting
Research Facility Marseille France Active Not Recruiting
Research Facility Toulouse France Active Not Recruiting
Research Facility Villejuif France Active Not Recruiting
Research Facility Hong Kong Hong Kong Active Not Recruiting
Research Facility Petah Tikva Israel Active Not Recruiting
Research Facility Aviano Italy Active Not Recruiting
Research Facility Milan Italy Active Not Recruiting
Research Facility Rozzano Italy Active Not Recruiting
Research Facility Chūōku Japan Active Not Recruiting
Research Facility Kashiwa-shi Japan Active Not Recruiting
Research Facility Daegu South Korea Active Not Recruiting
Research Facility Goyang-si South Korea Active Not Recruiting
Research Facility Seoul South Korea Active Not Recruiting
Research Facility A Coruña Spain Active Not Recruiting
Research Facility Barcelona Spain Active Not Recruiting
Research Facility Madrid Spain Active Not Recruiting
Research Facility Tainan Taiwan Active Not Recruiting
Research Facility Taipei Taiwan Active Not Recruiting
Research Facility Adana Turkey (Türkiye) Active Not Recruiting
Research Facility Ankara Turkey (Türkiye) Active Not Recruiting
Research Facility Antalya Turkey (Türkiye) Active Not Recruiting
Research Facility Diyarbakır Turkey (Türkiye) Active Not Recruiting
Research Facility Istanbul Turkey (Türkiye) Active Not Recruiting
Research Facility Tekirdağ Turkey (Türkiye) Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06174987 on ClinicalTrials.gov ↗ ← All trials in the USA