100
Participants
Start Date
September 30, 2025
Primary Completion Date
February 2, 2028
Study Completion Date
February 2, 2028
Dato-DXd
All participants will receive Dato-DXd (6 mg/kg IV on Day 1, Q3W; up to a maximum of 540 mg Q3W for participants ≥ 90 kg) until investigator-defined disease progression according to RECIST 1.1 or until unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met. Continued treatment with the same study drug post-progression may be allowed, based on prior discussion with sponsor/sponsor representative/study physician on a case-by-case basis following written investigator's confirmation of continuing clinical benefit to the patient post progression. The study is anticipated to enrol for an 18-month period, and DCO is expected to occur approximately 6 months after the last participant has been dosed.
Research Site, Seoul
Research Site, Seoul
Research Site, New York
Research Site, A Coruña
Research Site, Granada
Research Site, Milan
Research Site, Madrid
Research Site, Madrid
Research Site, Aviano
Research Site, Largo
Research Site, Montpellier
Research Site, Seville
Research Site, Bukgu
Research Site, Valencia
Research Site, Fort Wayne
Research Site, Meldola
Research Site, Florence
Research Site, Clermont-Ferrand
Research Site, Pierre-Bénite
Research Site, Paris
Research Site, Houston
Research Site, Napoli
Research Site, La Roche-sur-Yon
Research Site, Puyallup
Research Site, Seoul
Research Site, Shandong
Research Site, Linyi
Research Site, Changsha
Research Site, Wuhan
Research Site, Zhengzhou
Research Site, Guangzhou
Research Site, Roma
Research Site, Goyang-si
Research Site, Seoul
Research Site, Seoul
Research Site, Seoul
Research Site, Barcelona
Lead Sponsor
Collaborators (1)
Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY