2026-09-02
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 152 → 186 locations
2026-08-03
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 109 → 152 locations
2026-07-08
minor
Study Status, Contacts/Locations v6
Trial sites expanded: 55 → 109 locations
2026-06-08
minor
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations, References v5
Trial sites expanded: 4 → 55 locations
Start dateestimated 2026-06-01→confirmed 2026-05-21
Eligibility criteria+65 characters
[...] C) with confirmed HER2-positive status by central laboratory.
Measurable disease only as per by RECIST v1.1/RANO-BM in stage 1.
Non-measurable disease allowed in stage 2.
Prev [...] ously untreated CNS metastases, or leptomeningeal metastases.
At least one prior line of anti-HER2-based therapy for LAI or metastatic disease.
Prior anti-HER2 antibody-drug conjugate (ADC), such as tras [...] b emtansine (T-DM1), in any treatment setting.
Participants for whomwithout prior ADC therapy wasmay only be enrolled if approved standard-of-care (SOC) anti-HER2 ADC is not appropriatelocally (e.g.accessible at screening, [...]
Secondary endpointsdetails revised at 4 of 20 entries
2026-05-08
notable
Study Status, Contacts/Locations v4
Recruitment opened
Trial sites expanded: 0 → 4 locations
Primary completion pushed: 2029-03-30 → 2029-05-01
Completion pushed: 2032-08-28 → 2032-09-29
Start date2026-04-30→2026-06-01
2026-04-08
minor
3 amendments v1-v3
3 re-verifications since 2026-02-26, no change to tracked fields
2026-02-10
minor
Original filing