This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors.
Adults ≥18 years or the minimum legal adult age (whichever is greater).
a) Disease State: If HER2 status is required for eligibility (for all populations), a documented HER2 test result must be available.
the metastatic setting, or
the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. HR-, HER2-low BC: have received a prior systemic cytotoxic therapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing (neo)adjuvant chemotherapy. HR+, HER2-low/ultralow BC: have received previous ET AND an additional line of ET must not be the next line of treatment considered in the participant's best interest.
None
Daiichi Sankyo
Lead sponsor
AstraZeneca
Collaborator