This is a dose escalation, and dose expansion study of T-DXd plus hyaluronidase administered subcutaneously, to assess the safety, tolerability, PK and efficacy of SC T-DXd plus hyaluronidase in participants with metastatic solid tumors.
Sign and date the ICF, prior to the start of any trial- specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater).
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.
At least 1 year has elapsed since last dose of exatecan derivative ADC.
The participant did not discontinue nor reduce the dose due to toxicity.
The participant did not experience any drug-related Grade 3/4 toxicity.
The participant did not experience ILD of any grade while on or after the exatecan derivative ADC treatment.
Daiichi Sankyo
Lead sponsor
AstraZeneca
Collaborator