Daiichi Sankyo
This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.
DS-1103a, a recombinant humanized IgG4 anti-SIRPα antibody designed to block the SIRPα-CD47 interaction, is being developed for the treatment of advanced cancers in combination with other anticancer therapies. This is the first-in-human, dose-escalation and dose-expansion clinical study designed to assess the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.
Inclusion Criteria: * Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures * Adults ≥18 years of age at the time the ICF is signed (please follow local regulatory requirements if the legal age of consent for study participation is \>18 years old) * Pathologically documented HER2-expressing or HER2-mutated (activating mutation) solid tumor that is unresectable or metastatic * Is willing and able to provide tumor tissue * Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per…
One IV infusion Q3W on Day 1 of each 21-day cycle
One IV infusion Q3W on Day 1 of each 21-day cycle