A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumor

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorDaiichi Sankyo

About this trial

This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.

Eligibility criteria

Qualifiers

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

Disqualifiers

Has had prior treatment with an anti-CD47 or anti-signal regulatory protein α (SIRPα) therapy.

Has an inadequate treatment washout period prior to start of study treatment as specified in the protocol

Medical history of myocardial infarction (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class II to IV

Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to >470 ms (females) or >450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)