A Study of DS3610a in Participants With Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
Sign and date the main ICF, prior to the start of any trial-specific 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 trial participation is >18 years old).
Relapsed from, refractory to, or intolerant to appropriate therapies (eg, SoC) to provide clinical benefit for their condition as assessed by their physician and/or investigator.
Is willing and able to provide an adequate pretreatment tissue sample prior to trial intervention or archival tumor tissue sample.
Disqualifiers
Has known symptomatic CNS metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated CNS metastases are not exclusionary provided that, in the opinion of the investigator, the participant is neurologically stable. MRI/CT of the brain is required for all participants during SCR Period
Myocardial infarction within 6 months prior to SCR.
Uncontrolled angina pectoris within 6 months prior to SCR.
New York Heart Association (NYHA) Class III or IV CHF.
Trial design
Treatments tested in this trial
- DS3610a
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov