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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
DS3610a
DrugParticipants will receive DS3610a at the target dose. Treatment will continue until radiographic disease progression, as determined by the investigator, or until another reason for discontinuation of trial intervention occurs.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: DS3610a at Escalating DosesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicities
Time frame
From first dose, up to approximately 24 monthsSecondary outcomes
1
Area Under the Blood Concentration-time Curve During Dosing Interval
Area Under the Blood Concentration-time Curve During Dosing Interval (AUCtau) will be used to asses PK parameters
Time frame
From baseline to postbaseline, up to approximately 36 months2
Antidrug Antibody Prevalence
The percentage of participants who are Antidrug Antibody positive at any point in time.
Time frame
From baseline to postbaseline, up to approximately 36 monthsSponsors and contacts
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Source ClinicalTrials.gov