A Study of DS5361b 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 aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.
Eligibility criteria
Qualifiers
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).
Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only).
Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H and/or MSI-H status. In Part 3, participants need to have documented TMB-H status.
Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.
Disqualifiers
Has spinal cord compression or clinically active central nervous system metastases.
Has a history of leptomeningeal carcinomatosis.
Uncontrolled or significant cardiovascular disease.
Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
Trial design
Treatments tested in this trial
- DS5361b
- Pembrolizumab
Treatment groups
192 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov