A Study of DS5361b in Participants With Advanced Solid Tumors
Phase 1
192
about 5.2 years
18+
5 sites in FL, RI, TX +1
What this study is about
Researchers are testing a treatment called DS5361b in people with advanced solid tumors. The goal is to see if it's safe, well-tolerated, and has some effect on the cancer. The trial will last for about 1888 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take DS5361b
- 2.Take Pembrolizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: Part 1, 2, and 3: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE), Part 3 Only: Objective Response Rate (ORR) Following the Administration of DS5361b at RDE(s) in Combination with Pembrolizumab
Secondary: Disease Control Rate (DCR) Following Administration of DS5361b Alone and in Combination with Pembrolizumab, Duration of Response (DoR) Following Administration of DS5361b Alone and in Combination with Pembrolizumab, Maximum Plasma Concentration (Cmax) of DS5361b, Part 1 and 2: Objective Response Rate (ORR) Following the Administration of DS5361b Alone and in Combination with Pembrolizumab, Time to Reach Maximum Plasma Concentration (Tmax) of DS5361b
Oncology