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A Study of DS5361b for Advanced Solid Tumors

This study is testing a new drug called DS5361b, both by itself and in combination with an existing drug called pembrolizumab, for people with advanced solid tumors. The main goals are to understand the safety and side effects of DS5361b, find the best dose, and see how well it works. Researchers will be looking for dose-limiting toxicities (serious side effects that stop treatment) and any treatment-related side effects. They will also measure the objective response rate (how many people's tumors shrink or disappear). You may be able to join if you are at least 18 years old and have a solid tumor that has come back, spread, or cannot be removed by surgery. The study plans to enroll 192 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 192 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events for up to approximately 5 years. Objective response rate will also be measured for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07182591

A Study of DS5361b in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Daiichi Sankyo
~192 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:DS5361bPembrolizumab

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs)
Measured over Cycle 1: Day 1 up to Day 21 (each cycle is 21 days)
+2 more outcomes measured

Conditions

Advanced Solid Tumor

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Where it's being run

7 sites across 5 states
Texas2
Japan2
Florida1
Rhode Island1
Virginia1

Who to contact

Contact for Trial Information
[email protected]
908-992-6400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

No prior systemic therapy.
Participants with PD-L1 TPS ≥1%. 9. Has histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.
No prior systemic therapy administered in the recurrent or metastatic setting.
Participants with PD-L1 CPS ≥1.

What this trial measures

  • Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs)Cycle 1: Day 1 up to Day 21 (each cycle is 21 days)

    A DLT is defined as any Treatment Emergent Adverse Event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc, that occurs during the DLT evaluation period (Day 1 to the end of Cycle 1) and is Grade ≥3.

  • Part 1, 2, and 3: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)From Screening up to approximately 5 years

    TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).

  • Part 3 Only: Objective Response Rate (ORR) Following the Administration of DS5361b at RDE(s) in Combination with PembrolizumabFrom first dose up to approximately 5 years

    ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by investigator per RECIST v1.1.