A Study of DS5361b in Participants With Advanced Solid Tumors

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NCT07182591 · readout in 1,307 d

Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

192estimated

Sites

Countries

Japan, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-10-02

actual

When the study began enrolling

Primary completion

2030-03-18

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-12-03

estimated

The whole study's end, after follow-up

First posted

2025-09-19

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Advanced Solid Tumor

Interventions

Drug: DS5361b
Drug: Pembrolizumab — also filed as Keytruda®

Primary outcomes

what the primary-completion date above is the date OF

Part 1 and 2: Number of participants with Dose-Limiting Toxicities (DLTs)

measured Cycle 1: Day 1 up to Day 21 (each cycle is 21 days)

Part 1, 2, and 3: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)

measured From Screening up to approximately 5 years

Part 3 Only: Objective Response Rate (ORR) Following the Administration of DS5361b at RDE(s) in Combination with Pembrolizumab

measured From first dose up to approximately 5 years

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