NCT07182591

A Study of DS5361b in Participants With Advanced Solid Tumors

A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS5361b in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	DS5361b	Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE. Dose Expansion Part: DS5361b will be administered at RDE.
DRUG	Pembrolizumab	Dose Escalation Part: Pembrolizumab will be administered at a standard dose. Dose Expansion Part: Pembrolizumab will be administered at a standard dose.

Timeline

• Start date: 2025-10-02
• Primary completion: 2030-03-18
• Completion: 2030-12-03
• First posted: 2025-09-19
• Last updated: 2026-03-20

Locations

7 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study