NCT07159126

A Study of DS3610a in Participants With Advanced Solid Tumor

A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.

Detailed description

This is a dose escalation study for participants with advanced or metastatic solid tumors. The primary objective of the study is to determine the Recommended Dose for Expansion (RDE), and to evaluate the safety, tolerability, PK, and preliminary efficacy of DS3610a in solid tumors.

Conditions

• Solid Tumors
• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	DS3610a	Participants will receive DS3610a at the target dose. Treatment will continue until radiographic disease progression, as determined by the investigator, or until another reason for discontinuation of trial intervention occurs.

Timeline

• Start date: 2025-10-09
• Primary completion: 2028-09-01
• Completion: 2031-02-01
• First posted: 2025-09-08
• Last updated: 2025-12-10

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study