NCT06074705

A Study of DS-1471a In Subjects With Advanced Solid Tumors

A Phase 1, Multicenter, First-in-human Study of DS-1471a In Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This first-in-human (FIH) study will assess the safety, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of DS-1471a in participants with advanced or metastatic solid tumors.

Detailed description

The objectives of this multinational, multicenter, open-label, 2-part, dose-escalation and dose-expansion, FIH study of participants with locally advanced or metastatic solid tumors are to evaluate the safety, maximum tolerated dose (MTD), recommended dose for expansion phase, preliminary efficacy, PK, and immunogenicity of DS-1471a.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	DS-1471a	Intravenous administration on Day 1 of each 28-day cycle

Timeline

• Start date: 2023-08-04
• Primary completion: 2025-07-29
• Completion: 2025-07-29
• First posted: 2023-10-10
• Last updated: 2025-08-22

Locations

5 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study