NCT05875168

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Detailed description

DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	DS-3939a	One IV infusion Q3W on Day 1 of each 21-day cycle

Timeline

• Start date: 2023-08-18
• Primary completion: 2026-03-17
• Completion: 2027-02-15
• First posted: 2023-05-25
• Last updated: 2026-01-12

Locations

32 sites across 8 countries: United States, Belgium, Canada, China, France, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study