NCT05765851

A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors

A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of DS-1103a combination therapy in patients with advanced solid tumors.

Detailed description

DS-1103a, a recombinant humanized IgG4 anti-SIRPα antibody designed to block the SIRPα-CD47 interaction, is being developed for the treatment of advanced cancers in combination with other anticancer therapies. This is the first-in-human, dose-escalating clinical study designed to assess the safety and efficacy of DS-1103a combination therapy in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumor
• Breast Cancer

Interventions

Type	Name	Description
DRUG	DS-1103a	One IV infusion Q3W on Day 1 of each 21-day cycle
DRUG	T-DXd	One IV infusion Q3W on Day 1 of each 21-day cycle

Timeline

• Start date: 2023-05-30
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-03-13
• Last updated: 2025-05-11

Locations

8 sites across 4 countries: United States, Canada, France, Spain

Regulatory

• FDA-regulated drug study