NCT06328673

A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors

A First-in-Human Open-label, Phase 1a / 1b Dose Escalation and Expansion Cohort Study of DM919, a Novel Anti-MICA/B Antibody, as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: D2M Biotherapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to define a safe and effective dose of DM919 for participants with solid tumors The main questions it aims to answer are: What is the safe and effective dose of DM919 when used alone or in combination with pembrolizumab? What cancers can be treated effectively with DM919 alone or in combination with pembrolizumab?? Participants will be asked to attend clinic and be given a intravenous infusion of DM919 or DM-919 in combination with pembrolizumab. They will have blood tests and other assessments to measure whether DM-919 will have the effect on tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	DM919	Anti-MICA/MICB monoclonal antibody
DRUG	Pembrolizumab	Anti-PD-1 monoclonal antibody

Timeline

• Start date: 2024-04-09
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-03-25
• Last updated: 2025-12-24

Locations

2 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study