NCT06328673

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

Active, enrolled Phase 1 Last updated 24 December 2025

What this trial tests

Phase 1 trial testing DM919 in Advanced Solid Tumor in 160 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 April 2024

Primary endpoint
1 March 2026

1 March 2026

Quick facts

Lead sponsor	D2M Biotherapeutics Inc.
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	160
Start date	9 April 2024
Primary completion	1 March 2026
Estimated completion	1 March 2026
Sites	2 locations across China, United States

Drugs / interventions tested

• DM919 — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

D2M Biotherapeutics Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel and potent MICA/B antibody is therapeutically effective in <i>KRAS LKB1</i> mutant lung cancer models.
   Kowash RR, Sabnani M, Gray LT, Deng Q, et al · · 2025 · cited 5× · PMID 39762078 · DOI 10.1136/jitc-2024-009867
2. A potential mechanism of tumor immune escape: Regulation and application of soluble natural killer group 2 member D ligands (Review).
   Huang S, Qin Z, Wang F, Kang Y, et al · · 2024 · cited 4× · PMID 39155864 · DOI 10.3892/or.2024.8796
3. Targeting NKG2D/NKG2DL axis in cancer immunotherapy: mechanisms and therapeutic applications.
   Wei H, Xiang L, Zhou Y, Huang Y, et al · · 2026 · cited 1× · PMID 41484787 · DOI 10.1186/s12967-025-07650-5
4. A fully human IgG1 antibody targeting MICA α1 domain inhibits interaction with NKG2D and activates immune effector functions against MICA-expressing cells.
   Campos I, González-Herrera F, Guerra Y, Garrido MJ, et al · · 2026 · PMID 41756291 · DOI 10.3389/fimmu.2026.1740184