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

NCT06328673 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-24

No results posted yet for this study

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

DRUG

DM919

Anti-MICA/MICB monoclonal antibody

DRUG

Pembrolizumab

Anti-PD-1 monoclonal antibody

Sponsors & Collaborators

  • D2M Biotherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Shiraj Sen, MD · NEXT Oncology

  • Ning Li · The Cancer Institute and Hospital, Chinese Academy of Medical Sciences(CAMS)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2026-03-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06328673 on ClinicalTrials.gov