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ACTIVE_NOT_RECRUITINGPHASE1

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

NCT06328673•D2M Biotherapeutics Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provide a signed written informed consent form (ICF) before any study-specific assessment.
•2. Be at least 18 years old on the day of signing the ICF.
•3. Have a histologically confirmed advanced metastatic or unresectable, locally invasive solid cancer.
•For monotherapy dose escalation cohorts from the 3mg/kg dose level, preferred indications include endometrial cancer, cervical cancer, non-small cell lung cancer, hepatocellular cancer, oral cavity cancer (parotid, salivary gland and others), HPV (+) laryngeal cancer and bile duct cancer. Other indications can be included as both sponsor and investigators agree.
•4. Have experienced progressive disease on at least one approved SOC systemic anti-cancer therapy for a given tumor type, or have been intolerant to SOC therapy, or in the opinion of the Investigator, have been considered ineligible for SOC therapy on medical grounds, or have no proven curative or life-prolonging approved SOC therapies available.
•5. Have at least one measurable tumor lesion per RECIST 1.1.
•6. Have a life expectancy of ≥3 months.
•7. Have an ECOG performance status of 0 or 1.
•8. Have adequate organ and bone marrow function.
•9. Female subjects must meet either of the following criteria:
+5 more criteria

Exclusion Criteria

•1. Received prior systemic anticancer treatment within 3 weeks before the first dose of study treatment (or 5 half-lives, whichever is shorter) or within 4 weeks before the first dose of study treatment in case of nitrosoureas or radio-immuno conjugate therapy.
•2. Current evidence of Grade ≥2 toxicity of prior therapy, except for any grade alopecia, Grade ≤2 peripheral neuropathy, and the following Grade ≤2 vitiligo, Grade ≤2 psoriasis not requiring systemic treatment and immune related Grade ≤2 endocrine disorders adequately managed by hormonal replacement therapy.
•3. Any history of discontinuation from prior therapy with anti-PD-1 or anti-PD-L1 inhibitor due to drug-related toxicity.
•4. Major surgery within 7 days before the first dose of study treatment or planned after the start of treatment, where 'major' is defined as any surgical procedure that requires more than 24 hours admission in a hospital.
•5. Radiotherapy within 2 weeks before the first dose of study treatment.
•6. Current evidence of symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Symptomatic treated brain metastases are allowed if subjects are clinically stable in the judgement of the investigator.
•7. Other primary malignancy histologically different than the cancer under study, that has required active treatment within 2 years before the first dose of study treatment or may require active treatment during the treatment period.
•8. Any history of severe hypersensitivity to monoclonal antibodies or another form of severe hypersensitivity.
•9. Grade ≥3 viral, bacterial, or fungal infection within 2 weeks before the first dose of study treatment.
•10. Known active HIV infection, as determined by detectable HIV-RNA viral load.
+17 more criteria

Locations (2)

NEXT Oncology

San Antonio, Texas, United States

The Cancer Institute and Hospital, Chinese Academy of Medical Sciences(CAMS)

Beijing, China

Key Dates

Start Date

April 9, 2024

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

December 24, 2025

Enrollment

160

ESTIMATED participants

Conditions

Advanced Solid Tumor

Interventions

DM919

DRUG

Pembrolizumab

DRUG

A Study of PYX-201 in Advanced Solid Tumors

NCT05720117

Solid TumorAdvanced Solid Tumor

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RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of PYX-201 in Advanced Solid Tumors

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

A Study of ASP1002 in Adults for Treatment of Solid Tumors

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)