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

NCT06328673 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: DM919-001
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of treatment-emergent events (TEAEs) in Dose Escalation

  TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.

  Up to 24 months

• RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab

  The tentative RDE(s) and RP2D(s) will be identified from the totality of the safety, PK / PDx, and preliminary anti-tumor efficacy data.

  Up to 24months

Secondary Outcomes (4)

• All cohorts

  Up to 24 months

• All cohorts

  Up to 24 months

• All cohorts

  Up to 24 months

• All cohorts

  Up to 24 months

Other Outcomes (2)

• Dose Expansion

  every 6 weeks for the first 24 weeks of treatment and then every 12 weeks until disease progression;up to 24 months

• Dose Expansion

  every 6 weeks for the first 24 weeks of treatment and then every 12 weeks until disease progression;up to 24 months

Study Arms (4)

Module A Dose Escalation

EXPERIMENTAL

Patients with advanced solid tumors enrolled in dose escalation cohorts treated with DM919

Drug: DM919

Module A Cohort Expansion

EXPERIMENTAL

Patients with select solid tumor types enrolled in expansion cohorts treated with DM919 at a dose selected from the Module A Escalation arm

Drug: DM919

Module B Combination Therapy Dose Escalation

EXPERIMENTAL

Patients with advanced solid tumors enrolled in dose escalation cohorts treated with DM919 in combination with pembrolizumab

Drug: DM919; Drug: Pembrolizumab

Module B Combination Therapy Cohort Expansion

EXPERIMENTAL

Patients with select tumor types enrolled in expansion cohorts treated with DM919 at a dose selected from the Module B Escalation arm, in combination with pembrolizumab

Drug: DM919; Drug: Pembrolizumab

Interventions

DM919 DRUG

Anti-MICA/MICB monoclonal antibody

Module A Cohort Expansion; Module A Dose Escalation; Module B Combination Therapy Cohort Expansion; Module B Combination Therapy Dose Escalation

Pembrolizumab DRUG

Anti-PD-1 monoclonal antibody

Also known as: Keytruda

Module B Combination Therapy Cohort Expansion; Module B Combination Therapy Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide a signed written informed consent form (ICF) before any study-specific assessment.
• Be at least 18 years old on the day of signing the ICF.
• 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.
• 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.
• Have at least one measurable tumor lesion per RECIST 1.1.
• Have a life expectancy of ≥3 months.
• Have an ECOG performance status of 0 or 1.
• Have adequate organ and bone marrow function.
• Female subjects must meet either of the following criteria:
• Women of childbearing potential (WOCBP, defined as \<12 continuous months of amenorrhea with no identified cause other than menopause, or not surgically sterile)
• Postmenopausal or surgically sterile females.
• Male subjects with female partners of childbearing potential must agree to remain sexually abstinent or use condoms during the treatment period and for at least 120 days after the last dose of study treatments.
• Male subjects must agree to not donate or preserve sperm during the treatment period and for at least 120 days after the last dose of study treatments.
• Able and willing to comply with the protocol and the restrictions and assessments therein.

You may not qualify if:

• 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.
• 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.
• Any history of discontinuation from prior therapy with anti-PD-1 or anti-PD-L1 inhibitor due to drug-related toxicity.
• 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.
• Radiotherapy within 2 weeks before the first dose of study treatment.
• 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.
• 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.
• Any history of severe hypersensitivity to monoclonal antibodies or another form of severe hypersensitivity.
• Grade ≥3 viral, bacterial, or fungal infection within 2 weeks before the first dose of study treatment.
• Known active HIV infection, as determined by detectable HIV-RNA viral load.
• a.Subjects on stable HAART therapy with undetectable HIV-RNA viral load and normal CD4 counts for at least 6 months before the first dose of study treatment are eligible.
• Known active HBV infection, as determined by detectable HBV-DNA viral load.
• Known active HCV infection, as determined by detectable HCV-RNA viral load.
• Known active or latent tuberculosis (TB). Testing for TB is not required at screening.
• Known active SARS-CoV-2 (COVID-19) infection, as determined by a positive COVID-19 test result within 2 weeks before the first dose of study treatment.

Sponsors & Collaborators

• D2M Biotherapeutics Inc.: lead

Study Sites (2)

NEXT Oncology

San Antonio, Texas, 78216, United States

Location

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

Beijing, China

Location

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Shiraj Sen, MD

  NEXT Oncology

  PRINCIPAL INVESTIGATOR

• Ning Li

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 25, 2024
• Study Start: April 9, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CN (1)