Advanced Solid TumorPhase 1NCT06328673
A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
A Phase 1 study testing DM919 and Pembrolizumab in people with Advanced Solid Tumor, run by D2M Biotherapeutics Inc. at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- DM919 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Apr 2024to 1 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Received a live or live-attenuated vaccine within 4 weeks before the first dose of study treatment. Injectable influenza vaccine and COVID-19 vaccine are permitted
- Uncontrolled or significant cardiovascular disease.
- Autoimmune disease that has required systemic treatment (i.e., disease modifying agents, corticosteroids above physiological doses [>10 mg daily of prednisone or equivalent] or immunosuppressive drugs) within 2 years before the first dose of study treatment.
- Any history of interstitial lung disease (ILD, including pneumonitis) that required systemic corticosteroid therapy.
- Diagnosis of immunodeficiency or receiving chronic systemic corticosteroid therapy at doses >10 mg daily of prednisone or equivalent or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment.
- Had an allogeneic solid organ or stem cell transplant.
- Received systemic corticosteroid use at doses >10 mg daily of prednisone or equivalent within 2 weeks before the first dose of study treatment or other systemic immunosuppressive agents within 4 weeks before the first dose of study treatment.
- Received hematopoietic growth factors (G-SCF, GM-CSF, EPO) or transfusion of blood components (RBC or platelets) within 2 weeks before the first dose of study treatment, or likely to require treatment with these agents during Cycle 1.
- Pregnant or breastfeeding women.
- History or clinical evidence of any surgical or medical condition that the Investigator judges as likely to interfere with the results of the study or pose an additional risk to study subjects, such as rapidly progressive or uncontrolled disease involving a major organ system (e.g., disorders of vascular, cardiac, pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or an immunodeficiency, or clinically significant active psychiatric or abuse disorders).
- History of chronic substance abuse within 12 months of the start of treatment.
- Sensitive substrates of cytochrome P450 enzymes should be excluded within 2 weeks (or 5 half-lives of the agent, whichever is longer) before the start of dosing in Phase 1a Dose Escalation part of the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences(CAMS)
Beijing
About this study
Official title: 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
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
- Being tested
- DM919, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM919Drug
Anti-MICA/MICB monoclonal antibody
PembrolizumabDrug
Also called Keytruda
Anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Module A Dose Escalation | Experimental | Patients with advanced solid tumors enrolled in dose escalation cohorts treated with DM919 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: DM919; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24months
Secondary outcomes (4)
All cohorts
Maximum drug concentration (Cmax) of DM-919
Measured: Up to 24 months
All cohorts
Terminal Half-life (t1/2) of DM919
Measured: Up to 24 months
All cohorts
Time to Cmax (Tmax) of DM-919
Measured: Up to 24 months
All cohorts
Area under the curve up to tau (AUCtau) of DM-919
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start9 Apr 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D2M Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiraj Sen, MD, Principal investigator, NEXT OncologyNing Li, Principal investigator, The Cancer Institute and Hospital, Chinese Academy of Medical Sciences(CAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328673
- Sponsor's protocol ID
- DM919-001
- Status last verified
- Dec 2025
- First submitted
- 5 Mar 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06328673
- Acronym / sponsor ID
- DM919-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- D2M Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Module A Dose Escalation | Experimental | Drug: DM919Patients with advanced solid tumors enrolled in dose escalation cohorts treated with DM919 |
| Module A Cohort Expansion | Experimental | Drug: DM919Patients with select solid tumor types enrolled in expansion cohorts treated with DM919 at a dose selected from the Module A Escalation arm |
| Module B Combination Therapy Dose Escalation | Experimental | Drug: DM919, Drug: PembrolizumabPatients with advanced solid tumors enrolled in dose escalation cohorts treated with DM919 in combination with pembrolizumab |
| Module B Combination Therapy Cohort Expansion | Experimental | Drug: DM919, Drug: PembrolizumabPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM919Anti-MICA/MICB monoclonal antibody | Drug | Module A Cohort Expansion, Module A Dose Escalation, Module B Combination Therapy Cohort Expansion, Module B Combination Therapy Dose Escalation |
| PembrolizumabAlso: KeytrudaAnti-PD-1 monoclonal antibody | Drug | Module B Combination Therapy Cohort Expansion, Module B Combination Therapy Dose Escalation |
Primary outcome
Number of treatment-emergent events (TEAEs) in Dose Escalation
Time frame: Up to 24 months
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.
RDEs or RP2Ds of DM919 alone and in combination with pembrolizumab
Time frame: Up to 24months
The tentative RDE(s) and RP2D(s) will be identified from the totality of the safety, PK / PDx, and preliminary anti-tumor efficacy data.
4 secondary outcomes
All cohorts
Time frame: Up to 24 months
All cohorts
Time frame: Up to 24 months
All cohorts
Time frame: Up to 24 months
All cohorts
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiraj Sen, MD principal investigator
NEXT Oncology
Ning Li principal investigator
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences(CAMS)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DM919 and Pembrolizumab in people with Advanced Solid Tumor, run by D2M Biotherapeutics Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-emergent events (TEAEs) in Dose Escalation (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.