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NCT03556228

VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma

Recruiting
PHASE1Ages 18–80InterventionalTreatment
VM Oncology, LLC
~242 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:VMD-928 100 mg TabletVMD-928 Tablet and Pembrolizumab (200 mg)

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and severity of treatment-emergent Adverse Events (Phase 1)
Measured over First cycle (21 days per cycle)
+4 more outcomes measured

Conditions

Head and Neck Carcinoma
Adenoid Cystic Carcinoma
Lung Cancer
Non-Small Cell Lung Cancer
Pancreatic Cancer
Mesothelioma
Esophageal Cancer
Any Solid Tumors Progressed After a Prior Immunotherapy
Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma HNSCC
Salivary Gland Carcinomas
Head and Neck Cancers - Salivary Gland
Head and Neck Cancers - Nasopharyngeal
Head and Neck Cancers - Throat
Small Cell Lung Cancer ( SCLC )
Lung Cancer (Locally Advanced or Metastatic)
Head and Neck Cancers - Tonsils
Head and Neck Cancers Hypopharynx
Head and Neck Cancers Larynx
Head and Neck Cancers Lip
Head and Neck Cancers Nasopharynx
Head and Neck Cancers Oral Cavity
Head and Neck Cancers
Head and Neck Cancers Oropharynx
Head and Neck Cancers Trachea

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Esophageal CarcinomaLung CarcinomaLymphomaMalignant Head and Neck NeoplasmMesothelial NeoplasmPancreatic CarcinomaSolid NeoplasmNTRK1 GeneNTRK1 wt Allele

NCT03556228

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atlantic Health System, Morristown Medical Center (site 124)

    Morristown, New Jerseystudy coordinator listed

    Recruiting

  • Cancer Care Associates of York (site 206)

    York, Pennsylvaniastudy coordinator listed

    Recruiting

  • Englewood Hospital and Medical Center (site 202)

    Englewood, New Jerseystudy coordinator listed

    Recruiting

  • Hartford Hospital (site 210)

    Hartford, Connecticutstudy coordinator listed

    Recruiting

  • Holy Cross Hospital (site 213)

    Fort Lauderdale, Floridastudy coordinator listed

    Recruiting

  • Memorial Cancer Institute at Memorial Healthcare Systems (site 132)

    Pembroke Pines, Floridastudy coordinator listed

    Recruiting

  • PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)

    San Juan, Puerto Ricostudy coordinator listed

    Recruiting

  • Presbyterian Kaseman Hospital (site 208)

    Albuquerque, New Mexicostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Development · STUDY_CHAIR · VM Oncology

Who to contact

Jay Wu, PhD
[email protected]
1-510-270-2790 · ext. 101
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.
Able to swallow and retain oral medication.
Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.
Adequate organ system function as defined as follows:

Exclusion

Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).
Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks.
Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.
Unresolved toxicity from previous anticancer therapy \> CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.
Known active infections including HIV disease.
Currently pregnant, nursing, or planning to become pregnant during the course of the study.
QTcF interval ≥ 480 msec.
Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.
Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.
Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.
Patient has had or is currently having other malignant tumors within 3 years.
Patients have multiple factors that affect their oral medication.
Patients have long-term unhealed wounds or fractures.
Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
Patients are taking the following drugs and can't stop them during the study:
Tylenol or medicine containing acetaminophen (paracetamol).
Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.
Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.
Negative result on TrkA immunohistochemistry (IHC) assay.
Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)
Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\>6 weeks).
Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.
For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.
Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.

What this trial measures

  • Number and severity of treatment-emergent Adverse Events (Phase 1)First cycle (21 days per cycle)

    TEAE

  • To determine the recommended Phase 2 dose for VMD-928 (Phase 1)First cycle (21 days per cycle)

    RP2D of monotherapy

  • To determine the RP2D of VMD-928 in combination with pembrolizumab (Phase 1)First cycle (21 days per cycle)

    RP2D of combination therapy

  • Antitumor activity of VMD-928 in subjects with TrkA-driven tumors (Phase 2)Up to 18 months

    Antitumor efficacy signal for monotherapy

  • Antitumor activity of VMD-928 in combination with pembrolizumab in subjects with TrkA-driven tumors (Phase 2)Up to 18 months

    Antitumor efficacy signal for combination therapy