Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

A Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma

VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma (NCT03556228) is a Phase 1 / Phase 2 interventional studying Head and Neck Carcinoma and Adenoid Cystic Carcinoma, sponsored by VM Oncology, LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Head and Neck Carcinoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 242 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Head and Neck Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Key Who May Qualify: #. diagnosed by tissue sample (biopsy-confirmed) diagnosis of any type of solid tumor malignancy or lymphoma: Phase 1 Dose Escalation only: Subjects with (A) any advanced solid tumors of 1. Head and Neck Cancers ("HNC") (of any types), 2. Esophageal cancer, 3. Lung cancers (of any types), 4. Mesothelioma, 5. Pancreatic cancers, Or, (B) any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R/R/I) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible. Phase 2 Monotherapy and Combination with Pembrolizumab only: Subjects must have 1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or, 2. any NTRK1+ solid tumors or lymphoma\*, that is R/R/I to SOC. Key Who May Qualify: - 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: 1. Absolute neutrophil count ≥1.5x10\^9/L 2. blood count (hemoglobin) at least 9g/dL 3. platelet count at least 100x10\^9/L 4. PT/INR, PTT ≤1.5xULN 5. Total bilirubin ≤1.5x ULN 6. AST, ALT ≤2.5xULN 7. Creatinine ≤1.2xULN for age, weight 8. Calculated creatinine clearance or 24h urine kidney function (creatinine clearance) at least 60mL/min Key Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: #. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma: Phase 1 Dose Escalation only: Subjects with (A) any advanced solid tumors of 1. Head and Neck Cancers ("HNC") (of any types), 2. Esophageal cancer, 3. Lung cancers (of any types), 4. Mesothelioma, 5. Pancreatic cancers, Or, (B) any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R/R/I) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible. Phase 2 Monotherapy and Combination with Pembrolizumab only: Subjects must have 1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or, 2. any NTRK1+ solid tumors or lymphoma\*, that is R/R/I to SOC. Key Inclusion Criteria: * 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: 1. Absolute neutrophil count ≥1.5x10\^9/L 2. Hemoglobin ≥9g/dL 3. Platelets ≥100x10\^9/L 4. PT/INR, PTT ≤1.5xULN 5. Total bilirubin ≤1.5x ULN 6. AST, ALT ≤2.5xULN 7. Creatinine ≤1.2xULN for age, weight 8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min Key Exclusion Criteria: * 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. For Phase 2 only: * 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.) For combination therapy with Pembrolizumab only: * 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.

Treatments Being Tested

DRUG

VMD-928 100 mg Tablet

Taken orally once daily for 21 days per 21-day cycle

DRUG

VMD-928 Tablet and Pembrolizumab (200 mg)

VMD-928 tablet (oral) starting at 300 mg daily for 21 days of 21-day cycle. Pemprolizumab at fixed intravenous dose of 200 mg once-every-21 days (per cycle) for max. 6 cycles.

Locations (15)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Providence Medical Foundation (site 209)
Santa Rosa, California, United States
Hartford Hospital (site 210)
Hartford, Connecticut, United States
The George Washington University Cancer Center (site 212)
Washington D.C., District of Columbia, United States
Holy Cross Hospital (site 213)
Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Healthcare Systems (site 132)
Pembroke Pines, Florida, United States
Englewood Hospital and Medical Center (site 202)
Englewood, New Jersey, United States
Summit Medical Group (site 205)
Florham Park, New Jersey, United States
Atlantic Health System, Morristown Medical Center (site 124)
Morristown, New Jersey, United States
Presbyterian Kaseman Hospital (site 208)
Albuquerque, New Mexico, United States
Weill Cornell Medicine, Cornell University (site 126)
New York, New York, United States
Taylor Cancer Research Center (site 204)
Maumee, Ohio, United States
Cancer Care Associates of York (site 206)
York, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center (site 127)
Houston, Texas, United States
Utah Cancer Specialists (site 203)
Salt Lake City, Utah, United States
PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)
San Juan, Puerto Rico

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03556228), the sponsor (VM Oncology, LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03556228 clinical trial studying?

This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03556228?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03556228?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03556228. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03556228. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.