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OncoMatch/Clinical Trials/NCT03556228

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

Is NCT03556228 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including VMD-928 100 mg Tablet and VMD-928 Tablet and Pembrolizumab (200 mg) for head and neck carcinoma.

Phase 1/2RecruitingVM Oncology, LLCNCT03556228Data as of May 2026

Treatment: VMD-928 100 mg Tablet · VMD-928 Tablet and Pembrolizumab (200 mg)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

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Non-Small Cell Lung Carcinoma

Pancreatic Cancer

Mesothelioma

Esophageal Carcinoma

Tumor Agnostic

Small Cell Lung Cancer

Biomarker criteria

Required: NTRK1 fusion

any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas

Required: NTRK1 overexpression

TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard of care — relapsed, refractory or intolerant (R/R/I) to SOC and for which there is no approved or curative therapy

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.

Cannot have received: chemotherapy with delayed toxicity (nitrosourea, mitomycin C)

Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).

Cannot have received: anticancer therapy (radiation, immunotherapy, biologic, surgery, tumor embolization)

Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks.

Cannot have received: investigational anticancer drug

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.

Lab requirements

Blood counts

Absolute neutrophil count ≥1.5x10^9/L; Hemoglobin ≥9g/dL; Platelets ≥100x10^9/L

Kidney function

Creatinine ≤1.2xULN for age, weight; Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min

Liver function

Total bilirubin ≤1.5x ULN; AST, ALT ≤2.5xULN; PT/INR, PTT ≤1.5xULN

Cardiac function

QTcF interval < 480 msec; No class II, III, or IV heart failure (NYHA); No acute coronary syndromes, angioplasty, or stenting within past 24 weeks

Adequate organ system function as defined as follows: Absolute neutrophil count ≥1.5x10^9/L; Hemoglobin ≥9g/dL; Platelets ≥100x10^9/L; PT/INR, PTT ≤1.5xULN; Total bilirubin ≤1.5x ULN; AST, ALT ≤2.5xULN; Creatinine ≤1.2xULN for age, weight; Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min; 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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Providence Medical Foundation (site 209) · Santa Rosa, California
  • Hartford Hospital (site 210) · Hartford, Connecticut
  • The George Washington University Cancer Center (site 212) · Washington D.C., District of Columbia
  • Holy Cross Hospital (site 213) · Fort Lauderdale, Florida
  • Memorial Cancer Institute at Memorial Healthcare Systems (site 132) · Pembroke Pines, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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