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.
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
Check if I qualifyExtracted 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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