Actively Recruiting
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Led by VM Oncology, LLC · Updated on 2025-12-11
242
Participants Needed
15
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with any type of solid tumor or lymphoma confirmed by tissue analysis
- For Phase 1: advanced solid tumors including head and neck, esophageal, lung, mesothelioma, or pancreatic cancers, or NTRK1 gene fusion positive tumors or lymphomas that are relapsed, refractory, or intolerant to standard care
- For Phase 2: TrkA-driven head and neck, esophageal, lung, mesothelioma, pancreatic cancers, or NTRK1 positive tumors or lymphoma that are relapsed, refractory, or intolerant to standard care
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to swallow and keep oral medication
- Available archival tumor tissue samples or consent to tumor tissue sampling before first dose
- Adequate organ function including specified blood counts and liver, kidney function tests
You will not qualify if you...
- Received chemotherapy with delayed toxicity within the last 14 days (six weeks for nitrosourea or mitomycin C)
- Received radiation, immunotherapy, biologics, surgery, or tumor embolization within the past 2 weeks
- Received investigational anticancer drugs within 14 days or 5 half-lives before first dose of VMD-928
- Unresolved toxicity greater than grade 1 from previous therapy except alopecia or anemia
- Known active infections including HIV
- Pregnant, nursing, or planning pregnancy during study
- QTcF interval 480 msec or greater
- Class II-IV heart failure or recent acute coronary events within 24 weeks
- Unstable or uncompensated respiratory, liver, kidney, or heart disease
- Psychological or social conditions interfering with study compliance
- Other malignant tumors within past 3 years
- Factors affecting oral medication intake
- Long-term unhealed wounds or fractures
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Use of certain medications that cannot be stopped during study (acetaminophen, antacids, proton pump inhibitors, H2 blockers, buffered vitamins)
- Epstein-Barr virus negative nasopharyngeal carcinoma
- For Phase 2: negative TrkA immunohistochemistry assay or visceral crisis
- For pembrolizumab combination: serious immune-related adverse events or pneumonitis/myocarditis from prior PD-1(L1) inhibitor therapy, less than 21 days washout from prior PD-1(L1) therapy, or relapse after prior PD-1(L1) inhibitor treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
Providence Medical Foundation (site 209)
Santa Rosa, California, United States, 95403
Actively Recruiting
2
Hartford Hospital (site 210)
Hartford, Connecticut, United States, 06102
Actively Recruiting
3
The George Washington University Cancer Center (site 212)
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
4
Holy Cross Hospital (site 213)
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
5
Memorial Cancer Institute at Memorial Healthcare Systems (site 132)
Pembroke Pines, Florida, United States, 33028
Actively Recruiting
6
Englewood Hospital and Medical Center (site 202)
Englewood, New Jersey, United States, 07631
Actively Recruiting
7
Summit Medical Group (site 205)
Florham Park, New Jersey, United States, 07932
Actively Recruiting
8
Atlantic Health System, Morristown Medical Center (site 124)
Morristown, New Jersey, United States, 07962
Actively Recruiting
9
Presbyterian Kaseman Hospital (site 208)
Albuquerque, New Mexico, United States, 87110
Actively Recruiting
10
Weill Cornell Medicine, Cornell University (site 126)
New York, New York, United States, 10065
Actively Recruiting
11
Taylor Cancer Research Center (site 204)
Maumee, Ohio, United States, 43537
Actively Recruiting
12
Cancer Care Associates of York (site 206)
York, Pennsylvania, United States, 17403
Actively Recruiting
13
The University of Texas MD Anderson Cancer Center (site 127)
Houston, Texas, United States, 77030
Actively Recruiting
14
Utah Cancer Specialists (site 203)
Salt Lake City, Utah, United States, 84106
Actively Recruiting
15
PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)
San Juan, Puerto Rico, 00935
Actively Recruiting
Research Team
J
Jay Wu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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