Actively Recruiting
A Phase 1/2 Open-Label Study of Oral VMD-928 Alone and With Pembrolizumab to Treat Solid Tumors or Lymphoma
Led by VM Oncology, LLC · Updated on 2025-12-11
242
Participants Needed
15
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VMD-928, taken alone or combined with pembrolizumab, in adults with advanced solid tumors or lymphoma that have not responded to other treatments or have no available curative options. This open-label Phase 1/2 study focuses on cancers with TrkA protein overexpression, including head and neck cancers, esophageal, lung, mesothelioma, and pancreatic cancers. The trial aims to find safe and active doses, especially in tumors driven by TrkA protein or NTRK1 gene fusions. Participants receive oral VMD-928 tablets daily in 21-day cycles either alone or with pembrolizumab given intravenously every 21 days up to six cycles. The study includes a dose-escalation phase to find recommended doses and a phase to assess antitumor activity. Pembrolizumab is fixed at 200 mg per dose when combined. Tissue samples are tested for TrkA protein to confirm eligibility. During the study, participants undergo regular monitoring including safety assessments, pharmacokinetic tests, tumor evaluations, and lab tests. Researchers track adverse events and tumor response over up to 18 months. The study also examines drug levels in blood and the relationship between tumor protein expression and treatment effects. Participants are followed closely during treatment cycles and through the study duration to evaluate safety and effectiveness.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed advanced solid tumors or lymphoma, including head and neck, esophageal, lung, mesothelioma, pancreatic cancers, or NTRK1 gene fusion positive tumors
- Relapsed, refractory, or intolerant to standard therapies with no approved curative option
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to swallow and retain oral medication
- Available archival tumor tissue samples or agreement to tumor sampling before first dose
- Adequate organ function as defined by blood counts and laboratory tests
You will not qualify if you...
- Received chemotherapy with delayed toxicity within 14 days (or six weeks for certain drugs)
- Received radiation, immunotherapy, biologics, surgery, or tumor embolization within past 2 weeks
- Received investigational anticancer drugs within 14 days or 5 half-lives before first dose
- Unresolved toxicity greater than mild from prior therapy except alopecia or anemia
- Active infections including HIV
- Pregnant, nursing, or planning pregnancy during the study
- QTcF interval ≥ 480 msec
- Class II, III, or IV heart failure
- Recent acute coronary events or stenting within 24 weeks
- Unstable or uncompensated major organ diseases
- Severe psychological or social conditions limiting study compliance
- Other malignant tumors within 3 years
- Multiple factors affecting oral medication intake
- Long-term unhealed wounds or fractures
- Uncontrolled pleural, pericardial effusions, or ascites needing repeated drainage
- Use of certain drugs like acetaminophen, antacids, proton pump inhibitors, or H2 blockers that cannot be stopped during the study
- Epstein-Barr virus negative nasopharyngeal carcinoma
- Negative TrkA protein test (Phase 2 only)
- Visceral crisis with severe organ dysfunction (Phase 2 only)
- Serious immune-related adverse events or pneumonitis/myocarditis from prior PD-1(L1) inhibitors (Combination therapy only)
- Less than 21 days washout after prior PD-1(L1) inhibitor therapy
- Relapse after prior PD-1(L1) inhibitor treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive oral VMD-928 daily in 21-day cycles either alone or in combination with pembrolizumab given intravenously once every 21 days for up to 6 cycles.
Treatment visits every 21 days corresponding to each cycle
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
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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