Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT03556228

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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