RecruitingPhase 1Phase 2NCT03556228

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

A Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma


Sponsor

VM Oncology, LLC

Enrollment

242 participants

Start Date

Jun 8, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer drug called VMD-928 — either on its own or combined with an immunotherapy drug called pembrolizumab — in people whose tumors have too much of a protein called TrkA, which can fuel cancer growth. **You may be eligible if...** - You have been diagnosed with an advanced solid tumor or lymphoma that has not responded to or relapsed after standard treatments - In the early phase, eligible cancers include: head and neck, esophageal, lung, mesothelioma, or pancreatic cancer, OR any tumor with a specific gene change (NTRK1 fusion) - In the later phase, tumors must have high TrkA protein levels confirmed by testing - There are no remaining standard treatment options that are likely to help you **You may NOT be eligible if...** - You have not yet tried standard therapies that might help - Your tumor does not meet the required protein or gene criteria - You are eligible for a stem cell transplant (for lymphoma patients) and have not yet had one Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVMD-928 100 mg Tablet

Taken orally once daily for 21 days per 21-day cycle

DRUGVMD-928 Tablet and Pembrolizumab (200 mg)

VMD-928 tablet (oral) starting at 300 mg daily for 21 days of 21-day cycle. Pemprolizumab at fixed intravenous dose of 200 mg once-every-21 days (per cycle) for max. 6 cycles.


Locations(15)

Providence Medical Foundation (site 209)

Santa Rosa, California, United States

Hartford Hospital (site 210)

Hartford, Connecticut, United States

The George Washington University Cancer Center (site 212)

Washington D.C., District of Columbia, United States

Holy Cross Hospital (site 213)

Fort Lauderdale, Florida, United States

Memorial Cancer Institute at Memorial Healthcare Systems (site 132)

Pembroke Pines, Florida, United States

Englewood Hospital and Medical Center (site 202)

Englewood, New Jersey, United States

Summit Medical Group (site 205)

Florham Park, New Jersey, United States

Atlantic Health System, Morristown Medical Center (site 124)

Morristown, New Jersey, United States

Presbyterian Kaseman Hospital (site 208)

Albuquerque, New Mexico, United States

Weill Cornell Medicine, Cornell University (site 126)

New York, New York, United States

Taylor Cancer Research Center (site 204)

Maumee, Ohio, United States

Cancer Care Associates of York (site 206)

York, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center (site 127)

Houston, Texas, United States

Utah Cancer Specialists (site 203)

Salt Lake City, Utah, United States

PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)

San Juan, Puerto Rico

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03556228


Related Trials