Study on VMD-928 Alone and with Pembrolizumab for Treating Solid Tumors or Lymphoma with High TrkA Levels
Sponsor: VM Oncology, LLC
ClinicalTrials ID:NCT03556228
This clinical trial is testing a new treatment using VMD-928, alone or with pembrolizumab, for adults with advanced solid tumors or lymphoma that have not responded to other treatments and have high levels of TrkA protein.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring a new treatment approach for adults with advanced solid tumors or lymphoma that have not responded to available therapies. The treatment involves using VMD-928, either by itself or combined with pembrolizumab, a type of immunotherapy. The study aims to find safe and effective doses of VMD-928 and to see if it can help control cancers that have high levels of a protein called TrkA. The focus is on cancers like head and neck, esophageal, lung, mesothelioma, and pancreatic cancers.
Description
This clinical trial is divided into two phases. In Phase 1, researchers will test different doses of VMD-928 to find the safest and most effective dose when used alone or with pembrolizumab. In Phase 2, they will expand the study to see how well the treatment works in shrinking tumors. The study is open to adults with certain types of advanced cancers that have high levels of TrkA protein. Participants will need to provide a tumor sample for testing and meet specific health criteria to join the study. The trial will take place at multiple centers and will involve regular health checks and monitoring to ensure safety and effectiveness.
Eligibility Criteria
Inclusion Criteria
- Adults with confirmed advanced solid tumors or lymphoma, specifically:
- Head and neck cancers
- Esophageal cancer
- Lung cancers
- Mesothelioma
- Pancreatic cancers
- Cancers must have high levels of TrkA protein or a specific gene fusion (NTRK1+).
- Must have tried standard treatments without success or have no other treatment options.
- Must be able to swallow pills and provide a tumor sample.
- Must have good overall health, with specific blood and organ function levels.
- ECOG performance status of 0 or 1, meaning fully active or with some restrictions but able to do light work.
Exclusion Criteria
- Recent chemotherapy or other cancer treatments within the last 2-6 weeks.
- Unresolved side effects from previous cancer treatments.
- Active infections, including HIV.
- Pregnant or breastfeeding women.
- Heart problems or recent heart procedures.
- Severe uncontrolled medical conditions.
- Psychological or social issues that could affect participation.
- Other cancers within the last 3 years.
- Difficulty taking oral medication.
- Uncontrolled fluid buildup in the body.
- Use of certain medications that cannot be stopped during the study.
- For Phase 2: Negative for TrkA protein in tumor tests.
- For combination with pembrolizumab: Serious immune-related side effects from previous similar treatments, or recent use of PD-1 inhibitors without a 21-day break.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Medical Foundation (site 209) | 95403 | Santa Rosa | California |
| Hartford Hospital (site 210) | 06102 | Hartford | Connecticut |
| The George Washington University Cancer Center (site 212) | 20037 | Washington D.C. | District of Columbia |
| Holy Cross Hospital (site 213) | 33308 | Fort Lauderdale | Florida |
| Memorial Cancer Institute at Memorial Healthcare Systems (site 132) | 33028 | Pembroke Pines | Florida |
| Englewood Hospital and Medical Center (site 202) | 07631 | Englewood | New Jersey |
| Summit Medical Group (site 205) | 07932 | Florham Park | New Jersey |
| Atlantic Health System, Morristown Medical Center (site 124) | 07962 | Morristown | New Jersey |
| Presbyterian Kaseman Hospital (site 208) | 87110 | Albuquerque | New Mexico |
| Weill Cornell Medicine, Cornell University (site 126) | 10065 | New York | New York |
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