VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Part of paid clinical trials in Santa Rosa, California.
- Sponsor
- VM Oncology, LLC
- Study ID
- NCT03556228
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Adenoid Cystic Carcinoma
- Any Solid Tumors Progressed After a Prior Immunotherapy
- Esophageal Cancer
- Head and Neck Cancers
- Head and Neck Cancers - Nasopharyngeal
- Head and Neck Cancers - Salivary Gland
- Head and Neck Cancers - Throat
- Head and Neck Cancers - Tonsils
- Head and Neck Cancers Hypopharynx
- Head and Neck Cancers Larynx
- Head and Neck Cancers Lip
- Head and Neck Cancers Nasopharynx
- Head and Neck Cancers Oral Cavity
- Head and Neck Cancers Oropharynx
- Head and Neck Cancers Trachea
- Head and Neck Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma HNSCC
- Lung Cancer
- Lung Cancer (Locally Advanced or Metastatic)
- Mesothelioma
- Non-Small Cell Lung Cancer
- Pancreatic Cancer
- Salivary Gland Carcinomas
- Small Cell Lung Cancer ( SCLC )
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- VMD-928 100 mg Tablet — DRUGTaken orally once daily for 21 days per 21-day cycle
- VMD-928 Tablet and Pembrolizumab (200 mg) — DRUGVMD-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.
Study Details
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
Key Dates
- Start date
- Jun 8, 2018
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 242 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: VMD-928 monotherapyVMD-928 tablet monotherapy
- Experimental: Combination TherapyVMD-928 tablet in combination with fixed dose of pembrolizumab 200 mg once-very-21-day (per cycle)
Primary Outcome Measure
Number and severity of treatment-emergent Adverse Events (Phase 1) [ Time Frame: First cycle (21 days per cycle) ]
Central Contacts
- Jay Wu, PhD1-510-270-2790
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Providence Medical Foundation (site 209) | Santa Rosa | California | 95403 | Ian C Anderson, MD (PRINCIPAL_INVESTIGATOR) |
| Hartford Hospital (site 210) | Hartford | Connecticut | 06102 | Jaykumar Thumar, MD (PRINCIPAL_INVESTIGATOR) |
| The George Washington University Cancer Center (site 212) | Washington D.C. | District of Columbia | 20037 | Sonal Paul, MD (PRINCIPAL_INVESTIGATOR) |
| Holy Cross Hospital (site 213) | Fort Lauderdale | Florida | 33308 | Georges Azzi, MD (PRINCIPAL_INVESTIGATOR) |
| Memorial Cancer Institute at Memorial Healthcare Systems (site 132) | Pembroke Pines | Florida | 33028 | Luis E Raez, MD (PRINCIPAL_INVESTIGATOR) |
| Englewood Hospital and Medical Center (site 202) | Englewood | New Jersey | 07631 | Dara Herman Minaxi Jhawer, MD (PRINCIPAL_INVESTIGATOR) |
| Summit Medical Group (site 205) | Florham Park | New Jersey | 07932 | David Gallinson, DO (PRINCIPAL_INVESTIGATOR) |
| Atlantic Health System, Morristown Medical Center (site 124) | Morristown | New Jersey | 07962 | Angela Alistar, MD (PRINCIPAL_INVESTIGATOR) |
| Presbyterian Kaseman Hospital (site 208) | Albuquerque | New Mexico | 87110 | Ethan Binder, MD (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medicine, Cornell University (site 126) | New York | New York | 10065 | Jessica Wilk Barbara Ma, M.D., M.S. (PRINCIPAL_INVESTIGATOR) |
| Taylor Cancer Research Center (site 204) | Maumee | Ohio | 43537 | John J Nemunaitis, MD (PRINCIPAL_INVESTIGATOR) |
| Cancer Care Associates of York (site 206) | York | Pennsylvania | 17403 | Katelyn Bean Chanh Huynh, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas MD Anderson Cancer Center (site 127) | Houston | Texas | 77030 | Madison Maas David S Hong, MD (PRINCIPAL_INVESTIGATOR) |
| Utah Cancer Specialists (site 203) | Salt Lake City | Utah | 84106 | Stephan DiSean Kendall, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Santa Rosa, CA
By specialty
By research site
Providence Medical Foundation· Santa Rosa, CAHartford Hospital· Hartford, CTThe George Washington University Cancer Center· Washington D.C., DCHoly Cross Hospital· Fort Lauderdale, FLMemorial Cancer Institute at Memorial Healthcare Systems· Pembroke Pines, FLEnglewood Hospital and Medical Center· Englewood, NJ
Related Studies
- Outcomes After Esophagectomy With a Focus on Minimally Invasive Esophagectomy and Quality of LifeRecruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
- Esophageal Cancer Risk RegistryRecruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
- Detection of Genetic Markers of Lung CancerRecruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
- Lung Cancer Biomarkers and ScreeningRecruiting · NYU Langone Health · New York, New York