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
VM Oncology, LLC
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
Description
This is an open-label, dose-escalation (Phase 1) and expansion (Phase 2) multi-center study conducted in five parts to identify the safe and pharmacologically active doses (MTD and/orRP2D) and regimen for oral VMD-928 monotherapy and in combination with a PD-1 inhibitor, pembrolizumab in cancer patients. An immunohistochemistry (IHC) assay specific for detecting TrkA protein in tumor tissue samples has been validated and is being used to detect TrkA protein expressions in patient tumor tissue samples at Pre-screening. The study is currently focusing on the top 5 solid tumor with the highest Tr…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: #. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma: Phase 1 Dose Escalation only: Subjects with (A) any advanced solid tumors of 1. Head and Neck Cancers ("HNC") (of any types), 2. Esophageal cancer, 3. Lung cancers (of any types), 4. Mesothelioma, 5. Pancreatic cancers, Or, (B) any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R/R/I) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be…
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
- Hartford Hospital (site 210)Hartford, Connecticut
- The George Washington University Cancer Center (site 212)Washington D.C., District of Columbia
- Holy Cross Hospital (site 213)Fort Lauderdale, Florida
- Memorial Cancer Institute at Memorial Healthcare Systems (site 132)Pembroke Pines, Florida
- Englewood Hospital and Medical Center (site 202)Englewood, New Jersey