NCT03556228

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: VM Oncology, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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 TrkA protein overexpression are: Head and Neck Cancers (HNC), Esophageal cancer, Lung cancers, Mesothelioma, and Pancreatic Cancer.

Conditions

• Head and Neck Carcinoma
• Adenoid Cystic Carcinoma
• Lung Cancer
• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Mesothelioma
• Esophageal Cancer
• Any Solid Tumors Progressed After a Prior Immunotherapy
• Head and Neck Squamous Cell Carcinoma
• Head and Neck Squamous Cell Carcinoma HNSCC
• Salivary Gland Carcinomas
• Head and Neck Cancers - Salivary Gland
• Head and Neck Cancers - Nasopharyngeal
• Head and Neck Cancers - Throat
• Small Cell Lung Cancer ( SCLC )
• Lung Cancer (Locally Advanced or Metastatic)
• 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
• Head and Neck Cancers Oropharynx
• Head and Neck Cancers Trachea

Interventions

Type	Name	Description
DRUG	VMD-928 100 mg Tablet	Taken orally once daily for 21 days per 21-day cycle
DRUG	VMD-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.

Timeline

• Start date: 2018-06-08
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2018-06-14
• Last updated: 2025-12-11

Locations

15 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study