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

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

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

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.

Sponsors & Collaborators

• VM Oncology, LLC

  lead INDUSTRY

Principal Investigators

• Clinical Development · VM Oncology

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-08

Primary Completion

2027-12-31

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations