Health Trials

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

ConditionsHead and Neck CarcinomaAdenoid Cystic CarcinomaLung CancerNon-Small Cell Lung CancerPancreatic CancerMesotheliomaEsophageal CancerAny Solid Tumors Progressed After a Prior ImmunotherapyHead and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma HNSCCSalivary Gland CarcinomasHead and Neck Cancers - Salivary GlandHead and Neck Cancers - NasopharyngealHead and Neck Cancers - ThroatSmall Cell Lung Cancer ( SCLC )Lung Cancer (Locally Advanced or Metastatic)Head and Neck Cancers - TonsilsHead and Neck Cancers HypopharynxHead and Neck Cancers LarynxHead and Neck Cancers LipHead and Neck Cancers NasopharynxHead and Neck Cancers Oral CavityHead and Neck CancersHead and Neck Cancers OropharynxHead and Neck Cancers Trachea
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVM Oncology, LLC

About this trial

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

Eligibility criteria

Qualifiers

Head and Neck Cancers ("HNC") (of any types),

Esophageal cancer,

Lung cancers (of any types),

Mesothelioma,

Disqualifiers

Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).

Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks.

Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.

Unresolved toxicity from previous anticancer therapy > CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.

Trial design

Treatments tested in this trial

  • VMD-928 100 mg Tablet
  • VMD-928 Tablet and Pembrolizumab (200 mg)

Treatment groups

242 Participants
are divided into 2 treatment groups

Locations

15
Puerto Rico
PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)00935, San Juan Puerto Rico
United States
California
Providence Medical Foundation (site 209)95403, Santa Rosa United States
Connecticut
Hartford Hospital (site 210)06102, Hartford United States
District of Columbia
The George Washington University Cancer Center (site 212)20037, Washington D.C. United States

Sponsors and collaborators

VM Oncology, LLC

Lead sponsor

Source ClinicalTrials.gov