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VMO-01C: An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects with Solid Tumors or Lymphoma

Clinical Trial Details

This is a clinical trial for adults with cancer, which has continued to grow despite the treatments already received, because the standard drugs used to treat the disease are no longer working, because the tumor cells are resistant to available treatments, or subjects are not a candidate for or intolerant of other available treatments. The subjects with solid tumors and lymphoma are eligible for this trial.
   

The major purposes of this study are to determine the maximum dose of the study drug VMD-928 that can be tolerated in humans, and once this dose is found, if it has any effect in subjects with solid tumors or lymphoma. This study is being performed:

  • To test the safety of the study drug and see what effects (good and bad) it has on people and cancer

  • To find the highest dose of the study drug that can be given without causing serious side effects when treatment is given every day from Day 1 to Day 21 of a 28-day cycle

  • To find the dose of the study drug that should be used in future studies

  • To learn what the human body does to the study drug

  • To test how much of the study drug gets into the bloodstream and how long the body takes to get rid of it

Certain DNA, RNA and proteins in the blood and/or in tumors that the study drug acts to may also be tested to learn which doses of study drug cause a change in those characteristics of the tumor after treatment with the study drug.

VMD-928 is an investigational new drug being tested in people with a solid cancer tumor or lymphoma that is not responsive to standard therapies or had progressed following standard therapy and for which there is no approved or curative therapy. “Investigational” means that the study drug has not been approved for sale in the United States by the U.S. Food and Drug Administration (FDA). The FDA is the U.S. government agency that reviews the results of research and decides if a drug can be sold in the U.S.

This study drug has never been given to people prior to this study. This is a first time in human study. It has only been tested in animals, and in the lab and in a limited number of human cancer subjects in Part 1 of this study. VMD-928, which selectively and potently blocks activation of human TrkA, an enzyme protein which is believed to speed cancer growth in some cancer types. VMD-928 has also been shown to decrease pain in animal studies. In animals, VMD-928 given alone has decreased the growth rate of some types of tumors. It has not been approved yet by the government for doctors to prescribe for patients.

VMD-928 is taken orally (by mouth) twice a day.
   
Subject may remain in the study as long as they are benefitting from it.

Key Eligibility: 
  • Open to men and women above the age of 18 who have been diagnosed with solid tumor malignancy or lymphoma

  • Solid tumor malignancy or lymphoma that is not responsive to standard therapies or had progressed following standard therapy and for which there is no approved or curative therapy

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Victoria Dai
(212) 746-2225
vid9053@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2004021968

ClinicalTrials.gov:

NCT03556228

Sponsor:

VMO-01C

Status

Open to Enrollment

Age Group

Adult

Sponsor