RECRUITING

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

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Conditions

Head 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 TracheaTrkANTRK1NSCLCPancreaticProgression after anti PD-1/PD-L1 immunotherapyProgressed after an immunotherapyEsophagealSCLCACCHNSCCHNCSalivary Gland CarcinomaNasopharyngealThroatTonsilsHypopharynxLarynxOral CavityOropharynxTrachea

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2018-06-08
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03556228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Head and Neck Cancers ("HNC") (of any types),
  2. 2. Esophageal cancer,
  3. 3. Lung cancers (of any types),
  4. 4. Mesothelioma,
  5. 5. Pancreatic cancers,
  6. 1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,
  7. 2. any NTRK1+ solid tumors or lymphoma\*, that is R/R/I to SOC.
  1. * Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).
  2. * Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks.
  3. * 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.
  4. * 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.
  5. * Known active infections including HIV disease.
  6. * Currently pregnant, nursing, or planning to become pregnant during the course of the study.
  7. * QTcF interval ≥ 480 msec.
  8. * Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
  9. * Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.
  10. * Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.
  11. * Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.
  12. * Patient has had or is currently having other malignant tumors within 3 years.
  13. * Patients have multiple factors that affect their oral medication.
  14. * Patients have long-term unhealed wounds or fractures.
  15. * Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
  16. * Patients are taking the following drugs and can't stop them during the study:
  17. * Tylenol or medicine containing acetaminophen (paracetamol).
  18. * Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.
  19. * Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.
  20. * Negative result on TrkA immunohistochemistry (IHC) assay.
  21. * Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)
  22. * Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\>6 weeks).
  23. * Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.
  24. * For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.
  25. * Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.

Contacts and Locations

Study Contact

Jay Wu, PhD
CONTACT
1-510-270-2790
OM@VMOncology.com

Principal Investigator

Clinical Development
STUDY_CHAIR
VM Oncology

Study Locations (Sites)

Providence Medical Foundation (site 209)
Santa Rosa, California, 95403
United States
Hartford Hospital (site 210)
Hartford, Connecticut, 06102
United States
The George Washington University Cancer Center (site 212)
Washington D.C., District of Columbia, 20037
United States
Holy Cross Hospital (site 213)
Fort Lauderdale, Florida, 33308
United States
Memorial Cancer Institute at Memorial Healthcare Systems (site 132)
Pembroke Pines, Florida, 33028
United States
Englewood Hospital and Medical Center (site 202)
Englewood, New Jersey, 07631
United States
Summit Medical Group (site 205)
Florham Park, New Jersey, 07932
United States
Atlantic Health System, Morristown Medical Center (site 124)
Morristown, New Jersey, 07962
United States
Presbyterian Kaseman Hospital (site 208)
Albuquerque, New Mexico, 87110
United States
Weill Cornell Medicine, Cornell University (site 126)
New York, New York, 10065
United States
Taylor Cancer Research Center (site 204)
Maumee, Ohio, 43537
United States
Cancer Care Associates of York (site 206)
York, Pennsylvania, 17403
United States
The University of Texas MD Anderson Cancer Center (site 127)
Houston, Texas, 77030
United States
Utah Cancer Specialists (site 203)
Salt Lake City, Utah, 84106
United States

Collaborators and Investigators

Sponsor: VM Oncology, LLC

  • Clinical Development, STUDY_CHAIR, VM Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-08
Study Completion Date2028-06

Study Record Updates

Study Start Date2018-06-08
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • TrkA
  • NTRK1
  • Head and Neck Carcinoma
  • Adenoid Cystic Carcinoma
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Mesothelioma
  • Pancreatic
  • Progression after anti PD-1/PD-L1 immunotherapy
  • Progressed after an immunotherapy
  • Esophageal
  • SCLC
  • ACC
  • HNSCC
  • Head and Neck Cancers
  • HNC
  • Salivary Gland Carcinoma
  • Nasopharyngeal
  • Throat
  • Tonsils
  • Hypopharynx
  • Larynx
  • Oral Cavity
  • Oropharynx
  • Trachea

Additional Relevant MeSH Terms

  • 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