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New treatment option for Head and Neck Carcinoma
Official title VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
ClinicalTrials.gov ID: NCT03556228
What this study is testing
What is VMD-928 100 mg Tablet?
VMD-928 100 mg Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for head and neck carcinoma.
Also referred to as Monotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Key #. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma: Phase 1 Dose Escalation only: people...
- Head and Neck Cancers ("HNC") (of any types),
- Esophageal cancer,
- Lung cancers (of any types),
- Mesothelioma,
You likely can't join if
- 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...
- Unresolved toxicity from previous anticancer therapy \> CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical...
- Known active infections including HIV disease.
- Currently pregnant, nursing, or planning to become pregnant during the course of the study.
See the full eligibility criteria
- Key #. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma: Phase 1 Dose Escalation only: people with (A) any advanced solid tumors of
- Head and Neck Cancers ("HNC") (of any types),
- Esophageal cancer,
- Lung cancers (of any types),
- Mesothelioma,
- Pancreatic cancers, Or, (B) any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R/R/I) to standard of care (SOC) and for which there is no approved or...
- TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,
- any NTRK1+ solid tumors or lymphoma\ , that is R/R/I to SOC. Key
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.
- Able to swallow and retain oral medication.
- people must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.
- Adequate organ system function as defined as follows:
- Absolute neutrophil count ≥1.5x10\^9/L
- Hemoglobin ≥9g/dL
- Platelets ≥100x10\^9/L
- PT/INR, PTT ≤1.5xULN
- Total bilirubin ≤1.5x ULN
- AST, ALT ≤2.5xULN
- Creatinine ≤1.2xULN for age, weight
- Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min Key
- 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...
- 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.
- Known active infections including HIV disease.
- Currently pregnant, nursing, or planning to become pregnant during the course of the study.
- QTcF interval ≥ 480 msec.
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.
- Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.
- 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...
- Patient has had or is currently having other malignant tumors within 3 years.
- Patients have multiple factors that affect their oral medication.
- Patients have long-term unhealed wounds or fractures.
- Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
- Patients are taking the following drugs and can't stop them during the study:
- Tylenol or medicine containing acetaminophen (paracetamol).
- Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.
- Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma. For Phase 2 only:
- Negative result on TrkA immunohistochemistry (IHC) assay.
- Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.) For combination therapy with Pembrolizumab only:
- 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).
- Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.
- For people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Rosa, California, United States
- Hartford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Pembroke Pines, Florida, United States
- Englewood, New Jersey, United States
- Florham Park, New Jersey, United States
- Morristown, New Jersey, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Maumee, Ohio, United States
- York, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- San Juan, Puerto Rico
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Rosa, California, United States; Hartford, Connecticut, United States; Washington D.C., District of Columbia, United States; Fort Lauderdale, Florida, United States; Pembroke Pines, Florida, United States; Englewood, New Jersey, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.