Is NCT03556228 recruiting in Florham Park, NJ?

Yes, NCT03556228 is currently recruiting participants at its Florham Park, NJ location. This head and neck carcinoma clinical trial is actively enrolling qualified participants.

How do I join the head and neck carcinoma clinical trial in Florham Park?

To join this clinical trial in Florham Park, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Florham Park clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Head and Neck Carcinoma Clinical Trial in Florham Park, NJ

About This Head and Neck Carcinoma Study in Florham Park

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

Sponsor: VM Oncology, LLC

Who Can Participate

Inclusion Criteria

#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma: Phase 1 Dose Escalation only: Subjects 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 curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible. Phase 2 Monotherapy and Combination with Pembrolizumab only: Subjects must have

TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,

any NTRK1+ solid tumors or lymphoma\*, that is R/R/I to SOC. Key Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.

Able to swallow and retain oral medication.

Subjects 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

Exclusion Criteria

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 \&amp;amp;gt; 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 jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.

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 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.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Florham Park?

Yes, this clinical trial (NCT03556228) has an active research site in Florham Park, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Head and Neck Carcinoma Treatment Options in Florham Park, NJ

If you're searching for head and neck carcinoma treatment options in Florham Park, NJ, this clinical trial (NCT03556228) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Florham Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced head and neck carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all head and neck carcinoma clinical trials near you to find additional studies recruiting in your area.

Head and Neck Carcinoma Clinical Trial in Florham Park, NJ

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