Salivary Gland Cancer

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PETCT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are studying the safety and tolerability of increasing doses of 177LuLu-AKIR001, a drug targeting CD44v6-expressing solid tumors that cannot be surgically removed or have spread. This early phase 1 trial focuses on patients with advanced cancers such as thyroid gland anaplastic carcinoma, poorly differentiated thyroid carcinoma, head and neck cancer, cervix carcinoma, vulvar cancer stage IV, and non-small cell lung cancer stage IV, who have no other reasonable treatment options. The main goal is to understand the toxicity profile of 177LuLu-AKIR001 by monitoring dose-limiting toxicities and serious adverse events.

Researchers are studying tumors that have somatostatin receptors SSTRs on their surface, which include tumors in the lung, head and neck, digestive tract, kidneys, and adrenal glands. This trial tests a drug called 212PbVMT-Alpha-NET, which is designed to target these receptors and potentially help shrink tumors that have spread and cannot be removed surgically. The study focuses on people aged 18 and older with these specific types of tumors and aims to determine the maximum tolerated dose and safety of the drug. Participants receive 212PbVMT-Alpha-NET through a vein on the first day of four 8-week cycles. Some participants will also receive a related imaging drug, 203PbVMT-Alpha-NET, a few days before the first two treatment cycles to allow whole-body scans that track how the drug spreads in the body. After each infusion, participants stay in the hospital for a few nights and have weekly blood tests during each treatment cycle. The study includes dose escalation to find the best dose and then dose expansion at that dose level. Throughout the study, participants undergo physical exams, blood and urine tests, imaging scans including PETCT and SPECTCT, heart function tests, and may provide tumor tissue samples if needed. Follow-up visits occur about 30 days after treatment ends, then every 12 weeks for up to 3 years, with annual check-ins continuing up to 6 years after the last treatment. Researchers monitor safety, response to treatment, and survival outcomes during this time.

Many patients receiving radiation therapy for head and neck cancer develop painful mouth sores called oral mucositis, causing severe pain that lasts through and beyond treatment. This study evaluates whether BupiZenge, a lozenge containing the long-acting pain reliever bupivacaine, provides better pain control than lidocaine solution. The trial aims to see if improved pain management with BupiZenge enhances quality of life and reduces opioid use in adults aged 18 to 80 with head and neck cancer undergoing radiotherapy. Participants are randomly assigned to receive either BupiZenge lozenges or lidocaine oral solution. BupiZenge is taken as one lozenge that dissolves slowly in the mouth with a dosing interval of at least 3 hours, up to 8 lozenges per day. Lidocaine is used as an oral solution held in the mouth, also every 3 hours as needed, with a maximum daily dose of 120 mL. The study includes a combined screening and run-in period up to five weeks, followed by treatment during radiotherapy and for up to six weeks total if pain and sores persist after radiotherapy. Participants will record their mouth pain daily using a 0 to 10 scale, with primary measurement focusing on pain reduction over 3 hours after taking the study treatment on the last day of radiotherapy. Additional assessments include pain at other time points, opioid use, quality of life questionnaires, laboratory tests, and safety monitoring. After treatment, there is a 30-day follow-up period to evaluate lasting effects and safety outcomes.

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are evaluating ALX2004, an antibody drug conjugate targeting EGFR, in adults with advanced or metastatic selected solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer. This Phase 1, open-label, multicenter study aims to find the appropriate dose and assess safety and response in participants who have previously received treatment for these cancers. The study is sponsored by ALX Oncology Inc. and plans to enroll up to 170 patients. The study includes three parts Phase 1a Dose Escalation with increasing doses of ALX2004 to find a safe dose, Phase 1a Dose Exploration where selected doses are further tested in specific tumor types, and Phase 1b Dose Expansion where the recommended dose is given to more patients. ALX2004 is given by intravenous infusion, and dosing is adjusted depending on the study phase and tumor type. Participants will have regular assessments including safety monitoring for dose limiting toxicities and adverse events, tumor response evaluations using RECIST criteria, and measurement of drug levels in the blood. Follow-up can last up to two years from the first dose. The study records outcomes like overall response rate, progression-free survival, and overall survival to understand ALX2004s effects. The total duration of participation depends on the treatment phase and follow-up period.

Researchers are exploring how people with breast, colorectal, and head and neck cancers can experience positive psychological changes called post-traumatic growth PTG after their cancer diagnosis and treatment. This project, called IC-Growth, aims to develop and test a new group-based program that helps adults with cancer improve their well-being, resilience, and quality of life beyond their pre-diagnosis levels. The study also seeks to create health policy recommendations to enhance psychosocial support for cancer patients in Greece. The research includes a randomized controlled trial comparing a manualized group intervention with standard follow-up care. The intervention is delivered in groups of 8-10 participants with the same cancer type and consists of 6-8 weekly 90-minute sessions led by trained psychologists. It uses techniques such as Acceptance and Commitment Therapy, mindfulness, cognitive restructuring, narrative exercises, and interpersonal support to promote growth in areas like self-perception, relationships, and life appreciation. The control group receives only standard oncology follow-up care. Participants will complete assessments before and after the intervention, measuring post-traumatic growth, quality of life, spiritual well-being, anxiety, depression, illness perceptions, distress, and stress biomarkers like cortisol. The study lasts about 6-8 weeks for the intervention period, with evaluations at baseline and post-intervention. This comprehensive approach integrates research and health policy to improve psychosocial care and support for people with cancer.

Researchers are evaluating a personalized physical activity program using motion exergames to help head and neck cancer patients manage fatigue and musculoskeletal pain during the first 6 months after their treatment. The study aims to compare this intervention, called PAfitME, to an attention control group receiving survivorship education and exergame equipment. The goals include measuring effects on fatigue, pain, functional status, and quality of life while exploring factors like physical activity self-efficacy and enjoyment that might influence results. The PAfitME intervention lasts 6 weeks and includes weekly sessions starting with an in-home setup, followed by FaceTime coaching calls and additional home visits. Participants receive personalized exergame prescriptions using platforms such as Wii Fit and Xbox Kinect, with progress adjustments during the program. The control group also receives exergame equipment and education from the National Cancer Institute but without the personalized coaching. Participants are monitored at the start and end of the 6-week period through patient-reported fatigue and pain scales, functional status tests including walk and grip strength tests, range of motion measurements, and quality of life questionnaires. The study involves 150 post-treatment head and neck cancer patients and uses statistical models to analyze outcomes. The total participation time is 6 weeks, with interventions delivered mainly at home and via telehealth.

Researchers are collecting de-identified tumor samples along with clinical and demographic data from cancer patients who have had or are scheduled for a tumor biopsy before starting treatment with PD-1PD-L1 inhibitors. The study aims to use these samples and information to develop and validate a diagnostic test that may help predict how patients respond to immunotherapy. This observational study involves multiple types of cancer including head and neck, lung, breast, and others. Participants are included if they have one of several specified cancers and have undergone or will undergo a tumor biopsy before beginning anti-PD-1PD-L1 treatment. The study does not require extra biopsies beyond those collected as part of standard care. Patients must have had medical imaging of the tumor before treatment and provide consent for their tissue and data to be used in related future studies. The main diagnostic tool studied is the OncoPrism assay, which analyzes the immune components of tumor tissue. During the study, participants tumor specimens and medical data are collected and de-identified to protect privacy. Researchers will review how patients respond to PD-1PD-L1 inhibitors over six months. No additional treatments or procedures are required beyond standard care and consent. The study is sponsored by Cofactor Genomics, Inc., and participation involves tracking tumor biopsy samples and clinical outcomes over time until the study ends in February 2027.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and preliminary anti-tumor activity of increasing doses of EPI-326 in patients with locally advanced or metastatic head and neck squamous cell carcinoma HNSCC and those with EGFR-mutant locally advanced or metastatic non-small cell lung cancer NSCLC. This first-in-human, phase 1 multicenter, open-label study aims to determine appropriate dosing and assess initial effects of EPI-326 in these patients. EPI-326 is a tissue-selective bispecific antibody targeting EGFR-driven cancers and is administered by intravenous infusion in the clinic. Patients will receive escalating doses of EPI-326 as a single agent until they experience disease progression, unacceptable side effects, choose to withdraw, or the study ends. This study includes a dose escalation period to identify the recommended dose and schedule for administration. Participants will be monitored for safety and tolerability, with assessments including blood tests to measure drug concentration over time, clearance, and distribution. Researchers will also evaluate tumor response and duration of response over a period of up to three years. The study involves continuous treatment and follow-up visits to observe effects and manage any adverse events during the trial period.