Salivary Gland Cancer

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PET/CT 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, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT 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 PET/CT 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 [177Lu]Lu-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 [177Lu]Lu-AKIR001 by monitoring dose-limiting toxicities and serious adverse events.

Researchers are studying a new cancer treatment called [212Pb]VMT-Alpha-NET for tumors that have somatostatin receptors (SSTRs) on their surface. These tumors include those found in the lungs, head and neck, digestive tract, kidneys, and adrenal glands. The study focuses on people with tumors that have spread and cannot be removed by surgery. The goal is to find the highest safe dose of this drug and evaluate its safety and effects on these cancers. The treatment involves giving [212Pb]VMT-Alpha-NET through a vein on the first day of each 8-week cycle, for a total of four cycles. Some participants will also receive a related imaging drug, [203Pb]VMT-Alpha-NET, a few days before the first two cycles to track where the drug travels in the body using scans. After each dose, participants will stay in the hospital for a few nights and have weekly blood tests during each cycle. Participants will have physical exams, blood and urine tests, heart function tests, and imaging scans before and during the study. Researchers will monitor safety, drug effects, and tumor response through scans, lab tests, and questionnaires. Follow-up visits will continue for up to six years after the last treatment to check on long-term outcomes and overall health.

Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.

Researchers are evaluating the safety, tolerability, and effectiveness of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that tests positive for human papillomavirus 16 (HPV16) and expresses the protein PD-L1. This Phase II/III trial includes patients whose tumors have a combined positive score of 1 or higher for PD-L1. The study is designed to generate important safety and efficacy data for these treatments in this patient group. The trial consists of two parts: Part A is a non-randomized safety run-in phase to confirm the safety and tolerability of BNT113 with pembrolizumab. Part B is a randomized phase comparing BNT113 combined with pembrolizumab versus pembrolizumab alone. Treatments are given by intravenous injection or infusion. Patients may receive treatment for up to 24 months. An optional pre-screening phase allows tumor samples to be tested centrally for HPV16 DNA and PD-L1 expression before entering the main trial. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events, overall survival, and progression-free survival for up to 48 months. Researchers will also measure response rates and duration, disease control, and any dose adjustments due to side effects. Patients provide tumor tissue samples before treatment and are monitored closely throughout the study period. The trial aims to collect comprehensive data on safety, treatment effects, and patient outcomes over this extended follow-up.

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 ALX2004's 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-1/PD-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-1/PD-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-1/PD-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 early anti-tumor activity of increasing doses of EPI-326 in patients with locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). This Phase 1 study is the first to test EPI-326 in humans and aims to understand how the drug behaves and affects these cancers. Participants will receive EPI-326 as a single agent through intravenous infusion in a dose escalation design to find the recommended dose and schedule. Treatment will continue until the disease progresses, unacceptable side effects occur, the participant withdraws consent, or the study ends. The study is open-label and conducted at multiple centers. During the study, participants will be monitored for safety and tolerability of EPI-326 for up to three years. Blood samples will be taken to measure drug levels and how the body processes it. Researchers will also assess tumor response, including the objective response rate and duration of response. Participants' organ function and overall health status will be evaluated regularly to ensure safety throughout the study period.