Fair Oaks

Lung cancer, specifically non-small cell lung cancer NSCLC, is a common cancer type where abnormal lung cells grow rapidly, disrupting normal lung function. This study focuses on adults with advanced NSCLC that cannot be removed by surgery or has spread to other body parts. Researchers are investigating TAK-928, a new immunotherapy designed to activate immune cells called T cells to better attack tumor cells, comparing it to the standard treatment, docetaxel, in adults whose cancer has resisted prior chemotherapy and immunotherapy. Participants receive either TAK-928, an antibody treatment given by intravenous infusion that targets specific immune pathways to activate T cells and natural killer cells, or docetaxel, a chemotherapy drug also given by intravenous infusion. Treatment may last up to two years depending on response and side effects. This is a randomized study with parallel groups where TAK-928s ability to improve immune response and tumor control is being compared directly to docetaxel. During the study, participants will visit the clinic multiple times for treatment and monitoring. Researchers will assess tumor response using imaging scans, monitor survival, and evaluate safety including side effects. Additional tests will measure immune response, drug levels in the body, and quality of life through questionnaires. Participants will be followed until treatment ends, with assessments continuing to track outcomes for up to 26 months.

Researchers are conducting a phase 1, multicenter, nonrandomized, open-label study to evaluate YL201 in patients with advanced solid tumors that have not responded to current treatments or lack standard therapy options. The study includes two parts Part 1 focuses on finding the maximum tolerated dose and recommended dose levels through dose escalation, while Part 2 enrolls patients with selected tumor types to further assess safety and efficacy of YL201. Participants will receive YL201 as an intravenous infusion once every three weeks in cycles. Some patients may receive YL201 alone at different dosages or in combination with atezolizumab during each 21-day cycle. Part 1 involves dose escalation cohorts to determine appropriate dosing, followed by Part 2 dose expansion cohorts to better define safety and evaluate treatment responses. Throughout the study, participants undergo tumor evaluations using RECIST criteria, laboratory tests, and safety monitoring to track adverse events, dose-limiting toxicities, and pharmacokinetics. For prostate cancer patients, prostate-specific antigen response and progression-free survival will be measured. The study lasts approximately 36 months, with ongoing assessments of tumor response, survival, and laboratory abnormalities conducted at regular intervals.

Researchers are evaluating a new mRNA vaccine that combines protection against both seasonal flu and COVID-19 in healthy adults aged 65 to 85 years. This early-stage Phase 1 study aims to assess the safety and immune response of this investigational vaccine compared to standard licensed flu and COVID-19 vaccines. The study is focused on measuring side effects and how well the vaccine builds protection against both infections. Participants will receive a single intramuscular injection of either one of three dose levels of the investigational mRNA combination vaccine, a licensed seasonal flu vaccine, or a licensed COVID-19 vaccine. The study groups are randomized and observer-blind. The investigational vaccine is given as a single dose, with three different dosage levels being tested sequentially for safety and immune response. During the study, participants will be monitored for side effects from the day of vaccination through several time points up to 181 days. Blood samples will be collected at specified intervals to evaluate immune responses against flu and COVID-19. The main measures include the number of participants experiencing laboratory abnormalities and adverse events, as well as immune protection markers such as antibody levels and seroconversion rates. The total participation spans from vaccination day through about six months of follow-up.

Researchers are evaluating the safety and effectiveness of Halneuron, given as a series of subcutaneous injections, for patients experiencing chemotherapy-induced neuropathic pain CINP. This randomized, double-blind, placebo-controlled Phase 2 study aims to compare Halneuron with placebo injections in managing pain caused by chemotherapy drugs such as platinum and taxane. Participants may have the option to continue in an open-label extension phase where all will receive Halneuron. Participants will be randomly assigned to receive either Halneuron or placebo by subcutaneous injection. After completing the randomized phase, those who choose to continue may enter an open-label extension where every participant receives Halneuron. The study includes careful monitoring during both phases to evaluate the treatments effects and safety. Throughout the study, participants will be closely monitored for pain levels using the Numeric Rating Scale NRS and safety assessments over a four-week period. Additional measurements include patient impressions of change, fatigue, sleep quality, and overall quality of life using standardized questionnaires. The total participation time includes the randomized phase and optional extension, providing ongoing evaluation of Halneurons impact on chemotherapy-induced neuropathic pain.

This research aims to evaluate the safety and immune response of a new pneumococcal vaccine called PG4 in children and adolescents aged 15 months to 18 years. It compares this new vaccine to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC, focusing on how both vaccines help protect against infections like pneumonia, meningitis, and ear infections caused by Streptococcus pneumoniae. The study is a phase 3 trial conducted internationally, including the United States and Puerto Rico. Participants are divided into three age groups 15 months to less than 2 years, 2 years to less than 5 years, and 5 years to less than 18 years. Within each group, participants are randomly assigned in a 21 ratio to receive a single injection of either the new PG4 vaccine or the 20vPnC vaccine. The vaccine is administered intramuscularly in the arm or thigh. The study lasts about 6 months and involves 2 clinic visits and 1 telephone follow-up. During the clinic visits, blood samples are taken to measure immune responses and participants are monitored for any side effects or adverse events. Researchers assess local and systemic reactions within 7 days after vaccination, adverse events up to 1 month, and serious adverse events up to 6 months after vaccination. The main outcomes include measuring specific antibody levels to evaluate the immune response. Participants are contacted by phone for a follow-up to check for any further side effects, ensuring ongoing safety monitoring throughout the study.