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Researchers are conducting an open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the effectiveness and safety of PET imaging using [18F]PI-2620 for detecting tau protein buildup in people with Alzheimer's disease and control subjects. The study compares PET imaging results during life with brain tissue analysis obtained after death through autopsy, aiming to improve diagnosis of tau-related brain changes. Participants will receive an intravenous injection of the radioligand [18F]PI-2620 at a dose of 185 MBq 20%. The PET imaging will be performed to visualize tau deposits in the brain. This study focuses on assessing the diagnostic accuracy of this imaging method by comparing it to post-mortem histopathology findings. Throughout the study, participants will undergo PET scans and assessments to determine the presence and extent of tau pathology. The primary outcome measure is the ability of visual assessment of [18F]PI-2620 PET images to correctly distinguish tau neurofibrillary pathology associated with Alzheimer's disease, confirmed at autopsy within about one year. Safety and tolerability during imaging procedures will also be monitored, with a total participation period depending on the timing of brain autopsy after death.

Researchers are studying a new treatment for HIV-1 infection that combines two medicines, islatravir and ulonivirine, taken once weekly. The goal is to see if this new study treatment works as well as the standard antiretroviral therapy (ART), which usually involves taking up to three medicines once or twice daily. This research also aims to learn about the safety and tolerability of the study treatment compared to the standard ART. The study compares the once-weekly combination of islatravir and ulonivirine with the standard daily treatment of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Participants will take either the study drugs or the standard drugs for 96 weeks. Some participants may receive matching placebos as part of the study design. The treatment is given orally as capsules or tablets according to the assigned group. Participants will be monitored throughout the study with regular assessments, including measuring the amount of HIV-1 virus in the blood to see if it is suppressed below 50 copies/mL at weeks 24 and 48. The study will also track any side effects or adverse events and whether participants stop the treatment due to these events. Overall, the study lasts about 96 weeks, with ongoing safety and effectiveness evaluations to understand how well the treatments work and how safe they are over time.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are evaluating the safety, effectiveness, best dose, and how the body processes (pharmacokinetics) an investigational drug called BNT326. This study includes people with advanced solid tumors that are metastatic, recurrent, or have progressed after previous treatments. The investigation is divided into two parts: Part 1 tests BNT326 alone, and Part 2 studies BNT326 alone or combined with other immunotherapy drugs, including pumitamig (BNT327). Participants have specific tumor types like melanoma, non-small cell lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer, among others. In Part 1, participants receive BNT326 by intravenous infusion in various groups based on cancer type and prior treatments. Part 2 involves BNT326 given alone or with pumitamig, also by intravenous infusion, in several defined cancer groups. Some groups are randomized to receive different dose levels or combinations to find the optimal treatment plan. The study includes a screening phase, treatment phase lasting up to 24 months or until progression or unacceptable side effects, a safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 38 months for Part 1 and 48 months for Part 2. During the study, participants undergo regular assessments including measuring tumor response using RECIST criteria, monitoring for side effects and serious adverse events up to months after treatment ends, and measuring drug levels in the blood. Researchers track treatment interruptions or discontinuations due to side effects and evaluate dose-limiting toxicities. Tumor tissue samples are required before enrollment. Safety and effectiveness data are collected throughout treatment and follow-up periods to understand how well BNT326 works alone or combined and its safety profile.

Researchers are evaluating VVD-130037, a new investigational drug, in people with advanced solid tumors. This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of VVD-130037 alone and combined with chemotherapy drugs docetaxel or paclitaxel, or with the immunotherapy drug pembrolizumab. The study focuses on participants whose cancers have progressed despite previous standard treatments and includes specific groups such as those with squamous non-small cell lung cancer or head and neck squamous cell carcinoma. The study consists of two parts: a dose escalation phase where participants receive VVD-130037 alone or in combination with docetaxel, paclitaxel, or pembrolizumab to determine safe dosage and observe dose-limiting toxicities. Cycle lengths are 21 days for single agent and docetaxel/pembrolizumab combinations and 28 days for the paclitaxel combination. The dose expansion phase involves further evaluation of safety, adverse events, serious adverse events, and laboratory abnormalities over up to approximately four years. Participants will undergo evaluations including tumor measurements based on RECIST criteria, performance status checks, and organ function tests. Safety is closely monitored during the early dose-limiting toxicity periods and throughout the study. Researchers will collect data on side effects, lab results, and overall clinical status to understand how the treatments affect participants over time. The study includes regular follow-up visits and assessments to ensure participant safety and gather comprehensive treatment information.

Researchers are conducting a first-in-human phase 1 study to evaluate MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adults with advanced breast cancer. This study focuses on participants whose cancer has recurred locally or metastasized and who have limited treatment options after prior therapies. The trial aims to assess the safety and appropriate dosing of MEN2312, alone or combined with elacestrant, an oral drug also being studied. Participants will receive MEN2312 tablets orally, either as a single treatment or alongside elacestrant tablets. The study allows participants who have undergone up to six prior systemic therapies for advanced disease, including chemotherapy or antibody drug conjugates. The study involves careful selection of participants based on genetic alterations in their tumor tissue related to PIK3CA, AKT1, or PTEN genes. Throughout the trial, researchers will monitor participants for dose-limiting toxicity over the first 28 days and determine the recommended phase 2 dose by six months. Safety assessments, treatment response, and side effects will be tracked closely. Participation requires ongoing evaluations to measure how the participant's cancer responds and to ensure safety while receiving the study treatments.

This research aims to evaluate the long-term safety and effectiveness of pirtobrutinib in patients with Chronic Lymphocytic Leukemia or Non-Hodgkin Lymphoma. It uses a master protocol design that includes participants from previous clinical studies (called originator studies) of pirtobrutinib. These participants can continue treatment or follow-up as part of this ongoing evaluation. Participants receive pirtobrutinib orally, continuing from their prior originator studies. The master protocol oversees individual study-specific appendices (ISAs) that include these participants, allowing for a structured and continuous assessment of the treatment's long-term use. During the study, researchers monitor the occurrence of significant treatment-related adverse events from the first dose until 30 days after the last dose or the start of a new anticancer therapy. This includes tracking and evaluating safety outcomes to better understand the long-term effects of pirtobrutinib in these patient populations.

Researchers are evaluating the safety and tolerability of the investigational drug KST-6051 in adults with advanced or metastatic solid tumors that have specific KRAS mutations. This includes cancers such as pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer that have progressed after prior treatments or could not tolerate standard therapies. This is a first-in-human, phase 1, open-label, multicenter trial designed to assess multiple aspects including pharmacokinetics, biomarkers, pharmacodynamics, and early signs of activity of KST-6051. Participants will receive KST-6051 orally as a tablet in a dose escalation phase, where doses will increase in subsequent groups to evaluate safety and tolerability. Those who benefit and tolerate the treatment can remain in the trial for ongoing therapy. The study includes monitoring for dose-limiting toxicities during the first 21-day treatment cycle and further safety assessments throughout the trial. During the trial, participants will undergo evaluations including safety and adverse event monitoring for up to about two years. Researchers will assess treatment-emergent and treatment-related adverse events, pharmacokinetics, and various biomarkers. Participants must have measurable disease and adequate organ function, and they will be followed for effectiveness and safety outcomes as long as they continue treatment and meet study criteria.

Researchers are evaluating CTX-8371, a drug given as a monotherapy, in adults with advanced or metastatic cancers that have not responded to standard treatments. This Phase 1, open-label study focuses on assessing the safety, tolerability, immune response, and how the body processes CTX-8371. The study involves patients with several cancer types, including non-small cell lung cancer, triple negative breast cancer, Hodgkin lymphoma, head and neck squamous cell carcinoma, and malignant melanoma. The trial is divided into two groups: Dose Escalation and Dose Expansion cohorts. In the Dose Escalation cohort, patients receive intravenous infusions of CTX-8371 every two weeks at gradually increasing doses from 0.1 to 10.0 mg/kg to determine safe dose levels. The Dose Expansion cohort receives fixed doses of 3.0 mg/kg or 10.0 mg/kg through IV infusion every two weeks. Treatment continues for an average of six months in Dose Escalation and up to two years in Dose Expansion, with safety monitoring extending 30 days after the last dose. The study uses a 3+3 design for dose testing and allocates Dose Expansion patients equally between the two dose levels. Participants undergo regular evaluations including safety and tolerability assessments, immune response tests, and pharmacokinetic studies to understand how CTX-8371 behaves in the body. Tumor response is also preliminarily assessed. Patients need to meet specific health criteria, and the study tracks adverse effects throughout treatment and for 30 days afterward. Total participation may last up to two years depending on the cohort, ensuring thorough monitoring and data collection on CTX-8371's profile and impact.

Researchers are evaluating CPO301, an antibody drug conjugate, in adults with advanced or metastatic solid tumors. This Phase 1 study aims to determine the safe and tolerable dose of CPO301, assess how the body processes it, monitor for immune responses against the drug, and explore its preliminary effectiveness. The study focuses on patients who have progressed after prior treatments or are unable or unwilling to undergo standard therapies, including those with Non-Small Cell Lung Cancer (NSCLC) and other tumor types. The study is divided into two parts. Part A involves dose escalation using a modified 3+3 design to find the maximum tolerated dose or recommended Phase 2 dose by administering CPO301 intravenously every 3 weeks. Dose adjustments and additional dose groups may be added to find the optimal dose. In Part B, patients receive CPO301 at the determined safe dose, focusing on NSCLC patients with EGFR mutations and possibly other cancers sensitive to the drug, with treatment continuing until the doctor advises stopping. Participants will provide informed consent and undergo screening to confirm eligibility. They will attend regular study visits for treatment and monitoring, including imaging scans to measure tumor response. Safety and tolerability will be assessed throughout, with follow-up visits every 3 months for up to 2 years to track disease progression and long-term effects. The study aims to complete assessments over about one year, focusing on dosing and safety outcomes.