Port St. Lucie

Researchers are evaluating KTX-2001 alone and in combination with darolutamide in men with metastatic castration-resistant prostate cancer mCRPC. This first-in-human, open-label Phase 1 study aims to assess the safety, dosage levels, and preliminary effectiveness of KTX-2001. The study also examines how these drugs behave in the body, intending to establish recommended doses for future research. Participants will receive escalating doses of KTX-2001 either alone or combined with darolutamide, an oral androgen receptor pathway inhibitor given at 600 mg twice daily total 1200 mg. The study has two parts Part A tests KTX-2001 monotherapy, and Part B tests KTX-2001 with darolutamide. Dose escalation occurs sequentially to determine the maximum tolerated dose and recommended Phase 2 dose. Participants will be monitored closely for dose-limiting toxicities over 21 days and overall safety up to three years. Assessments include pharmacokinetic measurements of drug concentrations in plasma and regular evaluations of health and side effects. Tissue biopsies of metastatic sites may be collected if safe and feasible. The study will continue until September 2028, with ongoing safety and efficacy follow-up throughout this period.

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating the safety, efficacy, and optimal dosing of a combination of two investigational treatments, BNT323 trastuzumab pamirtecan and BNT327 pumitamig, in people with advanced breast cancer. This includes those with hormone receptor-positive or -negative, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study is a Phase III multi-site, open-label trial with a focus on advanced breast cancer treatment options. The study has two parts. Part 1 involves dose escalation of BNT323 combined with BNT327 to determine the recommended Phase 2 dose using six different dose levels. Part 2, which begins after Part 1 completion, includes dose optimization and exploratory cohorts. Cohort 1 in Part 2 uses randomization into four treatment arms, including combination therapy at different doses and monotherapies of either BNT323 or BNT327. Other cohorts receive the recommended dose without randomization. Participants will undergo assessments including tumor scans and cardiac function tests, with monitoring for side effects and tumor response up to 36 months. Researchers will track dose-limiting toxicities and treatment-emergent adverse events during early treatment cycles and monitor objective response rates and disease control over time. Safety and efficacy data will be collected through scheduled visits and tumor assessments during and after treatment to evaluate the study drugs effects and tolerability.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of HCB101, an intravenous Fc-fusion protein targeting the SIRP-CD47 pathway, in adults aged 18 years and older with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. This Phase 1, open-label, multi-center study aims to identify the maximum tolerated dose and monitor any side effects in participants who have failed standard therapies or are considered unsuitable for such treatments. Participants will receive HCB101 through intravenous injection at gradually increasing doses, starting from 0.08 mgkg up to 36 mgkg sequentially. Treatment will continue until unacceptable adverse events, disease progression, withdrawal, loss to follow-up, death, or study termination. The study involves dose escalation to determine the optimal dose level for further research. During the study, participants will undergo regular safety monitoring, blood sampling for pharmacokinetics, and tumor assessments using established criteria. Researchers will measure adverse event rates, immune responses, tumor response rates, and drug concentration over a 12-month period. The study includes comprehensive evaluation of anti-tumor effects and safety, with participants followed until study completion or withdrawal.

Researchers are evaluating the characteristics and outcomes of individuals with asthma across different levels of disease severity in routine clinical practice. The study aims to describe participants sociodemographic and clinical features, treatment patterns, disease burden, biomarkers, and both asthma-specific and general quality of life. This research includes both a cross-sectional analysis and a prospective follow-up to observe changes in disease progression over time. The study involves participants receiving standard asthma care, including treatment with varying doses of inhaled corticosteroids andor biologic therapies. Participants are grouped based on asthma control levels and biomarker status. The first part of the study collects baseline data cross-sectionally, while the second part follows participants prospectively to assess differences in asthma symptom control, treatment use, lung function, and comorbidities over a two-year period. Participants will be involved in scheduled data collection including patient and physician-reported outcomes, lung function tests, blood samples, and questionnaires assessing quality of life and symptom control. The study monitors treatment utilization and health resource use from the prior year and during follow-up visits at one and two years. The total participation period spans up to two years with ongoing assessment of disease characteristics and outcomes.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating DB-1324 in people with advanced or metastatic gastrointestinal tumors in a first-in-human Phase 12 clinical trial. The study aims to understand the safety, tolerability, how the drug moves and acts in the body, the maximum dose that can be tolerated, and the potential antitumor activity of DB-1324. This trial is open-label and multicenter, focusing on participants who have malignant GI tumors that have progressed after standard treatments or have no standard options. Participants will receive DB-1324 intravenously in multiple dosing schedules across different study parts. Phase 1 includes dose escalation, backfill, and dose expansion to find the maximum tolerated dose and recommended doses for later phases. Phase 2 will further explore safety and possible efficacy in selected GI tumor groups. Treatment continues until disease progression, unacceptable side effects, loss of benefit, participant withdrawal, or other stopping criteria. During the study, participants will have evaluations for adverse events, dose-limiting toxicities, and pharmacokinetic measures up to about 30 days after treatment. Researchers will also assess tumor response and survival outcomes over approximately three years. Participants will undergo tumor biopsies or provide archived tissue to measure biomarkers. Safety monitoring, including heart function and organ tests, will be part of the assessments throughout the study.

This research aims to evaluate the antiviral effects of S-337395 compared with a placebo in adults who are not hospitalized but have respiratory syncytial virus RSV infection and are at high risk of progressing to severe disease. Participants must start treatment within 72 hours of showing RSV symptoms. The study is a Phase 2b trial and involves adults with specific risk factors such as older age and chronic lung or cardiovascular disease. Participants will be randomly assigned to receive either a high dose or low dose of S-337395, or a matching placebo. The treatment is given orally twice daily for up to 5 days. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered during the trial. Throughout the study, participants will be monitored closely with assessments including nasal swabs to measure RSV RNA levels at several time points up to day 6. Researchers will also track symptoms using questionnaires and record any side effects up to 28 days. Blood samples will be collected to measure drug levels, and safety will be monitored throughout the study, which runs until December 2026.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are evaluating the use of apixaban compared to aspirin to prevent stroke or death in patients who have had a recent intracerebral hemorrhage ICH and also have atrial fibrillation AF. This phase III randomized, double-blinded trial aims to determine if apixaban is superior in preventing any type of stroke or death, as well as if it leads to better functional recovery measured by the modified Rankin Scale. The study will enroll 700 patients and follow them for 12 to 36 months to assess these outcomes. Participants will be randomly assigned to receive either apixaban or aspirin. Apixaban dosing is typically 5 mg twice daily, with a reduced dose of 2.5 mg twice daily for those meeting specific criteria such as older age, lower body weight, or certain medication use. Aspirin is given once daily at a dose of 81 mg. The study includes a treatment period after recent ICH, with careful monitoring for safety and efficacy. During the study, participants will undergo regular assessments including evaluation of stroke occurrence, death, and changes in functional status using the modified Rankin Scale. Safety and adherence will be monitored throughout the follow-up period, which ranges from 12 months up to 3 years. The research team will collect data to understand the benefits and risks of apixaban versus aspirin in this patient population.