Port St. Lucie

Researchers are evaluating KTX-2001, alone and combined with darolutamide, in men with metastatic castration-resistant prostate cancer (mCRPC) to assess safety, how the drugs behave in the body, and preliminary effectiveness. This Phase 1, open-label study aims to find the best doses of KTX-2001 alone and with darolutamide for future studies. Participants will receive increasing doses of KTX-2001 either alone or together with darolutamide, an oral androgen receptor pathway inhibitor. The study is divided into parts where some men receive just KTX-2001 and others receive the combination treatment. Dosing will be carefully increased to monitor safety and determine the maximum tolerated dose. Participants will undergo scans and biopsies to confirm metastatic disease and monitor progress. Safety assessments include checking for dose-limiting toxicities within 21 days. Laboratory tests will evaluate kidney, liver, and blood function, while researchers track how the drugs move through and affect the body. The study monitors treatment effects and safety over time to guide future research.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are conducting a Phase I/II, multi-site, open-label study to evaluate the safety, effectiveness, and optimal dosing of the investigational treatments BNT323 combined with BNT327 in adults with advanced breast cancer. This includes those with hormone receptor-positive or negative types, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study aims to understand how these treatments work alone and together in this patient population. The study has two parts: Part 1 involves dose escalation where participants with chemotherapy-pretreated advanced breast cancer receive BNT323 and BNT327 together to find the recommended Phase 2 dose. Part 2 is an expansion phase that tests the safety and effectiveness of the chosen dose, including randomized comparisons of combination therapy at different doses and monotherapies. Participants may be assigned to one of four treatment arms, with dosing administered via intravenous infusion. Participants will be monitored for dose-limiting toxicities during the first 21 days of treatment, as well as adverse events up to 90 days after the last dose. Tumor response will be assessed for up to 36 months. Evaluations include heart function tests, tumor imaging, safety assessments, and tracking of side effects. The study carefully monitors treatment safety, effectiveness, and participant health throughout the trial duration.

Researchers are evaluating the safety and effectiveness of an intravenous injection of HCB101, a drug targeting the SIRPα-CD47 pathway, in adults aged 18 and older with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. This Phase 1, open-label, multi-center, dose-escalation study focuses on patients who have not responded to standard therapies or for whom no standard treatment exists. The goal is to determine the maximum tolerated dose and monitor any side effects that may occur. Participants will receive HCB101 through intravenous infusion. Treatment will continue until unacceptable side effects occur, the disease progresses as seen on scans or clinical evaluation, participants withdraw consent, are lost to follow-up, pass away, or the study ends. The study does not specify fixed dosing intervals but involves escalating doses to evaluate safety and tolerability. During the study, participants will undergo various assessments including physical exams, imaging scans, laboratory tests, and tumor tissue sample collection. Researchers will monitor adverse events, pharmacokinetics, and anti-tumor activity over a 12-month period. The study includes close safety monitoring and evaluation of the drug's impact on the tumors and overall health of the participants.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

This research aims to evaluate the antiviral effects of S-337395 compared with placebo in nonhospitalized adult participants who have symptomatic respiratory syncytial virus (RSV) infection and are at high risk of progressing to severe disease. The study focuses on adults with recent onset of RSV symptoms and important risk factors such as advanced age or chronic lung or cardiovascular disease. It is designed as a Phase 2b, randomized, double-blind, placebo-controlled trial to assess safety, tolerability, and efficacy. Participants will receive either S-337395 or a matching placebo according to a specified dosing schedule. The treatment begins within 72 hours of RSV symptom onset. The study measures changes in RSV viral RNA load from baseline to Days 2, 4, and 6 using nasopharyngeal swabs and quantitative reverse transcription polymerase chain reaction (qRT-PCR) tests to monitor antiviral effects. During the study, participants will be monitored for safety and effectiveness through viral load testing at multiple time points. Medical history, physical exams, vital signs, and ECGs are conducted to ensure stability aside from RSV symptoms. The study also tracks symptoms and any adverse events to evaluate treatment tolerability. Total participation includes screening and follow-up assessments as outlined by the study protocol.

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are evaluating the safety and effectiveness of apixaban compared with aspirin in patients who recently had an intracerebral hemorrhage (ICH) and also have atrial fibrillation (AF). The study aims to find out if apixaban is better than aspirin in preventing any type of stroke or death from any cause. It also looks at whether apixaban leads to better functional recovery measured by the modified Rankin Scale. This is a phase III, randomized, double-blinded trial enrolling 700 patients over 3.5 years. Participants will be randomly assigned to receive either apixaban, an oral blood thinner that inhibits Factor Xa, or aspirin, an oral antiplatelet medication. The study lasts from 12 months up to 36 months of follow-up after enrollment. Treatments are given orally, and patients will be monitored throughout the study period. Recruitment and coordination occur through NIH/NINDS StrokeNet sites. During the study, participants will undergo assessments including brain imaging (CT or MRI) to confirm diagnosis, functional outcome measurements using the modified Rankin Scale, and monitoring for any strokes or death. Safety will be closely observed, and patients will provide informed consent before joining. The primary outcome measured is stroke or death up to 3 years, and secondary outcomes include functional status changes. Participants are followed regularly to track these outcomes and overall health status.

Researchers are evaluating the safety, tolerability, and initial effectiveness of a drug called BL-B01D1 in people with metastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors. This global, multi-center Phase 1 study includes various types of cancers such as breast, esophageal, small cell lung, nasopharyngeal, head and neck, prostate, ovarian, endometrial, cervical, and triple-negative breast cancer. The study aims to determine the maximum tolerated dose or maximum administered dose and identify recommended doses and schedules for further study. The study is organized into three parts: dose escalation, dose finding, and dose expansion. Participants will be divided into two groups, Cohort A and Cohort B, based on dosing schedules. Cohort A receives BL-B01D1 on Day 1 and Day 8 of a continuous 21-day cycle, while Cohort B receives BL-B01D1 only on Day 1 of the cycle. Different dose groups exist within each cohort to assess safety and dosing. The study drug BL-B01D1 is administered as an intravenous drug during these cycles. Participants will be involved for up to one year, during which researchers will monitor dose-limiting toxicities, serious adverse events, treatment-emergent adverse events, physical exam changes, ability to care for themselves and perform daily and physical activities, ECG readings, and lab test results. The study also tracks pharmacokinetics and initial drug efficacy. Safety and tolerability will be carefully assessed throughout the study, with regular evaluations to understand the best dose and schedule for future research.

Researchers are evaluating the effectiveness, safety, and tolerability of Suzetrigine in adults with pain caused by diabetic peripheral neuropathy (DPN). This phase 3 study focuses on participants who have had diabetes type 1 or type 2 with bilateral lower limb pain for at least one year and aims to compare Suzetrigine's effects against a placebo. Participants will receive either Suzetrigine tablets or a placebo that looks like Suzetrigine, taken orally. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment. The main goal is to measure the change in weekly average daily pain intensity using the Numeric Pain Rating Scale (NPRS) over 12 weeks. During the study, participants will track their daily pain levels to assess treatment effects. Researchers will monitor safety and tolerability throughout the 12-week period, focusing on changes in pain intensity compared to the baseline. Participants must weigh at least 45 kilograms and have a body mass index between 18 and 40 kg/m². The study allows adults aged 18 to 80 years with controlled diabetes and specific pain levels to join.