Myrtle Beach

Researchers are evaluating the use of aglatimagene besadenovec combined with valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to undergo external beam radiation therapy (EBRT). This phase 2a, open-label, multi-center study aims to understand how the treatment spreads in the body and its impact on immune system markers. The study focuses on men with intermediate-risk prostate cancer and compares a treatment group receiving the gene therapy plus valacyclovir alongside EBRT to a control group receiving EBRT alone. Participants in the treatment group will receive three intraprostatic injections of aglatimagene besadenovec, a genetically modified virus carrying a specific gene, administered either through the rectum or perineum. Each injection is followed by a 14-day course of oral valacyclovir. EBRT will begin after the second injection. The control group will receive standard or moderately hypofractionated prostate-only EBRT without the gene therapy. Biospecimens such as blood, urine, and semen will be collected at specific times before and after injections to track the presence of the virus and measure immune responses. Participants will be monitored closely throughout the study. Researchers will regularly evaluate safety by tracking adverse events and laboratory tests. The main outcome measured is the biodistribution of aglatimagene besadenovec up to three months after the last injection. Immune system activation markers, viral shedding in various body fluids, and tumor-related proteins will also be assessed. The study involves approximately 45 men divided between the treatment and control groups, with continuous safety monitoring during and after treatment.

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 new treatment options for high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that affects the tissue lining the bladder but has not spread to the muscle or beyond. The study aims to assess the safety and tolerability of MK-3120, a biological treatment given directly into the bladder. This phase 1/2 study focuses on patients who have undergone a surgical procedure called transurethral resection of bladder tumor (TURBT) to remove tumors. Participants receive MK-3120 through intravesical administration, which means the medicine is delivered directly into the bladder at one of three doses as outlined by the study protocol. The treatment is given after TURBT, and the study includes patients who are either new to Bacillus Calmette-Guérin (BCG) therapy or have been previously treated with BCG. The study does not include a control group but monitors participants for side effects and tolerability during treatment. Throughout the study, researchers closely observe participants for any dose-limiting toxicities within about 5 weeks, adverse events up to 24 months, and treatment discontinuation due to side effects for up to 12 months. Participants undergo regular assessments to monitor safety and treatment effects. The total duration of follow-up may extend up to two years to ensure thorough safety monitoring and evaluation of the treatment's impact.

Researchers are evaluating enicepatide, a dual GLP-1/GIP receptor agonist, to see how well it works and how safe it is for weight management in adults who are obese or overweight and do not have Type 2 diabetes. The study compares different doses of enicepatide with a placebo to understand its effects. Participants must have a body mass index (BMI) of at least 30, or a BMI between 27 and 30 with at least one weight-related health issue such as prediabetes, hypertension, or sleep apnea. Participants will receive once-weekly injections of either enicepatide or a placebo using an integrated drug-device combination product. The treatment is randomized and double-blinded, meaning neither participants nor researchers know who gets the active medication or placebo during the study. The study is a Phase III trial, and treatments continue over a period leading up to week 72. Throughout the study, participants will be monitored for changes in body weight, with the primary measure being the percent change from baseline to week 72. Safety and efficacy will be assessed regularly, and participants will self-administer the injections or receive help if needed. The study also tracks any side effects and overall health status to understand the long-term effects of enicepatide for weight management.

Researchers are conducting a Phase 1, first in human, open-label, multicenter study to evaluate BHV-1530 in adult participants with advanced or metastatic solid tumors. This study focuses on patients who have progressed after or are intolerant to standard treatments, including specific cancers such as urothelial cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma, with or without certain FGFR3 alterations. The purpose is to assess safety, dosing, and potential expansion for later trials in these advanced cancer types. BHV-1530 will be given as an intravenous infusion on Day 1 of each 21-day treatment cycle. The study includes dose-escalation, dose-expansion (backfill), and dose-confirmation cohorts to determine the recommended dose and evaluate safety. Participants will receive repeated cycles of therapy, and dosing adjustments will be based on observed effects and tolerability. The treatment period is expected to last up to approximately 48 months, covering the full study duration. Participants will be closely monitored through regular assessments including tumor measurements by RECIST 1.1 criteria, laboratory tests, vital signs, and performance status evaluations. Researchers will track adverse events throughout the study to evaluate safety and tolerability. Additional evaluations include liver and kidney function tests, hematologic status, and pregnancy tests for women of childbearing potential. The primary outcomes measured are the number of patients experiencing adverse events and determining the optimal BHV-1530 dose for future studies.

Researchers are evaluating the safety and feasibility of Belzupacap Sarotalocan (AU-011) treatment for bladder cancer, specifically urothelial carcinoma. This phase 1 open-label trial aims to test AU-011 with or without laser application, focusing on minimizing disruption to patients' standard care. The study targets participants with non-muscle invasive bladder cancer (NMIBC) and urothelial carcinoma to assess initial safety and technical aspects of the treatment. The study involves administering AU-011 directly into the tumor (intratumorally) and into the bladder wall (intramurally), either alone or combined with medical laser treatment. Different cohorts receive variations of these treatments to evaluate feasibility and safety. The trial procedures are designed to integrate smoothly with standard care practices, allowing researchers to observe effects with minimal interference in usual treatments. Participants will be closely monitored for safety outcomes, including serious adverse events and dose-limiting toxicities, for up to 12 months. Assessments include clinical evaluations, laboratory tests, and monitoring for any side effects or complications related to the treatment. The study's total duration includes treatment and follow-up periods to thoroughly evaluate participant safety and response to AU-011 therapy.

This research aims to evaluate the effects and safety of ASP5541, a new form of abiraterone acetate given as a muscle injection, in men with advanced prostate cancer. The study focuses on men with metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), including Japanese men. It compares ASP5541, with or without the steroid prednisone/prednisolone, to the standard oral abiraterone acetate with prednisone/prednisolone. The goal is to see how well ASP5541 works and its safety profile compared to current treatments. Participants are divided into three groups. Group 1 includes men with mCRPC not previously treated with androgen receptor pathway inhibitors (ARPIs), receiving either ASP5541 with prednisone/prednisolone or abiraterone acetate with prednisone/prednisolone. Group 2 includes men with mHSPC not previously treated with ARPIs, receiving either ASP5541 alone or abiraterone acetate with prednisone/prednisolone. Group 3 includes Japanese men with mCRPC or mHSPC who may have prior ARPI treatment, receiving ASP5541 with prednisone/prednisolone. ASP5541 is given as an injection every 12 weeks, prednisone/prednisolone is taken orally once or twice daily depending on cancer type, and abiraterone acetate is taken as daily tablets. All groups continue standard androgen deprivation therapy. During the study, men will visit clinics regularly for health checks, cancer scans, and safety monitoring. Some men in Group 2 will monitor blood pressure weekly at home. Researchers will track prostate specific antigen (PSA) levels, adverse events, vital signs, and lab tests for up to 37 months. The study evaluates how well ASP5541 lowers PSA compared to abiraterone acetate and monitors for side effects and overall health status throughout treatment and follow-up.

Researchers are evaluating the efficacy and safety of UGN-104, a new formulation of UGN-101 (known as JELMYTO), for treating patients with low-grade upper tract urothelial cancer (LG-UTUC). This Phase 3, single-arm, multicenter study focuses on patients with LG-UTUC in the upper urinary tract. The study aims to measure the complete response rate about 3 months after the first treatment instillation. Participants will receive UGN-104 once weekly for 6 weeks, totaling 6 doses. UGN-104 is a drug combining mitomycin with a sterile hydrogel that changes from liquid to gel when warmed, helping deliver the medication directly to the upper urinary tract. Patients who achieve a complete response with no detectable disease at the primary disease evaluation visit may enter a follow-up period, where they can receive monthly maintenance doses of UGN-104 for up to 11 months. Patients will be monitored every 3 months during follow-up for up to 12 months or until disease progression, recurrence, or death. Throughout the study, patients undergo evaluations including urine cytology, visual inspections with ureteroscopy, and biopsies if needed. Response determination is centrally reviewed using laboratory and histopathology assessments. Safety and disease status will be closely monitored during treatment and follow-up visits to assess treatment effect and patient well-being.

Researchers are evaluating AZD4512, an antibody-drug conjugate targeting CD22, in a Phase I/II open-label global study for adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL). This study aims to assess the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of AZD4512 given alone or with other anticancer agents. Participants include those who have undergone at least two prior treatments and continue to have active disease with limited standard options. The study involves AZD4512 administered by intravenous infusion. The first module focuses on AZD4512 monotherapy in participants with relapsed or refractory B-NHL. Additional modules may later be added to evaluate AZD4512 alone or combined with other anticancer agents in specific B-NHL subtypes. Treatment and dosing details will be adapted based on ongoing study findings. Participants will be monitored for dose-limiting toxicities within the first four weeks and for treatment-emergent, treatment-related, and serious adverse events during treatment and up to 30 days after the last dose. Researchers will also track clinically significant changes in vital signs and laboratory tests. The study includes regular assessments to evaluate safety, efficacy, and participant health throughout the treatment period.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.