Myrtle Beach

Researchers are evaluating aglatimagene besadenovec combined with valacyclovir in men with localized, intermediate-risk prostate cancer who plan to receive external beam radiation therapy EBRT. This phase 2a, open-label, multi-center study aims to assess how the treatment spreads in the body and its effects on immune activation. The study compares this combination therapy plus EBRT to EBRT alone in two groups of participants. Participants in the treatment group will receive three intraprostatic injections of aglatimagene besadenovec, each 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 alone. Biospecimens including blood, urine, and semen will be collected at specific times before and after injections or treatments to measure viral presence and immune response. Throughout the study, safety will be monitored continuously by tracking treatment-emergent adverse events and lab results. Researchers will measure the biodistribution of aglatimagene besadenovec up to three months after the last injection. They will also evaluate immune activation biomarkers and tumor-related proteins during this period. Participation includes regular sample collection and clinical assessments, with the total study duration extending up to three months post-treatment.

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 MK-3120, a study medicine, for its safety and tolerability in people with high-risk non-muscle invasive bladder cancer HR NMIBC. This type of cancer affects the tissue lining the inside of the bladder without spreading to the muscle or beyond. Standard treatment involves removing the tumor through a procedure called transurethral resection of the bladder tumor TURBT, and this study aims to see how MK-3120 works after TURBT. Participants in this study will receive MK-3120 through intravesical administration. The treatment is given once weekly for the first 6 weeks, followed by once monthly for 9 months. The study includes people who are either new to Bacillus Calmette-Gurin BCG therapy or have been exposed to BCG under specific conditions. The dosing and schedule are designed to assess safety and participant tolerance over an extended period. During the study, participants will be closely monitored for dose-limiting toxicities, adverse events, and treatment discontinuations due to side effects. Researchers will also evaluate the complete response rate within approximately 3 months. The overall safety assessment will continue for up to 24 months, while treatment discontinuations due to adverse events will be tracked for about 12 months. This extended monitoring helps ensure thorough evaluation of MK-3120s effects.

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

Researchers are conducting a Phase 1 study to evaluate BHV-1530 alone and in combination with cemiplimab in adults with advanced or metastatic solid tumors. This first-in-human, open-label trial aims to determine the safety, dosing, and potential benefits of BHV-1530 for patients whose cancer has progressed after standard treatments or who have no other available therapies. The study focuses on specific cancers including urothelial cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma, especially those with certain genetic alterations. Participants will receive BHV-1530 as an intravenous infusion on Day 1 of each 21-day cycle, either alone or combined with cemiplimab given on the same schedule. The study includes dose escalation, expansion, and optimization phases to find the maximum tolerable dose and recommended dose range. Some groups may receive the drug alone, while others receive it combined with cemiplimab, with treatment continuing over multiple cycles as determined by the study protocol. During the trial, participants will have regular assessments to monitor safety and treatment effects, including tumor measurements according to RECIST 1.1 criteria and performance status evaluations. Researchers will collect tumor tissue samples, perform laboratory tests, and monitor drug levels in the blood. The main outcomes include determining optimal dosing, safety profile, and clinical benefit rates over an estimated 48 months. Participants health and response to treatment will be carefully followed throughout the study period.

Researchers are evaluating a new form of hormone therapy called ASP5541 for men with advanced prostate cancer that has spread to other parts of the body. This phase 2 study compares ASP5541 given by injection with the standard abiraterone acetate tablets, both combined with a steroid called prednisone or prednisolone. The study aims to assess how well ASP5541 works and its safety in men who have not previously been treated with androgen receptor pathway inhibitors, including specific evaluation in Japanese men. Participants are divided into three groups based on their cancer type and treatment history. ASP5541 is given as a muscle injection every 12 weeks, while abiraterone acetate is taken as a daily tablet. Men with metastatic castration-resistant prostate cancer take prednisone or prednisolone twice daily, and men with metastatic hormone-sensitive prostate cancer take it once daily. All groups also receive standard care such as androgen deprivation therapy. Some participants will monitor blood pressure at home weekly. During the study, men visit the clinic regularly for health checks, safety monitoring, and scans to observe any changes in their cancer. The frequency and type of visits depend on each participants health and treatment stage. Researchers will measure prostate-specific antigen PSA levels, adverse events, physical exams, ECGs, and performance status to evaluate treatment effects and safety. The study may last up to about 3 years for some outcomes, with longer follow-up for certain measures.

Researchers are studying UGN-104, a new formulation of UGN-101 also known as JELMYTO, to evaluate its effectiveness and safety in treating patients with low-grade upper tract urothelial cancer LG-UTUC. This phase 3, single-arm study focuses on patients with this specific type of cancer affecting the upper urinary tract, aiming to assess how well the treatment works and its safety profile. Participants will receive UGN-104 once a week for six weeks, with each dose administered directly into the upper urinary tract via a ureteral catheter or nephrostomy tube. The dose consists of 4 mg mitomycin per 1 mL sterile hydrogel. After the initial treatment period, patients who have no detectable disease at the primary disease evaluation visit about three months after the first dose may enter a follow-up phase where they could receive monthly maintenance doses for up to 11 months, depending on the investigators decision. During the study, participants will have evaluations every three months to check for disease response or recurrence. These assessments include urine cytology, visual inspection via ureteroscopy, and biopsies if needed. Researchers will monitor the complete response rate at three months as the primary outcome and track the duration of response, durable complete response rate, and any treatment-related side effects for up to 15 months. The total participation time varies depending on response and disease status.

Researchers are evaluating AZD4512, an antibody-drug conjugate targeting CD22, for its safety and effectiveness in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma B-NHL. This Phase III open-label global study explores AZD4512 alone or combined with other anticancer agents, focusing on participants who have previously undergone at least two lines of therapy. The trial also aims to study pharmacokinetics, pharmacodynamics, and immunogenicity of AZD4512 in this population. The study includes a dose escalation phase and a pharmacodynamicsafety backfill phase to determine the maximum tolerated dose or optimal biological dose of AZD4512 monotherapy. Participants receive AZD4512 through intravenous infusion, and additional modules may be added to study specific B-NHL subtypes or combination treatments. This modular design allows for assessment of AZD4512 alone or with other anticancer agents across various B-NHL subgroups. Participants will be monitored for dose-limiting toxicities, adverse events, and changes in vital signs or laboratory tests from the first dose through 30 days after the last dose. Long-term outcomes such as response rates, duration of response, progression-free survival, overall survival, and drug pharmacokinetics will be followed for up to two years. Safety and efficacy data collected will help understand AZD4512s impact on this patient population under medical supervision.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.