Lake Success

Researchers are evaluating the safety and effectiveness of EscharEx (EX-03 5% formulation), a gel made from a sterile lyophilized powder containing proteolytic enzymes, compared to a placebo gel without enzymes. The study focuses on the treatment of Venous Leg Ulcers (VLU), which are wounds on the legs caused by poor venous blood flow. This Phase 3 trial will involve at least 216 adults with VLUs that range in size from 2 to 25 square centimeters and have lasted between 4 weeks and 12 months. Participants will be randomly assigned to receive either EscharEx or the placebo in a double-blinded setup, meaning neither patients nor researchers know which treatment is given. The study lasts up to 29 weeks and includes several stages: a screening period with two visits one week apart; a daily treatment phase with up to eight daily applications over two weeks to remove necrotic tissue; a weekly wound management period lasting up to 12 weeks with up to 13 visits, plus up to two weeks for confirming wound closure; and finally, a 12-week monthly follow-up with three visits to monitor wound closure durability. Throughout the study, researchers will visually assess the removal of dead tissue after each treatment application and monitor the time it takes for the wound to fully close. Patients will undergo standardized wound care and regular clinical evaluations, including measurements of the wound area. Safety and wound healing progress will be carefully tracked during all visits, ensuring comprehensive monitoring of treatment effects and wound status over the entire study duration.

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are studying an experimental drug called REGN10597 alone or combined with cemiplimab in adults with advanced solid tumors, including melanoma and clear-cell renal-cell carcinoma. The study focuses on understanding the safety, tolerability, and effectiveness of these treatments. It also explores how the drugs behave in the body and whether the body produces antibodies that might affect treatment. The study includes Phase 1 and Phase 2a parts, with dose escalation and dose expansion groups. REGN10597 and cemiplimab are given according to the study protocol. Phase 1 is conducted only in the United States, while Phase 2 is conducted globally. Participants in dose escalation cohorts have progressed on standard therapies, while those in dose expansion cohorts have specific tumor types and may undergo biopsies before and during treatment. Participants are involved for up to approximately six years, with researchers monitoring for side effects, serious adverse events, and laboratory abnormalities. They assess tumor response using established criteria and track drug levels and immune responses. Safety and treatment effects are followed closely throughout the study.

This research focuses on participants with ovarian and breast cancers who have previously been treated with niraparib in GlaxoSmithKline/TESARO-sponsored studies. The aim is to provide continued access to niraparib and to better understand its long-term safety over an extended period. This global extension study involves adult participants who have met the primary objectives in prior clinical trials and are still benefiting from niraparib treatment. Participants will continue to take niraparib orally in the form of tablets or capsules once daily. This open-label, multicenter study allows participants who are judged by their investigators to benefit from ongoing treatment to receive niraparib beyond their initial studies. The treatment focuses on maintaining the therapy rather than comparing it to another drug or placebo. During the study, participants will be regularly monitored for safety through assessments such as adverse events, changes in performance status, blood tests, vital signs, and physical examinations. Researchers will also track the use of other medications. The study collects data for up to five years, ensuring comprehensive long-term safety information while participants adhere to scheduled visits and treatment plans.

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, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and early anti-tumor effects of increasing doses of EPI-326 in patients with locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). This first-in-human, phase 1, open-label study involves multiple centers and focuses on patients whose tumors have documented EGFR mutations confirmed by molecular testing like next-generation sequencing (NGS). The study aims to establish the recommended dose and schedule for EPI-326 administration. EPI-326 is a tissue-selective bispecific antibody targeting EGFR-driven cancers. It is given as an intravenous (IV) infusion in the clinic. Patients will receive this treatment until their disease progresses, they experience unacceptable side effects, they choose to withdraw consent, or the study ends. The doses of EPI-326 will be increased gradually to assess how well patients tolerate the drug and to identify the best dosing regimen. Participants will be monitored for safety and tolerability of EPI-326 for up to three years. Researchers will assess how the drug behaves in the body (PK and PD) and evaluate its preliminary anti-tumor activity. Patients' overall health will be tracked, including performance status and organ function. The study will collect data on side effects and any disease progression during and after treatment to determine the drug's recommended dose and schedule.

Researchers are evaluating CTX-10726, a new drug given as a monotherapy, in adults with advanced or metastatic cancers including gastroesophageal cancer, hepatocellular carcinoma, endometrial cancer, and renal cell carcinoma. This Phase 1, open-label study aims to assess the safety, tolerability, immune response, and how the drug behaves in the body. Preliminary effects against tumors will also be explored. The study is divided into two parts: a dose escalation phase to find the best dose and a dose expansion phase to further evaluate safety at selected doses. Participants in the dose escalation group will receive CTX-10726 through intravenous infusion every two weeks at increasing dose levels from 0.3 to 10.0 mg/kg, following a 3+3 design. Once safe doses are determined, the dose expansion group will receive the drug at those levels. Treatment cycles last two weeks, and safety monitoring continues during and after treatment. The study drug is administered only by IV infusion throughout both phases. During the study, participants will have regular assessments including monitoring for side effects, lab tests to check organ function, and imaging to measure tumor size. Safety will be closely observed by tracking any treatment-related adverse events from the first dose through follow-up periods lasting up to two years for the dose expansion group. Other evaluations include immune response and pharmacokinetics of CTX-10726. Total participation time varies but includes treatment cycles and safety follow-up visits after the last dose.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are studying a treatment approach to prevent Graft-Versus-Host Disease (GVHD) in adults with blood cancers who undergo allogeneic hematopoietic stem cell transplantation (HSCT). The study has two phases: Phase I aims to find the highest safe dose of abatacept when combined with post-transplant cyclophosphamide (PTCy) and bortezomib, while Phase II evaluates this treatment in groups receiving stem cells from either matched or mismatched donors. This trial includes adults 18 years and older who meet specific health criteria and transplant standards. Participants will receive a standard conditioning regimen followed by peripheral blood stem cell transplants. Those receiving unrelated donor transplants will also get rabbit anti-thymocyte globulin (rATG). The study drugs — abatacept, PTCy, and bortezomib — are given as prevention for GVHD. In Phase I, dosing of abatacept will be gradually increased to find the maximum tolerated dose (MTD). In Phase II, patients will receive this MTD and be grouped based on donor matching. During the study, participants will be monitored for safety and treatment effects up to two years. Researchers will assess the maximum tolerated dose of abatacept combined with PTCy and bortezomib. Patients will undergo regular health evaluations, including lab tests and heart and lung function assessments, and will be asked to comply with all study procedures. The study aims to understand how well this combination prevents GVHD and its safety over the long term.

Researchers are evaluating a new approach to prevent cardiovascular events in patients at increased risk due to age and conditions like type 2 diabetes, prediabetes, or metabolic syndrome but without known symptomatic cardiovascular disease. The study compares a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy with standard risk factor-based care to see if the former can better reduce cardiovascular events. The Cleerly system uses imaging to visualize and quantify coronary artery disease and guides personalized treatment and education based on this assessment. The trial uses the Cleerly CAD Staging System device, which employs a proprietary algorithm to detect and stage coronary artery disease and generate a risk score to guide treatment decisions. Participants receive either this stage-based care or the usual care based on traditional risk factors. The study is prospective, randomized, and pragmatic, designed to follow patients over an average of 3.5 years to compare cardiovascular event outcomes between these two care approaches. Participants will be monitored through cardiovascular event tracking throughout the study period. Data collected includes imaging results, risk scores, and treatment adherence to evaluate the impact of the care strategies. The primary outcome is the comparison of cardiovascular event risk between the Cleerly stage-based care and risk factor-based care groups. The study also includes ongoing safety monitoring and personalized management by a cardiologist-led team via digital communication devices.