Lake Success

The trial investigates the use of EscharEx, a proteolytic enzyme gel, compared to a placebo gel in treating venous leg ulcers VLU in adults. The goal is to evaluate how well EscharEx works and how safe it is for removing dead tissue debridement and preparing the wound bed for healing. This study involves adult patients who have VLUs with specific size and duration criteria. Participants will be randomly assigned to receive either EscharEx EX-03 5% formulation or a placebo gel. The treatment involves applying a gel made by mixing a sterile powder with water to the wound area. The study lasts up to 29 weeks and includes several phases a screening period, up to 8 daily visits for debridement within 2 weeks, weekly wound management visits for up to 12 weeks including wound closure confirmation, and monthly visits over 12 weeks to monitor wound closure durability. During the study, patients will undergo regular clinical assessments of the wound, including visual checks for complete debridement and wound closure, as well as evaluations of healthy tissue growth. The study measures the time taken for complete wound closure and the presence of healthy tissue. Safety and wound healing progress are closely monitored throughout the treatment and follow-up periods, ensuring adherence to the protocol and proper wound management.

Researchers are studying an experimental drug called REGN10597, given alone or with another drug called cemiplimab, in adults with advanced solid tumors such as melanoma and clear-cell renal-cell carcinoma. This Phase 12a trial aims to evaluate how safe, tolerable, and effective these study drugs are in treating cancers that have spread in the body. The study also explores side effects, drug levels in the blood, and whether the body produces antibodies against the drugs that might affect their activity or cause side effects. Participants receive REGN10597 alone or combined with cemiplimab in different dose levels to find the best dose for future studies. The study includes dose escalation and dose expansion phases, with separate groups for melanoma and renal-cell carcinoma patients. Dosing and administration follow the study protocol, and participants may have biopsies at screening and other times for research purposes. During the study, participants will be monitored closely for side effects and treatment responses. Researchers assess tumor response using established criteria and track various safety outcomes over approximately six years. Blood samples are collected to measure drug concentrations and antibody development. Participants will have regular visits for evaluations, and their health status will be followed for a long-term period to understand treatment effects and safety.

This research aims to provide continued access to niraparib and to further assess its long-term safety in participants with ovarian or breast neoplasms who are currently receiving niraparib treatment within previous GlaxoSmithKlineTESARO-sponsored studies. It focuses on participants who have completed earlier studies where the primary objectives were met and are judged by their doctors to still benefit from niraparib. The study is a phase 2, open-label extension trial designed to monitor treatment continuation and safety over time. Participants will receive niraparib once daily by mouth, following the same dose and schedule as in their previous parent study. Treatment is organized in 90-day cycles and will continue until disease progression, unacceptable side effects, new anticancer therapy unrelated to the parent study, withdrawal, or other reasons for discontinuation occur. The dosing regimen mirrors what was assigned in the prior study, ensuring consistency for each participant. During the study, participants will have regular evaluations to monitor safety and health status for up to five years. These assessments include tracking adverse events, serious side effects, and specific safety concerns, as well as monitoring physical exams, vital signs, blood tests, and medication use. Participants must comply with scheduled visits and treatments while using effective contraception if of childbearing potential. The study duration and follow-up are designed to gather detailed long-term safety information on niraparib treatment.

Researchers are conducting a master protocol study to evaluate the long-term safety and efficacy of the drug pirtobrutinib in patients who have completed previous clinical studies involving this medication. This study includes participants with chronic lymphocytic leukemia or non-Hodgkin lymphoma and aims to monitor their health over an extended period. The master protocol organizes individual study-specific appendices ISAs representing participants from earlier originator studies. Participants continue to receive pirtobrutinib as they did in their original clinical study, with the drug administered orally. The study allows these individuals to keep taking the treatment or to continue with follow-up visits under this master protocol framework. The study is designed to gather safety and survival data over many years. During the study, participants will be closely monitored for any serious treatment-related side effects, with assessments focused on adverse events occurring from the first dose until shortly after the last dose or when starting a new anticancer therapy. Researchers will also track overall survival for up to 93 months. This long-term follow-up ensures comprehensive safety and health evaluations throughout the participants involvement, which may last several years.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and preliminary anti-tumor activity of increasing doses of EPI-326 in patients with locally advanced or metastatic head and neck squamous cell carcinoma HNSCC and those with EGFR-mutant locally advanced or metastatic non-small cell lung cancer NSCLC. This first-in-human, phase 1 multicenter, open-label study aims to determine appropriate dosing and assess initial effects of EPI-326 in these patients. EPI-326 is a tissue-selective bispecific antibody targeting EGFR-driven cancers and is administered by intravenous infusion in the clinic. Patients will receive escalating doses of EPI-326 as a single agent until they experience disease progression, unacceptable side effects, choose to withdraw, or the study ends. This study includes a dose escalation period to identify the recommended dose and schedule for administration. Participants will be monitored for safety and tolerability, with assessments including blood tests to measure drug concentration over time, clearance, and distribution. Researchers will also evaluate tumor response and duration of response over a period of up to three years. The study involves continuous treatment and follow-up visits to observe effects and manage any adverse events during the trial period.

Researchers are conducting a Phase 1a1b open-label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PLN-101095 combined with pembrolizumab in adults with advanced or metastatic solid tumors. Participants must have tumors for which pembrolizumab is indicated and must show disease progression or relapse after at least three months of pembrolizumab treatment. The study includes consecutive dose-escalation and dose-expansion cohorts to explore different dosing levels and tumor types. The study has two main parts Part 1 uses a Bayesian optimal interval design for dose escalation with accelerated titration to test increasing doses of PLN-101095 combined with pembrolizumab, while Part 2 uses Simons two-stage design for dose expansion. Doses of PLN-101095 range from 250 mg twice daily up to 2000 mg twice daily or 1000 mg three times daily, given in combination with pembrolizumab administered intravenously every three weeks. Participants in expansion cohorts include those with non-small cell lung cancer, clear cell renal cell carcinoma, or tumor mutational burden-high solid tumors, receiving PLN-101095 as monotherapy or combined with pembrolizumab. Participants will be monitored for safety and tolerability from first dose through 16 weeks after treatment ends, and anti-tumor activity will be measured from first dose until disease progression or death. Pharmacokinetics of PLN-101095 will be assessed at specified time points. The study evaluates participants measurable lesions and organ function, with follow-up assessments for adverse events and treatment response. The total duration varies depending on treatment response and tolerability, with ongoing monitoring throughout the study period.

Researchers are conducting a Phase 1, open-label study to evaluate CTX-10726 monotherapy in adults with metastatic or locally advanced cancers that are relapsed or refractory to standard treatments, or when no effective standard therapy exists. This first-in-human trial aims to assess the safety, tolerability, immune response, and how the body processes CTX-10726, while also observing preliminary anti-tumor effects. The study is sponsored by Compass Therapeutics and focuses on cancers including renal cell carcinoma, hepatocellular carcinoma, gastroesophageal cancer, and endometrial cancer. Participants will receive CTX-10726 through intravenous infusions given every two weeks. The study is divided into two parts a Dose Escalation Cohort where doses range from 0.3 to 10.0 mgkg to determine safe and tolerable levels, followed by a Dose Expansion Cohort that uses doses selected from the escalation phase. Treatments continue in cycles of two weeks, with infusions administered repeatedly based on the study design and patient response. Throughout the trial, participants will undergo safety monitoring for side effects, assessments of immune response, and tests measuring drug levels in the blood. Tumor responses will be evaluated using standard criteria, and disease progression and survival will be tracked for up to two years. Organ function tests, imaging, and other health evaluations will be performed regularly. Participants are followed closely to monitor treatment effects and safety from the first dose until after treatment ends.

Researchers are evaluating the safety and tolerability of DB-1303BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 12a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts an initial dose-escalation phase using an accelerated titration followed by a classic 33 design to find the maximum tolerated dose MTD or recommended Phase 2 dose RP2D, and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303BNT323 by intravenous infusion once every three weeks Q3W at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

Researchers are studying the use of abatacept combined with post-transplant cyclophosphamide PTCy and bortezomib to prevent graft-versus-host disease GVHD after allogeneic hematopoietic stem cell transplantation HSCT in adults with blood cancers. The study is conducted in two phases a phase I dose-escalation to find the maximum tolerated dose of abatacept and a phase II evaluation in two groups based on donor matching. Participants must meet institutional criteria and have matched or partially matched donors. Participants receive a standard conditioning regimen followed by peripheral blood stem cell transplants. Those with unrelated donors also get rabbit anti-thymocyte globulin rATG. The study drugsPTCy, bortezomib, and abataceptare given as GVHD prevention. The phase II dose of abatacept is determined from phase I results. Participants are grouped by donor type matched sibling, matched unrelated, or mismatched unrelated donors. Throughout the study, participants are monitored for safety and treatment effects, including determining the maximum tolerated dose of abatacept over up to two years. They undergo regular assessments per standard care protocols and study procedures. The study is open-label and non-randomized, with no placebo group. Participants must be available for the full duration and comply with all study procedures.

Researchers are evaluating a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.