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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 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 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.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Gastroesophageal reflux disease (GERD) happens when stomach acid or food repeatedly flows back into the esophagus, causing discomfort like heartburn and pain in the stomach, chest, or throat. This condition can affect people of all ages, including children. This research is focused on children aged 2 to 11 years who have symptomatic nonerosive GERD, which means they experience GERD symptoms without damage to the esophagus. The study aims to assess if different doses of the drug dexlansoprazole, adjusted based on body weight, can help relieve these symptoms in children. Participants in this study will receive daily oral doses of dexlansoprazole capsules in one of three amounts: 15 mg, 30 mg, or 60 mg. Children weighing 30 kilograms or less will be randomly assigned to take either 15 mg or 30 mg, while those weighing more than 30 kilograms will be assigned to 30 mg or 60 mg. The medication is taken once daily at the same time throughout the 12-week treatment period. The study will include up to 70 children across multiple centers worldwide. Children and their caregivers will keep an electronic diary to record any heartburn symptoms during the study. The research team will conduct multiple clinic visits over a period of up to 16 weeks, including up to 4 weeks for screening before treatment and a follow-up phone call 5 to 10 days after the final dose. The main outcome measured is the percentage of days without hurting or burning in the stomach, chest, or throat during the 12 weeks of treatment, alongside monitoring for side effects.

This research aims to assess the effectiveness, safety, and tolerability of NGM120 in adults diagnosed with colorectal cancer who also have cancer cachexia, a condition characterized by significant weight loss. This Phase 2, randomized, double-blind, placebo-controlled, multi-center study focuses on participants with active colorectal cancer and cachexia as defined by specific weight loss criteria. Participants will receive either NGM120 administered subcutaneously every 4 weeks or every 8 weeks, or a placebo given subcutaneously every 4 weeks. The study compares these different dosing schedules of NGM120 to evaluate their impact on cancer cachexia symptoms. During the study, researchers will monitor changes in body weight from the start to Week 12, as well as track any treatment-emergent adverse events over a 44-week period. Participants will undergo regular assessments to evaluate safety and treatment effects throughout the study duration.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are evaluating a Phase II randomized trial focused on high residual risk breast cancer patients who are estrogen receptor positive and HER-2 negative. These patients have completed or are currently receiving adjuvant endocrine therapy and are within seven years of completing definitive breast surgery. The study aims to guide second-line adjuvant therapy based on circulating tumor DNA (ctDNA) results to manage the risk of cancer recurrence. Participants undergo ctDNA surveillance using Signatera testing during routine follow-up visits every 4 to 6 months. Those who test positive for ctDNA and show no signs of metastatic disease on CT scans of the chest, abdomen, and pelvis are randomly assigned to receive either palbociclib plus fulvestrant for two years or continue their standard endocrine therapy. Pre- and peri-menopausal patients in the palbociclib and fulvestrant group receive additional GnRH analogue therapy. The maximum treatment duration is two years, with up to 26 cycles allowed. After two years without recurrence, patients may resume their original endocrine therapy plan. Throughout the study, participants are monitored via regular clinical visits, imaging, and ctDNA testing to track cancer recurrence and treatment effects. Researchers assess outcomes over an average of six years, including ctDNA surveillance and therapeutic responses. Safety monitoring, adherence to therapy, and long-term follow-up are integral to evaluating the effectiveness and tolerability of the treatment strategies.