Fort Bragg

This trial is studying how safe and effective the VARIPULSE catheter system is for treating persistent atrial fibrillation PsAF, a heart rhythm disorder. It focuses on participants undergoing catheter ablation procedures that isolate veins in the heart, specifically pulmonary vein isolation PVI and superior vena cava isolation SVCI, with or without posterior wall isolation PWI. The study also looks at safety for participants receiving a left atrial appendage occlusion LAAO procedure during the catheter ablation to reduce stroke risk. Participants will be treated with the VARIPULSE catheter system, which delivers pulsed field ablation, using the VARIPULSE bi-directional catheter and TRUPULSE generator. The study has two groups one undergoing PVI and SVCI, and another undergoing PVI, SVCI, plus PWI. Some participants may also receive the LAAO procedure using commercially available devices as per device instructions. All participants will be followed for up to 36 months after their procedure. During the study, participants will undergo catheter ablation treatment and may receive the LAAO procedure if applicable. Researchers will monitor safety by tracking early adverse events up to 7 days post-procedure and will assess how well the treatment prevents atrial tachyarrhythmia episodes from day 61 to 180 and up to one year. Quality of life will be measured at baseline and 12 months after treatment. Participants need to comply with pre-, post-, and follow-up testing throughout the study and will be observed for up to three years in total.

Researchers are evaluating a combination treatment for men and post-menopausal women with hormone receptor positive HR, HER2-negative advanced or metastatic breast cancer that has specific alterations in the PI3K pathway, such as mutations in the PIK3CA gene, PTEN loss, or AKT1 mutation. This Phase 1b2, open-label pilot study aims to determine the safety of evexomostat combined with either alpelisib or capivasertib plus fulvestrant, measure the severity and number of hyperglycemic events, and assess the anti-tumor effects of these triplet therapies. Participants will first receive evexomostat plus fulvestrant for 14 days before adding either alpelisib or capivasertib, depending on the oncologists choice, forming the triplet therapy. Treatment cycles last 28 days, and doses of evexomostat may be adjusted based on safety data. Patients may continue the triplet therapy for up to seven cycles, or longer if clinical benefit is observed, with ongoing safety and efficacy monitoring. During the study, patients will undergo tumor assessments and monitoring of hyperglycemic events, glucose control, insulin resistance, and various biomarkers related to tumor and metabolic activity. Safety data, adverse events, and quality of life will be evaluated up to 42 to 48 months. Participants must attend scheduled visits and comply with fasting requirements on designated days. The study allows continuation of therapy until disease progression, unacceptable toxicity, or withdrawal.

Researchers are evaluating QXL138AM in adults with locally advanced unresectable andor metastatic solid tumors and multiple myeloma in this Phase 1a1b study. It is an open-label, multicenter first-in-human trial designed to assess the safety, how the drug moves through the body, and early signs of activity. The study includes patients who have progressed despite standard therapies or have no effective treatment options available. The study is divided into two main parts, each with two sub-parts based on tumor type. Part A involves dose escalation Part A1 enrolls patients with various solid tumors including ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal, lung, prostate, and breast cancers using a modified 33 design to find the recommended dose. Part A2 focuses on multiple myeloma dose escalation once the solid tumor dose is identified or signs of activity appear. Part B involves dose expansion to further explore safety and anti-tumor activity in selected solid tumors Part B1 and multiple myeloma Part B2, with patients randomized to receive the recommended dose or one dose level lower. Participants will receive QXL138AM by intravenous infusion every two weeks, administered over 30 to 60 minutes. Researchers will monitor safety through adverse events over approximately 3.5 years, measure drug levels in the blood, assess the presence of anti-drug antibodies, and evaluate anti-tumor activity during dose expansion. The study includes various assessments such as tumor measurements and blood tests to track response and tolerability throughout the treatment and follow-up periods.