Chermside

Researchers are studying pulmonary arterial hypertension PAH, a condition where lung blood vessels become thick and narrow, causing high blood pressure in the lungs and making it hard for the heart to work. PAH can cause difficulty breathing and limit activity. While standard treatments help symptoms, they do not stop the disease from worsening. This research focuses on sotatercept, a targeted therapy aimed at specific proteins involved in PAH, to learn about its long-term safety and tolerability when added to usual PAH treatments. Participants in this long-term follow-up study, who previously took part in certain sotatercept trials, may continue receiving sotatercept by subcutaneous injection every three weeks. Those coming from blinded studies start at 0.3 mgkg with possible increases up to 0.7 mgkg, while those from unblinded studies continue their current dose with possible titration to 0.7 mgkg. The study monitors participants over an extended period to assess continued effects alongside their usual PAH therapy. During the study, participants will have regular assessments including monitoring for adverse events, blood tests for blood components and chemistry, body weight, blood pressure, and ECG readings. Researchers will also evaluate exercise capacity, heart function markers, and risk scores related to PAH. The study aims to follow participants for up to approximately 7 to 8 years to understand long-term safety, treatment tolerability, and health changes while using sotatercept with standard PAH care.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating tabelecleucel, an off-the-shelf, allogeneic T-cell immunotherapy, for treating Epstein-Barr virus-associated post-transplant lymphoproliferative disease EBV PTLD after failure of rituximab or rituximab plus chemotherapy. This phase 3, multicenter, open-label study includes participants with EBV PTLD following solid organ transplant or allogeneic hematopoietic cell transplant. The study aims to determine the clinical benefit and safety profile of tabelecleucel in these patient groups. Participants receive intravenous tabelecleucel in 5-week cycles, with doses given on Days 1, 8, and 15, followed by observation through Day 35. Treatment continues until maximal response, unacceptable toxicity, initiation of other therapy, or tabelecleucel failure, with limits on the number of different HLA restrictions used. The study allows up to 5 years of follow-up for disease and survival status, with more frequent assessments for certain participants and responders. During the study, participants undergo regular assessments including imaging with PET-CT or MRI to measure disease response. Researchers monitor objective response rate, duration of response, overall survival, and rates of allograft loss or rejection. Safety and treatment effects are closely followed, and participants are observed for up to one year after initial response. The total study duration includes treatment cycles and extended follow-up to evaluate long-term outcomes.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the efficacy and safety of azenosertib ZN-c3, an oral drug that inhibits WEE1, in people with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. This Phase 2 study includes patients whose tumors test positive for Cyclin E1 protein. The study is designed to understand how azenosertib affects cancer cell growth by allowing damaged cells to continue the cell cycle, leading to cancer cell death. The study has two parts Part 1 included all patients regardless of biomarker status and has completed enrollment. Part 2 focuses on patients with Cyclin E1 positive tumors. Participants receive azenosertib orally at doses of either 300mg or 400mg daily, following a schedule of five days on treatment followed by two days off. Several study arms explore different dosing groups within this intermittent treatment plan. Participants will be monitored for up to approximately 12 months after the last patients enrollment. The study includes regular assessments of tumor response using RECIST criteria, measurement of biomarkers like CA-125, and tracking of side effects. Researchers will measure objective response rate as the primary outcome, along with duration of response, progression-free survival, clinical benefit rate, and treatment-emergent adverse events. This comprehensive monitoring aims to understand the treatments effects and safety profile over time.

This research aims to evaluate HER3-DXd monotherapy in adults with locally advanced unresectable or metastatic solid tumors who have previously received at least one systemic anticancer therapy. The study includes participants with various cancers such as melanoma, head and neck squamous cell carcinoma, HER2-negative gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, lung cancer, and breast cancer. The focus is to assess the treatments safety, tolerability, efficacy, and pharmacokinetics, along with exploring the relationship between HER3 protein expression and treatment response. Participants will receive intravenous infusions of HER3-DXd at a dose of 5.6 mgkg every three weeks Q3W. The trial is designed as a phase 2, multicenter, multicohort, open-label study involving a single treatment group receiving HER3-DXd monotherapy. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The study will also collect tumor tissue samples before treatment to analyze HER3 protein expression. During the study, participants will undergo regular assessments including imaging scans to evaluate tumor response, safety evaluations, laboratory tests, and pharmacokinetic sampling at specified cycles. The primary outcomes include measuring objective response rates and, for prostate cancer participants, the proportion achieving significant decreases in PSA levels. Secondary outcomes cover treatment-emergent adverse events, duration of response, clinical benefit, disease control, progression-free survival, overall survival, and pharmacokinetic parameters. Participants will be followed for up to approximately 27 months to monitor these outcomes.

Researchers are evaluating treatments for people with metastatic colorectal cancer mCRC who have already received certain standard therapies including irinotecan, oxaliplatin, fluoropyrimidine, and bevacizumab. The study aims to see if treatment with precemtabart tocentecan Precem-TcT, alone or combined with bevacizumab, can prolong overall survival compared to the combination of trifluridinetipiracil FTD-TPI plus bevacizumab. This is a randomized, open-label Phase 3 clinical trial investigating these options for previously treated mCRC patients. Participants are randomly assigned to one of three groups Precem-TcT alone given intravenously once every 3 weeks in 21-day cycles Precem-TcT combined with bevacizumab, where bevacizumab is administered intravenously every 3 weeks or every 2 weeks depending on the cycle schedule or FTD-TPI plus bevacizumab, with FTD-TPI given orally twice daily on specified days in 28-day cycles. The study observes treatment effects while participants receive these medications according to their assigned group. During the trial, participants will be regularly assessed for overall survival and disease progression over about 19 months. Researchers will also monitor tumor response, duration of response, adverse events, drug concentrations, immune response to the drugs, and quality of life using questionnaires. These assessments include clinical evaluations and laboratory tests conducted at scheduled intervals throughout treatment. Participants remain under close medical monitoring to track treatment impact and safety until the studys end.

Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement TAVR using the Sapien 3 valve. This international, multi-center study aims to determine if the algorithm improves technical success immediately after the procedure and device success 30 days later. The study also examines how additional imaging techniques like gated computed tomography and artificial intelligence-based simulations influence treatment decisions. The study involves about 290 patients eligible for TAVR or surgical aortic valve replacement SAVR. Physicians use the ABC Bicuspid Sizing Algorithm to guide treatment allocation between TAVR and SAVR, as well as valve sizing and deployment for those receiving TAVR. Some patients may have further evaluation with gated CT or AI simulations to assess risks. Data for TAVR patients is collected at baseline, during the procedure, at hospital discharge, 30 days after, and annually up to 5 years. SAVR patients have data collected at baseline and during the procedure only. Participants will undergo diagnostic imaging including CT scans evaluated with the sizing algorithm and may receive additional assessments if indicated. Researchers collect data on procedure success, device outcomes, conduction disturbances, pacemaker implants, stroke, vascular complications, mortality, valve function, and hospitalizations for heart failure over 5 years. Follow-up visits occur at 30 days and annually, allowing long-term monitoring of outcomes after treatment.

This research aims to evaluate the safety and effectiveness of Mirvetuximab Soravtansine in female participants aged 18 years and older who have platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high levels of folate receptor alpha FR. The study includes two groups a randomized Phase 2 group and a hepatic impairment group, with about 110 participants expected worldwide. The purpose is to better understand how this investigational antibody drug conjugate works by targeting cancer cells carrying FR to deliver a cell-killing drug. Participants in the randomized Phase 2 group receive Mirvetuximab Soravtansine intravenously on one of two schedules either a standard dose on day 1 every 21 days or a lower dose on days 1 and 15 every 28 days. The hepatic impairment group evaluates the starting dose for participants with moderately abnormal liver function, receiving different doses on day 1 of a 21-day cycle. Treatment and monitoring continue for up to about 24 months, including dose optimization and safety assessments. During the study, participants will visit the hospital or clinic regularly for medical exams, blood tests, and scans to track treatment effects and side effects. Researchers will measure responses including corneal adverse events, tumor response rates, drug concentrations in the body, and survival outcomes. Safety is closely monitored through assessments of vital signs, laboratory values, and physical exams. The total participation time is approximately 24 months, with ongoing evaluations to determine how well the treatment works and its safety profile.