Chermside

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

This research aims to evaluate the clinical benefit and safety of tabelecleucel for treating Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in patients who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT) and have failed prior rituximab or rituximab plus chemotherapy treatments. The study focuses on participants with EBV+ PTLD after failure of rituximab alone or with chemotherapy, including subgroups based on chemotherapy eligibility and transplant type. Tabelecleucel, an off-the-shelf allogeneic T-cell immunotherapy, is given intravenously in 5-week cycles, with doses administered on Days 1, 8, and 15, followed by observation through Day 35. Treatment continues until maximal response, unacceptable side effects, new non-protocol therapy starts, or treatment failure. The study includes cohorts for solid organ transplant recipients (with or without chemotherapy) and hematopoietic cell transplant recipients, with up to 2 or 4 different HLA restrictions allowed, respectively. Participants undergo disease assessments including PET-CT or MRI scans to measure response, and safety is monitored throughout treatment. Follow-up lasts up to 5 years for some participants, with more frequent monitoring every 3 months for others, depending on enrollment timing and response. The primary outcome measured is the objective response rate over 2 years in different participant groups receiving commercial or comparable tabelecleucel products.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the efficacy and safety of a drug called azenosertib (ZN-c3) in women with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. This Phase 2 study focuses on patients whose tumors test positive for Cyclin E1 protein, determined by a specific assay developed by the sponsor. The study aims to understand how well azenosertib works in this group and its safety profile. The study involves administering azenosertib orally to participants. It is divided into two parts: Part 1 included all patients regardless of biomarker status and has completed enrollment; Part 2 requires tumors to be Cyclin E1 positive. Participants receive azenosertib and are monitored throughout the study according to the protocol. Participants will be involved in various assessments including tumor measurements following RECIST version 1.1 criteria up to about 12 months after the last participant enrolls. Researchers will track the objective response rate to evaluate tumor response. Safety and efficacy evaluations, along with monitoring of side effects and overall health, will take place during the study period to gather comprehensive data on the treatment.

Researchers are evaluating HER3-DXd monotherapy in adults with locally advanced unresectable or metastatic solid tumors who have been previously treated with at least one systemic anticancer therapy. This phase 2 proof-of-concept study includes participants with various cancers such as melanoma, squamous cell carcinoma of the head and neck, HER2-negative gastric cancer, ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, lung cancer, and breast cancer. The study aims to assess the safety, tolerability, efficacy, and pharmacokinetics of HER3-DXd, as well as the relationship between HER3 protein expression in tumor tissue and treatment response. Participants receive HER3-DXd as an intravenous infusion at a dose of 5.6 mg/kg every 21 days on Day 1 of each cycle. The study is organized into multiple cohorts based on tumor type, with treatment continuing until disease progression, unacceptable toxicity, withdrawal, or other specified reasons. HER3 protein expression and its association with treatment outcomes are also investigated. Throughout the study, participants undergo regular assessments including tumor response evaluations according to RECIST v1.1 criteria, radiographic imaging, and laboratory tests. For prostate cancer participants, prostate-specific antigen (PSA) levels are monitored each cycle. Safety and tolerability are closely observed up to approximately 27 months. Participants provide tumor tissue samples either from archival or fresh biopsies before treatment initiation. The overall study duration includes screening, treatment cycles, and follow-up for disease progression or other outcomes.

Researchers are evaluating treatments for participants with metastatic colorectal cancer who have already been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab. The study aims to see if precemtabart tocentecan (Precem-TcT), alone or combined with bevacizumab, can prolong overall survival compared to trifluridine/tipiracil (FTD-TPI) plus bevacizumab. This is a phase 3 randomized, open-label trial focused on improving outcomes for these patients. Participants are assigned to one of three groups: one receiving Precem-TcT alone every three weeks intravenously on day 1 of each 21-day cycle; another receiving Precem-TcT with bevacizumab, which is given intravenously either every three weeks on day 1 of a 21-day cycle or every two weeks on days 1 and 15 of a 28-day cycle; and a third group taking FTD-TPI tablets orally twice daily on days 1 to 5 and days 8 to 12 of each 28-day cycle, combined with bevacizumab on the same schedule as the second group. Throughout the study, researchers will monitor overall survival from the date of randomization up to about 19 months. Participants must be able to swallow oral tablets and comply with scheduled evaluations. Safety and treatment response are assessed through regular clinical visits and evaluations. This study helps determine the best treatment approach for patients with metastatic colorectal cancer after prior therapies have been tried.

Researchers are evaluating the effects of the ABC Bicuspid Sizing Algorithm on clinical outcomes for patients with bicuspid aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. This study aims to determine whether the algorithm improves technical success immediately after the procedure and device success 30 days post-procedure. It is a multi-center, international, prospective cohort study enrolling about 290 patients eligible for TAVR or surgical aortic valve replacement (SAVR). The ABC Bicuspid Sizing Algorithm helps doctors assess CT scans to guide decisions on whether patients should receive TAVR or SAVR and to select the appropriate valve size for TAVR patients. In some cases, gated CT scans or artificial intelligence-based simulations are used for further evaluation. Physicians consider these findings along with other clinical factors to decide on the final treatment and valve deployment. About 230 patients are expected to undergo TAVR using the Sapien 3 valve. Participants will have data collected at several points: before the procedure, during the procedure, at hospital discharge, and at 30 days and one year after the procedure for TAVR patients. SAVR patients will have data collected only at baseline and during their procedure. The main outcome measured is the proportion of cases achieving technical success immediately after the procedure. The study includes sites across Canada, Latin America, the Middle East, and Asia Pacific regions.

Researchers are evaluating the effects of TX000045 in patients with pulmonary hypertension caused by heart failure with preserved ejection fraction (PH-HFpEF). This Phase 2, double-blind, randomized, placebo-controlled proof-of-concept study aims to assess two dosing regimens of TX000045 over a 24-week treatment period to understand its impact on pulmonary vascular resistance and safety profile. Participants will be randomly assigned to one of three groups: a placebo group receiving subcutaneous injections every two weeks, a group receiving Dose A of TX000045 subcutaneously every two weeks, and a group receiving Dose B of TX000045 subcutaneously every four weeks alternating with placebo every two weeks. The treatment period lasts for 24 weeks. Throughout the study, participants will undergo assessments including pulmonary vascular resistance measurements, physical examinations, laboratory tests, and monitoring for adverse events from baseline up to 30 weeks after the first dose. Safety evaluations focus on treatment-related side effects and changes in lab values. The study plans to enroll about 180 participants between 18 and 83 years old with specific heart and lung function criteria.

Researchers are evaluating the safety and effectiveness of Mirvetuximab Soravtansine in women with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers that have high levels of folate receptor alpha (FRb1). This is a Phase 2 study that includes two groups: a randomized phase 2 cohort and a hepatic impairment cohort. The randomized cohort compares two different dosing schedules of Mirvetuximab Soravtansine, while the hepatic impairment cohort focuses on patients with moderate liver dysfunction to find the right starting dose. The study plans to enroll about 110 participants at around 75 locations worldwide, lasting approximately 24 months. Participants in the randomized cohort receive Mirvetuximab Soravtansine through intravenous infusion either once every 21 days or on days 1 and 15 every 28 days. The hepatic impairment group receives the drug to assess how liver function affects dosing and drug levels. The study monitors various safety and response outcomes, including eye-related side effects and the drug's concentration in the blood over time. During the study, participants will attend regular visits to a hospital or clinic for assessments that may include medical exams, blood tests, and scans. Researchers will measure treatment effects, track adverse events, and monitor drug levels, especially in those with liver impairment. The total participation duration is about 24 months, with close follow-up to evaluate safety and treatment response.

Researchers are evaluating the effect of a medicine called BI 765423 on lung function in adults aged 40 years and older who have idiopathic pulmonary fibrosis (IPF). Participants must have a forced vital capacity (FVC) of at least 45% of the predicted value and lung fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The study compares BI 765423 to a placebo to see if it can improve lung capacity after three months of treatment and also examines changes in lung health markers. Participants are randomly assigned to receive either BI 765423 or a placebo. The study drug is given as an intravenous infusion every four weeks. Participants may continue their standard IPF treatments during the study. The study lasts 8 to 10 months and includes several visits for screening, treatment, and follow-up. During the study, doctors regularly measure lung function by testing FVC and take blood samples to assess study outcomes. Researchers monitor participants' health and record any side effects. The main outcome measured is the absolute change in FVC from baseline after 12 weeks of treatment. Results from both groups will be compared to evaluate the treatment's effects.