Albury

Researchers are exploring new treatment options for neovascular age-related macular degeneration NVAMD, a condition affecting the eyes. This trial aims to compare a new medicine called tiespectus also known as MK-8748 or EYE201 with the standard treatment aflibercept to see if tiespectus works as well in treating NVAMD. The study includes adults aged 50 and older who have not previously received treatment for this condition. Participants will be randomly assigned to one of three groups tiespectus low dose, tiespectus high dose, or aflibercept. Those in the tiespectus groups will receive three initial injections every 4 weeks, followed by injections every 8 weeks up to week 48. After week 48, treatment will continue at intervals based on individual response until week 92. The aflibercept group will receive three initial injections followed by injections every 8 weeks until week 92. During the study, participants will have their vision tested using the Best-Corrected Visual Acuity BCVA score and their eye structure examined with imaging techniques. Researchers will monitor changes in vision over one year and track any side effects up to approximately 96 weeks. Participants will attend regular visits for treatment and assessments throughout the study period lasting about 92 weeks.

Researchers are investigating treatments for people with advanced solid cancers that have a specific genetic change called the KRASG12C mutation. This trial focuses on combining two drugs sotorasib, which is already approved and targets cancer cells with this mutation, and BAY3498264, a new drug that aims to block a related protein called SOS1. The studys main goal is to find out how safe BAY3498264 is when given with sotorasib and to determine the highest safe dose for this combination. Participants will first receive BAY3498264 alone for seven days, followed by treatment cycles of BAY3498264 combined with sotorasib every day. These cycles last 21 days each, and treatment continues as long as it is beneficial and safe, or until the cancer progresses or the participant or doctor decides to stop. The study includes three parts dose escalation to find the right dose, backfill cohorts to gather more safety and drug data, and expansion cohorts to explore further effects and safety. During the study, participants will have blood and urine samples taken and undergo imaging scans like CT, PET, MRI, and X-rays. Heart health will be checked using electrocardiograms, and participants overall health will be closely monitored. Researchers will measure side effects, drug levels in the body, and cancer response, with treatment effects evaluated regularly. The study runs until about mid-2027, with ongoing safety and effectiveness assessments throughout.

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are studying the safety and tolerability of elritercept in adults with anemia linked to very low, low, or intermediate risk Myelodysplastic Syndromes MDS. The study aims to understand how elritercept affects red blood cell production and the progression of MDS, including how well participants tolerate different doses of the drug. This phase 2, open-label trial focuses on anemia associated with lower-risk MDS and evaluates the impact on healthy red blood cell production. Participants receive elritercept as a subcutaneous injection every 4 weeks, with doses ranging from 0.75 mgkg to 5.0 mgkg during an initial period of up to 4 cycles each 28 days. Following this, participants continue treatment with elritercept every 4 weeks for up to 24 cycles, with dose adjustments based on individual response. Different cohorts include participants with or without ring sideroblasts, those requiring red blood cell transfusions, and those with chronic myelomonocytic leukemia CMML. Some participants may enter a long-term extension phase receiving elritercept every 4 weeks for up to about 10 years. During the study, participants undergo regular monitoring including blood tests, assessments of red blood cell parameters, and tracking of adverse events and disease progression. Researchers measure treatment-emergent adverse events, progression to higher-risk MDS or acute leukemia, transfusion independence, and hematologic improvements over up to 11 years. The study includes follow-ups to evaluate the duration and timing of responses, safety, and overall effects on anemia and MDS progression.

Researchers are studying the use of VX-01, an oral medication, to treat people with moderate to severe Non-Proliferative Diabetic Retinopathy NPDR, a condition related to diabetes affecting the eyes. This Phase 2 clinical trial aims to evaluate how effective and safe VX-01 is compared to a placebo over one year of treatment, including how the body processes the drug and its effects on the disease. Participants will be randomly assigned to one of two groups one group will receive VX-01 tablets at a dose of 150 mg twice daily, and the other group will receive placebo tablets twice daily. The treatment period lasts 52 weeks, followed by a 12-week follow-up after treatment ends. The study is double-masked, meaning neither participants nor study staff know which treatment is being taken during the trial. During the study, participants will have their vision and eye health regularly assessed using standardized tests such as the Early Treatment Diabetic Retinopathy Study ETDRS letter score and diabetic retinopathy severity scores. Safety will be monitored by tracking any adverse events. Participants must attend scheduled visits for evaluations and agree to avoid other investigational studies during the trial. The main goal is to see how VX-01 affects diabetic retinopathy after one year of daily treatment.

Researchers are evaluating FWY003 in adults aged 50 and older with geographic atrophy GA caused by age-related macular degeneration AMD. The study aims to understand the relationship between different doses of FWY003 and their effects on the size of GA lesions, as well as the safety and overall effectiveness of the treatment compared to a placebo. This is a randomized, multi-center, double-masked Phase 2 trial designed to gather detailed information about dosing and outcomes. Participants are randomly assigned to one of four groups receiving either one of three dose levels of FWY003 or a placebo. The treatment period lasts 18 months, during which doses are administered and monitored regularly. The study includes extensive assessments of visual function using various eye tests and imaging to measure changes in GA lesion areas. Blood samples are also collected to measure FWY003 levels. Throughout the study, participants undergo periodic evaluations including eye exams, imaging, and visual acuity tests to track changes in their condition and monitor for any adverse effects. Safety is closely observed from the first dose through month 19. The primary measurement is the change in GA lesion size over 18 months. Participants are followed for the full duration of the trial, which lasts until 2029, ensuring comprehensive monitoring of treatment effects and safety.

Researchers are exploring new treatments for people with advanced or metastatic colorectal cancer CRC who have a specific mutation called KRAS G12D. This mutation is linked to fewer treatment options and a poorer outlook. The study is assessing the safety, how well people tolerate the study drug BAY 3771249, how the body processes it, and whether it can help shrink or control tumors in this group. The study includes people who have already tried other treatments for their cancer. Participants will receive BAY 3771249 either alone or combined with another drug called cetuximab. The study begins with a dosage escalation phase where the dose of BAY 3771249 is gradually increased to find the highest safe amount. After this, more participants may join the dosage expansion phase, receiving the study drugs until their disease progresses or unacceptable side effects occur. The treatments are given orally for BAY 3771249 and by intravenous infusion for cetuximab. During the study, participants will have regular health assessments, including monitoring for side effects and laboratory tests for vital signs and blood work. Researchers will track tumor response using standard criteria and measure drug levels in the blood over time. Participants may continue receiving BAY 3771249 after the study if they benefit. The total participation time varies, with safety and effectiveness monitored for up to about two years.

Researchers are evaluating a combination treatment including stereotactic body radiotherapy and durvalumab added to a well-tolerated two-week chemotherapy and radiation regimen for adults with esophageal cancer that is locally advanced or has spread to other parts of the body. This Phase II trial aims to see if this combined approach can help the bodys immune system control cancer progression and improve swallowing difficulties. All participants will receive ten daily radiotherapy sessions to the primary esophageal tumor over two weeks alongside weekly intravenous chemotherapy with carboplatin and paclitaxel. Durvalumab, an immune therapy given intravenously, starts at the beginning of radiation and continues every four weeks for up to 24 months or until the cancer worsens. Participants with metastatic tumors will also receive three doses of stereotactic radiotherapy to metastases one month after initial treatment. Throughout the study, participants will undergo regular safety blood tests every two to four weeks and CT scans every six weeks up to week 24, then every 12 weeks until disease progression. They will also complete questionnaires about wellbeing and nutrition. Researchers will track progression-free survival, symptom relief, nutritional status, quality of life, response rates, toxicity, and survival over the study period, which may last up to two years.

Researchers are studying the safety, tolerability, and pharmacokinetics of tuspetinib HM43239 in adults with acute myeloid leukemia AML, myelodysplastic syndromes with increased blasts grade 2 MDS-IB2, or chronic myelomonocytic leukemia CMML that has relapsed or is refractory after at least one prior treatment, as well as in newly diagnosed AML patients who cannot receive intensive chemotherapy. This phase 12 open-label study aims to find a safe and potentially effective dose of tuspetinib for future research. Tuspetinib will be given either alone or combined with other drugs such as venetoclax or venetoclax plus azacitidine, depending on the study part. The study includes several parts Part A dose escalation with up to 6 dose levels of tuspetinib alone, Part B dose exploration at up to 4 dose levels, Part C dose expansion testing tuspetinib alone or with venetoclax at specified doses, and Part D dose exploration combining tuspetinib with venetoclax and azacitidine for newly diagnosed AML patients ineligible for intensive chemotherapy. Participants will be closely monitored through blood tests, physical exams, and assessments of drug levels in the blood during at least one 28-day treatment cycle and up to four years for long-term safety and response. Researchers will measure adverse events, determine the maximum tolerated dose, and evaluate treatment responses such as remission rates and survival outcomes. The study involves multiple centers and aims to provide detailed information on how tuspetinib works and is tolerated alone and in combination treatments.