Albury

Researchers are investigating new treatment options for adults with advanced solid tumors that have a KRASG12C mutation. This mutation causes cancer cells to grow, and while the drug sotorasib is approved to target these cancer cells, it usually works only for a limited time before the cancer grows again. The study is testing BAY3498264, a drug designed to block a protein called SOS1 that works with KRAS, hoping this will enhance the effects of sotorasib by providing a longer or stronger response. This is a first-in-human Phase 1 study focusing on the safety and best dosing of BAY3498264 when combined with sotorasib. Participants will first take BAY3498264 alone for seven days, then receive it together with sotorasib in repeated 21-day cycles. Sotorasib is given daily at a standard approved dose alongside BAY3498264. Treatment will continue as long as it benefits participants without causing severe side effects, or until the cancer progresses, or if the participant or doctor decides to stop. The study consists of three parts: dose escalation, backfill, and expansion to determine safe dosing and to monitor effects. Throughout the study, participants will have blood and urine samples collected and undergo imaging scans such as CT, PET, MRI, and X-rays. Their heart health will be checked using ECGs. Researchers will closely monitor safety by tracking any side effects, serious adverse events, drug levels in the blood, and any toxicities during the first treatment cycle. The study will last approximately three years to assess the maximum tolerated dose and overall safety of the drug combination.

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the safety and tolerance of elritercept, a recombinant fusion protein, in adults with anemia linked to lower-risk myelodysplastic syndromes (MDS). The study aims to understand how elritercept affects red blood cell production and to monitor participants for any worsening of MDS during treatment. This is a Phase 2, open-label study focused on patients with very low, low, or intermediate risk MDS. Participants receive elritercept through subcutaneous injections at different dose levels to assess safety and effects. The study includes multiple parts, with initial treatment cycles followed by an extension phase for those who complete the first part without dose-limiting toxicities and may benefit from continued treatment. The study also includes several cohorts based on specific MDS characteristics and transfusion needs. During the study, participants undergo regular evaluations including blood tests, bone marrow assessments, and monitoring for adverse events. Researchers will track the number of treatment-emergent and serious adverse events for up to 11.2 years. Participants are closely monitored for how well they tolerate elritercept and its impact on anemia and red blood cell production throughout the study duration.

Researchers are evaluating the safety, effectiveness, and how the body processes VX-01 as an oral treatment for people with moderate to severe Non-Proliferative Diabetic Retinopathy (NPDR) without clinically significant diabetic macular edema (CI-DME). This Phase 2, multi-center study compares VX-01 to a placebo over 52 weeks, aiming to see if daily doses can improve the condition in adults with Type 1 or Type 2 diabetes. Participants will be randomly assigned to receive either VX-01 tablets (150 mg twice daily) or matching placebo tablets twice daily for one year. The study groups are balanced based on the presence of proliferative diabetic retinopathy and blood sugar control levels. After the 52-week treatment period, there is a 12-week follow-up phase where all participants continue to be monitored without the study drug. During the study, participants will have regular eye exams, including imaging and visual acuity tests, and blood tests to monitor safety and treatment effects. Researchers will track adherence to medication and evaluate outcomes such as vision changes and diabetic retinopathy progression. Safety and tolerability will also be closely observed throughout the treatment and follow-up periods, with total participation lasting about 64 weeks.

Researchers are evaluating the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.

Researchers are studying the safety and how well different doses of FWY003 work in people with geographic atrophy (GA) caused by age-related macular degeneration (AMD). This Phase 2 study aims to understand the relationship between the dose of FWY003 and its effects compared to a placebo. The study is randomized, multi-center, and double-masked, ensuring that neither participants nor researchers know who receives the drug or placebo. Participants will be assigned to receive either FWY003 at specific doses or a placebo. The study is designed to find the best dose by comparing the effects of FWY003 against placebo in patients with GA secondary to AMD. Treatments will be given according to the study protocol, and the response to different doses will be monitored to assess both efficacy and safety. During the study, participants will be evaluated for changes in the size of their GA lesions from the start of the study to month 18. Eye examinations and imaging will be used to monitor the lesion area and vision status. Safety will be closely observed throughout the study, with regular check-ups and assessments to monitor any side effects or changes in eye health.

Researchers are investigating treatments for people with advanced or metastatic colorectal cancer (CRC) that has a specific mutation called KRAS G12D. This mutation is linked to a poorer outlook and fewer treatment options. The study focuses on evaluating the safety, tolerability, and effectiveness of a drug named BAY 3771249, which is designed to block the activity of this mutated KRAS protein. The study also explores how BAY 3771249 works alone or combined with another drug called cetuximab, particularly in patients who have already tried other treatments. Participants will receive BAY 3771249 either by itself as an oral medication or combined with cetuximab delivered through intravenous infusion. The study begins with a dose escalation phase to find the highest safe dose, followed by a dose expansion phase where more participants receive the determined safe dose. Some parts of the study may randomly assign participants to different treatment groups or doses. The study is open-label, so both doctors and participants know which treatment is given. During the study, researchers will monitor participants for up to two years, tracking any treatment-related side effects, changes in vital signs like pulse rate and blood pressure, and laboratory test results. They will also measure how well tumors respond to treatment using standard criteria. Safety is closely observed, including the occurrence of dose-limiting toxicities in the first three weeks. If participants benefit from the treatment, they may continue receiving BAY 3771249 after the study ends. The study aims to improve treatment options for people with this type of colorectal cancer mutation.

Researchers are evaluating the addition of stereotactic body radiotherapy and durvalumab to a well-tolerated two-week chemotherapy and radiation treatment regimen for adults with locally advanced or metastatic esophageal cancer. This phase II clinical trial aims to see if combining chemotherapy, radiation, and immune therapy can better prevent cancer progression and improve swallowing difficulties in people with esophageal or gastro-esophageal junction cancer. Participants will receive 10 daily radiotherapy treatments over two weeks targeting the primary esophageal tumor, along with weekly intravenous chemotherapy including carboplatin and paclitaxel during the same period. Durvalumab, an immune therapy drug, will be given intravenously every four weeks starting at the beginning of radiation therapy and continued for up to 24 months or until the cancer worsens. Those with metastatic tumors will receive an additional three doses of radiotherapy given in one week, four weeks after the initial radiotherapy. Throughout the study, safety blood tests will be collected every two weeks starting at week 2 and then every four weeks from week 9 onward, with additional tests as needed. CT scans to assess tumor response will be done every six weeks until week 24, then every 12 weeks or until cancer progression. Participants will also complete questionnaires about their wellbeing and nutrition during the study. The primary outcome measured is progression-free survival at six months, meaning participants are alive without cancer worsening by that time.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of tuspetinib (HM43239) in patients diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) who have relapsed or are refractory after at least one prior therapy, as well as in newly diagnosed AML patients. This Phase 1/2, open-label, multi-center study aims to determine a safe and potentially effective dose of tuspetinib for future research. Tuspetinib is given as a daily continuous oral dose either alone or combined with venetoclax or venetoclax plus azacitidine, depending on the study part. Part C evaluates tuspetinib alone in relapsed or refractory AML patients, focusing on safety and preliminary efficacy. Part D assesses tuspetinib combined with venetoclax and azacitidine in newly diagnosed AML patients ineligible for intensive chemotherapy. Participants will undergo assessments including monitoring of drug-related adverse events over 4 years, pharmacokinetic measurements like plasma concentration and half-life during the first treatment cycle, and determination of the recommended Phase 2 dose. Safety, tolerability, and efficacy are carefully evaluated throughout treatment, and participants agree to avoid other interventional studies during the trial.