Hirakata

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating BMS-986500 as a treatment for people with advanced solid tumors and those with advanced breast cancer previously treated with CDK4/6 inhibitors. This phase 1 study aims to assess BMS-986500 alone and in combination with other therapies, focusing on its safety and tolerability in these patient groups. Participants will receive BMS-986500 either by itself or combined with palbociclib and fulvestrant at specified doses on designated days. The study includes a group with advanced solid tumors and a subgroup with CCNE1-amplified ovarian cancer for specific evaluation. Treatment schedules and doses are defined according to the study protocol. During the study, researchers will monitor participants for dose-limiting toxicities, adverse events, serious adverse events, treatment-related events leading to discontinuation, and those resulting in death, all assessed up to 28 days after the last dose. Participants will undergo disease evaluations and performance status assessments to track treatment effects and safety throughout the study period.

Researchers are evaluating the clinical effectiveness, safety, and how the body processes HLX10, a recombinant humanized anti-PD-1 monoclonal antibody, when combined with chemotherapy (carboplatin-etoposide) in Japanese patients who have not previously been treated for extensive stage small cell lung cancer (ES-SCLC). This phase II, single-arm, open-label study focuses on patients diagnosed with this advanced form of lung cancer. Participants will receive HLX10 combined with chemotherapy as their treatment. The study does not include a comparison group and aims to assess outcomes over a period that can extend up to two years. Treatment involves the administration of the investigational antibody alongside standard chemotherapy drugs carboplatin and etoposide. The study monitors response rates and safety during this time. Throughout the study, participants will be closely monitored for their response to treatment, specifically looking for complete or partial responses by week 24 and continuing up to two years. Assessments will include imaging to measure tumor response, regular health evaluations, and safety monitoring. Researchers will also collect data on how the drug behaves in the body (pharmacokinetics). Participants are expected to complete all study procedures and follow-up assessments as scheduled.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating the anti-tumor activity of amivantamab combined with pembrolizumab and carboplatin compared to pembrolizumab, 5-fluorouracil (5-FU), and platinum therapy (carboplatin or cisplatin) in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial focuses on participants who have not received prior systemic treatment in the recurrent/metastatic setting. HNSCC is a type of cancer affecting the outer tissue layer of the mouth and throat and other head and neck regions. Participants will receive either amivantamab added to pembrolizumab and carboplatin or the standard care regimen of pembrolizumab, 5-FU, and a platinum agent (carboplatin or cisplatin). 5-FU will be given as an infusion over a 4-day period. The study is a phase 3, randomized, open-label, multicenter trial comparing these treatment combinations. During the study, researchers will monitor overall survival and the objective response rate using standard tumor evaluation criteria for up to about 3 years and 7 months. Participants will undergo assessments to measure disease response, including imaging and other evaluations, to track how well the treatments work. Safety and side effects will also be monitored throughout the trial period.

Researchers are evaluating the safety, tolerability, how the body processes, and early anti-cancer effects of a new drug called BG-C477. The study includes participants with advanced solid tumors that have been previously treated or for whom no standard treatment exists. This trial is a Phase 1a/b, first-in-human study conducted by BeOne Medicines, formerly BeiGene, to better understand BG-C477 alone and combined with other cancer treatments. Participants will receive BG-C477 intravenously, either by itself or combined with other anticancer agents such as Tislelizumab or chemotherapy given according to local guidelines. The study includes dose escalation to find the maximum tolerated or administered dose, followed by dose expansion to evaluate recommended doses. This process may last up to approximately two years, with specific focus on safety, dosing, and preliminary effectiveness. During the study, participants will be monitored for side effects and treatment responses through clinical assessments, laboratory tests, and imaging to measure tumor changes. Researchers will collect samples from tumors and track adverse events from the first dose until 30 days after the last dose, with follow-up lasting up to two years. The primary outcomes include safety measurements, dose recommendations, and overall response rate to treatment.

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are types of blood cancers that can cause symptoms like enlarged lymph nodes, spleen, or liver, night sweats, weight loss, and fever. People with these conditions have shorter life expectancy, creating an urgent need for new treatments to extend life and control symptoms. This research evaluates the safety and effectiveness of a drug called BGB-16673 compared to other treatments chosen by doctors in participants previously treated with both Bruton tyrosine kinase inhibitors (BTKi) and B-cell leukemia/lymphoma 2 protein inhibitors (BCL2i). Participants with relapsed or refractory CLL or SLL will be randomly assigned to receive either BGB-16673 taken orally or one of the investigator's chosen treatments, which include idelalisib plus rituximab (for CLL only), bendamustine plus rituximab, or venetoclax plus rituximab retreatment. The study plans to include approximately 250 participants worldwide. Treatments are given according to the assigned group to compare how well each controls disease progression. During the study, researchers will monitor participants for about 36 months to measure progression-free survival, which is the length of time patients live without their disease worsening. Participants will undergo assessments including imaging and laboratory tests to evaluate their health and treatment response. Safety and effectiveness will be closely followed throughout the study period to better understand the potential benefits and risks of BGB-16673 compared to other treatment options.