Minami Alps

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are investigating new treatments for rheumatoid arthritis (RA), a condition where current therapies like methotrexate (MTX) may not fully control symptoms for many people. This Phase 2b study evaluates a medicine called tulisokibart to see if it can better reduce RA symptoms in individuals already taking MTX. The trial aims to determine if one or more doses of tulisokibart work better than a placebo, which looks like the medicine but contains no active drug. The study includes a 12-week period where participants receive either tulisokibart or a placebo by subcutaneous injection while continuing their MTX treatment, which can be given by injection or orally. Following this, there is a long-term extension lasting 116 weeks, composed of a 44-week main extension and a 72-week optional extension, to further assess the medication's effects and safety over time. Participants will undergo assessments to measure treatment response, including the American College of Rheumatology 20% response criteria at week 12 to gauge symptom improvement. Throughout the study, researchers will monitor for safety and effectiveness, with evaluations extending through the long-term extension periods, totaling over two years of participation.

This research aims to evaluate the safety and tolerability of CBA-1205, an anti-DLK1 monoclonal antibody, in patients with various advanced cancers including solid tumors, hepatocellular carcinoma (HCC), malignant melanoma, and pediatric cancers. It is a first-in-human, multicenter, open-label Phase I study conducted in five parts, focusing on patients who have no standard treatment options or who have not responded or are intolerant to standard therapies. The study also includes pharmacokinetic (PK) analysis to understand how the drug behaves in the body. The study is divided into five parts with different patient groups and dosing schedules. Parts 1 through 4 focus on adults with solid tumors, advanced or recurrent HCC, and malignant melanoma, testing escalating doses of CBA-1205 given intravenously ranging from 0.1 to 30 mg/kg. Part 5 focuses on pediatric cancer patients aged 2 to under 20 years, starting with a 10 mg/kg dose. Each part evaluates safety, tolerability, and determines recommended doses, with some parts also assessing efficacy. Participants will be closely monitored for dose-limiting toxicities during the first 28 days after the initial dose and for adverse events for up to 12 months. Assessments include physical exams, laboratory tests to check organ function and blood counts, and performance status evaluations. Safety will be continuously reviewed throughout the study. The total duration of participation varies by study part, with detailed follow-up to ensure participant well-being and collect data on treatment effects.

Researchers are evaluating the safety and effectiveness of bomedemstat (MK-3543) compared with the best available therapy (BAT) in adults with essential thrombocythemia (ET) who have not responded well to or cannot tolerate hydroxyurea. This phase 3 clinical trial aims to determine if bomedemstat provides a better durable clinicohematologic response in these participants. Participants will receive either bomedemstat as an oral capsule or one of the best available therapies, including anagrelide (oral capsule), busulfan (oral tablet), interferon alfa or its pegylated forms (subcutaneous solution), or ruxolitinib (oral tablet). The study involves a randomized, open-label design where treatments are compared directly. Throughout the study, participants will be monitored for their hematologic response up to about 52 weeks. Assessments include platelet and neutrophil counts before starting treatment to ensure eligibility. Safety and efficacy are tracked to evaluate the long-term impact of the treatments on ET.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are evaluating the safety, tolerability, drug levels, and early biological and clinical effects of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader of B-cell lymphoma 6 (BCL6). This study focuses on participants with relapsed or refractory non-Hodgkin lymphoma (R/R NHL) and explores BMS-986458 both alone and in combination with other anti-lymphoma agents. The study involves administering BMS-986458 at specified doses on designated days. It also evaluates combinations with other lymphoma treatments including Rituximab, Glofitamab/Obinutuzumab, and Mosunetuzumab, each given at specified doses on scheduled days. This is a Phase 1/2, multi-center, open-label, dose-finding study designed to determine the best dose and evaluate multiple treatment regimens. Participants will be monitored for safety and effectiveness through assessments of adverse events, including serious events and those causing treatment discontinuation or death, over a period of up to two years and one month. The study will track drug pharmacokinetics and pharmacodynamics as well as preliminary efficacy. Participants must follow a pregnancy prevention plan and undergo evaluations including imaging to confirm measurable disease. The study aims to provide data on the tolerability and biological activity of these treatments in R/R NHL patients.

Researchers are evaluating the effectiveness and safety of combining golcadomide with rituximab compared to the investigator's choice of treatment in adults with relapsed or refractory follicular lymphoma who have already received at least one prior systemic therapy. This Phase 3, multicenter, randomized, open-label study focuses on participants with confirmed follicular lymphoma grades 1, 2, 3a, or classic FL, who have measurable, PET-positive disease and require anti-lymphoma treatment. Participants will be assigned to receive either golcadomide plus rituximab or the investigator's choice of therapy, which may include drugs such as lenalidomide, cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone, or bendamustine. Each drug will be given at specified doses on specified days as determined by the study protocol. The study monitors treatment effects over time with a planned follow-up of up to approximately 32 months. During the study, participants will undergo various assessments including imaging scans to measure disease progression, laboratory tests, and evaluations by an independent review committee to determine progression-free survival. Safety and response to treatment will be closely monitored throughout the study. Participants must meet specific health and laboratory criteria to join and will be followed for outcomes related to disease control and treatment safety.

Researchers are evaluating whether adding zilovertamab vedotin to standard treatment helps people with previously untreated diffuse large B-cell lymphoma (DLBCL) live longer without their cancer growing or spreading. This Phase 3 study compares zilovertamab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The goal is to see if the new combination improves progression-free survival. Participants receive treatments through intravenous infusions of study drugs including zilovertamab vedotin, rituximab or its biosimilar, cyclophosphamide, doxorubicin, and vincristine, along with oral prednisone or prednisolone as per approved guidelines. Some may receive rescue medication such as granulocyte colony-stimulating factor (G-CSF) if needed. The study is open-label and conducted across multiple centers. During the study, participants are closely monitored for how long they live without their disease worsening, with follow-up up to approximately 50 months. Assessments include imaging scans like PET to evaluate disease status, heart function tests, and regular evaluations of overall health and side effects. Safety is monitored throughout, and researchers measure progression-free survival as the primary outcome to determine the effectiveness of the treatments.

Researchers are investigating the abscopal effect in patients with metastatic renal cell carcinoma (mRCC) who are receiving immune checkpoint inhibitors (ICIs) combined with image-guided ultra-hypofractionated radiotherapy (IGU). This study aims to determine the abscopal response rate (ARR) one year after IGU and to identify clinical and immunological factors linked to the abscopal effect's occurrence and timing. The study is a multicenter prospective observational registry designed to clarify the incidence and predictors of this immune-related response in mRCC patients undergoing combined treatment. Participants will receive IGU using stereotactic or equivalent ultra-hypofractionated radiation techniques (usually 24-30 Gy in 1-3 fractions) targeting one or a few metastatic lesions. The choice of irradiation site and dosage follows local standards. Patients will continue their ICI therapy as directed by their oncologists. Imaging assessments using CT or MRI will be performed before treatment and at 3, 6, 9, and 12 months afterward to evaluate tumor responses in both irradiated and non-irradiated sites. Optional blood samples will be collected at these times for cytokine analysis. During the year-long observation, researchers will record clinical status, lab tests, and any side effects. The primary outcome is the abscopal response rate at one year, defined as at least a 30% reduction in non-irradiated lesions without new tumors appearing. Secondary outcomes include tumor shrinkage rates, overall survival, disease-specific survival, and progression-free survival at one year. The study also explores immune biomarkers that may predict or accompany the abscopal effect, providing important insights for future combined immunotherapy and radiotherapy approaches in mRCC.

Researchers are evaluating the effectiveness and safety of bomedemstat compared to hydroxyurea in people diagnosed with essential thrombocythemia (ET) who have not yet received cytoreductive therapy but need it. This Phase 3 study aims to determine if bomedemstat leads to a better lasting clinicohematologic response than hydroxyurea in these patients. Participants will receive either oral bomedemstat capsules or oral hydroxyurea capsules, with placebos used to maintain the study's double-blind design. The study compares these two treatments to see which better manages ET with a focus on sustained treatment response. The treatments are taken as capsules, but specific dosing schedules are not detailed in the available information. During the study, researchers will monitor participants up to 52 weeks to measure their durable clinicohematologic response. Participants will undergo regular assessments to evaluate treatment effects and safety. The study includes safety monitoring and collects data on how well patients respond to the therapies over time, ensuring comprehensive evaluation of both treatments.