Minami Alps

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating CBA-1205, an anti-DLK1 monoclonal antibody, in a first-in-human Phase I study involving patients with advanced solid tumors, hepatocellular carcinoma HCC, malignant melanoma, and pediatric cancers. The study aims to assess the safety and tolerability of CBA-1205 across five parts, including dose escalation and evaluation in different patient groups where standard treatments are unavailable or ineffective. This trial is conducted at multiple centers and is non-randomized and open-label. Participants receive CBA-1205 intravenously at two-week intervals in 28-day cycles. The study includes seven dose cohorts ranging from 0.1 mgkg to 30 mgkg for solid tumors in Part 1, with subsequent parts focusing on specific cancers such as HCC, melanoma, and pediatric cancers. Treatment continues until criteria for discontinuation are met. Pharmacokinetic analysis is also part of the evaluation. During the study, participants will undergo safety monitoring for dose-limiting toxicities and adverse events up to 12 months. Blood samples will be collected to measure serum drug concentration and immunogenicity. Efficacy assessments occur at screening, during treatment cycles, and until treatment discontinuation. Overall, participant involvement includes regular visits for treatment administration and comprehensive monitoring throughout the study duration.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Polycythemia vera PV is a rare blood cancer where the body produces too many red blood cells, causing thicker blood and raising the risk of serious problems like blood clots. This study aims to see if rusfertide can help Japanese adults with PV keep their hematocrit levels under control and reduce the need for regular blood removal procedures called phlebotomies. The study is a phase 2, open-label trial, meaning both participants and researchers know the treatment being given. Participants will receive rusfertide injections under the skin once a week for an initial 52-week period, followed by a long-term extension period of 182 weeks where treatment continues. After the treatment phases, there is a 4-week safety follow-up to monitor participants. All participants receive rusfertide, and no placebo or comparator group is involved. During the study, participants will have regular hematology tests to monitor their blood levels and hematocrit control. Researchers will track the number of phlebotomies needed and measure the percentage of participants maintaining hematocrit below 45%. Follow-up visits and assessments will continue for up to about 244 weeks, including screening, treatment, extension, and safety follow-up to evaluate the treatments impact and safety.

Researchers are evaluating the safety and effectiveness of zilovertamab vedotin ZV combined with standard treatments for people with relapsed or refractory diffuse large B-cell lymphoma rrDLBCL. This Phase 23 study is divided into two parts Dose Confirmation and Efficacy Expansion. It aims to compare ZV combined with rituximab, gemcitabine, and oxaliplatin R-GemOx against R-GemOx alone, and ZV combined with bendamustine rituximab BR against BR alone, focusing on progression-free survival. Enrollment in the BR-related arms has been discontinued with no analysis planned for those arms.

This research focuses on adults with relapsed or refractory Non-Hodgkin Lymphoma NHL. It aims to study the safety, tolerability, drug levels, and early biological and clinical effects of BMS-986458, a specialized drug designed to target B-cell lymphoma 6 BCL6. The study evaluates BMS-986458 both alone and combined with other anti-lymphoma treatments to better understand its potential in managing NHL. Participants may receive BMS-986458 alone or in combination with drugs like Rituximab, GlofitamabObinutuzumab, Mosunetuzumab, Epcoritamab, or Golcadomide. Dosing occurs on specified days tailored to each treatment group. The study is divided into multiple parts, including single-agent and combination treatment groups, all actively monitored for response and safety. During the trial, participants will have regular assessments for adverse events, drug levels, and treatment responses using criteria like the Lugano response. The study includes monitoring up to three years for outcomes such as overall survival and progression-free survival. Participants will undergo scans, laboratory tests, and clinical evaluations throughout the study to measure treatment effects and safety over time.

Researchers are investigating the efficacy and safety of golcadomide combined with rituximab compared to investigators choice treatments in adults with relapsed or refractory follicular lymphoma who have received at least one prior systemic therapy. This multicenter, randomized, open-label Phase 3 study focuses on participants with confirmed follicular lymphoma that has returned or not responded to previous treatments, aiming to better understand treatment options in this setting. Participants will be randomly assigned to receive either golcadomide plus rituximab or one of the investigators chosen regimens, which may include rituximab combined with lenalidomide, R-CHOP chemotherapy rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisoneprednisolone, or rituximab with bendamustine. Each treatment involves specified doses on specified days, and the study compares these approaches over a treatment period. During the study, participants will be closely monitored through evaluations such as imaging scans, pathology reviews, and quality of life questionnaires. Researchers will assess progression-free survival up to approximately 32 months, along with other measures like overall response rate, overall survival, duration of response, and minimal residual disease status. Safety and treatment effects will be tracked, and participants may be followed for up to nearly seven years to gather comprehensive outcome data.

Researchers are evaluating whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

This research aims to understand 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. The study focuses on measuring the abscopal response rate ARR one year after IGU and identifying clinical and immunological factors linked to this effect. It is a multicenter observational study conducted from 2025 to 2028, led by Prof. Hiroshi Onishi and managed by Dr. Zhe Chen. Participants receive IGU using stereotactic or similar ultra-hypofractionated radiotherapy techniques, typically delivering 24-30 Gy in 1-3 fractions to selected metastatic lesions, following institutional standards. Patients continue their ICI therapy as determined by their oncologist. There is no randomization or additional treatment beyond standard care. The study includes a one-year follow-up period with imaging assessments and optional blood samples for cytokine analysis. During the study, tumor responses at irradiated and non-irradiated sites are evaluated using CT or MRI at baseline and at 3, 6, 9, and 12 months post-IGU. Clinical status, laboratory tests, and toxicity are monitored throughout. Researchers measure the abscopal response rate at one year, tumor shrinkage rates, overall survival, disease-specific survival, and progression-free survival. Blood samples may be collected to explore immune biomarkers. Data is recorded electronically, and participants are followed for one year to assess outcomes.

Researchers are evaluating the safety and effectiveness of a 14-day intravenous infusion of teplizumab in Japanese children and adults aged 1 to 34 years who have Stage 2 Type 1 Diabetes T1D. This Phase 2, parallel study aims to confirm the effects of teplizumab on delaying progression to Stage 3 T1D, building on prior studies conducted in Western countries. The study also assesses pharmacokinetics, pharmacodynamics, and immunogenicity of this treatment regimen. Participants are randomly assigned to receive either teplizumab via intravenous infusion for 14 days or no treatment as a control. The dosing regimen matches the FDA-approved schedule for delaying Stage 3 T1D onset in patients aged 8 years and older. The study duration is about 756 days, during which participants are monitored for clinical outcomes and safety. During the study, participants undergo regular assessments including blood tests for C-peptide, insulin, glucose tolerance, and hemoglobin A1c, as well as monitoring for adverse events and vital signs. The primary outcomes include the number of participants progressing to Stage 3 T1D within 104 weeks and changes in insulin production measures. Safety is monitored throughout the study period with laboratory tests, electrocardiograms, and recording any treatment-emergent adverse events.