Akita

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the tolerability and safety of a drug called ONO-4685 when given alone to patients with relapsed or refractory T Cell Lymphoma and Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL. This is an open-label Phase I trial designed to identify potential side effects and appropriate dosing in these patient groups where standard therapies may no longer work or are unavailable. ONO-4685 is administered through intravenous infusion and will be given repeatedly until the disease progresses or unacceptable side effects occur. The study does not include a control group and focuses solely on the effects of ONO-4685 in these patients. The trial includes a dose escalation phase to find the best tolerated dose. Participants will be closely monitored for safety and effectiveness for about one year. This includes tracking any dose-limiting toxicities, adverse events, and changes in vital signs like body temperature, pulse, and blood pressure. Laboratory tests, chest X-rays, and ECGs will be performed regularly. Researchers will also assess tumor response, survival outcomes, and various pharmacokinetic measures during the study period.

Researchers are evaluating the safety and effectiveness of ONO-2020 in adults aged 55 to 90 years with agitation linked to Alzheimers Disease dementia. This phase 2a, randomized, placebo-controlled study is conducted across multiple centers in Japan and aims to better understand how ONO-2020 affects agitation symptoms in this population. Participants will be randomly assigned to receive either two ONO-2020 tablets or two placebo tablets once daily. The treatment period lasts up to 12 weeks, during which patients are hospitalized from 21 days before treatment starts through the treatment phase. The study is designed as a double-blind, parallel-group trial to compare ONO-2020 against placebo. Throughout the study, researchers will monitor changes in agitation using the Cohen-Mansfield Agitation Inventory CMAI and assess safety through vital signs, ECG measurements, laboratory tests, and the Columbia-Suicide Severity Rating Scale. Additional assessments include cognitive function tests and daily living activity scores. The study will continue safety monitoring up to 16 weeks, with the primary evaluation of agitation changes by week 12.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are evaluating whether sacituzumab tirumotecan alone or combined with pembrolizumab can treat people with triple-negative breast cancer TNBC that is locally recurrent, unresectable, or metastatic. The study aims to determine if these treatments help participants live longer overall or without their cancer growing or spreading compared to chemotherapy chosen by their physician. This is a phase 3, randomized, open-label trial focusing on patients whose tumors express PD-L1 at less than 10 combined positive score CPS. Participants are assigned to one of three groups. One group receives sacituzumab tirumotecan intravenously every two weeks until disease progression, toxicity, or stopping treatment. Another group gets the same sacituzumab tirumotecan schedule plus pembrolizumab intravenously every six weeks for up to about two years. The third group receives the physicians choice of chemotherapy, which may include paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin, given intravenously on various schedules until disease progression, toxicity, or discontinuation. Pre-medications are given before sacituzumab tirumotecan to help manage side effects. Participants will be monitored for how long they live without their cancer worsening and overall survival, with follow-up lasting up to around 61 months. Researchers will assess treatment response, quality of life using questionnaires, and physical and emotional functioning. Safety will be closely tracked by recording adverse events and treatment discontinuations. The total participation time depends on treatment duration and follow-up assessments.

Researchers are evaluating the effectiveness and safety of a combination of follitropin alfa and lutropin alfa in Japanese women with luteinizing hormone LH and follicle stimulating hormone FSH deficiency who are undergoing assisted reproductive technology ART. This Phase 3 study focuses on women who have had at most one previous ART stimulation without pregnancy and aims to compare this combination product with human menopausal gonadotropin hMG. Participants will receive either a fixed combination of recombinant follitropin alfa and lutropin alfa in a 21 ratio or hMG during ovarian stimulation. The follitropin alfalutropin alfa combination is administered subcutaneously once daily starting with 150 IU of follitropin alfa and 75 IU of lutropin alfa for up to 18 days. Additional medications such as cetrorelix acetate, corio gonadotropin alfa, and progesterone gel are used during ovarian stimulation, final follicular maturation, and luteal phase support. During the study, participants will be monitored through vaginal ultrasound scans, semen analysis, and cytologic tests. Researchers will measure the total number of oocytes retrieved, hormone levels, number of follicles, fertilization rates, blastocyst freezing, and pregnancy outcomes. Safety will be assessed by tracking adverse events, ovarian hyperstimulation syndrome occurrences, laboratory changes, and local reactions over approximately 5.5 months for nonpregnant participants and up to 13 months for those with confirmed pregnancy.

Researchers are studying multiple myeloma, a type of blood cancer, to see if the drug elranatamab, alone or combined with daratumumab, can offer more benefits compared to a combination therapy of daratumumab, pomalidomide, and dexamethasone. This Phase 3 clinical trial focuses on people who have already been treated for multiple myeloma, including with lenalidomide. The study also evaluates the safety and activity of elranatamab with daratumumab and assesses infection protection measures for participants. The trial has three parts. Part 1 tests different doses of elranatamab combined with daratumumab to check safety and activity. In Part 2, participants are randomly assigned to one of three groups elranatamab alone, elranatamab plus daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 examines how increased infection prevention affects those treated with elranatamab alone or with daratumumab. Treatments are given until the disease worsens, side effects become unacceptable, or participants choose to stop. Participants will be monitored for side effects, disease progression, and overall response using standardized criteria from the International Myeloma Working Group. Safety is closely watched, especially in early treatment phases, and quality of life is assessed with questionnaires. Outcome measures include progression-free survival, response rates, adverse events, and lab results. Participant involvement may last up to 51 months with regular evaluations during the study.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating ELVN-001 in Japanese adults with chronic phase chronic myeloid leukemia CML, including those with or without the T315I mutation. The study focuses on patients who have not responded to, cannot tolerate, or are not candidates for at least two prior tyrosine kinase inhibitors TKIs. This phase 1 trial aims to assess the safety, tolerability, and appropriate dosing of ELVN-001 for future clinical use, while also monitoring changes in the BCR-ABL1 transcript to understand the drugs impact on CML. The study involves two parts an initial dose escalation phase where ELVN-001 is given orally once or twice daily to small groups of participants to identify safe and tolerable doses. Following this, a dose exploration phase will enroll participants at or below these dose levels to further evaluate safety and dosing. The treatment is administered continuously, with careful monitoring for adverse events and laboratory abnormalities. Participants will undergo regular evaluations including safety assessments, laboratory tests, and electrocardiograms ECGs for up to three years. Researchers will measure dose-limiting toxicities, adverse events, and specific molecular responses related to CML. Pharmacokinetic parameters such as concentration levels of ELVN-001 will also be studied over six months. This long-term follow-up aims to understand the drugs effects and safety profile comprehensively during and after treatment.