Akita

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 evaluating the safety and tolerability of ONO-4685, given alone, in patients with relapsed or refractory T Cell Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). This is a Phase I, open-label, uncontrolled dose escalation study focused on patients whose tumors have no established standard therapy or who are refractory or intolerant to existing treatments. The study aims to understand the side effects and laboratory changes caused by ONO-4685. Participants receive ONO-4685 through intravenous infusion. Treatment continues until the disease progresses or unacceptable side effects occur. The trial does not include a control group and focuses on increasing doses to find the tolerable level. The drug is given as monotherapy without combination treatments. During the study, participants are closely monitored for dose-limiting toxicities over the first three weeks and followed for an average of one year. Researchers will assess adverse events, clinical laboratory abnormalities, vital signs including body temperature, pulse, blood pressure, changes in weight, chest X-rays, and detailed electrocardiogram (ECG) measurements. These evaluations help determine the safety and tolerability of ONO-4685 throughout the study duration.

Researchers are assessing the effectiveness and safety of ONO-2020 in Japanese patients who experience agitation linked to Alzheimer's Disease dementia. This phase 2a study focuses on patients aged 55 to 90 years with probable Alzheimer's, who show specific agitation symptoms and cognitive impairment as measured by standard scales. The goal is to better understand how ONO-2020 may impact agitation in this population. Participants will be randomly assigned to receive either ONO-2020 or a placebo. Those in the ONO-2020 group will take two tablets by mouth once daily. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo during the trial. Treatment and evaluation periods will extend up to 16 weeks. During the study, participants will undergo various assessments including changes in agitation scores, safety monitoring through vital signs and electrocardiograms, and laboratory tests. Researchers will also track adverse events and monitor for suicidal thoughts or behaviors using a specific rating scale. The study includes hospitalization during treatment to ensure participant safety and close observation throughout the trial period.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with pembrolizumab can treat triple-negative breast cancer (TNBC). This phase 3 study compares these treatments to chemotherapy chosen by the physician, aiming to see if participants live longer or have longer periods without cancer growth or spread. The study focuses on people with previously untreated locally recurrent unresectable or metastatic TNBC with low PD-L1 expression. Participants receive sacituzumab tirumotecan through intravenous infusion alone or with pembrolizumab, also given intravenously. The study compares these to treatment options including paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin. Pre-medications like antihistamines, acetaminophen, and steroids are given before sacituzumab tirumotecan infusions to help reduce side effects. The trial evaluates safety and effectiveness over several months. Throughout the study, researchers monitor participants up to about 39 months for progression-free survival and up to about 61 months for overall survival. Participants undergo regular assessments to track cancer status and side effects. The study includes careful safety monitoring, and participants must meet specific health criteria to join. The total time in the study and follow-up depends on each participant's response and health status.

Researchers are evaluating the safety, effectiveness, and tolerability of subcutaneous blinatumomab for treating Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL in participants aged 12 years and older. This Phase 1/2 study aims to find the maximum tolerated dose and recommended dose for Phase 2, as well as to assess clinical pharmacokinetics of two blinatumomab formulations (SC1 and SC2). Blinatumomab will be given as a subcutaneous injection. The study includes several parts: a dose escalation phase to determine safety and dosage, followed by dose expansion and Phase 2 cohorts to further evaluate efficacy and drug concentrations. Different participant groups will receive treatments based on their disease status, with monitoring periods ranging from up to 29 days for early toxicities to approximately 28 weeks for adverse events and up to 10 weeks for remission outcomes. Participants will undergo regular assessments including safety evaluations, response to treatment, and pharmacokinetic measurements. Researchers will monitor for treatment-related side effects, remission status, and drug levels in the blood. The study involves ongoing follow-up to capture complete remission rates, disease response, and safety for up to several months after treatment begins.

Researchers are evaluating the study medicine elranatamab alone and in combination with daratumumab for people with relapsed or refractory multiple myeloma who have received prior treatments including lenalidomide and a proteasome inhibitor. The study aims to compare elranatamab to a combination therapy of daratumumab, pomalidomide, and dexamethasone, while also assessing the safety and activity of elranatamab with daratumumab. This is an open-label, phase 3 randomized trial involving multiple centers. The study includes three parts. Part 1 evaluates the safety and activity of different doses of elranatamab combined with daratumumab. In Part 2, participants are randomly assigned to receive either elranatamab alone, elranatamab with daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 investigates the effect of increased infection protection measures in participants treated with elranatamab alone or with daratumumab. All drugs are given by either subcutaneous injection or orally depending on the medication. Participants will receive study treatment until their disease worsens, unacceptable side effects occur, or they decide to stop. Researchers will monitor safety by tracking dose limiting toxicities during the first 42 days after starting elranatamab and treatment-emergent adverse events during the first 84 days. Progression-free survival will be assessed up to 51 months after randomization. Throughout the study, participants will undergo regular assessments to evaluate treatment safety and effectiveness.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating the safety, tolerability, and appropriate dosing of ELVN-001, an investigational drug, in Japanese adults with chronic phase chronic myeloid leukemia (CML), including those with and without the T315I mutation. This study focuses on patients whose disease has not responded to at least two prior tyrosine kinase inhibitors (TKIs), or who are intolerant or ineligible for such treatments. The study aims to understand ELVN-001's effects on disease markers and to inform future clinical development in this population. The trial is a first-in-human, phase 1 dose escalation study where participants receive ELVN-001 orally once or twice daily. The initial part of the study evaluates safety and dose-limiting toxicities over 28 days to determine recommended doses for further research. Following this, participants may continue treatment with long-term safety monitoring for up to three years. Participants will be closely monitored through clinical assessments, laboratory tests, and electrocardiograms (ECGs) to track adverse events, laboratory abnormalities, and heart-related effects. The study will also assess changes in BCR-ABL1 transcript levels to evaluate drug activity. Overall, the trial involves ongoing safety evaluations and pharmacokinetic analyses, with total participation lasting up to three years.