Yokohama

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating KK2260 in patients with advanced or metastatic solid tumors in a Phase 1 clinical trial. The study aims to find the maximum tolerated dose (MTD) and assess the safety, tolerability, and effectiveness of KK2260 across multiple cancer types, including esophageal and head and neck cancers. The study includes initial dose escalation followed by evaluations of different dosing regimens tailored by cancer type. KK2260 is given through an intravenous infusion at various dose levels. The study is divided into parts: Part 1a focuses on finding the MTD while monitoring safety; Part 1b and Part 2 involve testing selected dosing regimens in specific cancers. Participants may undergo tumor biopsies before and after treatment to help assess the drug's effects. Participants will be closely monitored for safety and treatment effects for about one year. This includes regular blood tests every week to check many laboratory values such as blood cell counts, liver and kidney function, electrolytes, and immune markers. Vital signs, electrocardiograms, and performance status will also be tracked weekly. Researchers will record any side effects and dose-limiting toxicities. The thorough monitoring helps understand KK2260's impact over time and supports participant safety throughout the study.

Researchers are investigating sacituzumab tirumotecan (MK-2870) alone or combined with other treatments to treat certain gastrointestinal cancers. These include colorectal cancer that cannot be removed by surgery or has spread, advanced pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and measure how many participants respond to the treatment by having their cancer shrink or disappear. Participants may receive sacituzumab tirumotecan by intravenous infusion alone or with other anticancer drugs such as fluorouracil (5-FU), leucovorin or levoleucovorin, cisplatin, and pembrolizumab. Rescue medications like diphenhydramine, H2 receptor antagonists, acetaminophen, dexamethasone, and a steroid mouthwash are given to prevent infusion reactions and oral side effects. Supportive care treatments for side effects, including antidiarrheal and antiemetic agents, are allowed throughout the study. During the study, researchers monitor participants for dose-limiting toxicities within about 4 weeks and track adverse events, treatment discontinuations, and tumor response over up to approximately 63 months. Assessments include safety evaluations and measuring cancer response using standardized criteria. This long-term follow-up helps evaluate both the effectiveness and safety of the treatments being studied.

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 effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are evaluating if ifinatamab deruxtecan (I-DXd), an antibody-drug conjugate that attaches to proteins on cancer cells to deliver treatment, can treat esophageal squamous cell carcinoma (ESCC). This Phase 2 open-label study aims to find out how many participants experience a reduction or disappearance of their cancer after receiving I-DXd. The trial is part of the KEYMAKER-U06 master screening protocol and focuses on patients with advanced or metastatic esophageal cancer who have already had prior treatments. Participants receive I-DXd through intravenous infusion, and rescue medications including 5-HT3 receptor antagonists, NK-1 receptor antagonists, and corticosteroids may be given according to approved guidelines to manage side effects. The study includes those with unresectable locally advanced or metastatic ESCC who have progressed after one or two previous systemic therapies. The study does not specify a maximum age limit but requires participants to be adults. During the study, researchers will monitor participants for up to approximately 15 months to measure the objective response rate, which means how many participants show cancer shrinkage or disappearance. Participants will undergo assessments to confirm diagnosis, measure disease progression, and monitor organ function. Safety will be closely observed, including monitoring for infections, cardiovascular issues, lung diseases, and other health conditions that might affect treatment. The goal is to better understand the treatment's effects and safety profile in this patient population.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are studying the dose-response effects of galvokimig compared with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition lasting at least one year. The study focuses on adults aged 18 years and older who have significant disease activity as measured by specific clinical scores and a history of inadequate response to topical treatments or contraindications to them. This phase 2 trial aims to evaluate the safety, effectiveness, and how the drug behaves in the body. Participants will receive either galvokimig or a placebo as an injection. The study uses a randomized, double-blind, placebo-controlled design with multiple doses tested in parallel groups. Treatments are given as solutions for injection, and the study monitors participants over a defined period to assess how the drug works and its safety profile. During the study, participants will undergo assessments including clinical scoring of their skin condition such as the Eczema Area and Severity Index at week 16 to measure response. Researchers will also monitor safety through physical exams, laboratory tests, and medical history reviews. The study requires stopping other systemic or topical treatments before starting and tracks participant adherence and outcomes carefully throughout the study duration.

Researchers are evaluating the efficacy, safety, and tolerability of zorevunersen in patients with Dravet syndrome, a condition marked by reduced levels of the Nav1.1 protein due to mutations in the SCN1A gene. Zorevunersen is an investigational antisense oligonucleotide designed to increase the expression of the sodium channel Nav1.1 protein by boosting the production of its messenger RNA. This Phase 3, multicenter, randomized, double-blind, sham-controlled study aims to assess the potential of zorevunersen for disease modification by measuring changes in major motor seizure frequency and other health outcomes. The study has two treatment periods. In Treatment Period 1, participants assigned to zorevunersen receive the drug by intrathecal administration on Day 1, Day 57, Day 169, and Day 281 with doses of 70 mg initially and then 45 mg later. The sham group undergoes a procedure mimicking drug administration without receiving the drug. In Treatment Period 2, those initially on zorevunersen receive 45 mg doses on Day 393, Day 477, and Day 589. Participants initially in the sham group are then given zorevunersen doses of 70 mg on Day 393 and Day 477, and 45 mg on Day 589. Participants will be closely monitored throughout the study with a primary focus on seizure changes measured at Week 28. Secondary assessments include behavior, cognition, clinical status, and quality of life. The study includes an initial 8-week baseline period and a 6-week observation period to confirm seizure frequency and stability of other treatments. Patients may continue to an open-label extension study to receive zorevunersen if eligible. The study involves children aged 2 to under 18 years and tracks safety and tolerability alongside efficacy outcomes.