治験一覧
8,963 件中 261〜280 件を表示
リポタンパク質(a)値が高い成人における主要な心血管イベントに対するムバラプリンの影響の評価
The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.
プラチナ製剤併用療法に難治性または不耐容の進行小腸腺癌患者におけるエンフォルツマブ・ベドチン
Small bowel adenocarcinoma is a rare cancer with a poor prognosis. For patients with locally advanced or metastatic disease, the usual first treatment is chemotherapy with platinum-based combinations such as FOLFOX or CapeOX. However, once the cancer grows after this treatment or the side effects become too severe, there is no widely accepted standard second-line therapy, and outcomes are generally poor. New treatment options are therefore urgently needed. Recent retrospective research from our group has shown that the majority of the small bowel adenocarcinomas strongly express a protein called Nectin-4 on the surface of cancer cells. High Nectin-4 expression was also associated with poorer survival, suggesting that Nectin-4 could be a crucial treatment target in this disease. Enfortumab vedotin is a targeted anticancer drug called an antibody-drug conjugate. It combines an antibody that recognizes Nectin-4 with vedotin, a cytotoxic anticancer agent (payload). After enfortumab vedotin binds to Nectin-4 on the tumor cell surface, it is taken up into the cell and releases the anticancer payload, which damages the cell's internal structure and leads to cell death and apoptosis. Enfortumab vedotin has already shown meaningful antitumor activity and an acceptable safety profile in patients with advanced urothelial carcinoma and is approved over the world. However, its efficacy has never been formally evaluated in patients with small bowel adenocarcinoma. ENVELOPE is a multicenter, single-arm, phase II investigator-initiated trial designed to evaluate the efficacy and safety of enfortumab vedotin in patients with locally advanced or metastatic small bowel adenocarcinoma that has progressed during or after, or is intolerant to, platinum-based combination chemotherapy (FOLFOX or CapeOX). Eligible patients are adults (aged 18 years or older) with histologically or cytologically confirmed small bowel adenocarcinoma, a good performance status, adequate organ function, and at least one measurable lesion on a CT scan. Patients who have genomic alterations that make them candidates for previously approved "tumor-agnostic" targeted drugs (for example, high microsatellite instability or high tumor mutational burden) must already have tried and not benefited from, or not tolerated, those treatments. Testing positive for Nectin-4 is not required to take part in this study. Participants will receive enfortumab vedotin as an intravenous infusion at a dose of 1.25 mg/kg on days 1, 8, and 15 of each 28-day treatment cycle. Treatment will continue as long as the cancer does not grow and side effects remain manageable. Tumor scans with contrast-enhanced CT will be performed every 8 weeks up to week 24 and every 12 weeks thereafter to monitor the response of the enfortumab vedotin. The primary objective is to determine the proportion of patients achieving a tumor response to enfortumab vedotin, as assessed by independent radiologic review. Key secondary objectives include progression-free survival, overall survival, duration of response, and safety profiling. In addition, this study includes a prespecified translational research program. Tumor samples will be examined for Nectin-4 expression using immunohistochemistry, and researchers will investigate the relationship between Nectin-4 levels and the effects of enfortumab vedotin. Blood and tissue samples will also be collected before treatment, during treatment, and at the time of cancer progression, when possible, for detailed "multi-omics" analyses. These translational studies aim to elucidate why some patients respond whereas others do not, and to identify biomarkers that could inform future treatment strategies for small bowel adenocarcinoma. The ENVELOPE trial has been approved by the Institutional Review Board of the National Cancer Center, Japan, as well as by the ethics committees at participating sites. The study is funded by the Japan Agency for Medical Research and Development (AMED), and enfortumab vedotin is supplied by Astellas Pharma. Enrollment began in October 2025 and is planned to continue through October 2027, with patients followed for at least 12 months after the last participant is enrolled.
BI 3820768の異なる投与量が進行癌（固形腫瘍）患者にどの程度耐えられるかを検証する研究
This study is open to adults with advanced germ cell tumours, endometrial cancer, or ovarian cancer whose previous treatments were not successful. People can join the study if they have no remaining treatment options or if standard therapy is not suitable. The purpose of this study is to test increasing doses of BI 3820768 to find a dose that people with these types of cancer can tolerate and that may make tumours shrink. BI 3820768 is a type of treatment that may help the immune system fight cancer. This is the first time BI 3820768 is being tested in humans. The study has 2 parts based on the way BI 3820768 is given. Depending on when participants join the study, they will receive BI 3820768 through one of two ways to inject the study medicine. All participants receive the study medicine. The medicine is given as an injection once a week for 2 cycles of 3 weeks each, followed by doses every 3 weeks. Participants are in the study for up to 3 years if they are benefiting from the treatment. During this time, they visit the study site regularly, and some visits will require overnight stays. Doctors will regularly check the size of the tumour and whether it has spread. Researchers want to find the highest dose of BI 3820768 that participants can tolerate by looking at the number of participants with certain severe health problems. The doctors also regularly check participants' health, take blood samples, and note any unwanted effects.
膵臓がんの成人患者におけるポンセグロマブという薬剤の効果に関する研究。膵臓がんは転移し、著しい体重減少と倦怠感を引き起こした。
Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.
全身性エリテマトーデス、特発性炎症性筋疾患、または関節リウマチの成人患者を対象に、AZD5492 の安全性、忍容性、薬物動態、および薬力学を調査する研究。
The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details include: • The study duration will be a minimum of 180 days in addition to the screening period. Additional follow-up visits may be required up to 12 months from study start. * Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2). * Study visits will occur at: Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.
左室肥大を伴う心不全患者における心臓の構造と機能に対するCDR132Lの異なる用量とプラセボの比較研究
This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.
重症喘息の成人患者を対象としたVerekitug（UPB-101）の長期安全性および有効性試験（VALOUR）
The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).
青年期の統合失調症治療におけるKarXTの有効性と安全性を評価する研究
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
BI 770371とペンブロリズマブ（セツキシマブの有無にかかわらず）の併用療法が、ペンブロリズマブ単独療法と比較して頭頸部がん患者に効果があるかどうかを検証する研究
This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site. Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
ステロイド依存性潰瘍性大腸炎患者におけるオザニモドの有効性
The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan
代謝機能障害関連脂肪肝疾患の成人における多剤併用療法のマスタープロトコル（SYNERGY-Outcomes）
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.
アルツハイマー病における認知機能障害に対するKarXT + KarX-ECの有効性と安全性を評価する研究（MINDSET 2）
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
高リスク非筋層浸潤性膀胱癌患者におけるTAR-210と膀胱内化学療法の比較研究
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
Beamion LUNG-3：手術で切除されたHER2変異陽性非小細胞肺がん患者に対するゾンゲルチニブの有効性を標準治療と比較して検証する試験
This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow. In this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation). Participants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits. Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects.
ALSに対するSHED-CMの静脈内投与の安全性と有効性
This study evaluates the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media (SHED-CM) in patients with Amyotrophic Lateral Sclerosis (ALS), using the Japanese version of the revised ALS Functional Rating Scale (ALSFRS-R) as an indicator.
再発性/難治性小細胞肺癌患者におけるBMS-986525単独およびニボルマブとの併用の安全性および忍容性を評価する試験
The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Nivolumab in participants with Relapsed/Refractory Small Cell Lung Cancer
薬剤耐性肺結核の治療におけるクアボデピスタット含有レジメンの研究
This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.
トリプルネガティブ乳がんに対するペムブロリズマブ＋パクリタキセル＋／－ベバシズマブ
* Breast cancer is histologically divided into non-invasive (approximately 10%) and invasive (approximately 90%), with invasive cancer being the target of chemotherapy. Invasive carcinoma is classified into four subtypes according to the expression levels of hormone receptor (HR) and human epidermal growth factor receptor type 2 (HER2). Among them, triple negative breast cancer accounts for 10% of invasive cancers and is the subtype with the poorest prognosis. * For triple negative breast cancer that is operable, chemotherapy with pembrolizumab is administered either preoperatively or postoperatively (perioperative period). For recurrent triple negative breast cancer , combination chemotherapy with multiple agents is the standard of care, especially in the case of PD-L1-positive patients, chemotherapy with an immune checkpoint inhibitor related to PD-1 (pembrolizumab or atezolizumab) is administered. * Although the KEYNOTE355 trial demonstrated the efficacy of pembrolizumab plus paclitaxel therapy in patients with PD-L1-positive triple negative breast cancer in postoperative relapse, this trial did not include patients who received pembrolizumab in the perioperative period. Therefore, it is not known if there is any benefit to re-administering pembrolizumab to these patients after relapse. * Bevacizumab is used as standard therapy for triple negative breast cancer in combination with paclitaxel. Bevacizumab itself is an anti-tumor agent that inhibits angiogenesis, but has also been reported to activate immunity against cancer, suggesting that it may enhance the effect of pembrolizumab. Based on the above, the investigators planned this trial to evaluate whether pembrolizumab + paclitaxel + bevacizumab therapy is more effective than pembrolizumab + paclitaxel therapy in PD-L1-positive triple negative breast cancer patients who relapse after receiving immune checkpoint inhibitors in the perioperative period.
HeFH患者におけるAZD0780のLDL-Cに対する効果を評価する第III相試験
This is a study to evaluate the efficacy and safety of AZD0780 in adults with HeFH and elevated LDL-C, either with clinical ASCVD and LDL-C levels of 55 mg/dL or higher or without clinical ASCVD and LDL-C levels of 70 mg/dL or higher. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.
VEGF抵抗性AMDにおける進行抑制と網膜退縮
The goal of this clinical trial is to assess safety and efficacy in patients with Neovascular Age-related Macular Degeneration with no response to existing therapy. The main measures it aims to answer are: * Investigation of adverse events * Changes in clinical testing data * Changes in vital signs * Changes in intraocular pressure of the therapeutic eye * Changes in testing of anterior segment of the therapeutic eye Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy. Researchers will compare pre and post implantation of therapeutic eye to see if any safety issues recognized