A Phase 2a Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients

Background:
Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes. This can lead to an enlarged spleen and lymph nodes. Current treatments for ALPS can have many adverse effects. Better treatments for ALPS are needed.
Objective:
To test a study drug (soquelitinib) in people with ALPS.
Eligibility:
People aged 16 years and older with ALPS.
Design:
Participants will have 8 clinic visits and 6 remote visits within 1 year.
Participants will be screened. They will have a physical exam with blood and urine tests. Some may have tests of their lung function.
Soquelitinib is a tablet taken by mouth twice a day. Participants will record their doses and any symptoms on a paper or online form.
Blood tests and other procedures will be repeated during study visits. Three visits will include imaging scans. Participants will lie on a table that slides through a doughnut-shaped machine while X-rays capture pictures of the inside of their body.
Some participants may be able to remain in the study for a second year.

开始日期2025-03-10

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT06561048

/ Recruiting临床3期

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

开始日期2024-10-02

申办/合作机构

Corvus Pharmaceuticals, Inc.

NCT06345404

/ Recruiting临床1期

A Phase 1, Randomized, Blinded, Placebo-controlled, Dose Escalation Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of ITK Inhibitor Soquelitinib in Participants With Moderate to Severe Atopic Dermatitis

Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD

开始日期2024-04-23

申办/合作机构

Corvus Pharmaceuticals, Inc.

100 项与 Soquelitinib 相关的临床结果

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100 项与 Soquelitinib 相关的转化医学

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100 项与 Soquelitinib 相关的专利（医药）

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项与 Soquelitinib 相关的文献（医药）

2024-07-23·Science Signaling

The kinase ITK controls a Ca ²⁺ -mediated switch that balances T _H 17 and T _reg cell differentiation

Article

作者: Anannya, Orchi ; Huang, Weishan ; August, Avery

The balance of proinflammatory T helper type 17 (T H 17) and anti-inflammatory T regulatory (T reg ) cells is crucial for immune homeostasis in health and disease. The differentiation of naïve CD4 + T cells into T H 17 and T reg cells depends on T cell receptor (TCR) signaling mediated, in part, by interleukin-2–inducible T cell kinase (ITK), which stimulates mitogen-activated protein kinases (MAPKs) and Ca 2+ signaling. Here, we report that, in the absence of ITK activity, naïve murine CD4 + T cells cultured under T H 17-inducing conditions expressed the T reg transcription factor Foxp3 and did not develop into T H 17 cells. Furthermore, ITK inhibition in vivo during allergic inflammation increased the T reg :T H 17 ratio in the lung. These switched Foxp3 + T reg -like cells had suppressive function, and their transcriptomic profile resembled that of differentiated, induced T reg (iT reg ) cells, but their chromatin accessibility profiles were intermediate between T H 17 and iT reg cells. Like iT reg cells, switched Foxp3 + T reg -like cells had reductions in the expression of genes involved in mitochondrial oxidative phosphorylation and glycolysis, in the activation of the mechanistic target of rapamycin (mTOR) signaling pathway, and in the abundance of the T H 17 pioneer transcription factor BATF. This ITK-dependent switch between T H 17 and T reg cells depended on Ca 2+ signaling but not on MAPKs. These findings suggest potential strategies for fine-tuning TCR signal strength through ITK to control the balance of T H 17 and T reg cells.

项与 Soquelitinib 相关的新闻（医药）

2025-03-17

·GlobeNewswire-Health Care

Corvus Pharmaceuticals Announces Initiation of Phase 2 Clinical Trial of Soquelitinib for Patients with Autoimmune Lymphoproliferative Syndrome (ALPS)

Trial for this rare genetic disease to be conducted by NIH/NIAID in partnership with Corvus ITK inhibition intended to address dysregulation of T cells that causes ALPS and has been shown to be effective at treating the disease in preclinical models March 12, 2025 -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has initiated a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease. The lead investigator of the trial is V. Koneti Rao, MD, FRCPA, Senior Research Physician, Primary Immune Deficiency Clinic (ALPS Clinic) at NIH Clinical Center. Dr. Rao previously presented preclinical data supporting the potential of soquelitinib in patients with ALPS. Other trial sites include Children’s Hospital of Philadelphia and Texas Children’s Cancer and Hematology Center. “Developing safe and effective targeted treatments to address ALPS and related disorders is a priority at the NIAID since this condition was first discovered in NIAID in the early 1990s,” said Dr. Rao. “ALPS typically begins to manifest by age two and most patients live into adulthood with burdensome symptoms often related to refractory autoimmune cytopenias (low blood counts). This requires ongoing surveillance and the risk for potentially fatal conditions such as infection, hemorrhage and malignant lymphoma. We look forward to investigating the potential of ITK inhibition with soquelitinib to improve immune system balance and reduce the buildup of dysfunctional T cells in lymph nodes and spleens and autoantibodies that drive the disease.” ALPS is most often caused by a mutation in the gene for the Fas protein, which spans the cell membrane and helps facilitate apoptosis, or programmed cell death. When this protein is missing or defective, T cells can build up and disrupt the immune system, leading to potentially debilitating symptoms and an increased risk for developing serious health conditions, including autoimmune diseases and lymphoma. There currently is no cure for ALPS and the disorder is managed by a variety of empirical methods aimed at addressing pathological changes caused by the disease, such low blood-cell counts (cytopenias), excessive lymphocyte production (lymphoproliferation), enlarged spleen or lymph nodes, and lymphoma. Treatments may include corticosteroids such as prednisone and other immunosuppressive medications to modulate the immune system, or cancer therapies to address lymphoma. “We are excited to expand the potential of ITK inhibition to address people with ALPS, which is a serious genetic disease that begins in childhood and gets worse due to progression during young adulthood and lacks good treatment options,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “There is compelling preclinical evidence that soquelitinib may address the immune dysregulation in T cells that is a hallmark of the disease. It also bridges the biology of T cell lymphomas and autoimmunity, highlighting the role that ITK inhibition may play in restoring immune balance in lymphoma and immune disease. This adds to our conviction for the potential of soquelitinib as we continue to enroll patients in our registrational Phase 3 trial in PTCL and Phase 1 trial in atopic dermatitis.” The Phase 2 clinical trial (NCT06730126) is designed to enroll up to 30 patients aged 16 or older with confirmed ALPS-FAS based on genetic testing. Two dosing cohorts will be studied. The patients will receive soquelitinib doses of 200 mg or 400 mg twice per day for a period of up to 360 days. The primary endpoint of the trial is efficacy determined by reductions in splenomegaly and lymph node volumes as measured by computed tomography (CT) or positron emission tomography/computed tomography (PET/CT). Improvements in cytopenias will be assessed by complete blood count (CBC). Cytopenias are caused by autoantibodies as well as splenic sequestration that may lead to destruction of red blood cells, platelets and/or neutrophils leading to anemia, thrombocytopenia or neutropenia. Improvements in cytopenias can improve quality of life and overall health, and they also serve as a valuable biomarker associated with ALPS disease activity. Secondary endpoints include safety and tolerability. This is the third indication under clinical development for soquelitinib, which is also in a registrational Phase 3 trial for peripheral T cell lymphoma (PTCL) and a Phase 1 trial for atopic dermatitis (AD). Corvus also plans to initiate a Phase 1 clinical trial of soquelitinib in patients with solid tumors in the second quarter 2025. ALPS is a rare genetic disease inherited as a germline autosomal dominant pattern or due to somatic mosaicism affecting children that manifests with lymphadenopathy, splenomegaly, cytopenias (low blood counts) and autoimmunity. The disease is caused by a mutation in the Fas gene, which provides instructions for making a signaling protein involved in the induction of apoptosis to get rid of redundant lymphocytes. The mutation results in immune dysregulation due to accumulation abnormally high levels of “double negative” T cells (CD4 and CD8 double negative), which infiltrate the blood, spleen and lymphoid tissues. Fas signaling is regulated by ITK and T cell receptor signaling and patients with ALPS have an imbalance in this regulation resulting in a failure of T cells to undergo apoptosis and an accumulation of abnormal T cells. Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation which has the potential to suppress autoimmune and inflammatory reactions. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company has initiated a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also being investigated in a randomized placebo-controlled phase 1 clinical trial in patients with atopic dermatitis. A recent publication describing the chemistry, enzymology and biology of soquelitinib appeared in npj Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website. Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. The content above comes from the network. if any infringement, please contact us to modify.

免疫疗法临床结果

2025-01-23

·摩熵医药

国内33款新药IND获批！50个品种过评，一品红制药等2家药企领跑……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 PART 01 周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵数据统计，新药申请与审批活动频繁，显示出医药创新领域的活跃态势。本文将深入分析2025年1月13日至2025年1月19日期间，国内外新药申请、临床试验批准以及仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。 PART 02 国内33款新药IND获批根据摩熵数据统计，2025年1月13日至2025年01月19日期间，共有80个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号60个，进口药品受理号20个。本周共计33款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药22款，生物药9款，中药2款。本周获批临床创新药/改良型新药（部分）信息速览(不含补充申请) 注：完整数据可识别“文末”二维码下载查看 PART 03 本周全球TOP10创新药研发进展在全球创新药研发领域，1月13日，强生宣布厄达替尼片上市申请已正式获NMPA批准，用于治疗携带易感型FGFR3基因变异，且既往接受至少一线含抗PD-1或抗PD-L1期间或之后出现疾病进展的手术不可切除的局部晚期或转移性尿路上皮癌（UC）成人患者。同日，NMPA官网最新公示，上海生物制品研究所申报的贝伐珠单抗注射液生物类似药上市申请已正式获批。贝伐珠单抗是一款抗血管内皮生长因子（VEGF）人源化单克隆抗体。贝伐珠单抗能与人血管内皮生长因子VEGF特异性结合，通过阻断VEGF与其受体作用，进而抑制肿瘤新生血管的形成，抑制肿瘤生长转移。此外，和黄医药、第一三共、强生等药企取得新进展。本周全球 TOP10 创新药研发进展截图来源：摩熵咨询周报 PART 04 50个品种过评，广州一品红制药等2家药企领跑根据摩熵数据统计，2025年1月13日至2025年1月19日期间，共有99项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号96项（包括化药3类，4类，5.2类），新注册分类临床申请受理号3项（包括化药3类），本周一致性评价申请受理号7项；本周7个品种通过一致性评价（按受理号计11项），本周43个品种视同通过一致性评价（按受理号计59项）。本周无生物类似物注册申报动态。本周过评/视同过评品种主要为血液和造血系统药物，过评/视同过评产品剂型主要为片剂；本周罗沙司他胶囊过评/视同过评受理号数量最多有5个，同时罗沙司他胶囊也是本周过评/视同过评企业数最多的品种有3家。截图来源：摩熵咨询周报在企业层面，本周河北天成药业股份有限公司、广州一品红制药有限公司和海南斯达制药有限公司等过评/视同过评品种数最多有2种，其余各企业过评/视同过评品种数紧随其后，本周过评/视同过评企业共包括河北天成药业股份有限公司、广州一品红制药有限公司和海南斯达制药有限公司等52家企业。截图来源：摩熵咨询周报本周有马来酸咪达唑仑片、盐酸右哌甲酯缓释胶囊2个品种首次过评/视同过评。本周首次过评/视同过评品种截图来源：摩熵咨询周报本周有奥美拉唑碳酸氢钠干混悬剂(Ⅰ)、复方甘草酸苷片、甲苯磺酸艾多沙班片3款过评/视同过评达 5 家企业品种。此外，在全球TOP 10临床结果中，1 月 13 日，Corvus 公布了随机、双盲、安慰剂对照 1 期临床试验的新中期数据，该试验评估了 soquelitinib在中度至重度特应性皮炎患者中的作用。本周全球 TOP10 积极/失败临床结果同日，上海市胸科医院陆舜教授牵头全国 54 家研究中心共同参与的一项重组全人抗 PD-L1 单克隆抗体注射液（索卡佐利单抗）或安慰剂联合卡铂和依托泊苷一线治疗广泛期小细胞肺癌的随机、双盲、安慰剂对照、多中心的 III 期临床研究发布阳性结果。摩熵咨询本期完整周报识别二维码领取下载 END 本文为原创文章，转载请留言获取授权近期热门资源获取后台回复关键词“深度报告”，获取价值18600元，报告大礼包后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

一致性评价临床申请生物类似药上市批准

2025-01-19

·药明康德

疾病控制率达90%的创新疗法；靶点作用率达95%的PI3Kα共价抑制剂…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 多肽偶联药物（PDC）AVA6000在治疗唾液腺癌（SGC）患者的1a期临床试验中获得积极数据，疾病控制率（DCR）达90%。 2. 蛋白降解药物BHV-1400在首个人体临床试验中获得积极结果，在最低剂量下只需一次注射，就可在4小时内将致病抗体水平降低60%。 3. PI3Kα共价抑制剂TOS-358在一项1期临床试验中对PI3Kα的靶点作用率达到95%。药明康德内容团队整理 AVA6000：公布1期临床试验数据 Avacta Therapeutics公司宣布，其在研多肽偶联药物AVA6000在治疗唾液腺癌患者的1a期临床试验中获得积极数据。唾液腺癌是一种在转移性阶段尚无标准治疗方案的疾病。AVA6000是Avacta研发管线中的首个多肽偶联药物，由阿霉素（doxorubicin）与Avacta专有的pre|CISION多肽偶联而成，该多肽可在肿瘤微环境中由成纤维细胞激活蛋白-α（FAP）特异性切割。FAP在大多数实体瘤中，与健康组织相比表达水平显著升高。Avacta的多肽偶联药物利用这一特征在肿瘤微环境中特异性释放活性药物，从而降低系统暴露和毒性，为患者提供最佳治疗效果。此次公布的数据显示，AVA6000在唾液腺癌患者中实现了显著且具有临床意义的肿瘤缩小。在接受250 mg/m²及以上剂量治疗的10名唾液腺癌患者中，DCR达90%，5名患者肿瘤显著缩小，其中包括一例部分缓解（PR，肿瘤缩小45%）和四例轻微缓解（MR，肿瘤缩小10%-19.5%）。安全性方面，在每两周一次和每三周一次两个剂量组中，AVA6000的耐受性良好，与常规剂量阿霉素相比，其血液学和心脏毒性明显降低。目前尚未在任一剂量组中确定最大耐受剂量（MTD）。 BHV-1400：公布1期临床试验的初步数据 Biohaven公司公布了其蛋白降解药物管线中的双特异性分子BHV-1400的最新结果。BHV-1400是一款基于耶鲁大学（Yale University）的MoDE技术的双特异性分子，它的一端与半乳糖缺乏型IgA1（Gd-IgA1）抗体结合，另一端与肝细胞表面的去唾液酸糖蛋白受体（ASGPR）结合。ASGPR介导肝细胞通过内吞过程，将靶点蛋白吞入细胞内进行降解。IgA肾病是由于Gd-IgA1的过度生产造成的，BHV-1400通过降低血液循环和肾脏中的Gd-IgA1水平，有望从根源治疗IgA肾病。此次公布的初步数据显示，BHV-1400在首个人体临床试验中获得积极结果，在最低剂量下只需一次注射，就可在4小时内将致病抗体水平降低60%。在某些患者中，观察到在8小时内将Gd-IgA1水平降低70%。此外，Gd-IgA1水平的降低在单次注射后可维持数天。安全性方面，迄今为止，BHV-1400在1期临床试验中的安全性和耐受性良好，未发现具有临床意义的先天和适应性免疫力的变化，并且未观察到剂量限制性毒性。这项研究将继续提高BHV-1400的剂量，探索降低Gd-IgA1水平的范围。基于该研究的积极结果，该公司还计划直接启动关键性临床试验，评估BHV-1400治疗IgA肾病的疗效和安全性。 ▲BHV-1400快速降低Gd-IgA1水平（图片来源：Biohaven公司官网） TOS-358：公布1期临床试验数据 Totus Medicines公司公布了其在研PI3Kα共价抑制剂TOS-358的1期临床试验数据。TOS-358是一款具高度特异性、强效的PI3Kα抑制剂，可在临床前模型中实现近100%的PI3Kα抑制，诱导带有PI3Kα突变的异种移植实体瘤的细胞死亡，包含结直肠癌、肺癌、乳腺癌、卵巢癌、食管癌、头颈癌，且几乎没有观察到非靶向抑制。此次公布的研究结果表明，TOS-358在低至5 mg每日两次（BID）的剂量下具有泛突变临床活性，对PI3Kα的靶点作用率达到95%，且观察到未经确认的完全缓解（CR）。安全性方面，未报道3/4级毒性。值得注意的是，几名接受给药的患者现在已超过6个月未发生进展。在成功完成1期剂量递增研究后，该公司现在启动了一项扩展研究，针对乳腺癌、子宫内膜癌、尿路上皮癌和头颈癌。 ORIC-944：公布1b期联合治疗试验数据 ORIC Pharmaceuticals公司公布了其选择性PRC2别构抑制剂ORIC-944联用阿帕鲁胺治疗转移性去势抵抗性前列腺癌（mCRPC）的1b期临床试验数据。截至2024年12月10日的数据，6例患者中有3例达到确认的PSA50应答（即PSA水平降低50%），其中2例达到确认的PSA90应答。所有PSA应答均维持≥12周，其中包括一例在38周时仍然持续的、确认的PSA90应答。 Soquelitinib：公布1期临床试验的中期数据 Corvus Pharmaceuticals公司公布了其小分子白细胞介素-2诱导的T细胞激酶（ITK）抑制剂soquelitinib用于治疗中度至重度特应性皮炎的1期临床试验的新中期数据。ITK是一种主要表达于T细胞中的酶，在T细胞和自然杀伤（NK）细胞的免疫功能中起重要作用。通过抑制ITK，soquelitinib有望抑制自身免疫和炎症反应。此次公布的结果显示，与安慰剂相比，soquelitinib治疗组在研究者总体评估（IGA）评分为0/1（皮肤症状清除或几乎清除）和湿疹面积和严重度指数较基线减少75%（EASI 75）这些临床终点方面显示出良好的疗效特征。在soquelitinib组的19例患者中，26%的患者达到IGA 0/1，37%的患者达到EASI 75。在安慰剂组的7例患者中，没有人达到IGA 0/1，也没有人达到EASI 75。安全性方面，未观察到明显的安全问题，也未发现临床上显著的实验室检测异常。 ▲治疗第28天达到终点IGA 0/1、EASI 75的患者占比（图片来源：参考资料[4]） ISM5411：公布两项1期临床试验数据英矽智能（Insilico Medicine）公司宣布，其自主研发的候选药物ISM5411已完成在澳大利亚和中国开展的两项1期研究，并取得了积极的初步结果。ISM5411是一种潜在用于治疗炎症性肠病（IBD）的小分子抑制剂，靶向PHD1/2靶点且具有新颖的分子结构，该候选药物设计和优化得到了英矽智能生成化学平台Chemistry42的支持。此次公布的结果显示，在所有剂量组中ISM5411均表现出良好的安全性和耐受性，并初步验证了肠道限制性药代动力学（PK）特征。基于1期临床试验的积极结果，英矽智能预计将于2025年下半年启动一项评估ISM5411在活动性溃疡性结肠炎患者中的2期临床试验。 MBX 1416：公布1期临床试验数据 MBX Biosciences公司公布了在健康成年受试者中开展的MBX 1416单剂量递增和多剂量递增临床试验的积极结果。MBX 1416是一种长效胰高血糖素样肽1（GLP-1）受体拮抗剂，用于治疗减肥后的低血糖症（PBH）。MBX 1416采用MBX公司新颖、专有的精准内分泌肽（PEP）平台设计，旨在防止PBH患者发生严重低血糖，使他们能够过上更健康、更独立的生活。此次公布的结果显示，MBX 1416通常安全性和耐受性良好，并且具有良好的药代动力学特征，支持每周一次给药。基于这些结果，该公司计划于2025年下半年在PBH患者中启动一项2期研究，以进一步优化剂量。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Avacta Announces Positive New Data from the AVA6000 Phase 1 trial Demonstrating Clinically Meaningful Tumor Shrinkage in Patients with Salivary Gland Cancers. Retrieved January 16, 2025, from https://www.globenewswire.com/news-release/2025/01/16/3010665/0/en/Avacta-Announces-Positive-New-Data-from-the-AVA6000-Phase-1-trial-Demonstrating-Clinically-Meaningful-Tumor-Shrinkage-in-Patients-with-Salivary-Gland-Cancers.html [2] Biohaven Highlights Portfolio Progress, Innovation, and Anticipated Milestones at the 43rd Annual J.P. Morgan Healthcare Conference; Reports Positive Degrader Data with Rapid, Deep, and Selective Lowering of Galactose-Deficient IgA1 with Next Generation Potential Therapy for IgA Nephropathy. Retrieved January 14, 2025, from https://www.prnewswire.com/news-releases/biohaven-highlights-portfolio-progress-innovation-and-anticipated-milestones-at-the-43rd-annual-jp-morgan-healthcare-conference-reports-positive-degrader-data-with-rapid-deep-and-selective-lowering-of-galactose-deficient-ig-302349336.html [3] Totus Medicines Announces Successful Completion of a Phase 1 Dose-Escalation Study and Initiation of an Expansion Trial Evaluating TOS-358, a Covalent PI3Ka Selective Therapy for the Treatment of Select Solid Tumors and Appoints Zelanna Goldberg as Chief Medical Officer. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/10/3007658/0/en/Totus-Medicines-Announces-Successful-Completion-of-a-Phase-1-Dose-Escalation-Study-and-Initiation-of-an-Expansion-Trial-Evaluating-TOS-358-a-Covalent-PI3Ka-Selective-Therapy-for-th.html [4] Corvus Pharmaceuticals Announces Data from Cohort 2 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008374/0/en/Corvus-Pharmaceuticals-Announces-Data-from-Cohort-2-of-Placebo-Controlled-Phase-1-Clinical-Trial-of-Soquelitinib-for-Atopic-Dermatitis.html [5] ORIC® Pharmaceuticals Provides Early Phase 1b Combination Data for ORIC-944, Operational Highlights for 2024, and Anticipated Upcoming Milestones. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008495/0/en/ORIC-Pharmaceuticals-Provides-Early-Phase-1b-Combination-Data-for-ORIC-944-Operational-Highlights-for-2024-and-Anticipated-Upcoming-Milestones.html [6] 英矽智能公布炎症性肠病药物ISM5411两项I期临床试验的积极结果. Retrieved January 17, 2025, from https://www.prnasia.com/story/474986-1.shtml [7] MBX Biosciences Announces Positive Phase 1 Topline Results for MBX 1416 for the Treatment of Post-bariatric Hypoglycemia. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/07/3005223/0/en/MBX-Biosciences-Announces-Positive-Phase-1-Topline-Results-for-MBX-1416-for-the-Treatment-of-Post-bariatric-Hypoglycemia.html [8] Mersana Therapeutics Announces Positive Initial Clinical Data from Phase 1 Clinical Trial of Emiltatug Ledadotin (XMT-1660); Initiation of Expansion in Triple Negative Breast Cancer. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/10/3007493/0/en/Mersana-Therapeutics-Announces-Positive-Initial-Clinical-Data-from-Phase-1-Clinical-Trial-of-Emiltatug-Ledadotin-XMT-1660-Initiation-of-Expansion-in-Triple-Negative-Breast-Cancer.html [9] Axcynsis Therapeutics Receives FDA Clearance for IND Application of AT03-65, a Differentiated CLDN6-Targeting ADC, Powered by AxcynDOT™ Technology. Retrieved January 17, 2025, from https://www.prnewswire.com/news-releases/axcynsis-therapeutics-receives-fda-clearance-for-ind-application-of-at03-65-a-differentiated-cldn6-targeting-adc-powered-by-axcyndot-technology-302350114.html [10] Ocugen, Inc. Announces Positive 2-Year Data Across Multiple Mutations from Phase 1/2 Clinical Trial of OCU400 —A Novel Modifier Gene Therapy for Retinitis Pigmentosa. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008252/0/en/Ocugen-Inc-Announces-Positive-2-Year-Data-Across-Multiple-Mutations-from-Phase-1-2-Clinical-Trial-of-OCU400-A-Novel-Modifier-Gene-Therapy-for-Retinitis-Pigmentosa.html [11] Verismo Therapeutics Announces First Patient Infused in Phase 1 CELESTIAL-301 Clinical Trial of SynKIR™-310. Retrieved January 17, 2025, from https://www.prnewswire.com/news-releases/verismo-therapeutics-announces-first-patient-infused-in-phase-1-celestial-301-clinical-trial-of-synkir-310-302347464.html [12] Caribou Biosciences Initiates the CB-010 GALLOP Phase 1 Trial in Lupus and Provides Outlook for Multiple Clinical Datasets in 2025. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008079/0/en/Caribou-Biosciences-Initiates-the-CB-010-GALLOP-Phase-1-Trial-in-Lupus-and-Provides-Outlook-for-Multiple-Clinical-Datasets-in-2025.html [13] Arcturus Therapeutics Announces Initiation of Phase 1 H5N1 Flu Vaccine Trial. Retrieved January 17, 2025, from https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-announces-initiation-phase-1-h5n1-flu [14] Korro Bio Announces Dosing of First Participants in REWRITE Phase 1/2a Study of KRRO-110 for Alpha-1 Antitrypsin Deficiency and Provides Pipeline Update. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008445/0/en/Korro-Bio-Announces-Dosing-of-First-Participants-in-REWRITE-Phase-1-2a-Study-of-KRRO-110-for-Alpha-1-Antitrypsin-Deficiency-and-Provides-Pipeline-Update.html [15] NextCure Announces First Patient Dosed in the Phase 1 Study of LNCB74 (B7-H4 ADC) as Therapeutic for Treating Multiple Cancers. Retrieved January 17, 2025, from https://ir.nextcure.com/news-releases/news-release-details/nextcure-announces-first-patient-dosed-phase-1-study-lncb74-b7 [16] LAVA Doses First Patient in Phase 1 LAVA-1266 Study in Hematological Cancers. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/10/3007674/0/en/LAVA-Doses-First-Patient-in-Phase-1-LAVA-1266-Study-in-Hematological-Cancers.html [17] Context Therapeutics Announces First Patient Dosed in the Phase 1 Clinical Trial of CTIM-76. Retrieved January 17, 2025, from https://www.globenewswire.com/de/news-release/2025/01/14/3009673/0/en/Context-Therapeutics-Announces-First-Patient-Dosed-in-the-Phase-1-Clinical-Trial-of-CTIM-76.html [18] Ocugen, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of OCU200—a Novel Integrin-Targeting Biologic for Diabetic Macular Edema. Retrieved January 17, 2025, from https://ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-first-patient-dosed-phase-1-clinical-trial [19] ProMIS Neurosciences Initiates Phase 1b Clinical Trial (PRECISE-AD) in Alzheimer’s Disease. Retrieved January 17, 2025, from https://www.promisneurosciences.com/news-media/press-releases/detail/236/promis-neurosciences-initiates-phase-1b-clinical-trial [20] Aptose Announces First AML Patients Dosed with Tuspetinib Triplet Frontline Therapy in TUSCANY Trial. Retrieved January 17, 2025, from https://www.aptose.com/news-media/press-releases/detail/307/aptose-announces-first-aml-patients-dosed-with-tuspetinib [21] ORYZON announces first patient dosed in NCI-sponsored iadademstat in combination with venetoclax and azacitidine clinical trial in first line acute myeloid leukemia. Retrieved January 17, 2025, from https://www.oryzon.com/en/news-events/news/oryzon-announces-first-patient-dosed-nci-sponsored-iadademstat-combination [22] 한미약품-GC녹십자, ‘파브리병’ 국내 1/2상 IND 승인. Retrieved January 17, 2025, from https://www.biospectator.com/news/view/24043 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床1期多肽偶联药物

100 项与 Soquelitinib 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
间变性大细胞淋巴瘤	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
滤泡性淋巴瘤	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
滤泡性T细胞淋巴瘤	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
免疫母细胞性淋巴结病	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
复发型外周T细胞淋巴瘤	临床3期	美国	Corvus Pharmaceuticals, Inc.	2024-10-02
自身免疫性淋巴细胞增生综合征	临床2期	美国	National Institute of Allergy & Infectious Diseases	2025-03-10
血细胞减少症	临床2期	美国	National Institute of Allergy & Infectious Diseases	2025-03-10
复发性T细胞淋巴瘤	临床1期	澳大利亚	Corvus Pharmaceuticals, Inc.	2019-05-03
复发性T细胞淋巴瘤	临床1期	韩国	Corvus Pharmaceuticals, Inc.	2019-05-03
复发性T细胞淋巴瘤	临床1期	中国	Corvus Pharmaceuticals, Inc.	2019-05-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06345404 (GlobeNewswire) 人工标引	临床1期	特应性皮炎	64	Soquelitinib 100 mg orally twice per day (Cohort 1)	(鹹齋獵醖艱襯醖製醖鏇) = 壓齋鏇範醖醖鹽選鬱顧衊遞衊築窪構鑰衊觸遞 (憲衊衊窪積鬱築鹹築製 ) 更多	积极	2025-01-13
NCT06345404 (GlobeNewswire) 人工标引	临床1期	特应性皮炎	64	Soquelitinib 200 mg orally once per day (Cohort 2)	(鹹齋獵醖艱襯醖製醖鏇) = 獵獵鑰淵願製鏇鹽繭憲衊遞衊築窪構鑰衊觸遞 (憲衊衊窪積鬱築鹹築製 ) 更多	积极	2025-01-13
NCT03952078 (CPI-818-001, Corporate Publications) 人工标引	临床1期	T细胞淋巴瘤	23	Soquelitinib	(製遞簾遞醖壓選築選範) = 構壓鬱獵淵築簾製繭網鏇範醖蓋鹹憲繭夢範窪 (壓鏇遞鹽繭選築膚淵鏇 ) 更多	积极	2024-05-06
NCT03952078 (GlobeNewswire) 人工标引	临床1期	T细胞淋巴瘤	36	Soquelitinib 200mg	(餘繭憲網鑰艱繭壓鬱繭) = 鏇鑰淵壓襯壓餘蓋鏇繭鏇餘構積蓋衊醖餘糧齋 (繭齋壓積選夢製遞願醖 )	积极	2023-12-09
NCT03952078 (GlobeNewswire) 人工标引	临床1期	T细胞淋巴瘤	36	Soquelitinib 200mg (≥1 to ≤ 3 therapies)	(廠網齋淵淵遞願鑰網艱) = 鹹膚艱築艱製製蓋範築鹹簾獵醖鹹鏇範網遞夢 (齋製觸繭餘構築襯遞蓋 ) 更多	积极	2023-12-09
NCT03952078 (ASH2023) 人工标引	临床1期	难治性T细胞淋巴瘤	3	soquelitinib	(獵齋糧簾積獵築鏇選醖) = soquelitinib induced normal CD4+ Th1 cells and CD8+ TEMRA cells and reduced CD4+ Treg cells in the tumor microenvironment in responding patients. 衊顧網廠醖遞糧遞齋壓 (製遞鑰鑰獵襯遞衊製艱 )	积极	2023-12-09
NCT03952078 (CPI-818-001, PRNewswire) 人工标引	临床1期	T细胞淋巴瘤	43	CPI-818	(築膚餘窪網衊獵願鬱繭) = 壓築齋醖製膚獵選繭觸艱窪鏇襯遞鏇膚製顧選 (鏇鑰廠艱選鹽製蓋糧構 )	积极	2022-12-12