A Randomized Phase 2 Study of Ompenaclid Versus Placebo in Combination With FOLFIRI Plus Bevacizumab in Patients With Previously Treated RAS Mutant Advanced or Metastatic Colorectal Cancer

The purpose of this study is to measure tumor response to treatment with ompenaclid (RGX-202-01) in patients with previously treated RAS mutant advanced or metastatic CRC. All patients will receive treatment with FOLFIRI and bevacizumab. In addition, patients will be randomized to receive either ompenaclid 3000 mg BID or matching placebo (herein referred to as Study Drug). Each treatment cycle is 28 days in duration.

开始日期2023-10-10

申办/合作机构

Inspirna, Inc.

NCT03597581

/ Completed临床1期

A Phase 1 Study of RGX-202-01 (Ompenaclid) , a Small Molecule Inhibitor of the Creatine Transporter SLC6a8, as a Single Agent and as Combination Therapy in Patients With Advanced Gastrointestinal Malignancies With Select Expansion Cohorts

This is a Phase 1 study currently evaluating PO administered ompenaclid in combination with FOLFIRI and bevacizumab in patients with advanced (i.e., locally advanced and unresectable, or metastatic) previously treated colorectal adenocarcinoma. The single agent ompenaclid dose escalation stage and the ompenaclid in combination with FOLFIRI and bevacizumab dose escalation stage of the study has been completed; the expansion stage of ompenaclid in combination with FOLFIRI and bevacizumab is ongoing. In April-24 a protocol amendment added a new dose escalation and expansion stage which will evaluate ompenaclid in combination with FOLFOX and bevacizumab in patients with metastatic CRC. It is anticipated that a total of 30 patients will be enrolled in this new dose escalation and expansion stage of the study.

开始日期2018-06-05

申办/合作机构

Inspirna, Inc.

100 项与 Ompenaclid 相关的临床结果

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100 项与 Ompenaclid 相关的转化医学

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100 项与 Ompenaclid 相关的专利（医药）

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项与 Ompenaclid 相关的文献（医药）

2026-02-26·JOURNAL OF MEDICINAL CHEMISTRY

Carboxylic Acid Bioisosteres of Creatine as Novel and Selective Substrate Competitive Inhibitors of the Creatine Transporter SLC6A8

Article

作者: Tavazoie, Sohail F. ; Schefer, Daniel ; Xu, Xiaoming ; Zahler, Robert ; Kaiser, Bernd ; Tavazoie, Masoud F. ; Meng, Ruifang ; Liu, Rui ; Patel, Amish J. ; Kurth, Isabel ; Liu, Zizhao ; Leites, Katya ; Zhao, Hui ; Martinez, Eduardo J. ; Liu, Jianchao ; Tian, Helen S. ; Vaz, Roy J. ; Wong, Darren H. ; Busby, Robert W. ; Wen, Lei

Creatine, a naturally occurring guanidine carboxylic acid, serves as a critical energy metabolite in tissues with high energy demands. Certain cancers upregulate creatine metabolism to supplement their energy needs. Ompenaclid, a salt form of the well-studied creatine transporter inhibitor 3-guanidinopropionic acid (β-GPA), is in clinical development for the treatment of patients with colorectal tumors. Existing SLC6A8 inhibitors are low-potency molecules and frequently interact with related transporters. Herein, we report the discovery of SLC6A8 inhibitors with increased selectivity as well as in vitro and in vivo potency. A bioisostere approach was used by replacing the carboxylic acid of β-GPA with surrogate functional groups to achieve these improvements. Docking of these inhibitors into the recently published SLC6A8 cryo-EM structure reveals key binding contacts and supports the observed structure-activity relationships.

2025-09-22·Journal of biomolecular structure & dynamics

Elucidating the binding mechanisms of GABA and Muscimol as an avenue to discover novel GABA-mimetic small molecules

Article

作者: Visser, Hendrik ; Erasmus, Elizabeth ; Wilhelm, Anke ; Issahaku, Abdul Rashid ; Schutte-Smith, Marietjie

Gamma-aminobutyric acid (GABA) signaling is the principal inhibitory pathway in the central nervous system. It is critical in neuronal cell proliferation and fate determination. Any aberration in GABA inhibition results in psychiatric and neurological diseases. Thus, modulating GABAergic neurotransmission has become the basis of drug therapy for psychiatric and several neurological diseases. Though GABA and muscimol are classical inhibitors of GABA receptors, the search for novel inhibitors continues unabated. In this study, the binding mechanism of GABA and muscimol was elucidated and applied in the search for small molecule GABAergic inhibitors using comprehensive computational techniques. It was revealed that a high-affinity binding of GABA and muscimol was mediated by a water molecule involving α₁Thr129 and then stabilized by strong interactions including salt bridges with β₂Glu155 and α₁Arg66 amidst hydrogen bonds, π-π stacking, and π -cation interactions with other residues. The binding of GABA and muscimol was also characterized by stability and deeper penetration into the hydrophobic core of the protein which resulted in conformational changes of the binding pocket and domain, by inducing correlated motions of the residues. Thermodynamics analysis showed GABA and muscimol exhibited total binding free energies of -19.85 ± 8.83 Kcal/mol and -26.55 ± 3.42 Kcal/mol, respectively. A pharmacophore model search, based on the energy contributions of implicating binding residues, resulted in the identification of ZINC68604167, ZINC19735138, ZINC04202466, ZINC00901626, and ZINC01532854 as potential GABA-mimetic compounds from metabolites and natural products libraries. This study has elucidated the binding mechanisms of GABA and muscimol and successfully applied in the identification of GABA-mimetic compounds.

2025-09-09·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Structural insights into the substrate uptake and inhibition of the human creatine transporter (hCRT).

Article

作者: Wang, Xiaojuan ; Shang, Yongfeng ; Yuan, Xinyi ; Jiang, Li ; Liu, Chang ; Wang, Yixue ; Wang, Kaiyan ; Li, Hongen ; Wang, Yue ; Yang, Maojun ; Ma, Zhaoqi ; Liu, Botong ; Yin, Jian ; Chen, Xudong ; Yang, Zi ; Chen, Meiying ; Zhang, Sensen ; Zhou, Niyun

Creatine plays a vital role in cellular energy production and adenosine triphosphate (ATP) homeostasis and has also been identified as a neurotransmitter in the mammalian brain. Creatine is transported into cells by the human creatine transporter (hCRT) (SLC6A8), an Na⁺/Cl^--dependent symporter encoded on the X chromosome. Mutations in hCRT cause cerebral creatine deficiency syndrome 1, a neurological disorder marked by intellectual disability, speech delay, and seizures. Beyond its role in the brain and muscle, hCRT is highly expressed in metabolically active tumors. Many cancer cells, including colorectal cancer and glioblastoma, upregulate hCRT to sustain intracellular creatine levels and buffer ATP under energy stress. Pharmacological blockade of hCRT by RGX202 has been shown to impair tumor growth by disrupting energy homeostasis. Here, we report the high-resolution cryo-Electron Microscopy (cryo-EM) structures of human hCRT in three states: apo, creatine-bound, and RGX202-bound. hCRT adopts a canonical LeuT-fold with 12 transmembrane helices and two pseudosymmetric inverted repeats. Creatine is coordinated in the central substrate-binding site through interactions with transmembrane helices TM1, TM3, TM6, and TM8, while the inhibitor RGX202 occupies the same binding pocket, engaging in overlapping contacts that competitively block creatine access. Our structural and mechanistic findings clarify substrate recognition and inhibitory binding of hCRT, providing a molecular rationale for targeting hCRT in both inherited metabolic diseases and cancer therapy.

项与 Ompenaclid 相关的新闻（医药）

2026-03-15

·药明康德

潜在“best-in-class”的口服小分子公布积极临床进展；治疗MASH，创新siRNA启动早期临床试验…… | 一周盘点

本期看点： 1. 潜在“best-in-class”的口服小分子EP4受体拮抗剂DT-9081用于治疗晚期、复发性和转移性实体瘤，在一项1期临床试验中取得了积极结果。 2. 旨在治疗代谢功能障碍相关脂肪性肝炎（MASH），Tangram Therapeutics公司的GalNAc偶联小干扰RNA（GalNAc-siRNA）药物TGM-312在1/2期临床试验中完成首例受试者给药。 DT-9081：公布1期临床试验数据 Kainova Therapeutics公司宣布，其用于治疗晚期、复发性和转移性实体瘤患者的候选药物DT-9081取得了积极的1期临床试验结果。DT-9081是一款潜在“best-in-class”的口服小分子EP4受体拮抗剂，旨在通过阻断由COX-2阳性肿瘤产生的前列腺素E2（PGE2）所介导的免疫抑制，恢复免疫功能正常环境并支持免疫再激活，从而提升包括化疗和某些免疫检查点抑制剂在内的抗癌治疗效果。临床前研究显示，在三阴性乳腺癌、肉瘤和结直肠癌模型中，DT-9081无论是单药还是与化疗或免疫检查点抑制剂联合使用，均具有显著的抗肿瘤效果。研究结果显示，DT-9081在所有测试剂量下均表现出良好的安全性特征，未报告任何剂量限制性毒性，证实了其临床耐受性并验证了其作用机制。药代动力学（PK）和药效学（PD）数据显示药物暴露量与剂量成正比，且在所有剂量水平下均实现了持续的EP4受体结合；此外，研究还观察到了早期的抗肿瘤活性迹象。这些发现进一步支持了DT-9081用于提高患者对免疫检查点抑制剂治疗反应的潜力。 TGM-312：1/2期临床试验完成首例受试者给药 Tangram Therapeutics公司宣布，其主打候选药物TGM-312的1/2期临床试验已完成首例受试者给药。TGM-312是一种基于Tangram Therapeutics公司专有的RNAi化学平台GalOmic开发的GalNAc-siRNA，旨在特异性沉默肝细胞中一个新靶点基因，用于治疗MASH。该药物有望实现每季度一次的皮下给药，提升患者用药便利性。在具有高度转化性的Gubra-Amylin NASH饮食诱导肥胖（GAN-DIO）小鼠模型的临床前研究中，TGM-312单药或与已获批及在研MASH疗法联用，均能显著降低NAFLD活动评分（NAS）、减轻肝脏炎症并减缓纤维化进程。 Delpacibart zotadirsen：公布1/2期临床试验及开放标签扩展研究的数据诺华（Novartis）公司旗下的Avidity Biosciences公布了抗体偶联寡核苷酸疗法delpacibart zotadirsen（del-zota）在治疗杜氏肌营养不良（DMD）患者的1/2期临床试验EXPLORE44和开放标签扩展研究EXPLORE44-OLE中获得的结果。Del-zota由抗转铁蛋白受体1（TfR1）抗体与诱导DMD基因外显子44跳跃的反义寡核苷酸（ASO）偶联而成。Del-zota旨在恢复肌营养不良蛋白的表达，在适用于外显子44跳跃治疗的DMD患者体内产生一种较短但具有功能的肌营养不良蛋白。在EXPLORE44和EXPLORE44-OLE研究中，共纳入42名DMD患者，其中可行走患者28例，不可行走患者14例，年龄为7–27岁。所有正在参与研究的受试者累计接受了约1年的del-zota治疗。试验结果显示，在这1年期间，中位血清肌酸激酶（CK）水平保持在接近正常范围的上限。在1年时，与自然疾病史数据相比，del-zota治疗与关键功能指标的改善相关。Del-zota总体显示出可接受的安全性和耐受性。研究者表示，这些结果支持del-zota有望改善特定DMD患者的生活质量。参考资料： [1] Benitec Biopharma Announces Positive Interim Phase 1b/2a Results for High Dose BB-301 and Continued Durable Improvements for Low Dose BB-301 Treatment at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference. Retrieved March 13, 2026, from https://www.globenewswire.com/news-release/2026/03/09/3251690/0/en/Benitec-Biopharma-Announces-Positive-Interim-Phase-1b-2a-Results-for-High-Dose-BB-301-and-Continued-Durable-Improvements-for-Low-Dose-BB-301-Treatment-at-the-2026-Muscular-Dystroph.html [2] AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in Adults. Retrieved March 13, 2026, from https://www.prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-a-phase-1-multiple-ascending-dose-study-of-abbv-295-a-long-acting-amylin-analog-in-adults-302707602.html [3] Kainova Therapeutics Announces Positive Phase I Results for DT-9081, an Oral EP4 Receptor Antagonist, in Advanced Solid Tumors. Retrieved March 13, 2026, from https://www.globenewswire.com/news-release/2026/03/10/3252479/0/en/Kainova-Therapeutics-Announces-Positive-Phase-I-Results-for-DT-9081-an-Oral-EP4-Receptor-Antagonist-in-Advanced-Solid-Tumors.html [4] Dyne Therapeutics Announces New Positive Cardiopulmonary Results from DELIVER Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD). Retrieved March 9, 2026, from https://www.globenewswire.com/news-release/2026/03/08/3251476/0/en/Dyne-Therapeutics-Announces-New-Positive-Cardiopulmonary-Results-from-DELIVER-Trial-of-Z-Rostudirsen-in-Duchenne-Muscular-Dystrophy-DMD.html [5] REGENXBIO REPORTS NEW POSITIVE INTERIM DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202. Retrieved March 11, 2026, from https://www.prnewswire.com/news-releases/regenxbio-reports-new-positive-interim-data-from-phase-iii-affinity-duchenne-trial-of-rgx-202-302711193.html [6] Biogen Presents Additional Salanersen Data Showing New Motor Milestones Achieved in Children with SMA Previously Treated with Gene Therapy. Retrieved March 11, 2026, from https://investors.biogen.com/news-releases/news-release-details/biogen-presents-additional-salanersen-data-showing-new-motor [7] Del-zota treatment is associated with near normalization of CK levels and improvements in key functional outcomes at 1 year in participants with DMD44. Retrieved March 12, 2026, from https://www.mdaconference.org/abstract-library/del-zota-treatment-is-associated-with-near-normalization-of-ck-levels-and-improvements-in-key-functional-outcomes-at-1-year-in-participants-with-dmd44/ [8] First Subjects Dosed in Cocrystal Pharma’s Phase 1b Study Evaluating CDI-988 for Norovirus Prevention and Treatment. Retrieved March 9, 2026, from https://www.globenewswire.com/news-release/2026/03/09/3251781/0/en/First-Subjects-Dosed-in-Cocrystal-Pharma-s-Phase-1b-Study-Evaluating-CDI-988-for-Norovirus-Prevention-and-Treatment.html 免责声明：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：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

siRNA临床2期临床1期临床申请寡核苷酸

2026-03-12

·FierceBiotech

Regenxbio posts clean safety profile for DMD gene therapy as pivotal data loom

Regenxbio plans to request a meeting to discuss a filing for accelerated approval of RGX-202 in mid-2026. \n Regenxbio has guided its Duchenne muscular dystrophy (DMD) gene therapy candidate through another test, reporting a clean safety profile and functional improvements as it heads toward pivotal data.The biotech expects to publish pivotal top-line data on the gene therapy, RGX-202, early in the second quarter. Wednesday, Regenxbio shared a new cut of data from the phase 1/2 trial that underpinned its decision to take RGX-202 into the pivotal study, generating more evidence that its gene therapy may be free from the liver toxicity issues that have affected Sarepta Therapeutics’ Elevidys.None of the 13 patients in the interim phase 1/2 safety dataset had serious adverse events or adverse events of special interest—including drug-induced liver injury—up to 24 months after treatment. Mean levels of two liver damage biomarkers among the 10 patients who received the pivotal dose were below the upper limit of normal up to 24 months.Regenxbio, which shared an earlier cut of the data in January, posted its updated safety results alongside the latest efficacy readout. The readout included one-year disease trajectory data, as measured on the North Star Ambulatory Assessment (NSAA), on more patients who received the pivotal dose. The expanded dataset provided more evidence that patients who receive RGX-202 outperform external controls and the expected disease trajectory on the NSAA. One-year data favored RGX-202 on other function tests such as time to stand. Regenxbio also shared data on the three patients who received a lower dose showing NSAA performance exceeded the expected disease trajectory after two years.Pivotal data are the next milestone for RGX-202. The new phase 1/2 results say little about whether the pivotal trial will hit its primary endpoint, which looks at the proportion of participants whose RGX-202 microdystrophin expression is 10% or higher at Week 12. Regenxbio included data on the expression of microdystrophin—a shortened version of the protein that is at the root of DMD—in the latest update but largely repeated figures shared in January. The addition of a child aged between 1 and 3 years to the analysis affected the data slightly. Regenxbio reported expression levels of 39.7% to 97.3% across three age-based cohorts that received the pivotal dose. All patients had microdystrophin expression levels above 10% at Week 12. Regenxbio will hit its primary endpoint if it replicates that result in the pivotal trial, although questions about whether the biotech will have enough for FDA approval will remain even if the study succeeds. The agency recently rejected another Regenxbio gene therapy over trial design issues and ordered uniQure to run a sham-controlled study. The biotech plans to request a meeting to discuss a filing for accelerated approval of RGX-202 in mid-2026. By the time the FDA is reviewing RGX-202, Regenxbio could have 12-month functional data from most of its pivotal trial patients and have largely enrolled its 30-participant confirmatory study. Regenxbio CEO Curran Simpson said on an earnings call last week that the company left its end-of-phase 2 meeting with the FDA believing similar efficacy and improved safety compared to Elevidys could be a route to accelerated approval. Yet Regenxbio reached alignment on its DMD program with the Biden-era FDA, making it unclear whether the current administration holds the same views.

临床结果基因疗法

2026-03-04

·思索新知

神经肌肉疾病治疗迎来新进展：2026 MDA大会关注基因疗法与肌肉再生

每年春天，神经肌肉疾病研究领域都会迎来一个重要时刻。来自世界各地的研究人员、临床医生、生物技术公司以及患者家庭，会汇集到同一个会议现场，交流过去一年里最重要的研究进展，也讨论未来治疗可能出现的突破方向。即将举行的2026年MDA Clinical & Scientific Conference，就是这样一场汇聚各方力量的会议。这个由Muscular Dystrophy Association（MDA）主办的年度大会，一直被视为神经肌肉疾病领域最重要的学术交流平台之一。会议现场通常会出现一种非常独特的组合：治疗患者的一线医生、在实验室研究疾病机制的科学家、开发新药的生物技术公司，以及长期关注研究进展的患者家庭。当这些不同角色的人坐在同一个会议厅里交流时，往往会产生很多意想不到的讨论。临床医生会带来真实世界中的治疗问题，科学家会分享最新的基础研究进展，而药企研发团队则会讨论药物开发的技术路线。正是在这种跨领域的碰撞中，很多新的研究思路逐渐成形。 MDA现任CEO Sharon Hesterlee在神经肌肉疾病领域已经工作了大约25年。她最初是一名神经科学研究者，后来先后在非营利组织、制药公司和生物技术企业参与过相关研究和药物开发工作。这样的经历，让她能够从更宏观的视角观察整个领域的变化。过去几年，她最大的感受是，这个领域正在同时推进大量不同方向的研究。与早期只有零散项目推进不同，现在从基础研究到临床试验，再到药物研发，几乎每一个环节都在同步推进。对于长期从事这一领域研究的人来说，这种“多条路线同时前进”的状态，本身就意味着未来可能正在发生变化。不过，如果把视线从宏观研究进展拉回到疾病本身，仍然可以看到很多尚未解决的问题。目前许多针对神经肌肉疾病的治疗方式，主要目标仍然是延缓肌肉功能的下降。例如一些基因疗法、RNA相关治疗以及其他药物，能够在一定程度上稳定肌肉细胞状态，让疾病进展速度减慢。但对于已经发生的肌肉损伤，这些治疗手段往往很难真正逆转。因此，越来越多研究者开始关注一个新的研究方向——肌肉再生。人体的肌肉组织其实具备一定的再生能力。在正常情况下，肌肉干细胞可以帮助修复受损的肌肉纤维。但在很多神经肌肉疾病中，这种再生机制会逐渐失效，肌肉修复速度远远跟不上损伤发生的速度。未来治疗策略的一个重要思路，是把不同治疗模式组合在一起。首先通过刺激肌肉再生机制，让患者恢复部分肌肉组织；随后再使用基因疗法或其他稳定肌肉结构的治疗手段，维持这些新形成的肌肉纤维。如果这种策略能够实现，治疗目标就不再只是“阻止恶化”，而是有可能让患者重新获得部分功能。在即将举行的MDA会议上，与肌肉再生相关的研究进展，也被认为是最值得关注的议题之一。除了肌肉再生之外，基因治疗如何在真实医疗体系中更安全地应用，也是会议讨论的重要内容。随着越来越多基因疗法进入临床实践，医疗中心需要建立新的治疗流程，包括患者筛选、治疗管理以及长期安全性监测等。与此同时，一些长期缺乏治疗手段的肌肉疾病也开始出现新的研究进展。例如肌强直性肌营养不良和面肩肱型肌营养不良等疾病，目前仍然缺乏真正意义上的新药。随着RNA调控技术、基因治疗以及新型递送系统的发展，这些疾病正在逐渐进入新的研究阶段。在整个研究生态中，还有一个经常被忽视却非常重要的角色——患者家庭。在神经肌肉疾病领域，患者家庭往往不仅是医疗体系的接受者，也在很多层面推动着研究的前进。许多研究基金、公益项目以及政策倡议，最初都来自患者群体的推动。对于科研机构和药企来说，来自患者家庭的反馈也会直接影响药物研发方向，因为只有真正理解患者需求，治疗方案才可能产生实际价值。从更宏观的角度来看，政府资金依然是神经肌肉疾病研究最重要的支持来源之一。虽然患者组织和公益基金会也在持续投入资源，但真正能够支撑长期科研项目和大型临床试验的，仍然是公共研究资金。最近，美国国会通过的一项联邦预算继续维持了多项医疗研究资金投入，同时还重新授权了一项针对罕见儿科疾病的激励机制。这项机制通过优先审评券等方式鼓励企业开发针对罕见儿童疾病的治疗药物。对于一些患者数量极少的疾病来说，这类政策激励有时甚至是企业进入这一领域的主要动力。当然，整个神经肌肉疾病研究社区仍然面临不少挑战。科研机构的经费压力、药物开发成本的持续上升，以及监管体系内部的一些变化，都可能影响研究推进的速度。但即便如此，这个领域仍然保持着一种相对罕见的气氛——谨慎中的乐观。越来越多新的治疗技术正在进入临床阶段，越来越多研究项目开始产生真实世界数据，而患者家庭也越来越多地参与到研究和政策推动之中。对于一个长期被认为进展缓慢的医学领域来说，这种多线推进的局面，或许已经意味着新的阶段正在慢慢到来。 🔹本文供医学科普使用，不构成医疗建议。本文内容基于公开资料整理，包括但不限于Fierce Biotech、The Guardian、Reuters、Nature、STAT News 等权威媒体与期刊。所有翻译与解读仅用于知识分享与医学科普，不构成任何医疗建议或临床指导。 🔹本文由「思索新知」团队基于海外权威资料整理，致力于提供可信赖的全球医疗科技动态。 DMD研究进展：RGX-202 基因治疗在 18 个月随访中偏离自然病程 PBGENE-DMD进入临床：DMD基因编辑研究走到哪一步了？ MD治疗研究更新：SGT-003三期临床启动，FDA沟通计划明确每个突变都值得被治愈：新一代 DMD 基因疗法 GNT0004 正式进入III期试验从延缓到逆转：只针对6%患者，却点燃全体DMD家庭的希望杜氏肌营养不良症（DMD）患者的“心脏希望”：Capricor细胞疗法再战FDA

100 项与 Ompenaclid 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Ompenaclid	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
结肠转移性腺癌	临床2期	比利时	Inspirna, Inc.	2023-10-10
结肠转移性腺癌	临床2期	法国	Inspirna, Inc.	2023-10-10
结肠转移性腺癌	临床2期	西班牙	Inspirna, Inc.	2023-10-10
RAS 突变结直肠癌	临床2期	美国	Inspirna, Inc.	2023-06-01
KRAS突变肿瘤	临床1期	美国	Inspirna, Inc.	2018-06-05
转移性结直肠癌	临床1期	美国	Inspirna, Inc.	2018-06-05
胃癌	临床1期	美国	Inspirna, Inc.	2018-06-05

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临床结果

适应症

分期

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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


NCT05983367 (CTgov)	临床2期	RAS 突变结直肠癌 \| 结肠转移性腺癌	76	FOLFIRI regimen+Bevacizumab+Ompenaclid (Ompenaclid + FOLFIRI + Bevacizumab)	夢顧鏇淵衊壓顧構襯製 = 簾鬱鹹膚齋壓餘襯餘簾範餘網範鹹鏇鏇願餘觸 (願糧膚築艱襯製醖壓鏇, 願網選憲齋積鹹艱衊廠 ~ 範廠糧鬱餘積簾獵醖窪) 更多	-	2026-02-20
				Placebo+Bevacizumab (Placebo + FOLFIRI + Bevacizumab)	夢顧鏇淵衊壓顧構襯製 = 鑰鑰鹹鹹積觸選構糧餘範餘網範鹹鏇鏇願餘觸 (願糧膚築艱襯製醖壓鏇, 顧鏇廠遞膚遞鏇簾窪顧 ~ 艱鏇夢獵鏇艱醖窪顧鑰) 更多
NCT03597581 (ESMO2024) 人工标引	临床1/2期	RAS 突变结直肠癌二线 RAS mutated (RASmt)	51	Ompenaclid 2400 mg BEV	壓製壓願齋積膚鬱襯構(築構觸繭繭遞顧膚夢網) = 網築蓋糧憲衊築醖積衊獵鏇獵繭夢糧衊願顧蓋 (繭鑰窪壓積簾膚獵醖築 ) 更多	积极	2024-09-16
				Ompenaclid 3000 mg BEV	壓製壓願齋積膚鬱襯構(築構觸繭繭遞顧膚夢網) = 鏇構憲獵夢網糧鹽獵齋獵鏇獵繭夢糧衊願顧蓋 (繭鑰窪壓積簾膚獵醖築 ) 更多
Corporate Publications 人工标引	临床2期	RAS 突变结直肠癌二线 RAS-mutated	41	Ompenaclid+FOLFIRI +bevacizumab	膚獵繭醖壓廠鏇淵衊艱(顧選範觸積憲齋窪餘蓋) = 繭醖遞壓夢膚膚範選獵遞夢憲齋獵窪願廠齋衊 (膚壓艱蓋簾範廠構鏇願 ) 更多	积极	2024-01-04
NCT03597581 (RGX-202-01, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	RAS 突变结直肠癌二线 RAS mutation	33	Ompenaclid + FOLFIRI+bevacizumab	廠鏇製獵繭構膚範窪鬱(鑰衊製選顧築築製襯淵) = nausea (50%), diarrhea (44%) 積廠糧選鑰鹽遞築廠觸 (膚艱選觸夢鑰齋鏇廠壓 ) 更多	积极	2023-10-22
				Ompenaclid + FOLFIRI+bevacizumab (RASm)
NCT03597581 (P-125, ESMO_GI2022)	临床1期	晚期结直肠腺癌二线	17	RGX-202-01 2400mg BID	鬱願艱糧艱鬱齋憲膚衊(廠築餘糧淵範淵夢鹽範) = 繭齋廠膚遞鑰艱憲顧範衊積顧膚鏇製範繭築簾 (築夢鹹夢範窪艱積獵獵 ) 更多	积极	2022-07-02
				RGX-202-01 3000mg BID	鬱願艱糧艱鬱齋憲膚衊(廠築餘糧淵範淵夢鹽範) = 蓋糧艱蓋餘簾網製壓艱衊積顧膚鏇製範繭築簾 (築夢鹹夢範窪艱積獵獵 ) 更多
NCT03597581 (ASCO2022) 人工标引	临床1期	晚期结直肠腺癌二线 KRAS Mutation	16	FOLFIRI+RGX-202-01+bevacizumab (dose escalation)	觸鑰遞獵鬱鑰鬱艱觸醖(簾鑰壓製積蓋積願淵餘) = 艱遞選窪鑰網艱艱鹽醖夢鹹廠鏇鏇襯蓋夢鹽艱 (鑰鏇願膚網築憲膚觸繭 ) 更多	积极	2022-06-02
				FOLFIRI+RGX-202-01+bevacizumab (dose expansion)	-
NCT03597581 (ASCO 12020 \| ASCO 22020) 人工标引	临床1期	胃肠道肿瘤	17	FOLFIRI+RGX-202	衊遞網選鏇獵鬱選築構(遞獵蓋願顧廠簾齋構簾) = Not reached 鹹齋簾壓憲網積憲窪襯 (範膚淵鏇蓋鏇鑰製鏇繭 ) 更多	积极	2020-05-29