Feasibility of CSF (Cerebrospinal Fluid) and Plasma ctDNA (Circulating Tumor Deoxyribonucleic) in BRAF (V-raf Murine Sarcoma Viral Oncogene Homolog B1)-Altered Glioma During Treatment With Plixorafenib

Evaluating the sensitivity and feasibility of using ctDNA assays optimized for detecting very low ctDNA counts from cerebrospinal fluid (CSF) and plasma. The investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline (defined as Cycle1 Day1 (C1D1) pre-treatment) and over time in response to treatment with plixorafenib co-administered with cobicistat in BRAF-V600E mutant glioma refractory to prior therapies.

开始日期2025-04-07

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT06385119

/ Completed临床1期

A Phase 1, Open-Label, 2-Part, Single Dose, Crossover Study to Examine the Effect of Food and Cobicistat Administration on the Pharmacokinetics and Safety of Plixorafenib in Healthy Participants.

The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine the following in two parts:
Part A
* The effect of food on the single dose PK of plixorafenib administered with cobicistat.
* The effect of cobicistat administration on the single dose PK of plixorafenib.
* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants.
Part B
* To examine the effect of a high-fat and a low-fat meal versus fasted state on the single dose PK of plixorafenib administered alone.
* To examine the effect of a low-fat meal versus fasted state on the single dose PK of plixorafenib administered with cobicistat.
* To determine the safety of plixorafenib administered alone or with cobicistat (low-fat meal only) in a single dose regimen.

开始日期2024-04-24

申办/合作机构

Fore Biotherapeutics, Inc.

NCT05503797

/ Recruiting临床2期

A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations

The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.

开始日期2023-02-21

申办/合作机构

Fore Biotherapeutics, Inc.

100 项与 Plixorafenib 相关的临床结果

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100 项与 Plixorafenib 相关的转化医学

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100 项与 Plixorafenib 相关的专利（医药）

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项与 Plixorafenib 相关的文献（医药）

2025-05-29·SCIENCE

BRAF oncogenic mutants evade autoinhibition through a common mechanism

Article

作者: Sahmi, Malha ; Lavoie, Hugo ; Hwa Jo, Chang ; Jin, Ting ; Tripathy, Sasmita ; Gendron, Patrick ; Maisonneuve, Pierre ; Rice, William J. ; Marinier, Anne ; Wang, Bing ; Therrien, Marc ; Decossas, Marion ; Lajoie, Driss ; Beaulieu, Pierre ; Schuetz, Doris A. ; Weber, Sandra ; Schriemer, David C. ; Arseneault, Geneviève ; Filandr, Frantisek

Uncontrolled activation of the rat sarcoma (RAS)–extracellular signal–regulated kinase (ERK) pathway drives tumor growth, often because of oncogenic BRAF mutations. BRAF regulation, involving monomeric autoinhibition and activation by dimerization, has been intensely scrutinized, but mechanisms enabling oncogenic mutants to evade regulation remain unclear. By using cryo–electron microscopy, we solved the three-dimensional structures of the three oncogenic BRAF mutant classes, including the common V600E variant. These mutations disrupted wild-type BRAF's autoinhibited state, mediated by interactions between the cysteine-rich domain and kinase domain, thereby shifting the kinase domain into a preactivated conformation. This structural change likely results from helix αC displacement. PLX8394, a BRAF inhibitor that stabilizes helix αC in an inactive conformation, restored the autoinhibited conformation of oncogenic BRAF, explaining the properties of this class of compounds.

2025-01-06·Theranostics

Oncogenic non-V600 mutations evade the regulatory machinery of RAF including the Cdc37/Hsp90 chaperone and the 14-3-3 scaffold

Article

作者: Yap, Jiajun ; Jubri, Karlina Bte ; Wan, Xiaoyu ; Tan, Nazereth Chor Boon ; Hu, Jiancheng ; Chen, Junjun ; Yap, Yoon Sim ; Ma, Yiying ; Hu, Jingyi ; Faruk, Regina ; Li, Yifan ; Fu, Nai Yang ; Lim, Yiting ; Li, Quan ; Wang, Mei ; Zhang, Ge ; Yuan, Jimin ; Lam, Paula

The Ser/Thr kinase RAF, particularly BRAF isoform is a dominant target of oncogenic mutations and many mutations have been identified in various cancers. However, how these mutations except V600E evade the regulatory machinery of RAF protein and hence trigger its oncogenicity remains unclear. Methods: In this study, we used mutagenesis, peptide affinity assay, immunoprecipitation, immunoblot, and complementary split luciferase assay as well as mouse xenograft tumour model to investigate how the function of RAF is cooperatively regulated by Cdc37/Hsp90 chaperones and 14-3-3 scaffolds and how this regulatory machinery is evaded by prevalent non-V600 mutations. Results: We found that Cdc37/Hsp90 chaperones engaged with mature BRAF proteins promoted together with 14-3-3 scaffolds a switch of BRAF proteins from active open dimers into inactive close monomers. Most non-V600 mutations were enriched on or around the Cdc37/Hsp90-binding segments of BRAF, which impair association of CDc37/Hsp90 chaperones with BRAF and hence trap BRAF in active open conformation favouring dimerization. These BRAF mutants with high dimer propensity sustained a prolonged ERK signaling, and were effectively targeted by RAF dimer breaker plx8394 in vitro and in vivo. In contrast, CRAF and ARAF existed as immature monomers highly packaged with Cdc37/Hsp90 chaperones, which will be released upon dimerization driven by RAS-GTP binding with their N-terminus as well as 14-3-3 scaffold association with their C-terminus. Mature CRAF and ARAF dimers also sustained a prolonged ERK signaling as non-V600 BRAF mutants by virtue of absence of the C-terminal Cdc37/Hsp90-binding segment. Conclusions: Cdc37/Hsp90 chaperones and 14-3-3 scaffolds cooperatively facilitate the switch of RAF proteins from open active dimers to close inactive monomers. Non-V600 mutations disrupt this regulatory machinery, and trap RAF in dimers, which could be targeted by RAF dimer breakers.

2024-10-10·JOURNAL OF CHEMICAL AND ENGINEERING DATA

Beyond the Veil: Free Energy Profiles and Partition Coefficients for Antimelanoma Drugs in Self-Assembled Nanomicelles via COSMOmic and Atomistic Molecular Dynamics Simulations

作者: Pricl, Sabrina ; Cavalieri, Gabriele ; Marson, Domenico ; Laurini, Erik ; Fermeglia, Maurizio ; Mio, Andrea

This study investigates the encapsulation efficiency (EE) and mol. interactions between amphiphilic dendrimer nanomicelles (AD NMs) and six BRAF inhibitors (BRAFis) used in melanoma treatment: dabrafenib (DAB), vemurafenib (VEM), ponatinib (PON), AZ 628 (AZ), PLX8394 (PLX), and encorafenib (ENC).Exptl. determination of EE coupled with computational methods, including mol. dynamics and COSMOmic simulations, was employed to explore the drug encapsulation behavior.The results indicate efficient encapsulation of all BRAF inhibitors by AD NMs with different EE values.DAB, ENC, and PLX exhibit a higher EE (∼75%), while VEM, AZ, and PON show slightly lower encapsulation efficiency (∼60%).Mol. dynamics and COSMOmic simulations identify three binding positions (POS 1, POS 2, POS 3) within the nanocarrier, revealing preferential sites for each BRAFi.Hydrophobic interactions dominate in POS 1, while electrostatic forces play a crucial role in POS 2 and POS 3.Partition coefficient (logK) anal. shows that DAB, ENC, and PLX have higher affinity for the nanocarrier.This study combines exptl. and computational insights to improve understanding of BRAFi-AD NM interactions, essential for optimizing drug delivery systems and advancing the development of melanoma treatment.

项与 Plixorafenib 相关的新闻（医药）

2025-09-22

·癌度

《癌度快报》2025年9月22日

临床试验病友交流群（点击）一、新药快讯 1、新一代口服靶向药PLX8394治疗BRAF突变肿瘤，平均64多个月无进展最近，一款名为Plixorafenib（代号：PLX8394）的前沿药公布了临床研究数据，这是一款可口服的下一代小分子BRAF基因靶向药，靶向广泛的BRAF基因突变，但是不影响正常BRAF基因的功能。本次公布的结果表明该药治疗BRAF突变的乳头状甲状腺癌和甲状腺未分化癌可实现持久疾病控制，对于确诊未做系统治疗的BRAF基因V600E突变的乳头状甲状腺癌，使用该药治疗的中位无进展生存时间达到了64个月，临床获益率达到了85.7%。该药将会扩大临床试验，招募肺癌和黑色素瘤患者入组用药。 2、前沿药JNJ-1900联合免疫治疗报道了疗效数据，近50%黑色素瘤患者病灶缩小最近，一款代号为JNJ-1900的药物报道了一期临床研究数据，这款药主要是与免疫检查点抑制剂联合使用，原则上可以治疗多种晚期肿瘤，首次研究则是聚集于多药耐药的黑色素瘤。JNJ-1900是由功能化二氧化铪纳米颗粒组成，经过一次性瘤内注射给药并通过放射疗法激活，诱导被注射肿瘤内大量癌细胞死亡，随后触发适应性免疫反应和长期的抗癌记忆。这款药可扩展到任何可以通过放疗治疗的实体瘤，首次19名患者使用该药与PD-1联合治疗的客观缓解率为47.4%，疾病控制率达到了78.9%，中位无进展生存时间达到了14.6个月。 3、免疫药物PD-1治疗无效怎么办？病毒免疫疗法CAN-2409让患者生存期超2年刚刚结束的2025年世界肺癌大会上，实验性病毒免疫疗法CAN-2409的研究结果表明，即便是接受过免疫治疗效果不理想的患者，仍然有超过37%的患者生存时间超过了2年，而且总体治疗的耐受性良好。CAN-2409的具体治疗方式是将经过改造的病毒药物注入到肿瘤组织，然后再配合口服药物将癌细胞变成目标靶子，从而激活人体的免疫系统对肿瘤进行攻击。不同肺癌亚型使用该疗法获益不同，肺腺癌的生存时间约为25.4个月，而肺鳞癌患者获益较小，中位生存时间为13.3个月，而且这个疗法会产生远隔效应，也就是非注射药物的肿瘤也会缩小。二、抗癌前沿 1、CT检查显著增加儿童患癌风险，可能导致10万例新发癌症 9月17日，发布在国际著名学术期刊《新英格兰医学杂志》的研究表明，大概10%的血液系统癌症可能源自CT检查的辐射暴露。研究人员还发现一整年的CT检查预计将导致10.3万癌症新发病例。如果累计辐射暴露的剂量越大患癌风险越大，成人中CT检查最可能引起的癌症是肺癌，其次是结直肠癌和白血病，对于儿童肿瘤则是甲状腺癌、肺癌和乳腺癌。综合看CT检查的癌症风险与饮酒、体重超重等其他高危因素处于同一个水平。当然也不是说完全不做CT，对于肺癌高危人群使用低计量螺旋CT筛查早期肺癌还是必要的，总之CT检查要权衡好风险比。 9月份福利癌度联手吉因加，推出“吉爱3000”惠民检项目，最低2000+可及的基因检测专属福利，详情微信扫码联系下方小助手进行免费咨询。咨询全球新药临床试验、报告解读同样可以扫描下面二维码咨询！

放射疗法免疫疗法临床结果

2025-09-22

·药明康德

临床应答率达100%的创新炎症性肠病疗法；临床获益优于标准疗法的小分子抗癌疗法…… | 一周盘点

本期看点 1. 用于治疗溃疡性结肠炎（UC）的在研药物PALI-2108的早期临床数据亮眼，患者的临床应答率达100%。 2. 靶向广泛BRAF突变体的小分子抑制剂plixorafenib用于初治（未接受过MAPK抑制剂治疗）的BRAF V600突变乳头状甲状腺癌（PTC）患者，中位无进展生存期（mPFS）达到64个月，临床获益率（CBR）达85.7%，与现有标准疗法的历史数据相比表现更为优越，且安全性良好。 PALI-2108：公布1b期临床试验数据 Palisade Bio公司公布了其用于治疗溃疡性结肠炎的在研药物PALI-2108的1b期临床试验数据。在UC和纤维狭窄型克罗恩病（FSCD）中，较高的PDE4B表达与局部炎症活动有关。PALI-2108是一种PDE4抑制剂前药，能在UC和FSCD等疾病部位局部活化，显著提升病变组织内PDE4抑制剂浓度，同时减少全身暴露，从而降低腹泻等传统PDE4抑制剂的不良反应。 1a期安全性和药代动力学（PK）研究结果显示，PALI-2108在临床试验中表现出良好的安全性，未报告严重不良事件，也无实验室指标异常或心电图异常。在1b期临床试验中，PALI-2108用于治疗UC患者的临床应答率达100%，5名患者中有2名根据FDA定义的终点实现了临床缓解，显示出其治疗UC的潜力。生物标志物分析显示，UC患者在基线时升高的186个与纤维化及克罗恩病狭窄相关的基因表达得到正常化，表明PALI-2108在治疗FSCD方面也具有一定潜力。该公司针对FSCD患者的1b期临床试验预计将于2025年下半年启动。 Plixorafenib（FORE8394）：公布1/2a期试验的新数据 FORE Biotherapeutics公司公布了plixorafenib的1/2a期临床试验的新数据。Plixorafenib是一款可口服的下一代小分子BRAF突变体选择性抑制剂，旨在靶向广泛的BRAF突变体，同时不影响野生型RAF蛋白的活性。此次公布的结果显示，plixorafenib用于治疗BRAF基因变异的乳头状甲状腺癌和甲状腺未分化癌（ATC）可实现持久的疾病控制，与现有标准疗法的历史数据相比表现更为优越，且安全性良好，与既往报告的药物安全性特征一致。在初治的BRAF V600突变PTC患者中，接受plixorafenib治疗患者的mPFS达到64个月，CBR达85.7%。 JNJ-1900（NBTXR3）：公布1期联合治疗试验数据 Nanobiotix公司公布了一项正在进行的1期研究的最新结果。该研究评估了JNJ-1900联合免疫检查点抑制剂治疗晚期癌症患者的效果，此次分析重点聚焦于原发性皮肤黑色素瘤患者。JNJ-1900由功能化二氧化铪（HfO2）纳米颗粒组成，经由一次性瘤内注射给药并通过放射疗法激活。它的物理作用机制为：通过放疗激活，诱导被注射肿瘤内大量的肿瘤细胞死亡，随后触发适应性免疫反应和长期的抗癌记忆。得益于该物理作用机制，Nanobiotix公司认为该药物可扩展到任何可以通过放疗治疗的实体肿瘤和任何联合治疗方案中，特别是与免疫检查点抑制剂联合。2023年，Nanobiotix宣布与强生旗下杨森公司（现名为强生创新制药）达成全球共同开发和商业化该药物的许可协议。此次公布的结果显示，在既往接受过多线治疗（包括抗PD-1治疗）后疾病进展的黑色素瘤患者中，JNJ-1900联合疗法表现出良好的安全性及早期疗效信号。在可评估的19例患者中，所有病灶的最佳客观缓解率（ORR）达到47.4%，疾病控制率（DCR）达78.9%（依据RECIST 1.1标准）。所有接受治疗的患者（n=21）的中位总生存期（mOS）为14.6个月。研究者认为，这些数据支持通过随机临床试验进一步验证该方案作为抗PD-1治疗初治或耐药原发性皮肤黑色素瘤患者的潜在新选择。 LP-184：公布1a期临床试验数据 Lantern Pharma公司宣布，其在研疗法LP-184的1a期临床试验达到了所有主要终点，显示出良好的安全性和PK特征，并观察到初步的抗肿瘤活性。目前患者入组已完成，部分患者因持续获得临床获益而继续接受治疗。LP-184是一种可穿透血脑屏障的小分子药物，通过“合成致死”机制靶向DNA损伤修复（DDR）缺陷肿瘤。此次公布的结果显示，在达到或高于治疗剂量阈值的可评估癌症患者中，48%的患者观察到临床受益，其中包括对现有疗法无效或已耗尽治疗选择的患者。值得注意的是，在胶质母细胞瘤（GBM）、胃肠道间质瘤（GIST）和胸腺癌等难治性肿瘤中观察到持久的临床获益。生物标志物分析显示，LP-184在DDR通路相关基因（如CHK2、ATM、STK11/KEAP1）突变的患者中具有显著潜力，此类患者出现了明显的肿瘤缩小。此外，该药良好的安全性和耐受性为其作为单药治疗或与PARP抑制剂、免疫疗法联合使用提供了支持。 ORKA-001：公布1期临床试验的中期数据 Oruka Therapeutics公司公布了其长效IL-23p19抗体ORKA-001的1期临床试验的中期数据。ORKA-001是一种新型皮下注射的半衰期延长型单克隆抗体，靶向IL-23p19，旨在为包括斑块状银屑病（PsO）在内的慢性皮肤病提供新的治疗方法。该药物在设计上与经过验证的risankizumab具有相似的表位结合和亲和力，有望实现每年给药一到两次的给药频率。临床数据显示，ORKA-001的半衰期约为100天，增加了其每年给药一次的潜力。ORKA-001具有良好的PK特征，可实现更高的药物暴露水平，从而可能带来更强的疗效和更长的停药后缓解期。此外，该药物在试验中耐受性良好，安全性特征与IL-23p19类药物一致。参考资料（可上下滑动查看） [1] Lion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B Following Earlier Fast Track and Orphan Drug Designations. Retrieved September 19, 2025, from https://www.prnewswire.com/news-releases/lion-tcr-achieves-triple-fda-milestones-with-ind-clearance-for-chronic-hepatitis-b-following-earlier-fast-track-and-orphan-drug-designations-302555819.html [2] Myrtelle Announces Nature Medicine Publication of Interim Results from Its Phase 1/2 Clinical Trial of Investigational Gene Therapy rAAV-Olig001-ASPA for Canavan Disease. Retrieved September 19, 2025, from https://www.prnewswire.com/news-releases/myrtelle-announces-nature-medicine-publication-of-interim-results-from-its-phase-12-clinical-trial-of-investigational-gene-therapy-raav-olig001-aspa-for-canavan-disease-302557585.html [3] Navigator Medicines Announces Positive Phase 1a Data from its Program of Potential Best-in-Class Bispecific Antibodies; NAV-240 Poised for Further Development in Inflammatory Disorders and Autoimmune Diseases. Retrieved September 19, 2025, from https://www.globenewswire.com/news-release/2025/09/17/3151352/0/en/Navigator-Medicines-Announces-Positive-Phase-1a-Data-from-its-Program-of-Potential-Best-in-Class-Bispecific-Antibodies-NAV-240-Poised-for-Further-Development-in-Inflammatory-Disord.html [4] Oruka Therapeutics Announces Positive Interim Phase 1 Results for ORKA-001. Retrieved September 19, 2025, from https://www.globenewswire.com/news-release/2025/09/17/3151351/0/en/Oruka-Therapeutics-Announces-Positive-Interim-Phase-1-Results-for-ORKA-001.html [5] Skyhawk Therapeutics Announces Positive First Interim Results in Patients from its Phase 1 Clinical Trial of SKY-0515 as a Treatment for Huntington's Disease. Retrieved September 19, 2025 from https://www.prnewswire.co.uk/news-releases/skyhawk-therapeutics-announces-positive-first-interim-results-in-patients-from-its-phase-1-clinical-trial-of-sky-0515-as-a-treatment-for-huntingtons-disease-302559094.html [6] Lantern Pharma’s LP-184 Phase 1a Clinical Trial Achieves All Primary Endpoints with Robust Safety Profile and Promising Antitumor Activity in Multiple Advanced Solid Tumors. Retrieved September 19, 2025 from https://www.businesswire.com/news/home/20250916022448/en/Lantern-Pharmas-LP-184-Phase-1a-Clinical-Trial-Achieves-All-Primary-Endpoints-with-Robust-Safety-Profile-and-Promising-Antitumor-Activity-in-Multiple-Advanced-Solid-Tumors [7] Palisade Bio Reports Positive PALI-2108 Phase 1b Clinical Data. Retrieved September 19, 2025 from https://www.globenewswire.com/news-release/2025/09/17/3151657/0/en/Palisade-Bio-Reports-Positive-PALI-2108-Phase-1b-Clinical-Data.html [8] NANOBIOTIX Announces New Results From a Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Combination With Immune Checkpoint Inhibitors as a 2L+ Therapy for Patients With Primary Cutaneous Melanoma Resistant to Anti-PD-1. Retrieved September 19, 2025 from https://www.globenewswire.com/news-release/2025/09/17/3152017/0/en/NANOBIOTIX-Announces-New-Results-From-a-Phase-1-Study-Evaluating-JNJ-1900-NBTXR3-in-Combination-With-Immune-Checkpoint-Inhibitors-as-a-2L-Therapy-for-Patients-With-Primary-Cutaneou.html [9] Astria Therapeutics Announces Positive Initial Results from the Phase 1a Healthy Subject Trial of STAR-0310 at the European Academy of Dermatology and Venereology. Retrieved September 19, 2025 from https://ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-positive-initial-results-phase-1a [10] Rubedo Life Sciences annuncia la concessione dell’autorizzazione IND da parte della U.S. FDA per il candidato farmaco principale RLS-1496, modulatore selettivo di GPX4, per la cheratosi attinica, nonché l’espansione del comitato consultivo clinico. Retrieved September 19, 2025 from https://www.businesswire.com/news/home/20250917265149/it [11] ProteinQure Announces First Patient Dosed in Phase I Clinical Trial of PQ203 in Advanced Metastatic Cancer. Retrieved September 19, 2025 from https://www.businesswire.com/news/home/20250917696518/en/ProteinQure-Announces-First-Patient-Dosed-in-Phase-I-Clinical-Trial-of-PQ203-in-Advanced-Metastatic-Cancer [12] Luxa Biotechnology Announces Publication in Cell Stem Cell Describing Positive Clinical Results for First-in-Human Clinical Trial for Dry AMD Therapy. Retrieved September 19, 2025 from https://www.luxabiotech.com/press-release/luxa-biotechnology-announces-publication-in-cell-stem-cell-describing-positive-clinical-results-for-first-in-human-clinical-trial-for-dry-amd-therapy 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

临床2期临床1期放射疗法临床结果

2025-05-27

·Business Wire

FORE Biotherapeutics to Participate in the Jefferies Global Healthcare Conference

PHILADELPHIA--(BUSINESS WIRE)--FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today announced that the Company will participate in the Jefferies Global Healthcare Conference on Tuesday, June 3, 2025 in New York. William Hinshaw, Chief Executive Officer, and Michael Byrnes, Chief Financial Officer, will host and participate in one-on-one meetings. Please contact your Jefferies salesperson or Argot Partners to schedule one-on-one meetings with the management team. About FORE Biotherapeutics Fore is a registration stage targeted oncology company dedicated to developing innovative treatments that provide better outcomes for patients with the hardest-to-treat cancers. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1st and 2nd generation BRAF inhibitors. Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a manageable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in FORTE, a global registrational basket trial to support three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn.

临床1期

100 项与 Plixorafenib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16038

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
BRAF突变实体瘤	临床2期	美国	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	澳大利亚	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	加拿大	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	法国	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	德国	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	意大利	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	挪威	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	韩国	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	西班牙	Fore Biotherapeutics, Inc.	2023-02-21
BRAF突变实体瘤	临床2期	瑞典	Fore Biotherapeutics, Inc.	2023-02-21

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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


NCT02428712 (Phase 1/2a study, AACR2025)	临床1/2期	BRAF突变实体瘤 BRAF alterations \| V600E \| class 2 SNVs ... 更多	71	Plixorafenib	鑰願夢選構製選膚淵餘(築顧窪獵艱築獵蓋網積) = 構製顧構衊鹽鑰衊襯築壓壓獵觸齋淵顧積願壓 (製齋遞簾艱餘鑰簾蓋網 )	-	2025-04-28
NCT02428712 (CTNI-76, SNO2023)	临床1/2期	中枢神经系统肿瘤 BRAF-altered \| BRAFV600+	113	Plixorafenib 900-3600 mg/day	膚糧積築夢夢築膚選壓(壓廠壓積獵餘觸醖衊蓋) = 艱醖淵鹽艱製憲鹽壓壓廠餘遞鹹觸衊鏇鏇廠艱 (窪願蓋淵夢糧鬱選範繭 )	积极	2023-11-10
NCT02428712 (ASCO 12023 \| ASCO 22023) 人工标引	临床2期	BRAF突变脑癌 \| HR阳性/HER2低表达实体瘤 BRAF	110	Plixorafenib±cobicistat	齋範餘艱糧築襯艱鹽齋(製廠窪選築網鹹鑰製鏇) = Dose-limiting toxicities were only observed at doses ≥1500 mg/day + cobi: 1500-1800 mg/day (4) and 2700-3600 mg/day (1). 願願範觸鬱獵製鏇鏇願 (蓋簾壓蓋鹹範顧鑰顧淵 )	积极	2023-05-31
NCT02428712 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤 \| 中枢神经系统肿瘤	110	FORE8394	願淵鹽鹽鑰築鹽夢繭蓋(憲壓獵遞膚齋獵鏇繭鑰) = 遞醖範願製製夢網襯鑰遞憲積願積築鹽醖築壓 (鏇齋壓繭繭獵觸淵製衊 ) 更多	积极	2023-05-26
NCT02428712 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤 \| 中枢神经系统肿瘤	110	FORE8394 (pts with MAPKi-naïve, V600 mutant tumors (excluding colorectal cancer [CRC]))	襯簾廠觸糧獵憲鑰壓膚(遞範餘壓製選顧衊鹹醖) = 糧衊餘蓋製齋願艱鑰範鹹築範獵鬱襯簾憲餘獵 (顧製蓋願繭遞膚淵糧鹹 )	积极	2023-05-26
NCT02428712 (ESMO2020)	临床1/2期	晚期癌症	69	PLX8394	積鏇鏇醖構網範襯積顧(網餘簾鹽艱壓鑰觸廠餘) = 4 pts 範積壓範鬱觸網鬱窪鏇 (壓鏇衊糧範齋衊網繭淵 ) 更多	积极	2020-09-18
NCT02428712 (ASCO 12018 \| ASCO 22018) 人工标引	临床1/2期	BRAF突变实体瘤 BRAF Mutation	31	PLX8394+cobicistat	鹹壓壓獵艱網鹹製築繭(繭範憲選壓襯繭遞淵艱) = 鬱網範醖構蓋夢鬱構願廠夢廠夢繭簾繭築糧蓋 (顧窪齋願窪鹹繭鏇壓獵 )	积极	2018-06-04
NCT02428712 (ASCO 12018 \| ASCO 22018) 人工标引	临床1/2期	BRAF突变实体瘤 BRAF Mutation	31	PLX8394+cobicistat	糧鑰窪廠簾鹹獵網衊餘(膚蓋衊網淵齋鏇夢繭簾) = 鏇選積繭鹽構夢願選遞觸選膚鹹積鬱糧積衊廠 (窪積製簾範選選繭淵顧 ) 更多	积极	2018-06-04