A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-triggered Expansion Cohort

This study will administer the investigational drug, BDTX-1535 to eligible patients with recurrent high-grade glioma (HGG) and newly-diagnosed glioblastoma (nGBM). BDTX-1535 was designed to block a growth signal important to some cancers. BDTX-1535 is being tested in this study to see if it can be given safely to people who have tumors that can be dependent on that growth signal because of changes in a protein called EGFR. These gene changes are called amplifications, mutations, fusions or alterations and are found only in the tumors.
The study design includes a Phase 0 component with PK/PD-trigger for participant enrollment into an Expansion Phase 1 component. The primary objective of the Phase 0 component is to evaluate the PK endpoints of BDTX-1535. The primary objective of the Phase 1 component is to establish the safe dose of BDTX-1535 to be used in participants with a specified treatment regimen, three of which include standard of care radiotherapy for nGBM participants.

开始日期2023-10-18

申办/合作机构

St. Joseph's Hospital

[+1]

NCT05256290

/ Active, not recruiting临床1/2期

A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer

BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles.
Phase 1 enrollment is now complete. Phase 2 is currently ongoing.

开始日期2022-03-31

申办/合作机构

Black Diamond Therapeutics, Inc.

100 项与 Silevertinib 相关的临床结果

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100 项与 Silevertinib 相关的转化医学

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100 项与 Silevertinib 相关的专利（医药）

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项与 Silevertinib 相关的文献（医药）

2025-09-02·EXPERT OPINION ON THERAPEUTIC PATENTS

Overcoming triple mutant EGFR-tyrosine kinase barriers in the therapeutics of non-small cell lung cancer: a patent review on fourth-generation inhibitors (2017–2024)

Review

作者: Nagpure, Narendra R. ; Patel, Harun M.

INTRODUCTION:

Non-small cell lung cancer (NSCLC) remains a leading cause of cancer mortality, with epidermal growth factor receptor (EGFR) mutations being the primary driver of tumor progression. This review highlights the significance of fourth-generation EGFR tyrosine kinase inhibitors (EGFR-TKIs) in addressing acquired resistance mechanisms, such as the C797S mutation, which compromises the efficacy of third-generation inhibitors like Osimertinib and explores their potential to revolutionize NSCLC treatment through enhanced molecular specificity.

AREAS COVERED:

This review covers the latest progress in patented fourth-generation EGFR-TKIs and their clinical trial status for the treatment of NSCLC from 2017 to the present.

EXPERT OPINION:

Osimertinib, a third-generation EGFR inhibitor, revolutionized treatment for T790M mutations but is limited by resistance from C797S mutations. Fourth-generation EGFR inhibitors, incorporating scaffolds like aminopyrimidine and quinazoline, are designed to selectively target resistant EGFR variants, including L858R/T790M/C797S. Preclinical trials highlight the potential of sulfonyl and phosphine oxide-based compounds for their potency, selectivity, and favorable pharmacokinetics. Promising clinical trials with inhibitors like BDTX-1535, JIN-A02, and HS-10504 could redefine NSCLC treatment, with future success likely relying on innovative strategies, such as combination therapies, to combat resistance and enhance efficacy.

2025-06-01·BIOORGANIC & MEDICINAL CHEMISTRY

A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer

Review

作者: Patil, Chandragouda R ; Patel, Harun M ; Gawli, Chandrakant S

"Epidermal growth factor receptor (EGFR)" mutations are pivotal in the pathogenesis of "Non-Small Cell Lung Cancer (NSCLC)," which is associated with high morbidity and mortality rates. The advent of third and fourth-generation EGFR tyrosine kinase inhibitors (TKIs) has significantly advanced the therapeutic landscape for EGFR-mutant NSCLC, particularly in overcoming resistance mutations such as T790M and C797S. This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib. Furthermore, it explores emerging fourth-generation EGFR TKIs designed to address resistance mechanisms beyond those targeted by their predecessors. Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation. The review emphasizes the importance of these advanced inhibitors in enhancing "progression-free survival and overall survival rates". By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors.

2024-11-01·Translational Cancer Research

Targeting C797S mutations and beyond in non-small cell lung cancer—a mini-review

Review

作者: Fenchel, Klaus ; Dempke, Wolfram C M

Non-small cell lung cancer (NSCLC) represents over 80% of lung cancer cases and has a high mortality worldwide, however, targeting common epidermal growth-factor receptor (EGFR) alterations (i.e., del19, L858R) has provided a paradigm shift in the treatment of NSCLC. Uncommon EGFR mutations, however, show variable efficacy to EGFR-targeted drugs depending on the molecular alterations within exons 18-21 which underlying biological mechanism are far from being clear. The substitution mutations of G719X in exon 18, L861Q in exon 21, S768I in exon 20, and exon 20 insertions are the most frequent mutations among the uncommon mutations. The development of fourth-generation EGFR-tyrosine kinase inhibitor (TKIs) has gained increased interest as these drugs are able to inhibit resistance mutations (e.g., C797S) often detected in NSCLC patients' resistance to third-generation EGFR TKIs. BDTX-1535 is an orally bioavailable, brain-penetrating, mutation-selective, irreversible EGFR inhibitor with significant antitumour activity in NSCLCs and glioblastomas (phase I/II trials ongoing). It is a fourth-generation EGFR inhibitor that was found to overcome resistance to osimertinib in preclinical models and has shown promising activity in NSCLC patients harbouring C797S mutations. In experimental models BDTX-1535 was found to inhibit all common EGFR mutations and more than 50 of uncommon mutations including T790M, C797S, L718X, E709X, S784F, V834L and A289V, however, exon 20 insertions are inhibited to a much lesser extent. In addition, mutations in the extracellular domain of the EGF receptor (e.g., EGFRvII, III, IV) can be blocked as well. It should be noted that in up to 50% of all NSCLC patients who progress following osimertinib or other EGFR TKI therapy no underlying resistance mechanism can be identified suggesting that non-mutational signal transduction pathways may also be operative, and intratumoural heterogeneity has been found to be a major contributor to resistance and it consists of three main mechanisms: (I) drug-tolerant persister (DTP) cells, (II) chromosomal instability, and (III) extrachromosomal extracellular DNA (ecDNA) (seen in over 50% of NSCLCs) suggesting that novel EGFR TKIs will include many challenges in sufficiently targeting on-target resistance mechanisms. The development of novel drugs that can overcome TKI resistance in NSCLC patients harbouring the C797S mutation and beyond is, therefore, eagerly warranted.

项与 Silevertinib 相关的新闻（医药）

2025-12-05

·凯石招募

肺癌客观缓解率60%，86%患者脑转移有好转，第四代EGFR靶向药BDTX-1535公布新的临床数据

2025年12月3日，Black Diamond Therapeutics公司公布了第四代EGFR抑制剂silevertinib（BDTX-1535）一线治疗携带非经典表皮生长因子受体（EGFR）突变非小细胞肺癌（NSCLC）患者的II期临床数据癌[1]。该研究共纳入了43例携带35种不同的非经典EGFR突变非小细胞肺癌一线患者，其中包括16例脑转移患者（7例存在可测量的中枢神经系统靶病灶）。截至2025年11月3日，中位随访时间为7.2个月，可评估的客观缓解率（ORR）为60%，其中包括25例确认的部分缓解（PR）和1例确认的完全缓解（CR）。另外，患者的中枢神经系统（CNS）ORR为 86%，疾病控制率（DCR）为91%。截至数据截止时，仍有29例患者在接受治疗，其中包括5例在疾病进展后继续接受治疗的患者。最长的持续缓解已超过19个月。非小细胞肺癌(NSCLC)患者EGFR的结构突变主要聚集在外显子18-21，常见主要有四种类型，外显子18点突变、外显子19缺失突变、外显子20插入突变和外显子20突变（T790M）、外显子21点突变，其中最常见的EGFR突变是外显子的19缺失突变和外显子21的点突变L858R。非典型罕见EGFR突变主要有 G719X、S768I、L861Q及其复合突变[2]。目前国内也有第四代EGFR抑制剂肺癌临床试验进行中，招募肺癌患者免费参加。 WSD0922-FU临床试验进行中在CDE官网显示[3]，一项评估WSD0922-FU治疗晚期非小细胞肺癌的Ⅰ/Ⅱ期临床研究正在进行中，招募晚期非小细胞肺癌患者（既往一线治疗接受第三代EGFR-TKI抑制剂治疗后疾病进展者）参加，若有需要，可咨询医学部老师。在CDE官网显示[3]，一项评估WSD0922-FU联合奥希替尼治疗局部晚期或转移性非小细胞肺腺癌受试者的安全性、耐受性、药代动力学和有效性的I/II期临床研究正在进行中，招募非小细胞肺癌患者，若有需要，可联系医学部老师。 WSD0922-FU片是威尚生物医药有限公司自主研发能穿透血脑屏障的EGFR/EGFRvIII 靶向抑制剂，是一种口服中枢神经系统（CNS）渗透剂、小分子、ATP非竞争性、可逆性EGFR抑制剂，可有效抑制非小细胞肺癌和高级星形细胞瘤（HGA）特异性EGFR异常[4-5]。 WSD0922-FU单药临床数据在2025年世界肺癌大会（WCLC）上，公布了第四代EGFR抑制剂WSD0922-FU治疗EGFR C797S突变晚期非小细胞肺癌（NSCLC）患者的I/II期临床数据[5]。截至2025年7月31日，共有42例患者接受了WSD0922-FU治疗，患者之前接受过第三代EGFR-TKI治疗。在可评估疗效的患者中（n=33），经研究者评估的客观缓解率（ORR）为60.6%（20/33），疾病控制率（DCR）为100%。中位无进展生存期（PFS）尚未达到。在120mg BID队列中，总体的ORR为63.2%（12/19）。120mg BID队列中，有4例患者基线脑转移符合RANO BM评估标准，其中3例患者在中枢神经系统达到客观缓解，ORR为75%（3/4），1例中枢神经系统疾病得到控制，DCR为100%（4/4）。凯石招募——临床试验招募平台肿瘤患者申请参加临床试验须知：参与临床试验的患者，可以免费用试验新药，与试验相关的检查也是免费的。目前有CAR-T、TIL等细胞疗法，PD-1/PD-L1等免疫治疗药物，小分子抑制剂、双抗、单抗、ADC等靶向药物的临床试验正在进行中。正在招募肺癌、食管癌、肝癌、胃癌、结直肠癌、宫颈癌、卵巢癌、乳腺癌、胆管癌、子宫内膜癌、黑色素瘤、肉瘤、恶性血液疾病、淋巴瘤等各种恶性肿瘤，想要了解或者参加临床试验项目，可以咨询我们医学部的老师。企业商务合作请联系：18516873961 👉点击上面公众号名片关注我们👈 参考文献： 1.Black Diamond Therapeutics Announces Preliminary Phase 2 Data for Silevertinib in 1L NSCLC and Plans for a Phase 2 Trial of Silevertinib in GBM，Black Diamond Therapeutics公司官网，文章发布于2025年12月3日. 2.冯英,谭力铭.TKIs治疗非小细胞肺癌中罕见EGFR突变的研究进展[J].巴楚医学2023年第6卷第3期:124-128. 3.国家药品监督管理局药品审评中心（CDE）官网. 4.威尚生物宣布其自主研发的脑癌新药WSD0922获美国FDA孤儿药资格，威尚生物官网，文章发布于2019年7月25日.http://www.wayshinebiopharm.com/cn/newsinfo.php?id=1296 5.C. Zhou, A. Xionag, H. Zhong,et al.Phase I/II Study on WSD0922-FU in EGFR C797S+ NSCLC.[J]. 2025 WCLC.

2025-12-04

·癌度

《癌度快报》肺癌第4代靶向药BDTX-1535公布2期临床数据，疾病控制率91%！

临床试验病友交流群（点击）一、新药快讯 1、肺癌第4代靶向药BDTX-1535公布2期临床数据，疾病控制率91%！近日，新型EGFR基因的四代靶向药BDTX-1535公布了2期临床中期数据，针对携带35种不同非常见EGFR突变的初治晚期非小细胞肺癌患者展现显著疗效。在43例可评估患者中，客观缓解率达60%（含1例完全缓解），疾病控制率达91%；在伴有脑转移的患者中，86%的患者实现颅内病灶显著缩小。该药为可强力入脑的第四代靶向药，临床前显示可覆盖50多种EGFR基因突变（含C797S耐药突变）。目前这款药在国外开展临床试验，试验状态暂时处于“非招募”状态。 2、白细胞或淋巴瘤迎来共价耐药的新治疗机会，FDA批准匹妥布替尼上市 2025年12月3日，美国FDA批准非共价（可逆）BTK抑制剂Jaypirca（匹妥布替尼）用于既往接受过共价BTK抑制剂治疗的复发/难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）成人患者。此项批准基于III期临床试验研究结果：在238例患者中，匹妥布替尼组中位无进展生存期达到了14个月，显著优于对照组（IdelaR或BR方案）的8.7个月，疾病进展风险降低了46%。该药是全球首个非共价BTK抑制剂，可克服共价BTK抑制剂的耐药问题，为经治CLL/SLL患者提供了治疗选择。 3、靶向ALK基因的分子胶降解剂TRI-611，ALK基因阳性肺癌新治疗方式！ 2025年12月4日，TRIANA Biomedicines宣布成功完成1.2亿美元B轮融资，这笔资金将会主要推进主打产品TRI-611的开发，TRI-611是一款靶向ALK的分子胶降解剂，这款药致力于为ALK阳性非小细胞肺癌带来全新的治疗方式，融资将会加速这款药推进至临床概念的验证阶段，同时推动其他分子胶降解药物的进步。分子胶是最近出现的一类新的抗癌药，通过连接蛋白质的不同区域,促使蛋白质之间形成稳定的复合物或调节蛋白质的结构与功能，进而影响癌细胞增殖。二、抗癌前沿 1、美国NCCN肿瘤临床实践指更新了肝癌和胃癌的治疗措施，重点如下！ 2025年底NCCN指南更新，肝癌部分，免疫联合疗法的地位进一步提升，纳武利尤单抗联合伊匹单抗新增为晚期肝细胞癌一线推荐方案，传统靶向药乐伐替尼与索拉非尼在二线治疗中被移出推荐。同时指南明确推荐NTRK融合突变患者使用恩曲替尼、拉罗替尼等靶向药物。胃癌部分，指南要求所有新确诊患者检测PD-L1，推荐PD-L1阳性可手术患者在FLOT化疗方案基础上联合度伐利尤单抗进行围术期治疗；针对HER2阴性晚期患者，优先推荐"氟尿嘧啶+奥沙利铂"化疗联合替雷利珠单抗。此次更新进一步强化了免疫治疗及精准靶向在消化道肿瘤中的前沿地位。 “吉爱3000”惠民检项目，最低2000+可及的基因检测专属福利，全球新药临床试验免费用药、基因检测报告解读，详情微信“长按”下图扫码联系癌度王博进行咨询。另外，由于微信公众平台的机制调整，恳请各位粉丝朋友花一两秒钟帮我们点亮文章下方的【小手】和【爱心】，这对我们至关重要。谢谢大家！点亮小手爱心，送来温暖鼓励

2025-12-03

·GlobeNewswire-Health Care

Black Diamond Therapeutics Announces Preliminary Phase 2 Data for Silevertinib in 1L NSCLC and Plans for a Phase 2 Trial of Silevertinib in GBM

Silevertinib delivers robust anti-tumor activity as demonstrated by an ORR of 60% and a CNS response rate of 86% in 43 1L NSCLC patients presenting with 35 different non-classical EGFR mutations; no new safety signals observed to datePFS data for 1L NSCLC patients expected in Q2 2026; Company continues to explore partnership opportunities for pivotal development of silevertinibBased on encouraging CNS activity of silevertinib in multiple trials across NSCLC and GBM, Company plans to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients in 1H 2026; initial data anticipated in 2028Cash, cash equivalents, and investments of $135.5 million as of September 30, 2025; expected to be sufficient to fund operations into 2H of 2028Company to host an investor webcast and conference call today at 8:00 AM ET CAMBRIDGE, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced topline data from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor receptor (EGFR) mutations (NCMs) and outlined plans for a randomized Phase 2 trial of silevertinib in patients with newly diagnosed glioblastoma (ND GBM). “We are pleased to share these initial data in frontline NSCLC patients showing silevertinib’s activity against a broad spectrum of 35 distinct non-classical EGFR mutations,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “We are particularly encouraged by the CNS activity of silevertinib in treating NSCLC patients with brain metastases, as published data clearly demonstrate that CNS metastases are a key factor in early disease progression for NCM NSCLC patients treated with second- and third-generation EGFR-TKIs. We also believe that silevertinib is uniquely positioned as a potential treatment for patients with newly diagnosed EGFR-altered GBM, and plan to initiate a randomized Phase 2 trial in the first half of 2026, while PFS data matures in our Phase 2 NSCLC study and we continue our partnering discussions.” Silevertinib Phase 2 1L NSCLC Initial Clinical Results and Program Update 43 frontline NSCLC patients harboring a broad spectrum of 35 distinct non-classical EGFR mutations were enrolled, including 16 patients with brain metastases (7 of whom had measurable CNS target lesions). All patients were enrolled at a 200mg oral daily dose of silevertinib. Efficacy and safety were assessed with a November 3, 2025 data cutoff; median follow-up time as of this date was 7.2 months and the study remains ongoing. Key data highlights include: For the 43 patients enrolled, preliminary efficacy data is as follows: 25 confirmed partial responses, 1 confirmed complete response60% Objective Response Rate (ORR by RECIST 1.1)86% CNS ORR (by RANO-BM)91% disease control rate (DCR) Initial duration of treatment data: 29 patients remain on therapy (5/29 after progression), longest ongoing for >19 months Summary of safety data: No new safety signals observedAdverse events (AEs) experienced by a majority of patients include rash, stomatitis, diarrhea and paronychiaAEs were managed with standard supportive care and dose interruptions/reductions without compromising response depth or durability to date The Company expects to present updated results from the Phase 2 NSCLC trial, including Duration of Response (DOR) and Progression-free Survival (PFS) data in both the recurrent (83 patients) and frontline (43 patients) settings, at a medical meeting in the second quarter of 2026. Black Diamond continues to explore potential partnerships to advance silevertinib into pivotal development. “These highly encouraging data speak to the potential of silevertinib to be the treatment of choice for frontline NSCLC patients with the full spectrum of non-classical EGFR mutations” said Sergey Yurasov, M.D., Ph.D., Black Diamond’s Chief Medical Officer. “We are struck by the compelling CNS response rate, which may translate to prolonged durability of response for patients with CNS metastases. Based on these data, and promising Phase 0/1 and Phase 1 GBM results, we are preparing to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients, one of the highest unmet needs in oncology.” GBM Program Update and Phase 2 PlansApproximately 50% of patients with glioblastoma (GBM) present with an oncogenic EGFR alteration that can be targeted by silevertinib; each year approximately 7,000 patients in the U.S. are diagnosed with GBM harboring these EGFR alterations. “Prior attempts to treat EGFR-altered GBM patients have been limited by poor brain penetrance of targeted therapies and/or lack of potency of these therapies on the full spectrum of EGFR alterations” said Elizabeth Buck, Ph.D., Chief Scientific Officer of Black Diamond. “Based on encouraging CNS activity demonstrated by silevertinib across multiple trials, and its preclinical potency on all EGFR alterations found in GBM, we believe that silevertinib has the potential to be the first targeted therapy for these patients.” Black Diamond plans to initiate a randomized Phase 2 trial in newly diagnosed GBM patients in the first half of 2026, with preliminary data expected in 2028. Key trial highlights include: Expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ (control arm) or silevertinib + TMZ (experimental arm)Initial focus will be on EGFRvIII-positive patients (approximately 30% of GBM) who are MGMT-negative (unmethylated)Randomization and treatment will begin after patients have had their surgical resection and radiationPrimary endpoint is PFS (RANO by Blinded Independent Committee Review), with an interim analysis; secondary endpoint is overall survival (OS)Trial will be governed by an Independent Data Monitoring Committee (IDMC) Updated Financial Guidance Black Diamond previously reported cash, cash equivalents and investments of approximately $135.5 million as of September 30, 2025, which the Company now believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.Financial guidance assumes Black Diamond funds the Phase 2 trial of silevertinib in ND GBM and a potential partner funds pivotal development in NSCLC. Financial guidance does not assume receipt of potential development milestones from the Company’s partnership with Servier Pharmaceuticals LLC for BDTX-4933 (now S241656). Conference Call Information Black Diamond will host a conference call and webcast on Wednesday, December 3, 2025, at 8:00 AM ET to discuss the preliminary Phase 2 data for silevertinib in 1L NSCLC and plans for a Phase 2 trial of silevertinib in GBM. The webcast may be accessed online here or by visiting the Events page in the Investors section of the Company’s website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available for 30 days on the Investors section of Black Diamond’s website. About Black Diamond Therapeutics Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com. From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this press release. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trial and the timing of clinical updates for silevertinib in patients with NSCLC and in patients with GBM, enrollment in the investigator sponsored Phase 0/1 clinical trial of silevertinib of newly diagnosed GBM patients with EGFR alterations, the expected timing for regulatory feedback and the disclosure of a potential registrational pathway for silevertinib in NSCLC, the potential of silevertinib to address the unmet medical need for newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across multiple lines of therapy, the potential future development plans for silevertinib in NSCLC and GBM, a potential partnership for silevertinib, and the Company’s expected cash runway. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. ContactFor Investors:investors@bdtx.comFor Media:media@bdtx.com

临床2期临床结果

100 项与 Silevertinib 相关的药物交易

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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
晚期鳞状非小细胞肺癌	临床2期	美国	Black Diamond Therapeutics, Inc.	2022-03-31
EGFR阳性非小细胞肺癌	临床2期	美国	Black Diamond Therapeutics, Inc.	2022-03-31
多形性胶质母细胞瘤	临床2期	美国	Black Diamond Therapeutics, Inc.	2022-03-31
转移性非小细胞肺癌	临床2期	美国	Black Diamond Therapeutics, Inc.	2022-03-31
继发性肺恶性肿瘤	临床2期	美国	Black Diamond Therapeutics, Inc.	2022-03-31
非小细胞肺癌	临床2期	美国	Black Diamond Therapeutics, Inc.	-
胶质母细胞瘤	临床前	美国	Barrow Neurological Institute	2025-04-29

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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


NCT05256290 (GlobeNewswire) 人工标引	临床2期	EGFR突变的非小细胞肺癌一线 EGFR Mutation	43	Silevertinib 200mg oral daily dose	鏇簾壓衊顧獵積願範壓(築製網糧壓糧選壓壓顧) = 繭網廠積餘夢憲範淵遞構齋壓鑰窪繭築憲鏇蓋 (餘蓋範鬱夢網膚鬱網選 ) 更多	积极	2025-12-03
NCT05256290 (GlobeNewswire) 人工标引	临床2期	复发性非小细胞肺癌二线 EGFR C797S	27	BDTX-1535 200 mg	積鑰鏇艱壓淵鹽網艱顧(網觸廠鑰網鏇衊網獵夢) = 餘醖襯廠選構鬱醖鹽餘蓋觸網齋鏇遞醖糧觸鏇 (鬱鬱遞選襯獵窪製鹽簾 ) 更多	积极	2024-09-23
NCT05256290 (GlobeNewswire) 人工标引	临床2期	复发性非小细胞肺癌二线 EGFR C797S	27	BDTX-1535 200 mg (either C797S or P-loop alpha-C helix compressing (PACC, a major subset of NCMs))	積鑰鏇艱壓淵鹽網艱顧(網觸廠鑰網鏇衊網獵夢) = 獵選襯網製廠構襯憲糧蓋觸網齋鏇遞醖糧觸鏇 (鬱鬱遞選襯獵窪製鹽簾 )	积极	2024-09-23
NCT05256290 (BDTX-1535-101, ASCO2024)	临床1期	复发性胶质母细胞瘤 EGFR alterations \| EGFRvIII \| missense mutations	54	BDTX-1535 15mg QD	醖構遞艱夢構壓觸襯鬱(觸鹽構鏇夢鹽淵壓構壓) = Gr 3 TRAEs ≥ 10% included rash (19%) reported at 300 or 400 mg QD doses 築衊範遞鹹遞鑰觸憲衊 (廠艱餘壓範鏇鹹繭壓鑰 ) 更多	积极	2024-05-24
NCT06072586 (Phase 0/1 trigger trial of BDTX-1535, ASCO2024)	早期临床1期	复发性恶性胶质瘤 EGFR alterations \| EGFR fusions	7	BDTX-1535 200 mg	鹹製廠齋廠糧製淵築鬱(夢鹽鹽構艱獵蓋齋範繭) = No serious adverse events were observed among patients in the Phase 1 component of the study 選願齋選淵範醖糧糧窪 (壓齋獵築憲醖鬱廠壓襯 )	积极	2024-05-24
NCT06072586 (GlobeNewswire) 人工标引	临床1期	复发性胶质母细胞瘤二线	22	BDTX-1535	鹽鏇獵淵範餘衊糧衊窪(簾築簾衊網糧襯顧鏇觸) = consistent with the EGFR tyrosine kinase inhibitor (TKIs) class of drugs, including primarily Grade 1 and 2 diarrhea and rash 選艱築蓋憲膚製積遞蓋 (餘觸觸網積艱積淵築醖 )	积极	2023-12-13
Corporate Publications 人工标引	临床1期	非小细胞肺癌	-	BDTX-1535	鏇鏇衊醖艱願糧鑰築鹹(廠築醖蓋鑰壓鹹簾窪獵) = No patients experienced dose limiting toxicity at 15-200 mg QD doses. One of 15 patients treated at the 300 mg QD dose experienced dose limiting diarrhea and 5 of 12 patients at the 400 mg QD dose experienced dose limiting toxicity (diarrhea, 2 patients; rash, stomatitis, fatigue and decreased appetite, 1 patient each). 鏇鹹繭築鹹積願製憲糧 (鹹鑰鏇壓壓衊簾窪淵遞 ) 更多	积极	2023-06-27