预约演示

更新于：2026-04-22

NKP-1339

更新于：2026-04-22

概要

概要

基本信息

药物类型

小分子化药

别名

sodium trans-[tetrachlorobis(1H-indazole)ruthenate(III)]、BOLD 100、BOLD-100

+ [3]

靶点

HSPA5 x p38 MAPK

作用方式

抑制剂

作用机制

HSPA5抑制剂(78kDa葡萄糖调节蛋白抑制剂)、p38 MAPK抑制剂(P38丝裂原活化蛋白激酶抑制剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [3]

在研适应症

胆道癌结直肠癌胃癌+ [6]

非在研适应症

新型冠状病毒感染头颈部肿瘤神经内分泌肿瘤+ [2]

原研机构

Medical University of Vienna

在研机构

Bold Therapeutics, Inc.

University Health Network

Seoul National University

+ [1]

非在研机构

Intezyne Technologies, Inc.

Niiki Pharma, Inc.

权益机构

Hana Pharm Co., Ltd.

University of Ottawa

Bold Therapeutics, Inc.

+ [1]

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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结构/序列

分子式C14H12Cl4N4NaRu

InChIKeyWVVOCRYXBTVDRN-UHFFFAOYSA-J

CAS号197723-00-5

关联

项与 NKP-1339 相关的临床试验

NCT07027423

/ Not yet recruiting临床1期IIT

A Phase 1b Trial of BOLD-100 Plus Doxorubicin in Advanced Soft Tissue Sarcomas

A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. The trial is divided into two phases: an initial dose-escalation phase for BOLD-100, followed by a dose-expansion phase based on the recommended dose for Phase 2. In the dose-escalation phase, we plan to enroll 12-15 patients, with an additional 17 patients in the dose-expansion phase.
Participants will receive BOLD-100 intravenously on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin (75 mg/m², intravenous) administered on Day 1 of each 21-day cycle for up to six cycles. Participants will continue to receive BOLD-100 for as long as the cancer is not getting worse, The maximum cycles of doxorubicin are 6 cycles.
Participants will undergo a screening assessment prior to the start treatment to determine eligibility for enrollment. Treatment will commence on Day 1 and will continue until the protocol-defined criteria for treatment withdrawal are met. Disease response will be assessed using CT or MRI scans, starting at 12 weeks after the initiation of treatment and continuing every 12 weeks until withdrawal.
Upon treatment discontinuation or study withdrawal, a post-treatment assessment will be conducted at end of treatment and at 30 days of the last BOLD-100 dose, with follow-up visits scheduled every 3 months thereafter.

开始日期2026-03-30

申办/合作机构

University Health Network

NCT04421820

/ Recruiting临床1/2期

A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.

开始日期2020-08-28

申办/合作机构

Bold Therapeutics, Inc.

NCT01415297

/ Completed临床1期

A Phase I Dose Escalation Study of NKP-1339 Administered on Days 1, 8 and 15 of Each 28-Day Cycle in Patients With Advanced Solid Tumors Refractory to Treatment

The purpose of this study is to determine the safety and maximal tolerated dose of NKP-1339, a ruthenium containing compound administered intravenously on a weekly schedule, in patients with advanced solid tumors. The responses to treatment in this population will be evaluated. In addition, the PD and PK properties of the compound will be explored.

开始日期2009-10-01

申办/合作机构

Niiki Pharma, Inc.

100 项与 NKP-1339 相关的临床结果

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100 项与 NKP-1339 相关的转化医学

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100 项与 NKP-1339 相关的专利（医药）

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项与 NKP-1339 相关的文献（医药）

2026-03-01·JOURNAL OF INORGANIC BIOCHEMISTRY

Additional functionality for plecstatin-1-analogous anticancer Ru(η6-p-cymene)Cl complexes

Article

作者: Siddiqui, Waseeq Ahmad ; Hanif, Muhammad ; Iqbal, Shahid ; Dill, Anne ; Hartinger, Christian G ; Lin, Zexiong ; Movassaghi, Sanam ; Jamieson, Stephen M F ; Ashraf, Adnan

The bioactivity of organometallic compounds can be enhanced by modifying the ligand to achieve higher potency or an altered mode of action. Here, we conjugated amino acids to pyridine-2-carbothioamides (PCAs) and formed their Ru^II(cym)Cl (cym = η⁶-p-cymene) organometallics, as confirmed by mass spectrometry, NMR spectroscopy and elemental analysis. The in vitro antiproliferative activities of ligands 1-4 and complexes 1a-4a were established against human non-small cell lung carcinoma (NCI-H460), cervical carcinoma (SiHA), colorectal carcinoma (HCT116) and colon adenocarcinoma (SW480) cell lines. Complexes 1a-3a showed no activity but 4a was moderately potent with an IC₅₀ value of 35 μM in NCI-H460 cells. Organoruthenium compound 4a was also more active than its PCA ligand 4 and the clinically investigated Ru complex KP1339 in NCI-H460 cells.

2025-06-01·INVESTIGATIONAL NEW DRUGS

Unraveling BOLD-100 synergistic potential in pleural mesothelioma treatment: an in vitro study

Article

作者: Martinotti, Simona ; Ranzato, Elia ; Bonsignore, Gregorio

Summary:

Pleural mesothelioma (PM) is a rare cancer affecting the pleural layer on the body’s serosal surfaces. Exposure to asbestos fibers, a naturally occurring fibrous material with insulating characteristics, contributes to PM’s prevalence. PM has a long latency period, making major surgery ineffective and necessitating systemic treatment. Despite the progress of mesothelioma treatment, the median survival is very poor; so, there is a strong need to explore new therapeutic approaches. This study explores the use of BOLD-100, a novel therapeutic drug that targets GRP78, a protein overexpressed in PM cells. BOLD-100, a ruthenium-based small molecule therapeutic drug, is being investigated for the treatment of advanced gastrointestinal malignancies in conjunction with chemotherapy. Our aim is to investigate cellular responses of several PM cell lines to a regimen that includes BOLD-100 in addition to other commonly used treatments. BOLD-100 is a ruthenium-based anticancer therapeutic.

2024-09-01·ARCHIV DER PHARMAZIE

Coumarin‐modified ruthenium complexes: Synthesis, characterization, and antiproliferative activity against human cancer cells

Article

作者: Sedić, Mirela ; Perić, Berislav ; Raić‐Malić, Silvana ; Bočkor, Luka ; Hamzic, Lejla F. ; Jakopec, Silvio ; Kirin, Srećko I. ; Car, Iris

Abstract:

Among ruthenium complexes studied as anticancer metallodrugs, NKP‐1339, NAMI‐A, RM175, and RAPTA‐C have already entered clinical trials due to their potent antitumor activity demonstrated in preclinical studies and reduced toxicity in comparison with platinum drugs. Considering the advantages of ruthenium‐based anticancer drugs and the cytostatic activity of organometallic complexes with triazole‐ and coumarin‐derived ligands, we set out to synthesize Ru(II) complexes of coumarin‐1,2,3,‐triazole hybrids (L) with the general formula [Ru(L)(p‐cymene)(Cl)]ClO4. The molecular structure of the complex [Ru(2a)(p‐cymene)(Cl)]ClO4 (2aRu) was determined by single‐crystal X‐ray diffraction, which confirmed the coordination of the ligand to the central ruthenium(II) cation by bidentate mode of coordination. Coordination with Ru(II) resulted in the enhancement of cytostatic activity in HepG2 hepatocellular carcinoma cells and PANC‐1 pancreatic cancer cells. Coumarin derivative 2a positively regulated the expression and activity of c‐Myc and NPM1 in RKO colon carcinoma cells, while the Ru(II) half‐sandwich complex 2cRu induced downregulation of AKT and ERK signaling in PANC‐1 cells concomitant with reduced intracellular levels of reactive oxygen species. Altogether, our findings indicated that coumarin‐modified half‐sandwich Ru(II) complexes held potential as anticancer agents against gastrointestinal malignancies.

项与 NKP-1339 相关的新闻（医药）

2026-04-19

·药明康德

HER2靶向ADC临床2期积极结果公布；潜在“first-in-class”小分子临床结果积极…… | 一周盘点

本期看点： 1. BioNTech和映恩生物（DualityBio）宣布，接受其在研HER2靶向抗体偶联药物（ADC）trastuzumab pamirtecan治疗的晚期子宫内膜癌患者的确认客观缓解率（ORR）近50%。 2. Bold Therapeutics宣布其潜在“first-in-class”小分子BOLD-100联合化疗方案FOLFOX治疗的胃肠癌患者，其oxaliplatin诱导的周围神经病变（OIPN）发生率显著低于历史对照水平。 Trastuzumab pamirtecan：1/2a期试验结果公布 BioNTech和映恩生物（DualityBio）近日公布了其在研HER2靶向ADC疗法trastuzumab pamirtecan（BNT323/DB-1303）的一项2期队列主要分析结果。该研究纳入HER2表达阳性的晚期子宫内膜癌患者，这些患者在一线化疗后（部分患者曾接受免疫检查点抑制剂治疗）疾病仍出现进展。该队列属于一项全球1/2a期临床试验的一部分，旨在评估trastuzumab pamirtecan在多种实体瘤中的治疗潜力。研究结果显示，该药物单药治疗在不同HER2免疫组化表达水平（IHC1+、IHC2+、IHC3+）患者中均表现具有明确临床意义的疗效。本次2期队列分析共纳入145例HER2表达阳性的晚期或转移性子宫内膜癌患者，其中经中心实验室确认HER2状态且曾接受免疫检查点抑制剂治疗的73例患者达到主要终点，ORR为49.3%（95% CI：37.4–61.3）。在所有经中心检测的患者（n=96）中，确认ORR为47.9%，中位无进展生存期为8.1个月。按当地检测HER2状态评估的143例可评估患者中，确认ORR为44.1%，不同HER2表达水平患者均观察到抗肿瘤活性，其中IHC1+、IHC2+和IHC3+患者的ORR分别为33.9%、40.4%和73.1%，中位缓解持续时间为10.3个月。安全性方面，该疗法的不良反应总体与HER2靶向ADC已知特征一致，常见治疗相关不良事件包括轻度恶心、贫血、血小板减少和疲劳。 BOLD-100：2期试验结果公布 Bold Therapeutics近日公布了其核心在研药物BOLD-100的最新数据，显示该药物在减轻化疗相关周围神经病变方面具有潜在保护作用。BOLD-100是基于钌基的潜在“first-in-class”小分子药物，其能（1）通过选择性抑制GRP78蛋白以改变未折叠蛋白质反应（UPR）；以及（2）诱导活性氧（ROS）引起的DNA损伤和细胞周期停滞。这些效果可共同导致对药物敏感和具耐药性的癌细胞死亡，使得BOLD-100在与其他抗癌疗法组合时（包含传统化疗、靶向疗法和免疫肿瘤疗法），具潜在改善各种实体和液体肿瘤预后的效果。 FOLFOX虽为胃肠道肿瘤的一线标准化疗方案，但其临床应用常受到急性及慢性周围神经病变的限制，大多数患者在治疗过程中会出现不同程度的不良反应。在正在进行的2期研究中，接受BOLD-100联合FOLFOX治疗的患者，其oxaliplatin诱导的周围神经病变发生率显著低于历史对照水平。具体来看，在结直肠癌患者中，任意级别神经病变发生率为14%，明显低于53%的历史基准；在胆道肿瘤患者中为35%，低于58%；在胃癌患者中为19%，显著低于63%。Bold Therapeutics公司将在正在举行的美国癌症研究协会（AACR）年会上分享BOLD-100神经保护功能的临床前研究结果和潜在作用机制。 STC-15：2期试验首例患者给药日前，STORM Therapeutics宣布完成5600万美元C轮融资，融资所得资金将主要用于推进其在研候选药物STC-15的临床开发。目前，公司已启动STC-15在特定肉瘤适应症中的2期单药临床研究，并已成功完成首例患者给药。肉瘤是一类发生于骨或软组织的恶性肿瘤，可累及肌肉、脂肪、软骨、血管以及其他结缔或支持性组织。本项研究旨在为STC-15探索潜在的加速审批路径提供支持，并为未来在更多肿瘤适应症中的临床开发奠定基础。 STC-15是一种潜在“first-in-class”口服小分子METTL3抑制剂。STC-15通过抑制RNA修饰酶METTL3发挥作用。该酶参与调控癌症干细胞分化过程，而这一过程在肉瘤及多种恶性肿瘤的发生发展中具有关键作用。在此前开展的1期单药临床研究中，STC-15在多种肉瘤亚型患者中显示出持久的肿瘤缓解效果，提示该疗法有望通过靶向并重编程可转化为癌细胞的祖细胞发挥抗肿瘤作用。参考资料： [1] BioNTech and DualityBio’s Antibody-Drug Conjugate Trastuzumab Pamirtecan Demonstrated Clinically Meaningful Efficacy in Patients with HER2-Expressing, Recurrent Endometrial Cancer. Retrieved April 13, 2026 from https://www.globenewswire.com/news-release/2026/04/11/3272109/0/en/BioNTech-and-DualityBio-s-Antibody-Drug-Conjugate-Trastuzumab-Pamirtecan-Demonstrated-Clinically-Meaningful-Efficacy-in-Patients-with-HER2-Expressing-Recurrent-Endometrial-Cancer.html [2] STORM Therapeutics Secures $56 Million Series C Financing and Doses First Patient in Phase 2 Sarcoma Trial of STC‑15. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/16/3275048/0/en/STORM-Therapeutics-Secures-56-Million-Series-C-Financing-and-Doses-First-Patient-in-Phase-2-Sarcoma-Trial-of-STC-15.html [3] TME Pharma Announces Publication of NOX-A12 “Triple Therapy” Phase 1/2 Expansion Arm A Findings from GLORIA trial in Nature Communications. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/16/3275041/0/en/TME-Pharma-Announces-Publication-of-NOX-A12-Triple-Therapy-Phase-1-2-Expansion-Arm-A-Findings-from-GLORIA-trial-in-Nature-Communications.html [4] Hinge Bio Announces First Subject Dosed in Phase 1 Trial of HB2198, a Novel B cell Depleting Agent, for Treating Autoimmune Disease. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/14/3273253/0/en/Hinge-Bio-Announces-First-Subject-Dosed-in-Phase-1-Trial-of-HB2198-a-Novel-B-cell-Depleting-Agent-for-Treating-Autoimmune-Disease.html [5] Oragenics Doses First Patient in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/13/3272489/0/en/Oragenics-Doses-First-Patient-in-Phase-IIa-Clinical-Trial-of-ONP-002-for-Mild-Traumatic-Brain-Injury.html [6] ImPact Biotech Presents Preliminary Data from Phase 1 Study of Padeliporfin VTP in LA-PDAC at SIR 2026 and Provides Strategic Business Update. Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/13/3272459/0/en/ImPact-Biotech-Presents-Preliminary-Data-from-Phase-1-Study-of-Padeliporfin-VTP-in-LA-PDAC-at-SIR-2026-and-Provides-Strategic-Business-Update.html [7] MetaVia Doses the First Patient in Higher-Dose Phase 1 Study of DA-1726, Its GLP-1 and Glucagon Dual Agonist for the Treatment of Obesity. Retrieved April 17, 2026 from https://www.prnewswire.com/news-releases/metavia-doses-the-first-patient-in-higher-dose-phase-1-study-of-da-1726-its-glp-1-and-glucagon-dual-agonist-for-the-treatment-of-obesity-302738622.html [8] Bold Therapeutics' Clinical-Stage Anticancer Agent BOLD-100 Demonstrates Protective Effects Against Chemotherapy-Induced Peripheral Neuropathy. Retrieved April 17, 2026 from https://www.prnewswire.com/news-releases/bold-therapeutics-clinical-stage-anticancer-agent-bold-100-demonstrates-protective-effects-against-chemotherapy-induced-peripheral-neuropathy-302744025.html [9] Cellectar Enrolls First Patient in CLR 125 Auger-Emitting Radioconjugate Phase 1b Clinical Trial Targeting Refractory Triple Negative Breast Cancer (TNBC). Retrieved April 17, 2026 from https://www.globenewswire.com/news-release/2026/04/14/3273404/29076/en/Cellectar-Enrolls-First-Patient-in-CLR-125-Auger-Emitting-Radioconjugate-Phase-1b-Clinical-Trial-Targeting-Refractory-Triple-Negative-Breast-Cancer-TNBC.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

2026-04-16

·动脉网

Bold Therapeutics公司的临床阶段抗癌药物BOLD-100展示了对化疗引起的周围神经病变的保护作用

VANCOUVER, BC 加拿大温哥华 , ，April 16, 2026 2026年4月16日/PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company that was founded to develop and commercialize novel metallotherapeutics, has shared new data highlighting the ability of its lead asset, BOLD-100, to demonstrate protective effects against chemotherapy-induced peripheral neuropathy.. /PRNewswire/ -- Bold Therapeutics是一家临床阶段的生物制药公司，致力于开发和商业化新型金属治疗药物，该公司分享了新的数据，强调其主要资产BOLD-100能够展示出对化疗引起的周围神经病变的保护作用。BOLD-100 is a first-in-class, ruthenium-based anticancer agent in Phase 2 clinical development for advanced gastrointestinal (GI) cancers in combination with the chemotherapy regimen FOLFOX. BOLD-100 plus FOLFOX improves overall survival and progression-free survival in patients, including advanced colon (mCRC), gastric (GC), and bile duct cancers (BTC). BOLD-100 是一种首创的、基于钌的抗癌药物，目前正处于针对晚期胃肠道 (GI) 癌症的二期临床开发阶段，并与化疗方案 FOLFOX 联合使用。BOLD-100 加上 FOLFOX 可改善患者的总体生存期和无进展生存期，包括晚期结肠癌 (mCRC)、胃癌 (GC) 和胆管癌 (BTC)。While FOLFOX is a standard-of-care therapy for GI cancers, its clinical utility is limited by acute and chronic peripheral neuropathies which present in the majority of patients. Remarkably, in the ongoing Phase 2 development of BOLD-100, significantly lower than expected incidence of oxaliplatin-induced peripheral neuropathy (OIPN) was observed in patients treated with BOLD-100 plus FOLFOX. 虽然FOLFOX是胃肠道癌症的标准治疗方案，但其临床应用受到急性及慢性周围神经病变的限制，这些症状在大多数患者中都会出现。值得注意的是，在BOLD-100的二期临床开发中，接受BOLD-100联合FOLFOX治疗的患者中观察到的奥沙利铂诱导的周围神经病变（OIPN）发生率显著低于预期。Compared to FOLFOX alone historical benchmarks, BOLD-100 plus FOLFOX any-grade neuropathy was:. 与单独使用FOLFOX的历史基准相比，BOLD-100加FOLFOX的任何级别神经病变是：。Colorectal Cancer 结直肠癌; 14% vs 53% benchmark ；14% 对 53% 基准Biliary tract cancer; 胆道癌；35% vs 58% benchmark 35% 对 58% 基准Gastric Cancer; 胃癌；19% vs 63% benchmark 19% 对 63% 基准 'These clinical findings are promising given the prevalence of peripheral neuropathy among patients undergoing chemotherapy,' said Mark Bazett, PhD, Senior Director of Preclinical Development. 'The potential to improve patient outcomes while simultaneously improving quality of life is a key differentiating characteristic of BOLD-100. “鉴于接受化疗的患者中周围神经病变的普遍性，这些临床发现很有前景，”Mark Bazett博士，临床前开发高级总监说道，“在提高患者疗效的同时改善生活质量，是BOLD-100的一个关键区别特征。”Our upcoming AACR presentation validates these important results in a range of preclinical models, and provides mechanistic understanding.'. 我们即将在AACR上展示的报告验证了这些在多种临床前模型中的重要结果，并提供了机制上的理解。Bold Therapeutics will be attending the American Association for Cancer Research (AACR) Annual meeting later this month in San Diego from April 17-22, where they will present advanced i Bold Therapeutics 将于本月晚些时候参加在美国圣地亚哥举行的美国癌症研究协会 (AACR) 年会，会议时间为 4 月 17 日至 22 日，届时他们将展示先进的...n vivo 在体内and 和in vitro 体外preclinical modelling of BOLD-100's neuroprotection, along with mechanism of action data. BOLD-100的神经保护临床前模型，以及作用机制数据。Abstract Title 摘要标题: Clinical-stage Anticancer Agent BOLD-100 Demonstrates Protective Effects Against Chemotherapy-Induced Peripheral Neuropathy 临床阶段抗癌药物BOLD-100显示出对化疗引起的周围神经病变的保护作用Session Time 会话时间: April 21, 2:00 PM - 5:00 PM ：4月21日，下午2:00 - 下午5:00Location 位置: Poster Section 14; Poster Board 11 ：海报部分14；海报板11Presentation Number 演示编号 : 5753 : 5753Abstract link: 抽象链接：https://aacrjournals.org/cancerres/article/86/7_Supplement/5753/778155 https://aacrjournals.org/cancerres/article/86/7_Supplement/5753/778155Bold Therapeutics is currently advancing BOLD-100 through a global Phase 2 randomized controlled trial across sites in Canada, European Union, and South Korea. This trial is investigating BOLD-100's anticancer efficacy but also includes important quality of life questionnaires focused on its neuroprotective potential. Bold Therapeutics公司目前正在加拿大、欧盟和韩国的多个中心推进BOLD-100的全球II期随机对照试验。该试验不仅研究BOLD-100的抗癌功效，还包括重要的生活质量问卷，重点关注其神经保护潜力。Please visit . 请访问。ClinicalTrials.gov 临床试验.govfor more information (NCT04421820). 更多信息（NCT04421820）。For more information or for interest in investing, please visit the Company's website at 欲了解更多信息或有兴趣投资，请访问公司网站https://www.bold-therapeutics.com/ https://www.bold-therapeutics.com/Contact: Jim Pankovich, EVP 联系人：Jim Pankovich，执行副总裁(604)262-9899 (604)262-9899[email protected] 电子邮件地址SOURCE Bold Therapeutics Inc. 来源：Bold Therapeutics Inc.21 21% %more press release views with 更多新闻发布视图与 Request a Demo 请求演示

2026-04-16

·PRNewswire

Bold Therapeutics' Clinical-Stage Anticancer Agent BOLD-100 Demonstrates Protective Effects Against Chemotherapy-Induced Peripheral Neuropathy

VANCOUVER, BC, April 16, 2026 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company that was founded to develop and commercialize novel metallotherapeutics, has shared new data highlighting the ability of its lead asset, BOLD-100, to demonstrate protective effects against chemotherapy-induced peripheral neuropathy. BOLD-100 is a first-in-class, ruthenium-based anticancer agent in Phase 2 clinical development for advanced gastrointestinal (GI) cancers in combination with the chemotherapy regimen FOLFOX. BOLD-100 plus FOLFOX improves overall survival and progression-free survival in patients, including advanced colon (mCRC), gastric (GC), and bile duct cancers (BTC). While FOLFOX is a standard-of-care therapy for GI cancers, its clinical utility is limited by acute and chronic peripheral neuropathies which present in the majority of patients. Remarkably, in the ongoing Phase 2 development of BOLD-100, significantly lower than expected incidence of oxaliplatin-induced peripheral neuropathy (OIPN) was observed in patients treated with BOLD-100 plus FOLFOX. Compared to FOLFOX alone historical benchmarks, BOLD-100 plus FOLFOX any-grade neuropathy was: Colorectal Cancer; 14% vs 53% benchmark Biliary tract cancer; 35% vs 58% benchmark Gastric Cancer; 19% vs 63% benchmark "These clinical findings are promising given the prevalence of peripheral neuropathy among patients undergoing chemotherapy," said Mark Bazett, PhD, Senior Director of Preclinical Development. "The potential to improve patient outcomes while simultaneously improving quality of life is a key differentiating characteristic of BOLD-100. Our upcoming AACR presentation validates these important results in a range of preclinical models, and provides mechanistic understanding." Bold Therapeutics will be attending the American Association for Cancer Research (AACR) Annual meeting later this month in San Diego from April 17-22, where they will present advanced in vivo and in vitro preclinical modelling of BOLD-100's neuroprotection, along with mechanism of action data. Abstract Title: Clinical-stage Anticancer Agent BOLD-100 Demonstrates Protective Effects Against Chemotherapy-Induced Peripheral Neuropathy Session Time: April 21, 2:00 PM - 5:00 PM Location: Poster Section 14; Poster Board 11 Presentation Number: 5753 Abstract link: Bold Therapeutics is currently advancing BOLD-100 through a global Phase 2 randomized controlled trial across sites in Canada, European Union, and South Korea. This trial is investigating BOLD-100's anticancer efficacy but also includes important quality of life questionnaires focused on its neuroprotective potential. Please visit ClinicalTrials.gov for more information (NCT04421820). For more information or for interest in investing, please visit the Company's website at Contact: Jim Pankovich, EVP (604)262-9899 [email protected] SOURCE Bold Therapeutics Inc. 21% more press release views with Request a Demo

临床2期临床结果AACR会议

100 项与 NKP-1339 相关的药物交易

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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
晚期恶性实体瘤	临床2期	美国	Bold Therapeutics, Inc.	2020-08-28
晚期恶性实体瘤	临床2期	加拿大	Bold Therapeutics, Inc.	2020-08-28
晚期恶性实体瘤	临床2期	爱尔兰	Bold Therapeutics, Inc.	2020-08-28
晚期恶性实体瘤	临床2期	韩国	Bold Therapeutics, Inc.	2020-08-28
胆管癌	临床2期	美国	Bold Therapeutics, Inc.	2020-08-28
胆管癌	临床2期	加拿大	Bold Therapeutics, Inc.	2020-08-28
胆管癌	临床2期	爱尔兰	Bold Therapeutics, Inc.	2020-08-28
胆管癌	临床2期	韩国	Bold Therapeutics, Inc.	2020-08-28
胃肠道肿瘤	临床2期	加拿大	Intezyne Technologies, Inc.	2020-08-28
胰腺癌	临床2期	美国	Bold Therapeutics, Inc.	2020-08-28

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临床结果

适应症

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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


NCT04421820 (BOLD-100-001, AACR2025)	临床2期	周围神经系统疾病二线	-	BOLD-100 + FOLFOX	壓繭鹹鹽鹽製窪範鹹窪(選構鑰鏇鬱範膚繭選夢) = 顧壓齋夢壓鏇鹹醖製鹹襯鏇選築夢製築鬱鑰蓋 (餘獵構範廠鏇蓋壓壓鏇 )	积极	2025-04-30
NCT04421820 (BOLD-100-001, AACR2025)	临床2期	周围神经系统疾病二线	-	FOLFOX alone	壓繭鹹鹽鹽製窪範鹹窪(選構鑰鏇鬱範膚繭選夢) = 壓鑰選蓋製鑰範餘壓憲襯鏇選築夢製築鬱鑰蓋 (餘獵構範廠鏇蓋壓壓鏇 )	积极	2025-04-30
NCT04421820 (BOLD-100-001, ESMO_GI 12024 \| ESMO_GI 22024) 人工标引	临床2期	转移性结直肠癌三线	38	BOLD-100 + FOLFOX	衊糧積鏇製繭構顧窪糧(網廠糧願製艱襯壓遞願) = 壓夢獵築遞壓鹽夢鑰壓繭衊醖艱齋醖餘顧繭糧 (襯廠醖淵鹽鬱壓鑰鹽醖, 3.0) 更多	积极	2024-06-27
NCT04421820 (BOLD-100-001, ASCO2024)	临床2期	晚期胃癌	21	BOLD-100 + FOLFOX	衊壓窪顧糧顧蓋醖窪築(製廠膚簾夢顧淵選壓築) = 鑰糧蓋製廠餘衊衊齋醖壓鬱顧積憲製鹹窪獵廠 (餘餘願網膚積廠獵憲範, 49 ~ 89) 更多	积极	2024-05-24
NCT04421820 (BOLD-100-001, ASCO2024)	临床2期	晚期胆道癌	22	BOLD-100 + FOLFOX	積淵網觸鏇鹽憲繭餘築(衊鏇鏇觸繭鬱積窪襯襯) = 鹽積獵簾餘積積餘廠糧醖糧願積鏇壓築構壓廠 (鏇壓鏇壓築餘網廠糧網, 1 ~ 23) 更多	积极	2024-05-24
NCT04421820 (BOLD-100-001 \| TRIO039, ASCO_GI2024) 人工标引	临床2期	转移性结直肠癌二线	36	BOLD-100+FOLFOX	觸鏇淵醖獵網膚繭鹹願(簾餘製蓋餘襯願築鬱網) = 簾鹹繭廠鑰齋遞構糧遞顧鬱觸襯鹽構獵廠範網 (鑰衊鹹繭築範積齋夢窪 ) 更多	积极	2024-01-17
NCT04421820 (TRIO039, ASCO2023) 人工标引	临床1/2期	晚期胆管癌 \| 晚期胃癌	35	BOLD-100+FOLFOX (BTC)	蓋鬱憲鑰築糧憲網願蓋(鏇繭蓋築夢構築鏇願廠) = 繭願遞膚膚鑰憲衊遞遞積廠衊觸壓鑰糧遞糧網 (衊齋範醖艱範積製繭遞 ) 更多	积极	2023-05-31
NCT04421820 (TRIO039, AACR2023) 人工标引	临床1/2期	晚期结直肠腺癌	17	BOLD-100+FOLFOX	願築選廠鬱願簾窪範築(壓製製製網鬱艱觸遞選) = 蓋壓獵遞廠廠選壓願衊餘蓋蓋獵簾襯鹹鏇艱鏇 (餘選鑰鹹獵糧網選築醖 ) 更多	积极	2023-04-14
NCT04421820 (BOLD-100-001 (TRIO039), ASCO2022)	临床1/2期	晚期恶性实体瘤	19	BOLD-100	齋淵壓範夢齋積鏇壓齋(製膚鹽憲壓窪簾醖簾鑰) = 繭網築遞憲廠觸繭網艱餘鬱網鬱簾窪構鏇壓範 (齋範鏇鏇艱網壓鬱選願 ) 更多	-	2022-06-02
NCT01415297 (Pubmed \| ESMO Open) 人工标引	临床1期	晚期恶性实体瘤	46	IT-139	窪廠餘獵製獵繭鬱廠艱(鹹艱窪鹽鹽鹽繭繭鏇窪) = ≥20% of patients were nausea, fatigue, vomiting, anaemia and dehydration. The majority of patients had AEs that were ≤grade 2 憲遞蓋選窪築顧齋獵願 (憲壓觸築齋製願築網鏇 )	积极	2017-02-23
ASCO2012	临床1期	晚期恶性实体瘤	34	NKP-1339	憲齋簾遞鏇窪顧選簾鏇(簾蓋構壓衊壓衊膚築壓) = 醖鏇壓觸鏇夢餘膚憲遞衊觸襯築鹽製廠觸膚積 (夢範壓憲膚廠觸範淵鹹 )	-	2012-05-20