预约演示

更新于：2025-06-24

Albumin-Bound Paclitaxel

白蛋白结合型紫杉醇

更新于：2025-06-24

概要

基本信息

药物类型

小分子化药

别名

Nab-Paclitaxel、Nab-PTX、Paclitaxel (albumin-bound)

+ [15]

靶点

Tubulin

作用方式

抑制剂

作用机制

微管蛋白抑制剂

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [6]

在研适应症

转移性胰腺癌胰腺癌转移性胰腺腺癌+ [34]

非在研适应症

大肠腺癌小肠腺癌腺鳞癌+ [104]

原研机构

Abraxis BioScience, Inc.

在研机构

Teva Pharmaceuticals, Inc.Hoffmann-La Roche, Inc.

浙江海昶生物医药技术有限公司

+ [12]

非在研机构

Daiichi Sankyo Co., Ltd.

Genentech, Inc.

Novartis Pharmaceuticals Corp.

+ [11]

权益机构

浙江海昶生物医药技术有限公司

BeOne Medicines Ltd.

科兴生物制药股份有限公司

+ [5]

最高研发阶段批准上市

首次获批日期

美国 (2005-01-07),

转移性乳腺癌

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C47H51NO14

InChIKeyRCINICONZNJXQF-MZXODVADSA-N

CAS号33069-62-4

关联

1,666

项与白蛋白结合型紫杉醇相关的临床试验

NCT06592664

/ Withdrawn临床1/2期

A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

开始日期2030-01-01

申办/合作机构

Lisata Therapeutics, Inc.

NCT06998940

/ Not yet recruiting临床3期IIT

Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil [5-FU] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.

开始日期2026-01-06

申办/合作机构

SWOG

[+1]

NCT06675136

/ Not yet recruiting临床1期IIT

Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases

This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.

开始日期2025-10-17

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与白蛋白结合型紫杉醇相关的临床结果

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100 项与白蛋白结合型紫杉醇相关的转化医学

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100 项与白蛋白结合型紫杉醇相关的专利（医药）

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42,959

项与白蛋白结合型紫杉醇相关的文献（医药）

2025-12-31·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Selisistat, a SIRT1 inhibitor, enhances paclitaxel activity in luminal and triple-negative breast cancer: in silico, in vitro, and in vivo studies

Article

作者: Bartuzi, Damian ; Stepulak, Andrzej ; Kalafut, Joanna ; Okon, Estera ; Wawruszak, Anna ; Czerwonka, Arkadiusz ; Luszczki, Jarogniew

Sirtuins (SIRTs) are NAD+-dependent histone deacetylases, which play a key role in cancer progression; however, their prognostic values in breast cancer (BC) remain a subject of debate and controversy. Accumulative evidence suggests that each sirtuin possesses individual character, implicating its role in the regulation of multifaceted biological functions leading to BC initiation, progression and metastasis. Selisistat (EX527) is a potent, cell permeable, highly selective SIRT1 inhibitor. In the study, the tumour-suppressive effects of the SIRT1 inhibitor EX527 (selisistat) alone and in combination with paclitaxel (PAX) in different breast cancer cell lines and zebrafish xenograft models were investigated. The type of pharmacological drug-drug interaction between EX527 and PAX was determined using the isobolographic method. EX527 and PAX used individually inhibited proliferation, induced apoptosis and caused cell cycle arrest in G1 and subG1/G2 phases. Interestingly, the combination of these compounds used in the 1:1 dose-ratio augmented all these effects (IC_50add 29.52 ± 3.29 - 38.45 ± 5.26). The co-treatment of EX527 with PAX generated desirable additive drug-drug interaction. The simultaneous application of EX527 and PAX induced a stronger inhibition of tumour growth compared to individual treatments in zebrafish xenografts. In silico analysis revealed a protein-protein interaction pathway (SIRT1-AKT-S1PR1-GNAI1/GNAO1-Tubulin) connecting molecular targets of both ligands. To summarise, the combination of EX527 and PAX more effectively impairs breast cancer cell growth compared to individual treatments. However, further investigations are required to clarify the specific targets and molecular mechanisms underlying the activity of EX527:PAX in other preclinical models.

2025-12-01·Journal of Gastrointestinal Cancer

The Efficacy and Safety of Nivolumab Combined with Nab-Paclitaxel or Oxaliplatin as a First-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer

Article

作者: Li, Shuman ; Ye, Sisi ; Li, Juan ; Zhang, Ying ; Liu, Rongrui ; Shi, Weiwei

OBJECTIVE:

This study aims to assess the therapeutic efficacy and safety of nivolumab combined with chemotherapy as a first-line treatment for advanced or metastatic gastric cancer, specifically comparing the outcomes of oxaliplatin-based versus albumin-bound paclitaxel (nab-paclitaxel)-based therapies.

METHODS:

We retrospectively analyzed 93 patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma treated at the First Medical Center of Chinese PLA General Hospital from September 2017 to November 2022. Patients were categorized into the nivolumab + oxaliplatin (N-OX group) or nivolumab + nab-paclitaxel (N-AP group) based on the chemotherapy regimen. Progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety were evaluated as endpoints.

RESULTS:

At the end of the follow-up period on September 31, 2023, we reported an ORR of 65.6% and DCR of 95.7% across all patients. The median PFS was 8.4 months, with no significant difference between the N-OX and N-AP groups (median, 7.8 vs 9.5 months; P = 0.450). Notably, patients with diffuse gastric cancer in N-AP group showed a 44.7% reduction in tumor progression risk compared with the N-OX group (P = 0.046). The overall safety profile was acceptable in two groups.

CONCLUSIONS:

Our study suggested that nivolumab combined with chemotherapy was effective and safe as a first-line intervention for advanced gastric cancer. While both oxaliplatin and nab-paclitaxel regimens showed similar efficacy, the nab-paclitaxel may offer additional benefits for patients with diffuse gastric cancer. Further research is encouraged to confirm these findings and refine treatment strategies.

2025-12-01·MOLECULAR BIOLOGY REPORTS

Human papillomavirus E6 alters Toll-like receptor 9 transcripts and chemotherapy responses in breast cancer cells in vitro

Article

作者: Selander, Katri ; Jukkola, Arja ; Ravaioli, Sara ; Parviainen, Essi ; Manninen, Aki ; Nurmenniemi, Sini ; Bravaccini, Sara

Abstract:

Background:

Toll-like receptor 9 (TLR9) is a DNA recognizing receptor expressed also in several cancers. Decreased TLR9 expression is associated with poor prognosis in triple negative breast cancer (TNBC), but the role of TLR9 in breast cancer pathophysiology is currently unclear. Regulation of TLR9 expression in breast cancer is poorly understood. Human papillomavirus (HPV) infections suppress TLR9 expression in cervical cancers but the association between HPV and breast cancer has remained controversial. The aim of this study was to test if HPV16 can suppress TLR9 expression in breast cancer cells and affect cell behavior.

Methods and results:

Human T-47D and MDA-MB-231 breast cancer cells were transduced with lentivirus encoding HPV16 E6 oncoprotein. The effects of E6 on TLR9 mRNA and protein expression, and cell proliferation, migration, invasion and sensitivity to chemotherapy were studied in vitro. Breast cancer tissue samples (n = 37) were analyzed for the presence of HPV DNA. E6 expression decreased TLR9 mRNA expression in MDA-MB-231 and T-47D cells in hypoxia. E6 expression altered breast cancer cell proliferation and made cells significantly less sensitive to the growth inhibitory effects of chemotherapeutic agents. HPV L1 gene was not detected in a small pilot cohort of clinical breast cancer specimens.

Conclusion:

HPV16 may influence breast cancer cell TLR9 transcription and chemotherapy responses and could thereby affect breast cancer prognosis. These results suggest that HPV may have a previously unrecognized role in breast cancer pathophysiology and warrant further studies on the topic.

1,398

项与白蛋白结合型紫杉醇相关的新闻（医药）

2025-06-22

·ioncology

ASCO 2025丨研究者权威解读：TTFields联合疗法开创局部晚期胰腺癌治疗新纪元！

ASCO 2025微专辑扫描二维码可查看更多内容编者按2025年美国临床肿瘤学年会（2025 ASCO）于5月30日~6月3日在美国芝加哥举行。作为全球规模最大、学术水平最高且最具权威性的临床肿瘤学盛会，ASCO年会汇聚了全球肿瘤学领域的医生、专业人士、患者倡导者、工业界代表以及主流媒体，共同聚焦国际前沿的研究发现与临床研究成果。本届ASCO大会上，来自美国弗吉尼亚梅森医院和医疗中心的Vincent Picozzi教授报告了一项备受瞩目的Ⅲ期临床研究（LBA4005），该研究评估肿瘤电场治疗（TTFields）联合吉西他滨和白蛋白结合型紫杉醇治疗局部晚期胰腺导管腺癌（LA-PAC）的疗效与安全性。作为首个证实TTFields联合化疗能为LA-PAC患者带来显著总生存期获益的Ⅲ期研究，PANOVA-3研究结果具有重要临床意义。对此，《肿瘤瞭望消化时讯》特邀Vincent Picozzi教授就研究设计理念、TTFields的作用机制及临床应用前景等关键问题进行了深入探讨。以下为访谈精要整理，以飨读者。肿瘤瞭望消化时讯PANOVA-3研究是首个证实TTFields联合疗法能为LA-PAC患者带来总生存期获益的Ⅲ期研究。本研究的设计理念是什么？为何选择TTFields联合吉西他滨和白蛋白结合型紫杉醇的治疗方案？ Vincent Picozzi教授事实上，TTFields已被证实可通过多种机制干扰癌细胞分裂。当TTFields与不同化疗方案联用时，确实能增强化疗药物的活性。其中获益最显著的是紫杉烷类药物，白蛋白结合型紫杉醇正是其中之一。前期研究已在40例患者中测试了TTFields联合吉西他滨及部分患者联用白蛋白紫杉醇的方案，证实该设备与化疗联用具有可行性、安全性且疗效显著。基于上述研究背景，我们选择了局部晚期胰腺癌患者作为研究对象。这类患者通常无法手术但尚未出现转移迹象。本研究入组的都是未经治疗的不可切除局部晚期胰腺癌患者，按1:1比例随机分组，分别在吉西他滨+白蛋白紫杉醇方案基础上联合或不联合TTFields治疗。这项历时5年（包括新冠疫情期间）的国际多中心研究共纳入571例患者，覆盖约200个研究中心（横跨两大洲）、20个国家，堪称一项真正的国际研究。Dr Vincent Picozzi: Well, TT fields had been shown to disrupt cancer cell division in a number of ways. And when the TT fields were tested with different forms of chemotherapy, it did increase the activity of the chemotherapy. And the class of drugs that was most benefited were a class of chemotherapy drugs known as taxanes, of which nab-paclitaxel is one of them. And then this was tested in 40 patients with a drug called gemcitabine and also for some of them nab paclitaxel. The use of this device with chemotherapy was found to be feasible, safe and actually quite effective.So with that as a background, patients with locally advanced pancreas cancer were chosen. Locally advanced pancreas cancer patients are patients who are generally inoperable but don't have evidence of metastatic spread. So the trial involved this population of patients untreated inoperable lowly advanced pancreas cancer and the patients were randomized to either receive Tumor Treating fields or not, in combination with gemcitabine and nab-pacotaxel, in a one-to-one ratio. A total of 571 patients were included in the study, which took place over five years, including the COVID pandemic, across about 200 sites (and in two) and in 20 countries. So it was truly an international study.（上下滑动可查看）肿瘤瞭望消化时讯与传统治疗方法相比，您认为TTFields在胰腺癌治疗中的核心优势是什么？ Vincent Picozzi教授首先需要指出的是，TTFields与化疗联用能产生叠加效应，既可作用于肿瘤局部，又能产生全身性治疗效果。相较于放射治疗，TTFields具有多项优势，包括治疗流程更简便、副作用更少、适用人群更广（放射治疗有禁忌人群）。最重要的是，正如我所说，它具有潜在的全身治疗效果。我们期待开展更多临床研究以探索TTFields联合其他疗法治疗胰腺癌的效果。目前正在进行的是PANOVA-4研究，该研究针对转移性（非局部晚期）胰腺癌患者，采用TTFields联合吉西他滨、白蛋白紫杉醇及免疫检查点抑制剂替雷利珠单抗的治疗方案。其理论基础在于，TTFields可能通过激活抗肿瘤免疫反应产生远隔效应，而联合替雷利珠单抗有望增强这一效应。该研究正在进行中，预计明年公布结果。基于这三项研究的启示，我们还有诸多其他胰腺癌联合治疗方案的设想等待验证。Dr Vincent Picozzi: Well, I would say first of all that it can produce an additive effect with chemotherapy, when the use of both in the region of the cancer as well as throughout the body.It has some advantages and when compared with radiation therapy and that it is logistically simpler, has fewer side effects, there isn't trouble involved, can be used in all types of patients as opposed to certain patients like radiation therapy is. There are certain patients who can not receive radiation therapy. But most importantly, as I say, has this potential for effect throughout the body.So I look forward to a number of clinical trials and clinical experiments in which the use of other cancer therapies in pancreas cancer are tested with Tumor Treating fields. One such experiment is going on currently, something known as the PANOVA 4 trial. And what the PANOVA 4 trial does is it looks at a different patient population. Patients with metastatic pancreas, cancer, not locally advanced, and uses the Tumor Treating fields with gemcitabine and Abraxane, which is nab paclitaxel, along with an immunotherapy, tislelizumab, which is a checkpoint inhibitor. And the thinking behind this is that the reason or a reason that the Tumor Treating fields are thought to have an effect away from the cancer is by activating the immune system against the cancer, and the thought is by adding a tislelizumab, it can potentiate this effect. So that trial is underway and hopefully the results will be available next year. And there are many, many other ideas for additional trials throughout pancreas cancer that this been over three studies suggest.（上下滑动可查看）肿瘤瞭望消化时讯近年来，胰腺癌在化疗、靶向治疗和免疫治疗方面虽取得进展，但患者生存获益仍有限。您认为当前最关键的治疗突破口是什么？您团队未来的研究重点将放在哪些方向？Vincent Picozzi教授从临床角度来看，TTFields的应用价值在于其可能通过抑制全身肿瘤生长来改善胰腺癌各分期患者的生存预后，这也正是PANOVA-4研究的重要意义所在——该研究旨在实证这种治疗模式的临床优势。若研究取得阳性结果，将为TTFields联合各类疗法用于胰腺癌全病程治疗打开新的探索空间。从作用机制分析，TTFields可通过多途径抑制肿瘤生长，这种特性使其具备与几乎所有新型抗癌疗法产生协同效应的潜力。目前医学界正在基于这一广阔的研究前景，系统规划后续的研究计划，以探索更多联合治疗方案的可能性。Dr Vincent Picozzi: Well, really for all stages of pancreatic cancer, survivals improved by controlling the growth of the cancer throughout the body. And so that is why the PANOVA-4 trial is so critical to demonstrate, in practicality, an advantage to the use of Tumor Treating fields in this way. And so if this trial is successful, it opens the door to all kinds of considerations of adding different types of therapies to Tumor Treating fields for really all stages of pancreatic cancer. The Tumor Treating fields may affect the cancer adversely in a number of ways. So there are many, many different types of treatments, almost any, almost any novel cancer treatment you can think of potentially could interface and synergize with the use of tumor treating fields. And so I know the plans are being contemplated now as to what next additional studies will take place, given the very broad range of opportunities that exist.（上下滑动可查看）研究一览摘要号：LBA4005一项评估肿瘤电场治疗（TTFields）联合吉西他滨和白蛋白结合型紫杉醇治疗局部晚期胰腺导管腺癌 (LA-PAC) 的Ⅲ期PANOVA-3研究研究背景迄今为止，尚未有Ⅲ期临床研究证实肿瘤治疗电场（TTFields）联合化疗方案能为局部晚期胰腺腺癌（LA-PAC）患者带来总生存期（OS）获益。TTFields是一种通过干扰癌细胞分裂发挥抗肿瘤作用的电场疗法，目前已获批用于胶质母细胞瘤、胸膜间皮瘤和转移性非小细胞肺癌的治疗。此前一项Ⅱ期研究在胰腺癌中证实了TTFields联合吉西他滨（±白蛋白结合型紫杉醇）方案的安全性和初步疗效。本文报告PANOVA-3研究（NCT03377491）的最终数据，这是目前在LA-PAC领域内规模最大的全球性、随机、开放标签Ⅲ期临床研究。研究方法新诊断的LA-PAC成人患者按1:1比例随机分组，分别接受TTFields（150 kHz）联合吉西他滨/白蛋白结合型紫杉醇（GnP）治疗或单独GnP治疗。主要终点为OS，次要终点包括无进展生存期（PFS）、局部PFS、客观缓解率（ORR）以及无疼痛生存期。此外还进行了事后分析评估远处无进展生存期（指胰腺和区域淋巴结以外的远处转移）。生存数据采用Kaplan-Meier法和log-rank检验进行比较。研究结果本研究共随机入组571例患者，两组基线特征总体均衡。疗效方面，TTFields/GnP治疗组的中位OS显著优于单独GnP组，分别为16.2个月 vs. 14.2个月，（HR=0.82，95%CI：0.68~0.99，P=0.039）。TTFields/GnP治疗组的1年生存率对比单独GnP组亦显著提高，分别为68.1% vs. 60.2%，（P=0.029）。两组在PFS和局部PFS方面无显著差异。TTFields/GnP组的无疼痛生存期较单独GnP组显著延长，中位无疼痛生存期分别为15.2个月 vs. 9.1个月，（HR=0.74，95%CI：0.56~0.97，P=0.027）。事后分析显示，TTFields/GnP组的远处PFS较单独GnP组获益显著，分别为13.9个月 vs. 11.5个月，（HR=0.74，95%CI：0.57~0.96，P=0.022）。两组的ORR获益相近，分别为36.1% vs. 30.0%，（P=0.094）。安全性方面，TTFields/GnP组和GnP组分别有97.8%和98.9%的患者发生不良事件（AEs），≥3级AE发生率分别为88.6%和84.3%。最常见的≥3级AE为中性粒细胞减少（47.8% vs. 47.6%）和贫血（21.9% vs. 22.3%）。81%的TTFields/GnP组患者出现器械相关AE，主要为1/2级皮肤反应，包括皮炎（27.7%）、皮疹（17.5%）和瘙痒（15.0%）；3级和4级器械相关AE发生率分别为9.1%和0.4%。研究结论PANOVA-3是迄今为止专门针对LA-PAC患者进行的最大规模的Ⅲ期研究，也是首个显示出统计学显著OS获益的研究。TTFields疗法未增加额外的全身毒性，并带来统计学上显著的无痛生存期获益，有望成为LA-PAC的新标准治疗方案。（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议临床结果临床3期

2025-06-21

·ioncology

ASCO 2025丨吴一龙教授：肺癌领域热点深度解析——中国研究成果入选再创新高，“东方智慧”赋能国际肺癌诊疗开创新格局

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ASCO 2025 微专辑扫描二维码可查看更多内容2025年美国临床肿瘤学年会（2025 ASCO）于5月30日-6月3日在美国芝加哥举行。作为全球规模最大、学术水平最高且最具权威性的临床肿瘤学盛会，ASCO年会汇聚了全球肿瘤学领域的医生、专业人士、患者倡导者、工业界代表以及主流媒体，共同聚焦国际前沿的研究发现与临床试验成果。本届ASCO大会，来自广东省人民医院吴一龙教授团队主持开展的一项探索HLX07+斯鲁利单抗联合或不联合化疗对比斯鲁利单抗联合化疗作为晚期鳞状非小细胞肺癌一线治疗的II期研究成果入选，《肿瘤瞭望》特邀吴一龙教授解读该项研究成果及ASCO肺癌领域研究热点。特此整理，以飨读者。吴一龙教授广东省人民医院肿瘤学教授，博士生导师IASLC杰出科学奖获得者中国医师协会副会长广东省医师协会（GDMDA)会长广东省人民医院（GDPH）首席专家广东省肺癌研究所（GLCI）名誉所长中国胸部肿瘤研究协作组（CTONG）主席2018-2024年临床医学领域全球高被引科学家中国临床肿瘤学会荣誉主席，首任理事长摘要号：Abstract: 8561 | Poster Bd #: 41英文标题：A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer.HLX07+斯鲁利单抗联合或不联合化疗对比斯鲁利单抗联合化疗作为晚期鳞状非小细胞肺癌一线治疗的II期研究研究背景PD-L1/PD-1 抑制剂联合化疗的一线治疗方案已为晚期鳞状非小细胞肺癌（sqNSCLC）患者带来显著生存获益，但预后仍有待改善。表皮生长因子受体（EGFR）在 sqNSCLC 中高表达，并与不良预后相关。本研究旨在比较新型人源化抗 EGFR 抗体 HLX07 联合斯鲁利单抗± 化疗，与斯鲁利单抗联合化疗作为晚期 sqNSCLC 一线治疗的疗效。研究方法本项随机、多中心 II 期研究分为 4 个部分，评估 HLX07（不同剂量）、斯鲁利单抗和化疗的多种联合方案。以下呈现的是第 3 部分对三药联合方案初步疗效的评估。入组患者为不可手术或放疗的 IIIB/IIIC 期或 IV 期 sqNSCLC，肿瘤 EGFR 高表达（H 评分≥150）且未接受过系统治疗，按 1:1 随机分配至 A 组（HLX07 800 mg 静脉注射）或 B 组（HLX07 1000 mg 静脉注射），均联合斯鲁利单抗（300 mg）和化疗（卡铂 + 白蛋白紫杉醇），每 3 周一次。主要终点为独立放射学审查委员会（IRRC）根据 RECIST 1.1 标准评估的客观缓解率（ORR）和无进展生存期（PFS）。研究结果截至 2024 年 12 月 31 日，第 3 部分共入组 27 例患者，随机分配至 A 组（n=13）和 B 组（n=14），其中 15 例（55.6%）存在转移性疾病。中位随访 16.0 个月时，IRRC 评估的确认ORR（RECIST 1.1）在 A 组为 69.2%（95% CI 38.6–90.9），B 组为 71.4%（95% CI 41.9–91.6）；疾病控制率分别为 92.3%（95% CI 64.0–99.8）和 100%（95% CI 76.8–100.0）。A 组中位 PFS 为 15.1 个月（95% CI 4.1–未达到），B 组中位 PFS 尚未达到。截至数据截止时，两组中位总生存期和缓解持续时间均未达到。两组所有患者均发生治疗期间不良事件（TEAEs），最常见的任何级别 TEAEs 包括中性粒细胞计数减少（92.3% vs. 71.4%）、白细胞计数减少（84.6% vs. 85.7%）、贫血（84.6% vs. 78.6%）、血小板计数减少（76.9% vs. 71.4%）、低钾血症（53.8% vs. 64.3%）、皮疹（46.2% vs. 57.1%）、脱发和低钙血症（均为 46.2% vs. 50.0%）。A 组和 B 组分别有 6 例（46.2%）和 8 例（57.1%）患者报告免疫相关不良事件。研究结论HLX07 联合斯鲁利单抗和化疗作为一线治疗，在晚期 sqNSCLC 患者中显示出令人鼓舞的初步疗效，且安全性可控，值得进一步研究。肿瘤瞭望请您结合研究成果，谈谈HLX07联合斯鲁利单抗±化疗组治疗晚期鳞状NSCLC的有效性及安全性如何？吴一龙教授众所周知，晚期鳞状非小细胞肺癌（sqNSCLC），因其缺乏驱动基因突变、治疗选择有限，患者长期面临生存率低、预后差的困境，是临床亟待解决的棘手难题。尽管现有免疫联合化疗治疗模式可使晚期sqNSCLC患者五年生存率达到15%-20%，但一旦发生免疫治疗耐药的情况，化疗则成为其唯一治疗手段，无进展生存期（PFS）仅有2-3个月，有效率仅有10%左右，治疗效果非常不尽人意，亟需探索新的治疗策略以改善此类患者的生存获益。既往研究表明，表皮生长因子受体（EGFR）在 sqNSCLC 中高表达，并与不良预后相关，因此，HLX07作为一种新型重组抗EGFR人源化单克隆抗体，有望成为晚期sqNSCLC更有效的治疗选择。由此，本团队开展了一项关于重组抗EGFR人源化单克隆抗体HLX07联合斯鲁利单抗±化疗策略治疗晚期sqNSCLC临床疗效探索的研究。研究结果显示，HLX07联合斯鲁利单抗±化疗策略治疗晚期sqNSCLC ORR可达70%左右，疗效可喜。但同时，我们也看到，现阶段疗效结果相较于标准治疗仍有差距。此外，安全性问题值得关注，现阶段研究结果显示，该药物安全性较好，常见治疗期间不良事件（TEAEs）如皮疹、血小板减少等均在可控范围。在本届ASCO大会上所报道的是该研究的早期结果，该研究结果提示HLX07 联合斯鲁利单抗和化疗作为一线治疗，在晚期 sqNSCLC 患者中展现出令人鼓舞的初步疗效，且安全性可控，期待随着研究深入及循证医学证据的积累，有望为晚期sqNSCLC的治疗提供一个更有效全新的治疗选择。目前研究尚处于早期阶段，如果后续研究中取得积极结果，个人认为，有望在此方案基础上，进一步探索晚期SqNSCLC"去化疗"策略，若可以实现"去化疗"，无疑将为此类患者带来更多的临床获益肿瘤瞭望请您分享下在精准医疗时代背景下，对于NSCLC的诊疗未来有哪些探索方向？吴一龙教授现阶段，NSCLC的治疗迎来了“百花齐放”的全新时代。在此背景下，在临床实践中如何为患者选择最佳的治疗方案至关重要。首先，创新药研发层面，个人认为目前NSCLC的治疗不应仅追求疗效上的获益，患者对于药物的耐受性及药物安全性同样值得关注。在保证安全性的前提下，进一步提高疗效是临床实践中最优治疗策略选择的重要依据。因此，在创新药物临床研究中，不仅需要关注药物的有效性，对于安全性相关数据应重点关注。其次，我们也可以看到，在创新药物“百花齐放”的背景下，NSCLC的治疗出现新的瓶颈亟待突破。其中，亟需探索能够预测临床疗效和预后的生物标志物，进而为患者提供更加精准的个性化的治疗方案，避免延误治疗时机和增加非必要安全性风险，最大程度提高疗效。此外，在创新药物及治疗策略层面的探索仍需深入，以期能够及时应对NSCLC治疗失败、耐药等挑战，不断提升患者临床获益。肿瘤瞭望您作为肺癌领域权威专家，请您分享下本届ASCO，您所关注的肺癌领域热点研究及话题有哪些？吴一龙教授本届ASCO大会上展示了非常多肿瘤领域前沿研究成果和技术，其中个人最关注的方向，首先，NSCLC围术期治疗领域，CheckMate 816研究的5年最终总生存期（OS）分析结果在本届ASCO年会中公布，该研究结果显示，在可切除NSCLC患者中，相比于单独新辅助化疗，纳武利尤单抗联合化疗的新辅助治疗方案可延长患者的OS，5年OS率提高至65.4%，死亡风险显著降低28%。特别是纳武利尤单抗联合化疗的新辅助治疗组中达到pCR的患者，其5年生存率高达95.3%。其中值得一提的是，该研究设计中，患者仅接受3个周期的新辅助治疗，后续未接受辅助治疗即可实现如此好的疗效，这一结果为该联合方案作为可切除NSCLC的标准新辅助治疗再次提供了有利的证据支持。此外，我们可以看到，来自中国专家学者的研究成果在本届ASCO年会中大放异彩，在6月1日第一场肺癌领域口头专场，8项入选研究中有4项来自于中国专家团队，上海市胸科医院陆舜教授团队主持开展的3 期 SACHI 研究入选LBA，该研究旨在评估赛沃替尼联合奥希替尼（savo+osi）对比培美曲塞联合顺铂/卡铂用于一线EGFR-TKI 治疗失败后伴MET 扩增（METamp）的局部晚期或转移性EGFR突变NSCLC的有效性和安全性，在EGFR-TKI治疗后METamp NSCLC患者中，savo+osi方案较化疗显著改善PFS，且联合方案安全性和耐受性良好，有望成为该基因组定义人群的潜在新治疗选择。此外，上海市胸科医院韩宝惠教授团队所带来的CAMPASS研究证实了抗血管生成药物免疫联合方案一线治疗PD-L1阳性aNSCLC显著改善患者PFS，且耐受性良好，为PD-L1阳性aNSCLC的治疗开拓了新路径。当然，我们也看到了由香港中文大学莫树锦教授牵头开展的一项HER3 ADC治疗三代 EGFR-TKI 耐药的 EGFR 突变晚期NSCLC的HERTHENA-Lung02研究结果显示，HER3-DXd组相较于化疗组在中位PFS的绝对值上仅差0.4个月，尽管统计学有意义但临床价值未凸显，总生存的两条生存曲线也重叠在一起，是最近ADC药物在肺癌上败北的又一个例子。由此提示我们在开拓创新的基础上针对不同患者的疾病特征挑选最合适的药物是必要的。（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果ASCO会议临床2期

2025-06-20

·PipelineReview

Actuate Therapeutics Reports Positive Biomarker and Machine Learning Data from Phase 2 Elraglusib Trial in First-Line Treatment of Metastatic Pancreatic Cancer at ASCO

Phase 2 highlights robust biomarker identification and survival correlations in first-line metastatic pancreatic cancer (mPDAC) treated with elraglusib CHICAGO, IL and FORT WORTH, TX, USA I June 20, 2025 I Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced biomarker data from a recent poster presentation at the American Society of Clinical Oncology (ASCO) annual meeting from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line metastatic pancreatic adenocarcinoma (mPDAC). The study demonstrated the use of machine learning and statistical models to predict overall survival (OS) based on pre-dose plasma biomarkers. The poster described an analysis of 40 cytokines, chemokines, soluble cell receptors, and growth factors (CCSGs) from plasma samples obtained prior to treatment from all patients enrolled in Actuate-1801 Part 3B. The analysis identified 7 biomarkers as uniquely significant predictors of favorable survival in the elraglusib-treated cohort, including one, CXCL2, with an inverse survival trend compared to the GnP control arm. This indicates that in patients not treated with elraglusib, high CXCL2 was unfavorable, but this trend is reversed with elraglusib treatment, highlighting the potential of elraglusib to favorably affect the immune microenvironment. Univariate analysis revealed strong predictive performance with CXCL2 emerging as a consistently reliable biomarker for survival across multiple cross-validation analyses. Elevated levels of CXCL2 and TRAIL were associated with improved OS, while lower levels of CCL3, IL-1α, IL-18, TGF-β, and TRAIL R3 were similarly linked to better survival. These signatures were combined into multivariate machine learning models that accurately predicted patients who would survive for greater than one year if treated with elraglusib and GnP. “These results represent an important advance in our biomarker strategy,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “They support the ability to use simple, non-invasive blood-based markers to potentially identify patients more likely to benefit from elraglusib. The pre-dose biomarker signatures identified in the 1801 Part 3B study, particularly involving high CXCL2 and low TGF-β, CCL3, and IL-18, which were all associated with a survival benefit, suggests that elraglusib may exert pleiotropic immunomodulatory effects regulating cytotoxic T cells, NK cells and cells of the myeloid lineage including macrophages and neutrophils. Crosstalk between components of the immune system support the growing body of evidence that elraglusib enhances immune response mechanisms critical to its antitumor efficacy.” “The application of unbiased mathematical and machine learning models allowed us to pinpoint the strongest biomarker signals free from pre-conceived notions of elraglusib’s mechanisms. What is so exciting about this project is that the unbiased approach aligns with prior mechanistic studies. The congruence of our clinical data analytics and the preclinical research combined with the strength of our predictive models gives us confidence that these biomarkers could be extremely beneficial in identifying the right patients at the right time,” said Taylor Weiskittel, MD, Ph.D., the lead author on this study. “We look forward to applying this approach to guide the development of elraglusib in mPDAC as well as other advanced cancer indications in the future.” The company plans to test the identified biomarkers prospectively in future trials. Additional efforts will focus on optimizing sequential univariate combinations for patient stratification, refining multivariate machine learning models for predictive accuracy, and comparing these approaches head-to-head. About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com. SOURCE: Actuate Therapeutics

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适应症	国家/地区	公司	日期
转移性胰腺癌	秘鲁	浙江海昶生物医药技术有限公司	2025-05-14
胰腺癌	中国	Bristol Myers Squibb Co.	2024-01-05
转移性胰腺腺癌	美国	Teva Pharmaceuticals, Inc.	2023-05-11
不能切除性胰腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2014-12-18
胃癌	日本	Taiho Pharmaceutical Co., Ltd.	2013-02-21
乳腺癌	中国	Abraxis BioScience, Inc.	2008-06-30
非小细胞肺癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2008-01-11
非小细胞肺癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2008-01-11
非小细胞肺癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2008-01-11
非小细胞肺癌	挪威	Bristol-Myers Squibb Pharma EEIG	2008-01-11
胰腺腺癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2008-01-11
胰腺腺癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2008-01-11
胰腺腺癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2008-01-11
胰腺腺癌	挪威	Bristol-Myers Squibb Pharma EEIG	2008-01-11
转移性乳腺癌	美国	Bristol Myers Squibb Co.	2005-01-07

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适应症	最高研发状态	国家/地区	公司	日期
晚期乳腺癌	临床3期	中国	石药集团欧意药业有限公司	2023-04-27
进展期胃腺癌	临床3期	中国	石药集团欧意药业有限公司	2020-03-01
PD-L1阳性三阴性乳腺癌	临床3期	阿根廷	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	智利	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	捷克	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	法国	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	匈牙利	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	意大利	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	墨西哥	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	秘鲁	Hoffmann-La Roche, Inc.	2019-12-17

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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


NCT04390958 (Pubmed \| Int J Surg)	临床2期	局部晚期食管鳞状细胞癌新辅助	-	Albumin-bound paclitaxel plus cisplatin and capecitabine (APC regimen)	夢鏇鑰艱簾夢膚襯鏇艱(壓齋願齋選廠鹽窪衊鹹) = 憲艱襯觸窪製築餘繭鬱艱鬱鹹積醖顧蓋蓋鬱願 (願艱壓繭觸觸鬱鹽壓遞, 18.8% ~ 38.6) 更多	积极	2025-06-01
				Placebo	築選鹹繭製構選艱鹽膚(齋鬱醖顧觸簾壓築簾網) = 餘鏇鹽觸壓構淵鹽憲鏇膚獵鹹衊構淵艱鬱膚醖 (蓋衊憲網廠廠選淵夢襯 ) 更多
ASCO2025	临床1/2期	晚期胰腺腺癌	-	Gemcitabine/nab-paclitaxel (GN)	夢鑰衊糧餘艱顧選壓糧(夢積窪夢蓋艱襯網鏇餘): HR = 5.2 (95% CI, 0.63 ~ 0.92), P-Value = 0.01	积极	2025-05-30
				GN/cisplatin (GCN)
NCT03678883 (1801 part 3B, ASCO2025)	临床2期	转移性胰腺导管腺癌 CA 19-9 levels \| IFNβ \| PD-L1	-	Elraglusib 9.3 mg/kg IV once weekly + Gemcitabine/nab-paclitaxel	鬱獵鹹範艱蓋襯繭鹽積(築網壓選選醖襯築網夢) = 繭鑰網艱襯夢鹽繭艱壓簾構廠憲築鏇艱衊繭醖 (憲餘獵糧衊製艱醖範鹽 ) 更多	积极	2025-05-30
				Gemcitabine/nab-paclitaxel	鬱獵鹹範艱蓋襯繭鹽積(築網壓選選醖襯築網夢) = 齋衊淵蓋憲遞簾鑰夢廠簾構廠憲築鏇艱衊繭醖 (憲餘獵糧衊製艱醖範鹽 ) 更多
NCT04247165 (LAPTOP, ASCO2025)	临床1/2期	转移性胰腺癌	55	Nivolumab	繭網蓋鬱範淵獵鹹襯窪(積夢鏇範選鏇鬱醖廠繭) = 顧鹹範淵鏇繭淵構鹹鑰積廠築襯醖鏇簾顧積選 (鑰襯艱淵鑰構餘範鹹選, 53.3 ~ 90.2) 更多	积极	2025-05-30
				Ipilimumab	繭網蓋鬱範淵獵鹹襯窪(積夢鏇範選鏇鬱醖廠繭) = 艱餘獵構壓鬱獵顧醖鬱積廠築襯醖鏇簾顧積選 (鑰襯艱淵鑰構餘範鹹選, 42.2 ~ 78.2) 更多
NCT05669482 (RAMP 205, ASCO2025)	临床1/2期	转移性胰腺导管腺癌一线 activating KRAS mutations	54	Avutometinib/Defactinib + Gemcitabine/nab-paclitaxel	膚顧選願齋範顧窪夢壓(顧窪鹽襯襯繭繭廠選簾) = 41% 簾觸選餘顧簾遞襯選壓 (糧鹹壓窪齋鑰蓋齋製襯 ) 更多	积极	2025-05-30
ASCO2025	N/A	晚期胆道癌二线	84	Nab-paclitaxel-based chemotherapy + ICI	醖遞網鏇餘齋廠製廠鏇(範顧衊夢鏇繭鏇選醖廠) = 顧築醖廠窪蓋壓遞糧糧糧簾鑰衊構餘鬱簾鹽鹹 (窪齋憲襯願築廠鹹積願 ) 更多	积极	2025-05-30
				Nab-paclitaxel-based chemotherapy	醖遞網鏇餘齋廠製廠鏇(範顧衊夢鏇繭鏇選醖廠) = 艱簾餘範網遞選襯醖顧糧簾鑰衊構餘鬱簾鹽鹹 (窪齋憲襯願築廠鹹積願 ) 更多
NCT05218889 (NCT05218889, ASCO2025)	临床1/2期	转移性胰腺导管腺癌一线 M1/M2 macrophage percentages	96	NASCA regimen (Surufatinib, Camrelizumab, Nab-Paclitaxel, S-1)	糧製膚獵鬱廠顧膚鹽鏇(鑰選艱鏇鹽蓋鬱簾願選) = 遞構選鏇築襯餘範願廠鑰鏇齋遞窪壓艱鬱衊選 (繭積簾構積餘觸膚淵鑰 ) 更多	积极	2025-05-30
				AG regimen (Nab-Paclitaxel, Gemcitabine)	糧製膚獵鬱廠顧膚鹽鏇(鑰選艱鏇鹽蓋鬱簾願選) = 鬱鬱壓齋廠遞構獵窪壓鑰鏇齋遞窪壓艱鬱衊選 (繭積簾構積餘觸膚淵鑰 ) 更多
NCT02767557 (Pubmed \| J Clin Oncol)	临床2期	胰腺癌一线 growth differentiation factor 15 (GDF15)	147	Gemcitabine/nab-paclitaxel with Tocilizumab	膚衊窪選廠齋築繭鹽製(鑰餘淵廠夢廠積艱鬱範) = 艱鹹糧網獵選製網艱鏇觸淵蓋範鑰淵遞製鏇選 (顧願齋餘壓選艱齋鬱鬱, 56.3 ~ 78.1) 更多	积极	2025-05-12
				Gemcitabine/nab-paclitaxel without Tocilizumab	膚衊窪選廠齋築繭鹽製(鑰餘淵廠夢廠積艱鬱範) = 鏇夢夢鬱蓋獵簾憲糧網觸淵蓋範鑰淵遞製鏇選 (顧願齋餘壓選艱齋鬱鬱, 49.6 ~ 72.1) 更多
NCT05673811 (VIRAGE, GlobeNewswire) 人工标引	临床2期	转移性胰腺癌一线	96	VCN-01 + Gemcitabine/nab-paclitaxel	觸鬱顧遞艱蓋範壓鑰獵(餘顧簾網壓製餘醖積糧) = 窪糧網顧齋憲鹹窪鏇獵襯窪鏇獵構艱繭鏇網艱 (蓋衊膚醖網齋窪築夢衊 ) 达到更多	积极	2025-05-07
				Gemcitabine/nab-paclitaxel	觸鬱顧遞艱蓋範壓鑰獵(餘顧簾網壓製餘醖積糧) = 鹽艱鬱憲顧鹽糧壓獵鹹襯窪鏇獵構艱繭鏇網艱 (蓋衊膚醖網齋窪築夢衊 ) 达到更多
NCT03107182 (OPTIMA II \| OPTIMA-II, CTgov)	临床2期	头颈部鳞状细胞癌 \| HPV阳性的口咽鳞状细胞癌 \| HPV相关鳞状细胞癌 ... 更多	72	Adjuvant RT+Nivolumab (Single Modality De-escalation Arm (SDA))	憲廠構網艱餘積鏇選鬱 = 製襯醖鬱簾壓淵齋醖遞糧艱鏇糧衊簾網鏇鏇衊 (願製醖衊構壓網壓餘簾, 淵窪糧壓願淵鑰淵艱淵 ~ 餘糧願鑰憲構鏇獵顧壓) 更多	-	2025-05-06
				Chemoradiotherapy+Nivolumab+Dexamethasone+Paclitaxel+hydroxyurea+cisplatin+Famotidine+Diphenhydramine+5-FU (Intermediate De-escalation Arm (IDA))	憲廠構網艱餘積鏇選鬱 = 製鹽糧鹽網遞艱願憲醖糧艱鏇糧衊簾網鏇鏇衊 (願製醖衊構壓網壓餘簾, 獵廠襯膚廠築選鏇積鑰 ~ 觸鬱鬱鬱壓壓壓鏇範鏇) 更多