白蛋白结合型紫杉醇(Albumin-Bound Paclitaxel) - 药物靶点：Tubulin_在研适应症：转移性胰腺癌，胰腺癌，转移性胰腺腺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Nab-Paclitaxel、Nab-PTX、paclitaxel protein-bound

+ [14]

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+ [32]

非在研适应症

大肠腺癌小肠腺癌腺鳞癌+ [114]

原研机构

Abraxis BioScience, Inc.

在研机构

WhiteOak Pharmaceutical BVHoffmann-La Roche, Inc.

Bristol Myers Squibb Co.

+ [11]

非在研机构

Novartis Pharmaceuticals Corp.

Novartis AG

Genentech, Inc.

+ [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

1,992

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]

NCT07033689

/ Not yet recruiting早期临床1期

Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.

开始日期2025-12-01

申办/合作机构

Sonire Therapeutics Inc

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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35,048

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·Journal of Gastrointestinal Cancer

FOLFIRINOX vs. Gemcitabine Nab-Paclitaxel in Pancreatic Cancer: A Real-World Single-Center Analysis of Efficacy and Safety

Article

作者: Noor, Sobia ; Shahnoor, Syeda Sana ; Khan, Arif Mohammed ; Rao, G V ; Bonda, Naga Avinash ; Ahmed, Rimsha ; Reddy, D Nageshwar ; Takreem, Safa ; Muddu, Vamshi Krishna ; Krishnaiah, Sannapaneni ; Siripurapu, Indraja

BACKGROUND:

Pancreatic cancer is among the most lethal malignancies, with limited real-world data comparing frontline chemotherapy regimens across disease stages. FOLFIRINOX and gemcitabine plus nab-paclitaxel (G + P) are standard treatments with differing toxicity profiles and outcomes. This study evaluated the comparative efficacy and safety of these regimens in metastatic, locally advanced (LAPC), and borderline resectable pancreatic cancer (BRPC).

METHODS:

We conducted a retrospective study of 150 patients treated between October 2019 and November 2023 at a tertiary center in India. Patients received FOLFIRINOX (n = 64) or G + P (n = 86) as first-line therapy. Subgroup sizes included metastatic (n = 89), LAPC (n = 34), and BRPC (n = 27). Outcomes assessed included progression-free survival (PFS), overall survival (OS), event-free survival (EFS), response rates, resectability, and toxicities. Kaplan-Meier analysis and Cox regression were used. Subgroup analyses were stratified by stage and CA 19-9 levels.

RESULTS:

In metastatic disease, median OS was 11 months (FOLFIRINOX) vs. 10 months (G + P; HR = 1.26, p = 0.38); PFS was 6 months in both groups. In LAPC, OS was 15.5 vs. 17 months (p = 0.84). In BRPC, FOLFIRINOX showed superior OS (37 vs. 16 months; p = 0.02) and higher surgical conversion (66% vs. 39%). Grade ≥ 3 toxicities occurred in 45% (FOLFIRINOX) vs. 21% (G + P). Elevated CA 19-9 (> 37 U/mL) independently predicted worse OS (HR = 1.72; p = 0.029).

CONCLUSION:

FOLFIRINOX and G + P have comparable efficacy in metastatic and locally advanced pancreatic cancer. FOLFIRINOX offers a survival benefit in BRPC but with higher toxicity.

1,519

项与白蛋白结合型紫杉醇相关的新闻（医药）

2025-09-11

·EndPoints

Revolution’s lead RAS blocker heads into Phase 3 in frontline pancreatic cancer after early data

Revolution Medicines said it will begin a late-stage test of its lead asset as a first-line treatment for a form of pancreatic cancer, after a Phase 1 study in this setting yielded promising data. The early-stage trial studied daraxonrasib in patients with treatment-naïve RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC). The drug works by inhibiting a protein called RAS that causes unchecked cell growth. The trial investigated the candidate as both monotherapy and in combination with chemotherapy. In the monotherapy cohort of 38 evaluable patients given a 300 mg daily oral dose of daraxonrasib, the objective response rate (ORR) was 47% , and the disease control rate (DCR) was 89%, Revolution said on Wednesday. As of the cutoff date of July 28, most patients remained on treatment, with a median follow-up of 9.3 months. Meanwhile, in the chemo combo arm, daraxonrasib was dosed at 200 mg per day with gemcitabine nab-paclitaxel (GnP) given every two weeks. In 31 patients with sufficient follow-up, the ORR was 55% and the DCR was 90%, with a median follow-up of 6.9 months. Revolution’s stock $RVMD ticked up by as much as 9% before market open on Thursday. Based on these data, the drugmaker is planning to start a global Phase 3 trial in first-line metastatic PDAC towards the end of this year. Dubbed RASolute 303, the trial will have monotherapy and GnP combo arms, which will be compared with a GnP control arm. In the combo arm, the Phase 3 trial will dose daraxonrasib at 200 mg per day, plus GnP, for six months, followed by 300 mg per day as monotherapy, according to a company presentation . Revolution also shared an update from a trial of daraxonrasib in the second-line RAS-mutant PDAC setting. As of June 30, a 300 mg daily pill resulted in ORRs of 35% and 29% in patients with a RAS G12X mutation or any RAS mutation, respectively. DCRs were 92% and 95%, in those respective groups. The median OS was 13.1 months in the RAS G12X mutant patients and 15.6 months in participants with any RAS mutation. Progression-free survival was 8.5 and 8.1 months, respectively. Median follow-up was 16.7 months. OS “compares very favorably” to the six to seven months seen in historic chemo trials, analysts from Jefferies wrote in a Wednesday note. The analysts said that the first-line PDAC opportunity is bigger and underappreciated compared with the second-line setting, where daraxonrasib is already in a pivotal trial and could yield data next year. Another pivotal trial, called RASolute 304, is planned for the fourth quarter of this year and will test daraxonrasib in the adjuvant setting. And the drug is also being tested in non-small cell lung cancer. Revolution recently formed a funding pact with Royalty Pharma for up to $2 billion, which should allow it to fund this suite of late-stage studies.

临床结果临床3期临床1期临床2期临床终止

2025-09-10

·科兴制药

强强联合拓新局！科兴制药引进人福普克乙磺酸尼达尼布共启呼吸领域全球征程

近日，公司与行业知名制药企业人福医药集团股份公司（以下简称“人福医药”，600079.SH）全资子公司人福普克药业（武汉）有限公司（以下简称“人福普克”）达成乙磺酸尼达尼布软胶囊的海外商业化合作。呼吸领域重磅药物全球商业价值持续攀升乙磺酸尼达尼布软胶囊全球唯二已获批且受指南推荐的特发性肺纤维化（IPF）治疗药物（另一款为吡非尼酮）。主要适应症为特发性肺纤维化（IPF）、具有进行性表型的慢性纤维化间质性肺疾病（ILDs）以及减缓系统性硬化症相关间质性肺疾病（SSc-ILD）患者的肺功能下降速度。作为多靶点酪氨酸激酶抑制剂，尼达尼布通过阻断血管内皮生长因子受体（VEGFR）、血小板衍生生长因子受体（PDGFR）和成纤维细胞生长因子受体（FGFR）的活性，抑制成纤维细胞增殖和炎症反应，从而减缓肺纤维化进程。凭借明确的临床疗效与安全性，该药物的原研药已在中国、美国、欧盟等全球数十个国家和地区成为呼吸领域临床治疗的核心选择。人福普克的乙磺酸尼达尼布软胶囊为中美双报项目，于2023年在国内获批，美国预计2026年可获批。商业价值方面，乙磺酸尼达尼布展现出强劲增长动力。原研药2023年销售额为35.1亿欧元，2024年销售额37.66亿欧元，同比增长7.3%。同时，数据显示，2015～2022年，全球IPF患病人数由140万人增长至170万人，复合年增长率为3.0%，预计2025年患病人数将达到180万人,尼达尼布作为呼吸领域抗纤维化重磅级产品，将持续发力保持有力增长。锚定跨国发展目标欧盟市场潜力巨大本次乙磺酸尼达尼布的海外商业化合作区域，包括除中国大陆（包括港澳台）、美国、沙特阿拉伯、厄瓜多尔、玻利维亚、巴拉圭、乌拉圭以外的全球其他国家和地区。凭借在生物药领域三十多年的深厚积累，科兴制药早已形成涵盖海外市场洞察、高效注册申报、精准营销推广的全链条国际化综合能力，也让“快速注册”逐步成为公司国际化竞争的核心优势。公司合作引进的核心产品白蛋白紫杉醇（下称 “白紫”）自2024年欧盟获批以来，已成功登陆全球30余个国家和地区，是公司海外商业化的拳头品种之一。白紫在欧盟的顺利推进同时也让科兴制药海外商业化迈进2.0时代，实现从新兴市场向欧盟市场的拓展，海外营销渠道进一步覆盖至70个国家和地区，以“全球选品，全球覆盖”的平台型出海模式，在海外重点市场建立子公司或办事处，强化本土化营销，深耕欧盟、拉美、东南亚、中东北非等医药市场。此次承接乙磺酸尼达尼布海外商业化亦包含了欧盟市场权益，将进一步扩充科兴制药在欧盟市场的产品布局。人福医药成立于1993年，1997年在上海证券交易所上市，是湖北省医药工业龙头企业、中国医药工业20强、国家企业技术中心、国家技术创新示范企业、中国医药企业制剂国际化先导企业，已在国内的神经系统用药、甾体激素类药物、维吾尔药等多个细分领域建立了领先地位。作为人福医药的全资子公司，人福普克的研发、生产实力强劲，与科兴制药的海外商业化能力将形成协同效应，叠加乙磺酸尼达尼布的全球临床认可度与“中美双报”优势，双方的合作值得期待！关于科兴制药科兴制药（股票代码：688136）是一家专注于重组蛋白、多功能抗体、细胞基因治疗等药物的研发、生产、销售一体化的创新型跨国生物制药企业。聚焦抗肿瘤、自身免疫、抗病毒等治疗领域，围绕未被满足的临床需求，打造新型蛋白、新型抗体、核酸药物等前沿生物技术平台，开发精准治疗及新型靶向递送药物，坚持“创新+国际化”双轮驱动的平台型发展模式，致力于成为高品质生物药领导者，服务全球患者。公司核心产品稳居国内同类品种前列，覆盖全国各省市地区约20000家终端，其中等级医院约8000家，已通过欧盟、巴西、菲律宾、印度尼西亚等全球70多个国家的市场准入并实现销售。推荐阅读 *药出海热点丨一文掌握2025年8月医药出海资讯 *CPHI（深圳）——中国医药产业出海新兴市场发展论坛顺利召开科兴制药携手合作伙伴共拓蓝海 *特应性皮炎药物，新兴市场的强烈需求

申请上市临床申请上市批准

2025-09-09

·Biotech前瞻

胰腺癌CLDN18.2阳性率高，齐鲁押注CLDN18.2/CD3双抗、信达梭哈CLDN18.2 ADC

点击蓝字关注我们本期看点针对于CLDN18.2靶点的创新药物形式包括单抗、双抗及ADC，除了胃癌布局三期以外，“癌王”胰腺癌领域迎来了齐鲁制药的CLDN18.2/CD3双抗(QLS31905)及信达生物的CLDN18.2 ADC(IBI343)的巅峰对决。有意思的是，信达生物本身也有一款CLDN18.2/CD3双抗(IBI389)，且在胰腺癌领域也有初步数据展示。本文聚焦CLDN18.2靶点相关药物形式的最新研究进展，密切关注“癌王”胰腺癌领域动向。本期内容 01 齐鲁制药丨CLDN18.2/CD3双抗 02 信达生物丨CLDN18.2 ADC 03 信达生物丨CLDN18.2/CD3双抗 04 总结与展望【01 齐鲁制药丨CLDN18.2/CD3双抗】 2025年9月8日，齐鲁制药QLS31905用于一线治疗晚期胰腺癌的注册III期临床试验已完成首例受试者入组，这是公司自主研发的Claudin18.2/CD3双抗创新药QLS31905 。早在2025年7月22日，齐鲁制药启动QLS31905 的Ⅲ期临床，计划入组602例CLDN18.2阳性晚期胰腺癌患者，评估其与白蛋白紫杉醇+吉西他滨联用的一线疗效，主要终点为48个月PFS。 QLS31905在2025 ASCO大会上公布了I期试验结果，共入组79例晚期实体瘤患者。剂量0.5–1200 μg/kg qw/q2w，未出现DLT，MTD未达；≥3级TRAE主要为淋巴细胞减少（21.5%）、CRS（3.8%），无死亡。在350–1200 μg/kg q2w的33例Claudin18.2阳性患者中，ORR 18.2%，DCR 87.9%；其中12例胰腺癌ORR 25%。药物安全可耐受，疗效积极，拟开展Ⅱ期联合研究。此次III期胰腺癌研究的开展，QLS31905由此成为同类进展最快品种，与信达IBI343共同把CLDN18.2赛道推向“癌王”攻坚战最前线。 02 信达生物丨CLDN18.2 ADC 2025年6月27日，药物临床试验登记与信息公示平台显示，信达生物在研的CLDN18.2 ADC IBI343 启动一项多中心、随机、双盲、对照 III 期研究（CTR20252528），旨在评估IBI343 单药联合最佳支持治疗 vs 安慰剂联合最佳支持治疗，用于既往接受过至少两线系统性治疗的 CLDN18.2 阳性、局部晚期不可切除或转移性胰腺癌的效果和安全性。来源：药物临床试验登记与信息公示平台这是既2025ASCO幻灯丨沈琳牵头，信达CLDN18.2 ADC胃癌大三期开展胃癌III期研究开展后又一大利好消息。针对于有着“癌王”之称的胰腺癌，创新产品的进展为行业所瞩目。突破性疗法认定 2025年6月19日，CDE 官网显示，IBI343拟纳入突破性治疗品种，适应症为：至少接受过两种系统性治疗的Claudin（CLDN）18.2表达阳性的局部晚期或转移性胰腺癌。截图来演：CDE官网 2025ASCO大会上，IBI343治疗胰腺癌的I期研究结果公布。标题： Claudin18.2 (CLDN18.2) 表达与胰腺导管腺癌 (PDAC) 疗效：一项 I 期剂量扩展队列研究 IBI343 的结果第一作者：虞先濬复旦大学附属肿瘤医院研究背景：在近 60% 的胰腺导管腺癌（PDAC）病例中，CLDN18.2 表达水平较高。 IBI343由针对CLDN18.2的单克隆抗体和拓扑异构酶I抑制剂exatecan组成，是首个在 PDAC 中显示出令人鼓舞疗效的 CLDN18.2 ADC。在此，我们报告了一项 I 期研究的结果，该研究评估了根据CLDN18.2 表达状态（≥60% vs <60%）进行分层的 PDAC 患者接受 IBI343 治疗的效果。编号为NCT05458219。研究方法：纳入标准为晚期 PDAC 且 CLDN18.2 中等到高表达（定义为通过免疫组化 [IHC] VENTANA CLDN18 [43-14A] 检测，在 ≥40% 的肿瘤细胞中膜染色强度 ≥2）的患者，这些患者对标准治疗无效或无法耐受。研究设计终点包括安全性、客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）、根据 RECIST v1.1 的无进展生存期（PFS）和总生存期（OS）。研究结果：截至 2024 年 12 月 27 日，共纳入来自中国和澳大利亚的 83 名患者。在剂量扩展阶段，分别有 44 名和 12 名肿瘤细胞中 CLDN18.2 表达在 ≥60%（+）和 <60%（-）的患者接受了 6mg/kg 的 IBI343 治疗（中位年龄分别为 60 岁和 64 岁；男性比例分别为 54.5% 和 66.7%；既往接受≥2L 治疗的比例分别为 61.4% 和 83.3%）。在接受治疗的所有患者（n = 83）中，82 名（98.8%）患者出现了治疗相关不良事件（TEAEs），42 名（50.6%）患者出现了≥3 级（G3）TEAEs。TEAEs 导致 6 名（7.2%）患者停止治疗。没有 TEAE 导致死亡。最常见的 TEAEs 是贫血（66.3%，15.7%≥3 级）、中性粒细胞计数减少（48.2%，9.6%≥3 级）和白细胞计数减少（47.0%，9.6%≥3 级）。IBI343 在 PDAC 中的安全性与之前的报道相当。在 CLDN18.2+ 患者（n = 44）中，确认的 ORR 为 22.7%（95% CI，11.5–37.8）；DCR 为 81.8%（95% CI：67.3–91.8），mPFS 为 5.4m（95% CI，4.1–7.4），mOS 为 8.5m（95% CI，6.6–12.1），而在 10 名确认部分缓解的患者中，中位 DoR 为 6.7m（95% CI，3.2–7.7）。在 CLDN18.2- 患者（n = 12）中，无患者出现客观缓解，DCR 为 41.7%（95% CI：15.2–72.3），中位 PFS 为 1.4m（1.3–3.2），mOS 为 6.2m（95% CI，1.4–9.0）。研究结论： IBI343 耐受性良好，继续在 PDAC 患者中显示出令人鼓舞的疗效。在 CLDN18.2 表达≥60% 的患者中，疗效最为显著，表明 CLDN18.2 可作为 PDAC 对 IBI343 疗效的预测生物标志物。【03 信达生物丨CLDN18.2/CD3双抗】信达生物也布局了CLDN18.2/CD3双特异性抗体IBI389，2024ASCO大会上公布了IBI389在晚期胰腺导管腺癌患者中的安全性和有效性的I期研究的初步结果（Abstract：4011，Clinical Science Symposium）第一作者: 郝继辉，天津医科大学癌症研究所暨医院肝胆肿瘤科方法纳入了符合条件的CLDN18.2阳性的局部晚期、难治性或转移性PDAC患者，这些患者对标准治疗失败或不能耐受。IBI389单药治疗在剂量递增和扩展的两阶段研究中，按6个剂量水平（5-600 mg/kg，每三周一次或每两周一次）静脉注射。在剂量≥30 mg/kg时，采用了先导剂量3至10 mg/kg的逐步剂量递增策略。主要目标是评估安全性，次要目标是根据RECIST v1.1标准由研究者评估的有效性，包括客观缓解率（ORR）和疾病控制率（DCR）。结果截至2024年1月9日，共有64名CLDN18.2阳性的PDAC患者被纳入（男性：64.1%，女性：35.9%，中位年龄：60.0岁，IV期：84.4%）。所有患者均接受过先前治疗，中位治疗线数为2（范围：1至5）。 62名（96.9%）患者出现了治疗相关不良事件（TRAEs），其中35名（54.7%）患者出现了3级或以上的TRAEs。最常见的3级或以上TRAEs（≥5%）包括γ-谷氨酰转移酶升高（20.3%）、淋巴细胞计数减少（9.4%）和恶心（7.8%）。33名（51.6%）患者出现了细胞因子释放综合征（CRS）相关不良事件，未见3级或以上的CRS。24名（37.5%）患者出现了导致剂量中断的TEAEs，3名（4.7%）患者出现了导致治疗中止的TEAEs。在CLDN18.2表达≥10%（免疫组化2+/3+）的患者中观察到了IBI389的初步疗效（600 mg/kg）。截至2024年1月31日，共有23名患者可评估疗效，其中7名患者部分缓解（PR），9名患者疾病稳定（SD）。ORR为30.4%（95%CI：13.2-52.9），DCR为69.6%（95%CI：47.1-86.8）。反应持续时间（DoR）和无进展生存期（PFS）的中位数尚未达到。将在会议上呈现更多关于安全性和有效性的更新数据。结论 IBI389在晚期PDAC患者中表现出可控的安全性。在CLDN18.2表达较低的患者中也观察到了初步疗效。【临床试验信息：NCT05164458；研究资助者：信达生物制药（苏州）有限公司。】 04 总结与展望肿瘤创新药的竞争残酷且无情，以胃癌为例，Claudin 18.2特异地表达在分化的胃黏膜上皮细胞，但在胃干细胞区不表达。虽然基于HER2的胃癌靶向药物已获批多款，但胃癌患者的HER2阳性突变率很低，大约只有10%~20%。而Claudin 18.2在所有胃癌患者中的阳性率可以达到近60%，具有更广泛的患者获益可能。而胰腺癌中Claudin 18.2 表达率也接近60%，所以，Claudin 18.2靶点竞争激烈，是有原因的。衷心期待在众多研究产品中能够为更广泛的肿瘤患者带来治疗新选择。 ★

ASCO会议临床3期临床结果抗体药物偶联物临床2期

100 项与白蛋白结合型紫杉醇相关的药物交易

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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

未上市

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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


NCT04862585 (CTgov)	临床2/3期	转移性乳腺癌	130	Quality-of-Life Assessment+Paclitaxel+Dexamethasone+Cimetidine+Famotidine+Ranitidine+Diphenhydramine (Arm I (Paclitaxel, Pre-medications))	鑰願觸醖網觸範鹹鬱鹽 = 獵鹽艱範遞衊鑰構簾積選艱糧壓蓋鏇襯憲築願 (艱蓋襯鹹糧膚顧製願醖, 選鬱顧齋獵簾窪鬱憲襯 ~ 繭膚夢鑰繭糧糧選淵顧) 更多	-	2025-08-20
				Quality-of-Life Assessment+Paclitaxel (Arm II (Paclitaxel))	鑰願觸醖網觸範鹹鬱鹽 = 簾簾願餘願鹹積範鏇襯選艱糧壓蓋鏇襯憲築願 (艱蓋襯鹹糧膚顧製願醖, 鹽壓齋艱膚獵鑰鬱顧構 ~ 淵艱築衊膚製餘獵網選) 更多
NCT04692051 (ChiCTR380004040, Pubmed \| BMC Cancer)	临床2期	晚期胆道癌一线	75	Nab-paclitaxel plus cisplatin	構齋餘觸夢蓋網廠觸膚(簾艱憲鹹鏇膚鬱鬱蓋壓) = 襯網積壓鑰鏇鹽製齋蓋蓋齋選膚簾選構憲艱廠 (醖鹽選繭獵鏇廠築襯觸, 5.4 ~ 14.0) 更多	非劣	2025-08-16
				gemcitabine plus cisplatin	構齋餘觸夢蓋網廠觸膚(簾艱憲鹹鏇膚鬱鬱蓋壓) = 壓網鹹廠鬱願廠獵蓋艱蓋齋選膚簾選構憲艱廠 (醖鹽選繭獵鏇廠築襯觸, 3.9 ~ 10.1) 更多
NCT03579771 (NEO-GAP, CTgov)	临床2期	肝内胆管癌	30	Nab-paclitaxel+Gemcitabine+cisplatin	淵艱窪簾鏇願衊餘憲鏇 = 願構築觸艱積獵齋夢窪餘衊鏇襯簾網顧壓醖構 (鏇築積觸襯膚構廠窪廠, 醖製壓廠鏇鬱醖築壓積 ~ 顧壓選膚艱壓鑰齋醖範) 更多	-	2025-08-15
NCT04294784 (Pubmed \| Oncologist)	临床2期	晚期胃癌二线	58	nab-paclitaxel+camrelizumab	壓窪夢觸選觸簾襯築蓋(顧餘顧夢鏇繭廠夢醖鹽) = 衊廠衊鬱窪簾鏇廠獵製膚獵鹹齋艱簾餘願鑰簾 (餘範醖醖選齋願壓窪夢 ) 更多	积极	2025-07-04
				nab-paclitaxel	壓窪夢觸選觸簾襯築蓋(顧餘顧夢鏇繭廠夢醖鹽) = 醖糧廠築遞繭顧鹹糧壓膚獵鹹齋艱簾餘願鑰簾 (餘範醖醖選齋願壓窪夢 ) 更多
NCT05497778 (COMBAT-PC, ESMO_GI2025) 人工标引	临床1期	胰腺癌	17	Lixumistat 400 malbumin-bound paclitaxelIV gemcitabine (Gem) (1000 mg/m²) + Lixumistatticle albumin-bound paclitaxel (NP) (125 mg/m²) and IV gemcitabine (Gem) (1000 mg/m²)	夢鏇鹽淵窪顧遞選憲積(醖觸窪蓋廠鏇鬱壓範壓) = 憲積鹽觸窪遞顧憲範襯蓋鏇範構顧鏇網遞衊壓 (夢憲觸製衊獵醖齋憲簾 ) 更多	积极	2025-07-03
				LixumistatLixumistat 800 mg QDalbumin-bound paclitaxelIV gemcitabine (Gem) (1000 mg/m²) + LixumistatLixumistat 800 mg QDalbumin-bound paclitaxel (NP) (125 mg/m²) and IV gemcitabine (Gem) (1000 mg/m²)	製鏇衊鹽選獵製鑰願築(築積衊積顧蓋膚構鹽範) = 鑰選築餘觸鹽觸齋壓淵鑰範願艱遞願餘積製鹹 (淵憲構鬱襯顧艱壓網獵 )
iLSTA (ESMO_GI2025 \| Company_Website) 人工标引	临床1/2期	晚期胰腺导管腺癌一线	30	GemcitabineGemcitabine + nab-paclitaxel + LSTA-1 + Durvalumab OR gemcitabine + nab-paclitaxel+placebo LSTA-1+ placebo durvalumab OR gemcitabinedurvalumab OR gemcitabine+ nab-paclitaxel+ activeo LSTA-1+placebo LSTA-1LSTA-1+ placebo durvalumab	鹽獵淵簾夢廠遞窪衊繭(顧夢顧觸壓糧築齋選襯) = 醖膚獵醖鬱鏇簾築製簾繭願觸淵壓窪齋觸糧餘 (簾願窪製衊憲願選繭醖 ) 更多	积极	2025-07-03
				gemcitabine+ nab-paclitaxel+ activeo LSTA-1+placebo LSTA-1+ placebo durvalumab (Cohort 2)	醖鹹遞襯夢膚餘衊鑰壓(鹹夢願鹹窪選鏇齋艱獵) = 餘築範製壓憲構遞淵觸遞簾襯艱壓餘窪餘糧糧 (鹹廠鏇鏇衊衊遞築壓鏇 )
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	選構繭鏇觸鬱膚範網鏇(醖選艱獵壓夢憲遞鹹餘) = 觸範壓淵齋襯憲繭範鬱願膚膚鹹構遞鬱鏇齋選 (齋醖襯遞襯淵鬱範簾糧, 56.3 ~ 78.1) 更多	积极	2025-06-20
				Gemcitabine/nab-paclitaxel without Tocilizumab	選構繭鏇觸鬱膚範網鏇(醖選艱獵壓夢憲遞鹹餘) = 鬱製鏇窪鑰網膚廠齋築願膚膚鹹構遞鬱鏇齋選 (齋醖襯遞襯淵鬱範簾糧, 49.6 ~ 72.1) 更多
ESMO_GCC2025	N/A	卵巢癌	214	Paclitaxel and Carboplatin chemotherapy	憲鏇鹽淵憲積襯築餘蓋(願鏇網衊襯糧鬱遞餘鬱) = 餘獵齋壓衊餘鬱餘窪鹽鏇遞夢積鏇簾餘鬱齋遞 (選顧築獵繭築鏇鑰窪餘 ) 更多	积极	2025-06-19
NCT03377491 (PANOVA-3, ASCO2025) 人工标引	临床3期	晚期胰腺导管腺癌	571	TTFields + gemcitabine/nab-paclitaxel (GnP)	顧夢蓋窪觸選夢憲積淵(夢齋夢網構願淵淵鹽艱) = 遞鬱顧構繭夢築膚壓淵鬱網網願壓遞艱窪憲鬱 (膚築齋構鏇蓋蓋鏇鹽鹹, 15.0 ~ 18.0) 更多	积极	2025-06-04
				Gemcitabine/nab-paclitaxel (GnP)	顧夢蓋窪觸選夢憲積淵(夢齋夢網構願淵淵鹽艱) = 糧夢鹹選積鹽壓鏇夢選鬱網網願壓遞艱窪憲鬱 (膚築齋構鏇蓋蓋鏇鹽鹹, 12.8 ~ 15.4) 更多
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)	夢製構選艱醖願鑰鹽網(製壓襯觸構鏇簾繭齋糧) = 壓餘觸夢窪積艱鏇簾築網壓鏇糧衊顧糧遞鑰願 (夢醖顧築網夢齋衊簾鏇, 18.8% ~ 38.6) 更多	积极	2025-06-01
				Placebo	夢憲艱鏇衊鬱範鏇艱選(糧艱淵淵糧醖襯淵淵衊) = 製廠顧衊鏇獵網網觸蓋鑰簾衊膚觸鬱獵窪構憲 (醖蓋衊鹽衊築餘艱構製 ) 更多