ITCC-104: HEM-iSMART International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Sub-Protocol E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol E is a phase I/II trial evaluating the safety and efficacy of capivasertib + venetocolax in combination with dexamethasone in children and AYA with R/R ped ALL/LBL whose tumor present with alterations of the PAM pathway, or lacking any mutations.

开始日期2026-10-01

申办/合作机构

Princess Maxima Centre For Pediatric Oncology

[+2]

CTIS2025-523460-21-00

/ Not yet recruiting临床2期IIT

A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.

开始日期2026-06-01

申办/合作机构-

NCT07486648

/ Not yet recruiting临床1/2期IIT

The Safety and Efficacy of Osimertinib Plus Capivasertib in EGFRm Advanced Non-small Cell Lung Cancer (NSCLC) Participants With PIK3CA/AKT1/PTEN Alterations Who Had Progressed on First-line Osimertinib Monotherapy or Plus Chemotherapy: a First-in-human, Phase Ib/Ⅱa Study (PRECISION)

The goal of this clinical trial is to learn if Osimertinib plus Capivasertib works to treat EGFRm advanced non-small cell lung cancer (NSCLC) in participants with PIK3CA/AKT1/PTEN alterations after progression on first-line Osimertinib (monotherapy or plus chemotherapy).
The main questions it aims to answer are:
Part A:
* Number of Dose-limiting toxicities (DLTs)
* Adverse events (AEs)/serious adverse events (SAEs) (graded by CTCAE Version 5.0)
* Recommended combined dose (RCD)
Part B:Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria.
Participants will:
Part A:Take Capivasertib twice daily from day 1 to 4 of a 7-day cycle, Osimertinib will be given orally QD(once daily) at 80 mg throughout the study treatment period.
Part B: Take Osimertinib (80mg QD, continuously) and Capivasertib(RCD,orally BID from day1-day 4 in 7-day cycle , 4 days on /3 days off) till disease progression (PD) or unacceptable toxicity.

开始日期2026-05-15

申办/合作机构

山西省肿瘤医院（山西省癌症中心）（山西医科大学附属肿瘤医院（山西医科大学肿瘤医学院）、山西省第三人民医院、山西省肿瘤研究所）

[+1]

100 项与卡匹色替相关的临床结果

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100 项与卡匹色替相关的转化医学

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100 项与卡匹色替相关的专利（医药）

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373

项与卡匹色替相关的文献（医药）

2026-12-31·Hematology

Neutrophil extracellular trap-related genes in PTCL: identification, prognosis and drug interaction prediction via bioinformatics-machine learning

Article

作者: Chen, Jing ; Cheng, Fanjun ; Fang, Jun

OBJECTIVE:

This study aimed to identify neutrophil extracellular trap-related genes (NET-RGs), explore their prognostic significance, and predict drug interactions in peripheral T-cell lymphoma (PTCL).

METHODS:

Differentially expressed NET-RGs (DE-NRGs) between PTCL and normal tissues were screened. Functional enrichment analysis was conducted. Bioinformatics and machine learning were used to identify hub genes and assess their diagnostic value. Univariate and multivariate analyses were used to evaluate prognostic roles. Correlation and immune infiltration analyses were performed to explore relationships with the tumor microenvironment (TME). Clinical data were collected from PTCL patients who received potential agents (lenalidomide) as first-line treatment.

RESULTS:

A total of 31 DE-NRGs were identified (18 upregulated and 13 downregulated), enriched in inflammatory response, extracellular matrix organization, and infection involvement. Four hub genes (AKT2, MAPK14, IRF1, and TNF) were identified as effective PTCL diagnostic markers. Higher AKT2/MAPK14 expression correlated with poorer overall survival (OS), while elevated TNF expression associated with better OS; AKT2 and TNF independently predicted OS. These genes were implicated in modulating TME remodeling. Potential therapeutic agents (e.g. capivasertib, lenalidomide) were predicted, and lenalidomide may represent a feasible initial treatment option for PTCL, with an objective response rate (ORR) of 40.0% and a maximum survival duration exceeding 50 months.

CONCLUSION:

NET-RGs play crucial roles in diagnosis, prognosis, and TME regulation, and lenalidomide, a putative TNF-targeting agent, may represent a feasible initial treatment option in PTCL.

2026-12-01·JOURNAL OF COMPUTER-AIDED MOLECULAR DESIGN

AI-driven peptide discovery for endometrial cancer: deep generative modeling and molecular simulation in the big data era

Article

作者: Fatima, Israr ; Meng, Yuxuan ; Ur Rehman, Hafeez ; Aldaw, Mohamed ; Rehman, Abdur ; Li, Yan ; Wang, Zhibo ; Liao, Mingzhi ; Warraich, Dawood Ahmed

The integration of artificial intelligence (AI) with molecular modeling offers new opportunities to accelerate therapeutic discovery. In this study, we developed an AI-driven generative pipeline combining deep reinforcement learning (DRL), generative adversarial networks (GANs), and variational autoencoders (VAEs) to design novel peptide-like molecules targeting major proteins implicated in endometrial cancer (EC), including AKT1, ESR1, Connexin-43, and CTNNB1. From over 14,200 generated structures, approximately 2313 peptides met drug-likeness and structural criteria and were screened using deep learning-enhanced docking. Top-ranked peptides, such as Gitoxoside (- 11.53 kcal/mol) and 9-Fluoro-11 (- 11.38 kcal/mol), demonstrated stronger binding to AKT1 than the reference inhibitor Capivasertib (- 8.50 kcal/mol). Similar high-affinity interactions were observed for CTNNB1-SCHEMBL (- 12.33 kcal/mol) and ESR1-1Estra-1,3 (- 11.05 kcal/mol). Molecular dynamics (MD) simulations confirmed the stability of these complexes with RMSD values below 2.5 Å and minimal residue fluctuations. WaterSwap free energy calculations yielded highly favorable binding energies (- 34 to - 37 kcal/mol), further validating stable ligand-protein interactions. ADMET predictions indicated acceptable pharmacokinetic properties and low predicted toxicity for most candidates. Collectively, this integrative AI framework efficiently explores peptide chemical space, enabling the rapid identification of peptide-based and peptidomimetic inhibitors with strong binding affinity and stability. The findings highlight the potential of AI-assisted peptide design as a scalable and cost-effective strategy for developing next-generation therapeutics against endometrial cancer.

2026-05-01·ANNALS OF ONCOLOGY

Capivasertib plus paclitaxel as first-line treatment for metastatic triple-negative breast cancer: results from the randomised, global phase III CAPItello-290 trial

Article

作者: Park, Y H ; Cardoso, F ; Foxley, A ; Robson, M E ; Yamashita, T ; Cortés, J ; Xu, B ; Grinsted, L ; Casalnuovo, M ; Schmid, P ; Ghosh, J ; Iwata, H ; D'Cruz, C ; Freitas-Junior, R ; de Bruin, E C ; Hegg, R ; Villalobos-Valencia, R ; Zurawski, B ; McArthur, H L ; Karnaukhov, I ; Demirci, U ; Chuken, Y L ; Nechaeva, M

BACKGROUND:

Adding the pan-Akt serine/threonine kinase (AKT) inhibitor capivasertib to first-line paclitaxel in metastatic triple-negative breast cancer (TNBC) led to significantly longer progression-free survival (PFS) and overall survival (OS) versus placebo-paclitaxel in the phase II PAKT trial. CAPItello-290 was designed to further assess capivasertib-paclitaxel, including in patients with PIK3CA/AKT1/PTEN-altered tumours.

PATIENTS AND METHODS:

Patients with previously untreated metastatic TNBC were randomised 1 : 1 to paclitaxel 80 mg/m² [day 1, weeks 1-3 (4-week cycle)] plus capivasertib 400 mg or placebo twice daily (days 2-5, weeks 1-3). PIK3CA/AKT1/PTEN alterations were analysed by retrospective central molecular testing. Dual primary endpoints were OS in the overall population and in patients with PIK3CA/AKT1/PTEN-altered tumours; investigator-assessed PFS was a key secondary endpoint.

RESULTS:

From July 2019 to February 2022, 812 patients were randomised; 30.7% of patients had PIK3CA/AKT1/PTEN tumour alterations. At final analysis [data cut-off (DCO) 18 March 2024], the median OS for the overall population was 17.7 and 18.0 months with capivasertib-paclitaxel and placebo-paclitaxel, respectively [hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.78-1.08, P = 0.3239] and for patients with PIK3CA/AKT1/PTEN-altered tumours, it was 20.4 months in both arms (HR 1.05, 95% CI 0.77-1.43, P = 0.7602). At PFS DCO (25 May 2022), the median PFS in the overall population numerically favoured capivasertib-paclitaxel (5.6 versus 5.1 months placebo-paclitaxel; HR 0.72, 95% CI 0.61-0.84); this was also the case in patients with PIK3CA/AKT1/PTEN-altered tumours (7.5 versus 5.6 months placebo-paclitaxel; HR 0.70, 95% CI 0.52-0.95). The most frequent adverse event (AE) of grade ≥3 was diarrhoea [12.7% versus 0.7% placebo-paclitaxel (overall population)]. Capivasertib was discontinued due to AEs in 8.5% of patients (4.9% placebo-paclitaxel; overall population); AEs led to death in 4.2% of all patients.

CONCLUSIONS:

Capivasertib-paclitaxel did not meet the prespecified boundary for improving OS in either population; PFS numerically favoured the combination, especially in PIK3CA/AKT1/PTEN-altered tumours. The safety of capivasertib-paclitaxel was generally manageable and consistent with prior studies.

706

项与卡匹色替相关的新闻（医药）

2026-05-07

·药通社

齐鲁超20亿元独家新药，即将报产！

乳腺癌是全球女性中最高发的恶性肿瘤之一。WHO《Breast cancer cases and deaths are projected to rise globally》报告指出，全球乳腺癌的发病与死亡人数呈上升趋势，平均每20名女性中就有1人可能在一生中被确诊。在众多亚型里，HR+/HER2-乳腺癌（激素受体阳性/人表皮生长因子受体2阴性）是绝对的主导亚型，约占患者总数的70%。 2026年4月30日，齐鲁制药官方宣布，近日，由其独家引进中国区域研发与商业化权益的创新靶向药afuresertib（研发代号：LAE002），联合氟维司群治疗HR+/HER2-晚期乳腺癌的重磅Ib/III期临床研究达到主要终点，齐鲁将推进国内上市申请。据公开资料显示，LAE002 （afuresertib）是来凯医药自主开发的一种AKT强效抑制剂，能同时抑制所有三种AKT亚型（AKT1、AKT2及AKT3），也是全球仅有的两种处于晚期临床开发阶段的针对乳腺癌及前列腺癌的AKT抑制剂之一。 AKT是一种丝氨酸/苏氨酸激酶，也是PAM (PI3K/AKT/mTOR) 信号通路的关键节点，对调控细胞生长、增殖、存活及代谢等进程具有核心作用。该通路的失调是乳腺癌（包括HR+、HER2扩增型及三阴性等多种亚型）中常见的致癌事件。因此，靶向AKT成为治疗多种乳腺癌亚型的一个极具吸引力的策略，尤其为克服常规治疗的耐药性提供了新方向。 2025年11月，齐鲁制药与来凯医药达成授权合作，独家引进该药物。根据协议，齐鲁制药全面获得该药在中国境内临床研究、药品开发、生产及商业化全部独家权益，来凯医药则负责完成HR+/HER2-乳腺癌III期临床试验（AFFIRM-205）。作为回报，若LAE002在中国获批首个适应症，来凯医药有权获得5.3亿元不可退还的首付款与总计最高20.45亿元的里程碑款项。此外，来凯医药有权基于中国地区该药物的未来净销售额收取销售分成，分成比率在十余个至二十余个百分点。在Ib期研究中，20例HR+/HER2-乳腺癌接受Afuresertib联合氟维司群治疗后，确认的客观缓解率（cORR）为30%，疾病控制率（DCR）为80%，中位PFS为7.3个月。在11例具有特异性生物标志物改变（PIK3CA/AKT1/PTEN）的患者中，cORR为45.4%，DCR为82%，中位无进展生存期（PFS）为7.3个月。 2026年4月15日，来凯医药正式对外宣布，其旗下在研管线LAE002（afuresertib）联合氟维司群，治疗HR+/HER2-乳腺癌III期临床试验（AFFIRM-205）取得强有力的积极顶线结果，成功达到其主要终点。成为国内首个在该靶点取得III期阳性结果的创新药。全球范围内，AKT抑制剂研发因靶点成药性差、脱靶毒性高，长期被视为创新药研发的“硬骨头”，仅阿斯利康Capivasertib、罗氏Ipatasertib等少数产品进入后期临床。其中Capivasertib已于2023年获FDA批准、2025年登陆中国市场，成为国内首款AKT抑制剂。2024年全球销售额已达4.3亿美元，放量势头强劲。但与此同时，罗氏却因III期数据不佳终止管线研发，这也凸显了该赛道研发的高风险性。在此背景下，齐鲁总计超20亿引进的这款独家新药即将报产，值得期待。参考：北京药研汇 ↓⭐关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525） *添加请注明备注及来意

2026-05-06

·astrazeneca.com

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognised a favourable benefit risk profile for AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), based on the CAPItello-281 Phase III trial. The Committee voted 7 to 1, with 1 abstaining. In August 2025, the FDA accepted the supplemental New Drug Application (sNDA) for Truqap in combination with abiraterone and ADTbased on positive results from the CAPItello-281 Phase III trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress and simultaneously published in Annals of Oncology.1 Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the trial, said: “Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes. Their disease significantly impacts their quality of life and inevitably progresses to more advanced stages that are associated with high mortality rates. In addition to this poor prognosis, patients currently have limited treatment options, which is why today’s recommendation of the capivasertib combination is welcome news for both patients and clinicians to address an urgent need for new treatments that delay progression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “CAPItello-281 is the first pivotal trial to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer and its severe course of disease. The Committee’s recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the Truqap combination verifies its potential to address this significant need and optimise outcomes for patients. We are committed to working closely with the FDA to bring the first and only targeted treatment option to the one in four patients with this form of metastatic hormone-sensitive prostate cancer.” Results from the primary analysis of the CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death and a clinically meaningful improvement in median radiographic progression-free survival (rPFS) of 7.5 months with the Truqap combination versus treatment with abiraterone and ADT with placebo (based on a hazard ratio [HR] of 0.81; 95% confidence interval [CI] 0.66-0.98; p=0.034). Median rPFS was 33.2 months for the Truqap combination versus 25.7 months for the comparator arm.1 A consistent benefit was observed with the Truqap combination versus treatment with abiraterone and ADT with placebo in key secondary endpoints of the trial, including prolonged time to castration resistance (29.5 vs. 22.0 months [HR 0.77; 95% CI: 0.63-0.94]) and prostate-specific antigen (PSA) progression (HR 0.73; 95% CI: 0.52-1.01), and fewer and delayed events in terms of symptomatic skeletal event-free survival (SSE-FS) (42.5 vs. 37.3 months [HR 0.82, 95% CI: 0.66-1.02]).1 Overall survival (OS) data were immature at the time of primary analysis; however, subsequent interim results for OS numerically favoured the Truqap combination versus the comparator arm. The trial will continue as planned to further assess OS as a key secondary endpoint. The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine.Consistent with the addition of a targeted treatment to background therapy, Grade 3 or higher adverse events occurred in 67% of patients treated with the Truqap combination versus 40.4% of patients treated with abiraterone and ADT with placebo. The most common Grade 3 or higher adverse events in the Truqap arm were rash (12.3%), hyperglycaemia (10.3%), hypokalaemia (8.7%), diarrhoea (6.2%), hypertension (5.8%) and anaemia (5.2%).1 The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the feedback as it reviews the submission and is not bound by the Committee’s recommendation. A regulatory application for Truqap in combination with abiraterone and ADT for the treatment of PTEN-deficient mHSPC is under review in the EU based on the CAPItello-281 Phase III trial. AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. References Fizazi K, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone sensitive prostate cancer: CAPItello-281 phase III study.Ann Oncol2026; 37(1):53-68. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 Apr 4. doi: 10.3322/caac.21834. American Cancer Society. Key Statistics for Prostate cancer. Available at: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html. Accessed April 2026. Chowdhury S, et al. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020;15(3):301-315. National Cancer Institute. Hormone Therapy for Prostate Cancer Fact Sheet. Available at: https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet. Accessed April 2026. American Society of Clinical Oncology Educational Book. Metastatic Hormone-Sensitive Prostate Cancer: Toward an Era of Adaptive and Personalized Treatment. Available at: https://ascopubs.org/doi/pdf/10.1200/EDBK_390166. Accessed April 2026. Cancer Research UK. Hormone therapy for metastatic prostate cancer. Available at: https://www.cancerresearchuk.org/about-cancer/prostate-cancer/metastatic-cancer/treatment/hormone-therapy-for-metastatic-prostate-cancer. Accessed April 2026. Hussain M, et al. Metastatic Hormone-Sensitive Prostate Cancer and Combination Treatment Outcomes A Review. JAMA Oncol. 2024;10(6):807-820. Cerner CancerMPact database. Accessed April 2026. Cuzick J, et al. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. Br J Cancer. 2013;108(12):2582-2589. Gasmi A, et al. Overview of the Development and Use of Akt Inhibitors in Prostate Cancer. J Clin Med. 2021;11(1):160. The content above comes from the network. if any infringement, please contact us to modify.

Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer

临床结果上市批准

2026-05-05

·医药笔记

股价一年涨10倍：Celcuity PI3K/Akt/mTOR抑制剂乳腺癌三期临床大获成功

▎Armstrong 2026年5月1日，Celcuity宣布其PI3K/Akt/mTOR抑制剂Gedatolisib在治疗PI3KCA野生型、HR+/HER2-乳腺癌的三期临床中达到具有临床意义的PFS改善终点，具体数据在ASCO会议上以late-breaking abstract的形式公布。去年7月28日，Celcuity宣布VITORIA-1三期临床达到PFS主要终点，此后其股价一路从14亿美元涨到如今的145美元，如今市值达到70亿美元。 PI3K/Akt/mTOR（PAM）的反馈loops为实体瘤的驱动基因通路，且不同PI3K亚型、AKT、mTOR之间存在冗余本来保证信号过通路通能，因此只抑制一个靶点效力有限，故而第一代的PAM都是pan-PI3K/mTOR抑制剂，但其毒性较大，经过不断地迭代，终于开发出今天更安全、活性更强的pan-PI3K/Akt/mTOR抑制剂。 PAM为实体瘤中最被低估的靶点，其突变率在主要实体瘤中高达38%，高于HER2（主要在乳腺癌）、EGFR（主要在肺癌）、ALK（主要在肺癌）。 Gedatolisib为一款高度差异化的分子，同时抑制不同PI3K亚型、mTOR、AKT，作用机制区别于Alpelisib、依维莫司、Capivasertib等。 HR+/HER2-乳腺癌仍然存在严重的未满足临床需求。此次公开数据的VIKTORIA-1二线治疗的三期临床方案设计如下。患者基线数据如下。三联疗法、二联疗法、氟维司群对照组的mPFS分别为9.3个月、7.4个月、2.0个月。中期OS分析显示获益趋势。 mDOR数据和ORR数据如下。 Gedatolisib的耐受性良好，大部分副作用为1级或2级，高血糖和副作用发生率低，口腔炎通常在1-2周内减轻至更低级别。与其他PAM抑制剂相比，Gedatolisib的副作用发生率更低。 Gedatolisib有望重塑HR+/HER2-二线治疗的临床格局。 Celcuity还在开展Gedatolisib联合CDK4/6抑制剂一线治疗HR+/HER2-乳腺癌的三期临床VIKTORIA-2。一线治疗的1b期临床已经展现出优异的疗效潜力，mPFS相比于标准疗法大幅延长（非头对头）。 Gedatolisib在前列腺癌、HER2阳性乳腺癌、卵巢癌等多个瘤种展现出初步疗效潜力。总结 Celcuity此前已经递交Gedatolisib的上市申请并获得优先审评，用于治疗PI3KCA野生型HR+/HER2-乳腺癌，PDUFA日期为今年7月17日。PI3K/Akt/mTOR三期临床大获成功意味着HR+/HER2-乳腺癌领域的重大进展，也意味着PAM多靶点抑制剂的里程碑，更多国产PAM或将迎来出海热潮。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床3期ASCO会议优先审批临床结果临床2期

100 项与卡匹色替相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11371	-	-	DB12218

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
ER阳性/HER2阴性乳腺癌	欧盟	AstraZeneca AB	2024-06-17
ER阳性/HER2阴性乳腺癌	冰岛	AstraZeneca AB	2024-06-17
ER阳性/HER2阴性乳腺癌	列支敦士登	AstraZeneca AB	2024-06-17
ER阳性/HER2阴性乳腺癌	挪威	AstraZeneca AB	2024-06-17
乳腺癌	加拿大	AstraZeneca Canada, Inc.	2024-01-26
HR阳性/HER2阴性乳腺癌	美国	AstraZeneca Pharmaceuticals LP	2023-11-16

未上市

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
去势敏感前列腺癌	申请上市	美国	AstraZeneca PLC	2025-08-01
HER2 阴性乳腺癌	临床3期	比利时	AstraZeneca PLC	2025-11-27
HER2 阴性乳腺癌	临床3期	德国	AstraZeneca PLC	2025-11-27
HER2 阴性乳腺癌	临床3期	葡萄牙	AstraZeneca PLC	2025-11-27
HR阳性乳腺癌	临床3期	比利时	AstraZeneca PLC	2025-11-27
HR阳性乳腺癌	临床3期	德国	AstraZeneca PLC	2025-11-27
HR阳性乳腺癌	临床3期	葡萄牙	AstraZeneca PLC	2025-11-27
转移性乳腺癌	临床3期	比利时	AstraZeneca PLC	2025-11-27
转移性乳腺癌	临床3期	德国	AstraZeneca PLC	2025-11-27
转移性乳腺癌	临床3期	葡萄牙	AstraZeneca PLC	2025-11-27

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临床结果

适应症

分期

评价

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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


AACR2026	临床2/3期	HR阳性/HER2阴性乳腺癌 HR Positive \| HER2 Negative	16	Imlunestrant alone	鹹鏇構壓鬱遞淵鏇積醖(醖鬱顧醖鹽襯餘廠艱築) = 淵淵淵製襯鑰鹽願網鑰鹽獵憲選積選鏇遞觸廠 (遞廠壓鏇鏇範簾窪蓋衊 ) 更多	积极	2026-04-21
				Camizestrant 75mg	鹹鏇構壓鬱遞淵鏇積醖(製膚遞窪糧廠積獵觸積) = 襯襯衊網範築製夢艱願衊築餘壓窪鑰繭蓋醖顧 (鏇鹹鹽鹽鬱醖遞鹽衊膚 ) 更多
NCT04862663 (CAPItello-292, SABCS2025)	-	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	48	Capivasertib + CDK4/6i + fulvestrant	顧製鏇獵窪餘壓壓鏇製(衊獵壓蓋鬱顧夢蓋鑰簾) = 壓憲顧壓遞艱築醖積範願鬱構願鏇範齋廠蓋簾 (壓鹹衊願窪襯衊醖獵襯 ) 更多	积极	2025-12-11
SABCS2025	N/A	HR阳性乳腺癌 PIK3CA \| ESR1	107	alpelisib+fulvestrant	廠淵鹹鏇繭鬱膚範選遞(鑰壓餘鹽蓋範鹹鑰積襯) = One patient with alpelisib experienced treatment interruption and dose reduction due to skin toxicity, while Elacestrant was well-tolerated without major adverse effects. 鏇鑰鑰醖齋蓋齋鑰淵構 (憲選衊壓糧衊糧憲鑰積 )	积极	2025-12-10
				capivasertib+fulvestrant
SABCS2025	N/A	HR阳性/HER2阴性乳腺癌 HR+ \| HER2- \| PI3K/AKT/PTEN pathway alterations	72	≥2 pathway inhibitors sequentially	醖餘窪窪構獵廠積餘憲(鏇夢築範糧艱廠遞願鏇) = 壓鬱簾壓憲築選觸構餘糧齋鏇鏇膚鬱願窪觸餘 (衊簾鹹選構鹹鬱襯蓋鏇, 9 ~ 28)	积极	2025-12-10
				alpelisib alone	醖餘窪窪構獵廠積餘憲(鏇夢築範糧艱廠遞願鏇) = 蓋鑰觸繭廠鹹網鬱鹽構糧齋鏇鏇膚鬱願窪觸餘 (衊簾鹹選構鹹鬱襯蓋鏇, 5 ~ 8)
NCT03997123 (CAPItello-290, ESMO_ASIA2025)	临床3期	转移性三阴性乳腺癌一线 PIK3CA \| AKT1 \| PTEN	128	Capivasertib + paclitaxel	艱窪觸憲壓遞鏇鏇鹹窪(糧積憲夢窪壓糧積鏇夢) = 鬱夢衊糧鏇鏇製淵製觸積構網襯襯蓋簾製觸鹽 (齋膚鑰願淵顧憲繭鏇構 ) 更多	积极	2025-12-06
				Placebo + paclitaxel	艱窪觸憲壓遞鏇鏇鹹窪(糧積憲夢窪壓糧積鏇夢) = 艱築衊艱艱憲餘衊鹹膚積構網襯襯蓋簾製觸鹽 (齋膚鑰願淵顧憲繭鏇構 ) 更多
NCT03801369 (AMTEC, CTgov)	临床2期	转移性乳腺癌 \| 转移性三阴性乳腺癌	24	Quality-of-Life Assessment+Olaparib+Durvalumab (Arm I (Olaparib, Durvalumab))	鹽鹽廠積顧繭衊鏇餘齋 = 積構膚鬱獵顧衊鑰醖選鹽繭鏇積夢壓繭夢窪衊 (艱夢範鹹淵網鏇窪窪築, 衊廠憲膚網鑰憲願壓簾 ~ 窪襯蓋積簾蓋網膚選鏇) 更多	-	2025-11-21
				Quality-of-Life Assessment+Olaparib+selumetinib (Arm II (Olaparib, Selumetinib))	夢構鹽夢範顧獵夢餘艱(齋餘壓衊製鬱襯衊觸夢) = 糧願獵選衊夢願鑰餘衊壓衊鏇鏇範顧遞膚醖壓 (積製簾鏇積鹹醖蓋憲獵, 蓋鬱觸襯憲顧積衊壓獵 ~ 蓋蓋鏇齋顧鑰憲鏇簾夢) 更多
NCT03660826 (NRG GY012, ESMO2025)	临床2期	转移性子宫内膜恶性肿瘤	168	Olaparib 300 mg PO BID + Durvalumab 1500mg q28 days	壓夢窪夢膚積範餘網窪(窪構範糧製積選淵糧壓) = 網觸鏇遞鑰夢網鑰餘鏇窪積網襯窪觸壓蓋鬱齋 (鹽蓋觸鹹淵襯鏇遞範淵 ) 更多	不佳	2025-10-17
				Cediranib 30 mg PO Daily	壓夢窪夢膚積範餘網窪(窪構範糧製積選淵糧壓) = 製淵選顧願膚憲鏇簾鹽窪積網襯窪觸壓蓋鬱齋 (鹽蓋觸鹹淵襯鏇遞範淵 ) 更多
ESMO2025	N/A	晚期乳腺癌 HR+ \| HER2-	16	Camizestrant	-	积极	2025-10-17
				Ribociclib plus ET
NCT04742036 (Pubmed) 人工标引	临床1期	晚期恶性实体瘤	16	Capivasertib (Part A)	築廠艱鹹鏇夢壓襯鬱壓(鹹構構憲衊憲膚遞築糧) = Hyperglycemia, diarrhea, and rash were the most common. Most adverse events were Grade 1-2. 糧醖鏇範製壓顧觸觸鑰 (選鏇膚積網製鬱構鹽積 )	积极	2025-10-14
				Capivasertib + Paclitaxel (Part B)
CAPItello-291 (ASCO2025)	N/A	HR阳性/HER2阴性乳腺癌 PIK3CA \| AKT \| PTEN ... 更多	34	Capivasertib	鏇鬱獵淵製構範衊築蓋(顧簾選鑰蓋鹹願遞憲餘) = 構淵壓夢製網網繭遞遞簾鏇壓觸鹹顧鏇齋壓遞 (鬱糧構觸憲製淵積鏇醖, 2.4 ~ 7.6) 更多	积极	2025-05-30
				Alpelisib	-