A Phase 3, Multicenter, Randomized, Controlled, Open-Label Clinical Trial of Aglatimagene Besadenovec (CAN-2409) Plus Prodrug and Pembrolizumab Versus Docetaxel for Stage IV Non-Squamous Non-Small Cell Lung Cancer Progressing on Pembrolizumab-based Treatment

This phase III trial compares the effect of the combination of aglatimagene besadenovec and pembrolizumab versus standard of care docetaxel chemotherapy for the treatment of stage IV non-squamous, non-small cell lung cancer. Aglatimagene besadenovec is a replication-deficient adenoviral vector encoding the herpes simplex virus thymidine kinase (HSV-tk) gene. When combined with an oral prodrug (valacyclovir), injection of aglatimagene induces targeted tumor cell death and stimulates a systemic immune response. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs 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. This trial may help doctors find out if giving aglatimagene with pembrolizumab is more effective at treating patients with stage IV non-squamous, non-small cell lung cancer than standard chemotherapy.

开始日期2026-06-15

申办/合作机构

Candel Therapeutics, Inc.

NCT07332000

/ Recruiting临床2期

A Biomarker Study in Men With Localized, Favorable, Intermediate-risk Prostate Cancer Treated With Aglatimagene Besadenovec

Phase 2a, open-label, multi-center study evaluating biomarkers and biodistribution of aglatimagene besadenovec plus valacyclovir in men with localized, intermediate-risk prostate cancer who are planning to receive external beam radiation therapy (EBRT).

开始日期2025-10-30

申办/合作机构

Candel Therapeutics, Inc.

NCT04495153

/ Active, not recruiting临床2期

CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients

The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint inhibitor (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409 is a viral immunotherapy approach that induces tumor-infiltrating T-cells and a consequent PD-L1 up-regulation. A combination of CAN-2409 added to standard of care (SOC) checkpoint inhibitors may lead to improved long-term outcomes for patients with NSCLC who have suboptimal response to ICI therapy.

开始日期2020-10-13

申办/合作机构

Candel Therapeutics, Inc.

[+1]

100 项与 Aglatimagene besadenovec 相关的临床结果

登录后查看更多信息

100 项与 Aglatimagene besadenovec 相关的转化医学

登录后查看更多信息

100 项与 Aglatimagene besadenovec 相关的专利（医药）

登录后查看更多信息

项与 Aglatimagene besadenovec 相关的文献（医药）

2026-06-01·LANCET ONCOLOGY

Aglatimagene besadenovec (CAN-2409) with radiotherapy for patients with localised prostate cancer: a phase 3, multicentre, randomised, double-blind, placebo-controlled trial

Article

作者: Schroeder, Thomas ; Rao, Shangbang ; Gandhi, Nilay M ; Barone, Francesca ; Liss, Michael A ; Nichols, W Garrett ; Polanco, Maria Lucia Silva ; Savage, Stephen J ; Tutrone, Ronald ; Sukin, Steven ; Goody, Megan ; Chesnut, Gregory ; Gejerman, Glen ; Wheeler, Thomas ; Sylvester, John ; Facelle, Thomas M ; Garzotto, Mark G ; Mehlhaff, Bryan ; Pieczonka, Christopher ; DeWeese, Theodore L ; Manzanera, Andrea ; Vogt, Jenessa ; Tak, Paul P

BACKGROUND:

About 30% of men with localised prostate cancer undergoing radiotherapy with curative intent have disease recurrence associated with progression-related symptoms and substantial toxicity of salvage therapies. Previous studies with aglatimagene besadenovec (CAN-2409, hereafter referred to as aglatimagene) showed synergy with radiation and immune-mediated cytotoxicity in patients with prostate cancer. We aimed to assess whether addition of aglatimagene plus prodrug (valacyclovir) to standard-of-care external beam radiation therapy (EBRT) could improve disease-free survival in this population.

METHODS:

We conducted a phase 3, randomised, double-blind, placebo-controlled trial at 51 medical centres (26 community and 25 institutional or military) across the USA and Puerto Rico in patients with intermediate or high-risk prostate cancer. Patients aged at least 18 years who were planning to undergo EBRT and with an Eastern Cooperative Oncology Group score of 0-2 were eligible. Patients were randomly assigned (2:1) via central block-randomisation to receive either three courses of intraprostatic aglatimagene (5 × 10¹¹ viral particles) plus valacyclovir or placebo plus valacyclovir, with randomisation stratified by risk category and androgen deprivation therapy (ADT) use. Patients received standard-of-care EBRT (78 Gy in 2 Gy fractions) or hypofractionated EBRT (60 Gy in 3 Gy fractions or 70 Gy in 2·5 Gy fractions) with optional ADT. The primary endpoint was disease-free survival, defined as time-from-randomisation to prostate cancer recurrence or death in the intent-to-treat population (all randomly assigned patients). Safety was assessed in all individuals who received at least one injection. The trial is registered at ClinicalTrials.gov, NCT01436968, and long-term follow-up is ongoing.

FINDINGS:

Between Feb 21, 2012, and Sept 9, 2021, 745 men (591 [79%] White, 121 [16%] Black) were randomly assigned to receive aglatimagene plus valacyclovir (n=496) or placebo plus valacyclovir (n=249). After a median follow-up of 50·3 months (IQR 35·2-63·3), median disease-free survival was not reached (95% CI 121·78 to not reached) in the aglatimagene plus valacyclovir group versus 86·1 (IQR 29·7-143·0) months in the placebo plus valacyclovir group (hazard ratio 0·70, 95% CI 0·52-0·94; p=0·016). Treatment-emergent adverse events (TEAEs) of grade 3 or worse occurred in 40 (8%) of 479 patients in the aglatimagene group and 17 (7%)of 232 patients in the placebo group. The most common TEAE of grade 3 or worse was acute kidney injury in both the aglatimagene group (nine [2%] of 479 patients) and the placebo group (four [2%] of 232 patients). Serious adverse events occurred in 28 (6%) of 479 patients in the aglatimagene group and 17 (7%) of 232 in the placebo group. Treatment-related serious adverse events occurred in eight (2%) patients in the aglatimagene group (four acute kidney injury, two pyrexia, and one each influenza-like symptoms and urinary retention) and five (2%) in the placebo group (four acute kidney injury, and one each increased creatinine levels and skin rash; one patient reported two serious adverse events). No treatment-related deaths were reported.

INTERPRETATION:

Aglatimagene plus valacyclovir was associated with longer disease-free survival than placebo plus valacyclovir when added to standard of radiotherapy for the treatment of localised prostate cancer, offering a meaningful benefit without increasing clinically significant toxicity.

FUNDING:

Candel Therapeutics and US National Institutes of Health.

2026-02-01·JTCVS open

Neoadjuvant intratumoral immune stimulation using gene-mediated cytotoxic immunotherapy for resectable non−small cell lung cancer: 5-Year outcomes

Article

作者: Jarrar, Doraid ; Aguilar-Cordova, Estuardo ; Predina, Jarrod ; Pechet, Taine ; Singhal, Sunil ; Niemeyer, Emma ; Albelda, Steven ; Rekhtman, David ; Nichols, William Garrett ; Aicher, Aidan ; Haas, Andrew ; Aguilar, Laura ; Kucharczuk, John ; Eisinger, Ella ; Davis, Christiana

Objectives:

Safety and immunologic priming using neoadjuvant, intratumoral gene-mediated cytotoxic immunotherapy (GMCI) has been established in a phase 1 clinical trial involving patients with resectable non-small cell lung cancer (NSCLC). Here we examine long-term clinical outcomes of this cohort and compare the results with a comparable contemporaneous control group.

Methods:

We performed a retrospective review of a prospective database involving our trial cohort. We then identified comparable patients in a ratio of 5:1 considering pathologic stage, histology, resection extent, and age. Kaplan-Meier curves were generated. Differences in disease-free and overall survival were measured by log-rank test.

Results:

Intratumoral GMCI was delivered to 12 patients with NSCLC by endobronchial ultrasound (n = 11) or video-assisted thoracic surgery (n = 1). Among patients receiving GMCI and control patients, more than 70% had stage II or stage III disease. Median follow-up for the surviving patients enrolled was 6.0 years (interquartile range, 5.2-6.7 years). Median diseases-free survival was significantly increased among patients receiving GMCI relative to control (2.4 years vs 1.0 year; P = .04). Median OS in the GMCI group was not reached (8 of 12 patients remain alive) versus 3.0 years in controls and was significant by log-rank at 2-7 years (P = .013-.035).

Conclusions:

Neoadjuvant immune stimulation induces local and systemic immune activation, is safe when combined with modern systemic therapies, and may confer long-term oncologic advantages. These data provide a foundation for additional trials exploring intratumoral immunotherapy for patients with NSCLC, especially in conjunction with immune checkpoint inhibitors.

2025-12-01·CHILDS NERVOUS SYSTEM

The effect of oncolytic virotherapy on pediatric brain tumor- a systematic review

Review

作者: Keerthana Veluswami ; Jonathan Roy Varghese ; Thirumalaivasan Dhasakeerthi ; Hari Vorappan Manickavelan ; Mansi Agrawal ; Gurunathan Srinivasan ; Praveen Nandha Kumar Pitchan Velammal

BACKGROUND:

Childhood mortality remains high among pediatric brain tumor (PBT) patients, and current treatments like surgery, chemotherapy, and radiotherapy have limitations. Oncolytic viral therapy (OVT) has emerged as a promising strategy in cancer treatment, including pediatric brain tumors. This study evaluates the clinical evidence on the use of OVT in PBT.

METHODS:

A systematic review was conducted following PRISMA guidelines, collecting clinical trial data up to December 2023 from English-language publications. Key search terms included "clinical trial," "oncolytic viruses," "glioma," "glioblastoma," "pediatric brain tumors," and "oncolytic virotherapy." Data on patient characteristics, interventions, survival outcomes, and adverse events were extracted by two independent researchers.

RESULTS:

Four clinical trials involving 40 pediatric patients (median age 14.5 years) with malignant gliomas were identified. Oncolytic agents studied included HSV G-207, DNX-2401, AdV-tk, and Lerapolturev. Reported tumor types included glioblastoma, diffuse intrinsic pontine glioma, anaplastic astrocytoma, recurrent ependymoma, and diffuse hemispheric glioma. Overall survival ranged from 4.1 to 47.7 months, and progression-free survival ranged from 1.7 to 47.7 months. Treatment was generally well tolerated; the most common adverse events were fever, headache, and nausea, while serious adverse events were infrequent and primarily related to disease progression. Many patients also received standard therapies such as surgery, radiotherapy, or chemotherapy.

CONCLUSION:

OVT appears safe and feasible in pediatric brain tumors, with signals of clinical benefit in selected patients. Larger, controlled trials are needed to clarify its survival impact and define optimal therapeutic strategies.

209

项与 Aglatimagene besadenovec 相关的新闻（医药）

2026-08-03

·BioSpace

Candel Therapeutics to Present Extended Data from Phase 3 Results of Aglatimagene Besadenovec at ASTRO 2026

NEEDHAM, Mass., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced that an abstract was accepted for poster presentation at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place September 26-30, 2026, in Boston, MA. Aglatimagene besadenovec – Localized Prostate Cancer Abstract Title: Quantitative Digital Pathology Defines Immune Activation Following Aglatimagene Besadenovec Immunotherapy in Localized Prostate Cancer Presenter: Francesca Barone, MD, PhD, Chief Scientific Officer, Candel Therapeutics, Needham, MA Session Title: PQA 06: Genitourinary Cancer, Gynecological Cancer and Health Care Access and Engagement Session Date/Time: Tuesday, September 29, 2026; 2:15 PM - 3:30 PM ET Location: Poster Hall – Exhibit Hall A, Thomas M. Menino Convention & Exhibition Center, Boston, MA About Candel Therapeutics Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA) and published in The Lancet Oncology . The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: . Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact Theodore Jenkins Vice President, Investor Relations, and Business Development Candel Therapeutics, Inc. tjenkins@candeltx.com Media Contact Ben Shannon ICR Healthcare CandelPR@icrhealthcare.com

快速通道免疫疗法ASCO会议临床3期临床2期

2026-07-29

·BioSpace

Candel Therapeutics to Present at Canaccord Genuity’s 46th Annual Growth Conference in Boston

NEEDHAM, Mass., July 29, 2026 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced that the Company will present at Canaccord Genuity’s 46th Annual Growth Conference, taking place August 11-13, 2026, in Boston, MA. Presentation Details: Date: Wednesday, August 12, 2026 Time: 12 PM EDT Webcast Link: Canaccord Genuity / Candel Presentation A webcast of the presentation will be available by selecting Events and Presentations in the Investors section of Candel’s website at . A replay of the webcast will be archived for up to 90 days following the session date. About Candel Therapeutics ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA) and published in The Lancet Oncology . The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC. Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. For more information about Candel, visit: . Forward-Looking Statements This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Investor Contact Theodore Jenkins Vice President, Investor Relations, and Business Development Candel Therapeutics, Inc. tjenkins@candeltx.com Media Contact Ben Shannon ICR Healthcare CandelPR@icrhealthcare.com

快速通道临床2期免疫疗法临床3期临床1期

2026-07-28

·今日头条

12类肿瘤迎来新突破！7月全球抗癌研究盘点，三大癌种成为焦点

2026年7月全球抗肿瘤新药研发持续迎来重磅进展，覆盖十二大类常见恶性肿瘤，从全新临床试验启动、三期积极数据出炉，到多款新药冲击上市，不断为晚期、耐药难治肿瘤患者开辟新的治疗出路，其中肺癌、胰腺癌、卵巢癌三大癌种的研究成果最为亮眼。肺癌领域针对KRAS G12C、ROS1、ALK等高频突变靶点接连传出好消息，多款创新疗法专门攻克免疫治疗、靶向药耐药难题；素有“癌王”之称的胰腺癌，针对高发KRAS G12D突变的精准靶向药、放化疗联合新方案持续推进，打破长期治疗手段匮乏的困境；卵巢癌方面，抗体偶联药物、免疫联合疗法、新型靶向药均公布亮眼临床数据，给铂类化疗耐药的晚期患者带来更多生存选择，除此之外胶质母细胞瘤、结直肠癌、胆管癌、肾癌、各类血液肿瘤也同步收获多项具备临床转化价值的研究成果。作为本月关注度最高的癌种，肺癌有两款重磅在研方案交出关键数据，其中一款是全新瘤内基因治疗联合免疫药CAN-2409搭配帕博利珠单抗，专门针对已经用过帕博利珠单抗联合含铂化疗后病情进展的转移性非鳞非小细胞肺癌患者，目前全球大型三期AURORA临床试验已经正式启动招募。这款疗法的作用机制十分特别，通过往肿瘤内部注射基因药物，搭配口服抗病毒药伐昔洛韦，能在病灶处生成杀伤癌细胞的物质，同时激活全身免疫系统，不光能消灭注射部位的肿瘤，还能抑制全身转移病灶。此前二期临床数据已经展现出巨大潜力，完成完整治疗流程的患者里，一半人总生存期超过24个月，和本次三期入组人群高度匹配的免疫耐药非鳞肺癌患者，中位总生存期达到25.4个月，反观目前这类患者标准治疗化疗药多西他赛，过往临床中位生存期仅9.8至11.8个月，生存提升幅度十分可观。本次三期试验在全球约150家医院同步开展，患者将1:1分组，一组使用CAN-2409+伐昔洛韦持续联用帕博利珠单抗，另一组采用传统多西他赛化疗，研究核心观察指标是总生存期，同时同步记录用药安全性与患者生活质量。截至目前，该药物整个研发项目已有超千名癌症患者接受治疗，整体耐受度良好，暂未出现严重安全隐患，美国FDA此前也授予其快速通道资格，加速后续审批流程。另一款肺癌新药Divarasib也在7月公布三期Krascendo 1试验的积极结果，这款新一代口服靶向药针对KRAS G12C突变晚期肺癌，适合经过多线治疗后病情进展的患者，早前已经拿到FDA突破性疗法认定与孤儿药资格。本次头对头试验直接对比两款已经上市的同靶点药物索托拉西布、阿达格拉西布，数据显示Divarasib在肿瘤控制时长、总生存期两项核心指标上均展现出明显优势，整体安全情况平稳，没有新增未知不良反应，完整详细数据将在后续国际医学大会上对外公布，研发企业也会同步向各国药监部门递交上市申报材料。虽然本月肿瘤领域成果颇丰，但大众需要理性区分，文中涉及的CAN-2409、Divarasib均处于临床试验阶段，还未在全球任何国家获批上市，胰腺癌、卵巢癌相关新疗法也大多停留在临床研究环节，距离普通患者常规使用还有较长转化周期。不同患者基因分型、身体基础条件存在巨大个体差异，临床试验数据不能直接套用到个人治疗方案中。免责声明本文仅为2026年7月全球肿瘤前沿科研进展科普整合，文中所有在研药物、临床试验方案均未正式获批临床使用，不构成肿瘤科个体化诊疗、用药指导，不能替代三甲医院肿瘤专科医师专业诊疗意见。恶性肿瘤患者切勿自行依据前沿研究更换现有治疗方案，靶向、免疫、基因治疗均存在严格适应症、禁忌症与用药风险，所有治疗调整请在主治医生评估后开展。文中临床试验阶段性数据仅为群体统计结果，无法预判单名患者治疗效果，请勿盲目囤积未上市试验药物。参考文献 [1] Candel Therapeutics.启动全球三期AURORA临床试验公告[R].2026-06-30. [2] Spencer Feldman.免疫治疗失败后肺癌新药AURORA三期试验解读[J].Cure Today,2026. [3] 罗氏制药.Divarasib三期Krascendo 1临床试验阳性结果新闻稿[R].2026-07-02. [4] 中国临床肿瘤学会.非小细胞肺癌诊疗指南（2025版）[J].中华肿瘤杂志,2025,47(06):461-474. [5] 盛诺一家.2026年7月全球肿瘤临床研究月度盘点[EB/OL].2026-07-28. 6.中华医学会肿瘤学分会.胰腺癌、卵巢癌规范化诊疗专家共识（2026）[J].中国实用外科杂志,2026,46(07):765-772.

100 项与 Aglatimagene besadenovec 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15074

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
非鳞状非小细胞肺癌	临床3期	美国	Candel Therapeutics, Inc.	2026-06-15
局限性前列腺癌	临床3期	美国	Candel Therapeutics, Inc.	2011-09-01
前列腺腺癌	临床2期	美国	Candel Therapeutics, Inc.	2025-10-30
转移性非小细胞肺癌	临床2期	美国	NYU Langone Health	2020-10-13
转移性非小细胞肺癌	临床2期	美国	Candel Therapeutics, Inc.	2020-10-13
非小细胞肺癌	临床2期	美国	Candel Therapeutics, Inc.	2020-10-13
前列腺癌	临床2期	美国	Candel Therapeutics, Inc.	2016-05-01
前列腺癌	临床2期	墨西哥	Candel Therapeutics, Inc.	2016-05-01
复发性前列腺癌	临床2期	美国	Candel Therapeutics, Inc.	2016-05-01
复发性前列腺癌	临床2期	墨西哥	Candel Therapeutics, Inc.	2016-05-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01436968 (ASTRO2025 \| Company_Website) 人工标引	临床3期	局限性前列腺癌	745	CAN-2409 + prodrug + EBRT ± ADT	構憲願廠積構觸簾範範(繭鏇鑰簾製衊製獵築繭) = CAN-2409 improved DFS in important subgroups, including hypo- or standard fractionated EBRT, with or without ADT. 夢築蓋淵膚夢選壓襯窪 (獵齋齋獵鹽網顧襯鏇壓 ) 更多	积极	2025-09-28
				Placebo + prodrug + EBRT ± ADT
NCT01436968 (Phase 3, ASCO2025)	临床3期	局限性前列腺癌	745	CAN-2409+prodrug	廠觸鬱膚壓餘範夢齋憲(廠憲獵憲窪醖膚鬱鏇齋) = 膚襯積鏇鏇選壓鏇簾淵獵獵鹹壓網範積鑰繭夢 (鬱醖齋構憲廠衊廠膚齋 )	积极	2025-05-30
				Placebo+prodrug	廠觸鬱膚壓餘範夢齋憲(廠憲獵憲窪醖膚鬱鏇齋) = 觸齋選蓋憲繭淵鏇範壓獵獵鹹壓網範積鑰繭夢 (鬱醖齋構憲廠衊廠膚齋 )
NCT04495153 (GlobeNewswire) 人工标引	临床2期	晚期非小细胞肺癌	46	CAN-2409 (cohort 1 and 2)	衊鏇窪艱網鬱獵願衊餘(繭觸遞夢鏇憲壓鹹壓鏇) = 廠醖繭鹹醖構顧顧選醖顧憲鹹製製淵蓋鑰築繭 (糧繭鹹鏇夢積獵鹹膚積 )	积极	2025-03-26
				CAN-2409 (cohort 2)	衊鏇窪艱網鬱獵願衊餘(繭觸遞夢鏇憲壓鹹壓鏇) = 觸鹽壓築窪夢願壓繭選顧憲鹹製製淵蓋鑰築繭 (糧繭鹹鏇夢積獵鹹膚積 )
NCT02446093 (PaTK02, Company_Website) 人工标引	临床2期	胰腺癌新辅助	13	CAN-2409 + valacyclovir + SoC	積夢獵顧窪淵繭願繭糧(顧鹹蓋鹹廠築積顧壓網) = 鬱鏇積顧憲鑰衊艱鑰鏇選衊觸憲鹹獵積襯壓糧 (夢憲壓艱醖鬱憲鏇繭觸 ) 更多	积极	2025-02-25
				SoC	積夢獵顧窪淵繭願繭糧(顧鹹蓋鹹廠築積顧壓網) = 憲淵蓋膚艱憲襯窪鬱膚選衊觸憲鹹獵積襯壓糧 (夢憲壓艱醖鬱憲鏇繭觸 ) 更多
NCT01436968 (PipelineReview) 人工标引	临床3期	前列腺癌	745	CAN-2409 plus Standard of care external beam radiation therapy	齋襯鬱廠衊壓選廠願餘(範獵壓鏇構襯構積襯願): HR = 0.7, P-Value = 0.0155 达到更多	积极	2024-12-11
				Standard of care external beam radiation therapy
NCT04495153 (ASCO2024) 人工标引	临床2期	非小细胞肺癌	73	CAN-2409 + valacyclovir	憲鹽淵範製鏇願築糧鏇(網壓積鬱鏇繭餘艱顧憲) = 構觸醖醖淵獵鏇衊廠淵廠網鹹鑰鬱壓築簾積鹽 (壓壓積鏇蓋壓願齋鏇鑰, 14.3 ~ NA) 更多	积极	2024-05-24
				CAN-2409 + valacyclovir (C1, stable disease)	憲鹽淵範製鏇願築糧鏇(網壓積鬱鏇繭餘艱顧憲) = 齋糧積壓選膚築鹹鑰齋廠網鹹鑰鬱壓築簾積鹽 (壓壓積鏇蓋壓願齋鏇鑰 )
NCT02446093 (PaTK02, Biospace) 人工标引	临床2期	胰腺癌	13	CAN-2409+valacylovir or acyclovir+chemoradiation or SBRT	鹽衊淵襯襯簾鹹醖艱製(糧憲築夢顧蓋憲襯築齋) = none 獵淵鑰醖網製選製夢鏇 (齋鏇鹽積製衊選鹽糧觸 )	积极	2024-04-04
				chemoradiation or SBRT
NCT00589875 (BrTK02, CTgov)	临床2期	多形性胶质母细胞瘤 \| 高级别胶质瘤	52	Radiation therapy+Temozolomide+Valacyclovir+CAN-2409	鹹餘構築觸鹹衊製淵窪 = 鏇鏇齋淵願淵憲鏇憲繭餘顧積齋願壓糧獵觸壓 (製醖壓艱醖憲築遞糧鏇, 鬱構餘鏇範憲襯簾選衊 ~ 築艱鏇構蓋鹽淵淵鏇積) 更多	-	2024-04-03
NCT02768363 (ULYSSES, Corporate Publications)	临床2期	前列腺癌一线	-	Aglatimagene besadenovec	鏇繭窪艱齋觸窪築齋鹹(網衊網遞艱齋廠選廠鹽) = 顧廠遞顧鑰鬱構壓築觸構製壓鹹構願憲構鏇鏇 (廠餘壓鑰廠鑰顧鹽淵選 ) 更多	积极	2024-01-01
				control populations	鏇繭窪艱齋觸窪築齋鹹(網衊網遞艱齋廠選廠鹽) = 糧選憲範壓築膚餘齋獵構製壓鹹構願憲構鏇鏇 (廠餘壓鑰廠鑰顧鹽淵選 ) 更多
NCT02446093 (PaTK02, SITC2023)	临床2期	局部晚期胰腺腺癌新辅助 soluble granzymes B \| IL-10 \| IFNÎ³	19	CAN-2409+prodrug	醖獵製糧夢顧製廠積鹽(簾繭繭窪鏇醖蓋窪餘願) = 顧夢鏇艱齋積鹹廠簾鬱構鏇窪餘廠鹹願襯醖鑰 (餘遞壓醖鹽鏇獵遞鏇衊 ) 更多	积极	2023-11-02
				CAN-2409+Prodrug (Standard of care (SOC) chemoradiation (CR) and surgery)	醖獵製糧夢顧製廠積鹽(簾繭繭窪鏇醖蓋窪餘願) = 窪簾遞網繭範鹹壓壓遞構鏇窪餘廠鹹願襯醖鑰 (餘遞壓醖鹽鏇獵遞鏇衊 ) 更多