AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.

开始日期2021-03-29

申办/合作机构

EpicentRx, Inc.

100 项与 AdAPT-001 相关的临床结果

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100 项与 AdAPT-001 相关的转化医学

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100 项与 AdAPT-001 相关的专利（医药）

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项与 AdAPT-001 相关的文献（医药）

2024-10-01·Journal for ImmunoTherapy of Cancer

TGF-β trap of AdAPT-001 turns up the heat on tumors and turns down checkpoint blocker resistance

作者: Oronsky, Bryan ; Caroen, Scott ; Conley, Anthony ; Reid, Tony R ; Williams, Jeannie

At the ASCO 2024 meeting, Anthony P Conley, coauthor on this editorial, presented promising data from the phase 1/2 clinical trial called BETA PRIME (ClinicalTrials.gov NCT04673942) with AdAPT-001 plus a checkpoint inhibitor (CI). All participants gave informed consent to participate in BETA PRIME before taking part. AdAPT-001 is an oncolytic adenovirus that expresses a transforming growth factor beta (TGF-β) trap to neutralize active TGF-β. This editorial proposes that the TGF-β trap of AdAPT-001 reverses the immunosuppressive environment of tumor cells, and thus makes these tumors susceptible to CIs like the anti-PD-1 agent, nivolumab, and potentially other therapies as well.

2024-06-01·Journal for ImmunoTherapy of Cancer

Hypothesis: AdAPT-001 and pseudoprogression – when seeing is not necessarily believing

Article

作者: Caroen, Scott ; Reid, Tony R ; Conley, Anthony ; Stirn, Meaghan ; Larson, Christopher ; Oronsky, Bryan

The purpose of this commentary is to highlight the high occurrence of clinical pseudoprogression and delayed responses that have been observed to date with the locally injected oncolytic adenovirus, AdAPT-001, currently in a Phase 1/2 clinical trial (NCT04673942) for the treatment of treatment-refractory tumors. Not surprisingly, these have led to confusion about response assessment and whether to continue patients on treatment. AdAPT-001 carries a transforming growth factor (TGF)-beta trap (TGF-β), which sequesters TGF-β, a cytokine that potently regulates inflammation, fibrosis, and immunosuppression in cancer. Pseudoprogression (PsP) or progression prior to response or stabilization, has been widely recognized with radiotherapy for primary brain tumors and immune checkpoint inhibitors (ICIs). PsP has also been described and documented in the context of oncolytic virotherapy but perhaps to a lesser extent. However, repeated intratumoral injections with these immunostimulatory agents may induce a more intense immune response and release more antigenic epitopes than with ICIs, for example, which are strictly T-cell directed rather than also tumor-directed like AdAPT-001.

2024-04-01·Cancer gene therapy

BETA prime: a first-in-man phase 1 study of AdAPT-001, an armed oncolytic adenovirus for solid tumors

Article

作者: Williams, Jeannie ; Gastman, Brian R ; Oronsky, Bryan ; Barve, Minal A ; Caroen, Scott ; Villaflor, Victoria M ; Coyle, Angelique ; Wagle, Naveed ; Bessudo, Alberto ; Reid, Tony R ; Stirn, Meaghan ; Roland, Christina L ; Kesari, Santosh ; Conley, Anthony P ; Abrouk, Nacer ; Burbano, Erica ; Larson, Christopher

Abstract:

AdAPT-001 is an oncolytic adenovirus (OAV) with a transforming growth factor beta (TGF-ß) trap, which neutralizes the immunosuppressive and profibrotic cytokine, TGF-ß. The aim or purpose of this phase 1 study was to assess the safety and tolerability and, secondarily, the efficacy of AdAPT-001 after single intratumoral injection (IT) (Part 1) and multidose IT injection (Part 2) in patients with superficially accessible, advanced refractory solid tumors. Part 1 enrolled 9 patients with a 3 + 3 single dose-escalation safety run-in involving 2.5 × 1011, 5.0 × 1011, 1.0 × 1012 viral particles (vps). No dose-limiting toxicities or treatment-related serious adverse events (SAEs) were seen. In Part 2, a dose-expansion phase, 19 patients received AdAPT-001 at 1.0 × 1012 vps until disease progression according to Response Evaluation Criteria in Solid Tumors or RECIST 1.1. The overall responses to treatment included confirmed partial responses (3), durable stable disease ≥ 6 months (5), and progressive disease (13). AdAPT-001 is well tolerated. Evidence of an anti-tumor effect was seen in both injected and uninjected lesions. The recommended Phase 2 dose was 1.0 × 1012 vp administered by intratumoral injection once every 2 weeks. Combination of AdAPT-001 with a checkpoint inhibition is enrolling.

项与 AdAPT-001 相关的新闻（医药）

2026-02-04

·PRNewswire

Oncolytic Virus Clinical Trial Landscape Gains Momentum: 100+ Companies Lead the Charge in Pioneering New Treatments | DelveInsight

The oncolytic virus therapy landscape has expanded steadily over the past decade, with over 100 companies worldwide pursuing clinical or preclinical programs. A few leaders, such as Candel Therapeutics, Binhui Biopharmaceutical, Oncolytics Biotech, EpicentRx, Hangzhou Converd, and others, anchor the mid and late-stage pipeline. LAS VEGAS, Feb. 4, 2026 /PRNewswire/ -- DelveInsight's Oncolytic Virus Competitive Landscape 2026 report provides comprehensive global coverage of pipeline oncolytic virus therapies across various stages of clinical development. The report offers an in-depth analysis of key trends, emerging therapies, and the competitive landscape, highlighting the strategies of major pharmaceutical companies to advance their pipelines and capitalize on future growth opportunities. In addition, it provides critical insights into clinical trial benchmarking, partnering and licensing, and regulatory pathways with the FDA and EMA, enabling stakeholders to make informed decisions and optimize development strategies in the oncolytic virus domain. Oncolytic Virus Clinical Trial Analysis Summary DelveInsight's oncolytic virus pipeline report highlights a robust landscape, with 100+ active players developing 110+ oncolytic virus drugs. Key oncolytic virus companies such as Oncolytics Biotech, SillaJen, Candel Therapeutics, Binhui Biopharmaceutical, Oryx GmbH, Oncolys Biopharma, EpicentRx, Theriva Biologics, Lokon Pharma, DNAtrix, Surv BioPharma Inc., Treovir, Immvira Pharma, Virogin Biotech, OrienGene Biotechnology, Apices Soluciones, Vyriad, Transgene, BioEclipse Therapeutics, Imugene, CG Oncology, Istari Oncology, Akamis Bio, Elicera Therapeutics, and others are evaluating new oncolytic virus drugs to improve the treatment landscape. Promising pipeline oncolytic virus therapies, such as Pelareorep, Pexa-Vec, CAN-2409, BS001, ParvOryx, Telomelysin, AdAPT-001, VCN-01, LOAd 703, DNX-2401, Surv.m-CRA-1, G207, MVR-T3011, VG161, OrienX010, AloCelyvir, Voyager-V1, TG6002, CRX-100, CF33-hNIS, CG0070, PVS-RIPO, NG-350A, ELC-201, and others, are in different phases of oncolytic virus clinical trials. Request a sample and discover the recent advances in oncolytic virus drugs @ Key Factors Driving the Oncolytic Virus Therapy Market Growing Cancer Incidence: The global rise in cancer prevalence, especially in hard-to-treat solid tumors, has intensified demand for novel, effective treatment modalities. Conventional therapies such as chemotherapy and radiation often have significant side effects and limited long-term efficacy, motivating the adoption of immunotherapeutic alternatives like oncolytic virus therapies. Increasing Understanding of Cancer Biology: Growing knowledge of cancer biology has enabled the development of oncolytic virus therapies that selectively target and destroy cancer cells while sparing healthy cells. Advancements in Viral Engineering: These advances are enabling more precise, targeted oncolytic virus therapies, significantly expanding the global oncolytic virus therapy market. Rising Adoption of Personalized Medicine: Oncolytic virus therapies align closely with personalized treatment approaches by enabling tailored viral constructs and immunomodulatory payloads based on tumor genomics. What is Oncolytic Virus Therapy? Oncolytic virus therapy is an innovative form of cancer treatment that uses genetically engineered or naturally occurring viruses to selectively infect and destroy cancer cells. These viruses replicate inside tumor cells, causing them to burst while leaving healthy cells largely unharmed. As the cancer cells break apart, they release tumor antigens that help activate the body's immune system, enhancing its ability to recognize and attack remaining cancer cells. This dual action, direct tumor destruction and immune stimulation, makes oncolytic virus therapy a promising approach in modern oncology, often used alongside other treatments such as immunotherapy or chemotherapy. Applications of Oncolytic Virus Therapy Oncolytic virus (OV) cancer therapies can be used for both diagnosis and treatment of cancer. OVs can function as cancer vaccines by boosting tumor-specific T-cell responses. Oncolytic viruses can be engineered with immunostimulatory molecules to enhance immune activation. OVs show strong synergy when combined with other immunotherapies, such as checkpoint inhibitors. Oncolytic Viruses in Combination with Chemotherapy Chemotherapy works systemically, unlike surgical resection or radiotherapy. It remains essential for treating patients with disseminated (widespread) cancer. Because chemotherapy is systemic, it is often combined with oncolytic viruses (OVs), which typically require localized delivery to achieve a strong antitumor effect. Systemically administered OVs have shown limited therapeutic benefit in several clinical trials. Delivering OVs effectively to metastatic sites remains a major challenge. Therefore, using chemotherapy as a systemic adjuvant to localized OV therapy is of significant clinical interest and is currently being actively investigated. Oncolytic Virus Market Analysis: Drug Profile IMLYGIC: Amgen IMLYGIC (talimogene laherparepvec), developed by Amgen, is a first-of-its-kind oncolytic viral therapy for melanoma that cannot be surgically removed. It combines direct tumors destruction with immune system stimulation. The therapy is based on a genetically engineered herpesvirus engineered to preferentially infect and destroy cancer cells, releasing GM-CSF to trigger a broader anti-tumor immune response. In the Phase III OPTiM trial, IMLYGIC produced durable responses in about 16% of patients, compared with 2% with GM-CSF alone, and overall responses in roughly 26%. Patients at earlier disease stages achieved better outcomes, with some achieving long-term control. The treatment is usually well tolerated, with most adverse effects being mild and resembling flu symptoms. Although its independent effect on survival and deep organ metastases is modest, its value is most evident when combined with checkpoint inhibitors. Early data show response rates approaching 56%, and ongoing studies aim to further define these synergistic benefits. As the first FDA-approved oncolytic virus in the West, IMLYGIC has validated the broader concept of viral immunotherapy and is now being explored as a component of combination immuno-oncology approaches. Oncorine: Shanghai Sunway Biotech Oncorine, also known as H101, is a genetically engineered adenovirus with an E1B gene deletion developed by Shanghai Sunway Biotech in China. It is administered alongside chemotherapy to treat nasopharyngeal carcinoma and head and neck cancers. Its approval and effective clinical use have significantly advanced oncolytic virus–based cancer immunotherapy. Marketed as Recombinant Human Adenovirus Type 5 Injection, Oncorine became the first oncolytic virus approved for cancer treatment by the Chinese State Food and Drug Administration (CFDA) in November 2005. Since its introduction, it has demonstrated a favorable safety profile and notable antitumor activity across various cancers and malignant pleural effusions. Exploratory clinical studies have also evaluated Oncorine for treating liver cancers, pancreatic cancer, cervical cancer, malignant melanoma, and metastatic liver tumors. Find out more about oncolytic virus cancer drugs @ Oncolytic Virus Analysis A snapshot of the Pipeline Oncolytic Virus Drugs mentioned in the report: Learn more about the emerging oncolytic virus therapies @ Oncolytic Virus Clinical Trials Recent Developments in Oncolytic Virus Treatment Space In November 2025, Imugene Ltd and JW Therapeutics announced a co-development collaboration to evaluate the combination of Imugene's oncolytic virus CF33-CD19 (onCARlytics) and JW's Carteyva®, a CD19-directed autologous CAR-T cell therapy, for patients with advanced solid tumors. This collaboration includes preclinical in vitro and in vivo studies, followed by a Phase I investigator-initiated trial to be conducted exclusively in China at premier CAR-T clinical centers. The approach utilizes Imugene's CF33-CD19 virus to induce CD19 expression on tumor cells, rendering them susceptible to targeting by CD19 CAR-T therapies, a transformative "mark and kill" strategy. In July 2025, Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company's allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma. In June 2025, Oncolytics Biotech presented a poster demonstrating the role of pelareorep in activating anti-tumor immunity in PDAC. In May 2025, Candel Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company's biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. CAN-2409 was also previously granted FDA Fast Track designation for the same indication. In May 2025, Elicera Therapeutics AB announced that it had entered into a Material Transfer Agreement (MTA) with University Hospital Tübingen in Germany. Under the agreement, the company's oncolytic virus candidates ELC-100 and ELC-201 will be included in tests aimed at developing a new type of companion diagnostic to predict the potential success of a novel neuroendocrine neoplasm (NEN) therapy, immuno-virotherapy. In April 2025, Hangzhou ConVerd Co., Ltd. announced that the first Phase IIa clinical study of hV01, ConVerd's first oncolytic vaccinia virus product, had successfully completed first patient dosing, with the subject in good condition. This phase IIa clinical study investigates the administration of a single dose of recombinant human IL-21 oncolytic poxvirus injection (hV01) per cycle for the treatment of patients diagnosed with advanced sarcoma and cervical cancer. It is important to note that the indication is for advanced sarcoma and recurrent or metastatic cervical cancer for which there is no standard of care available at this stage of the treatment process, or where standard of care has failed. Scope of the Oncolytic Virus Pipeline Report Coverage: Global Key Oncolytic Virus Companies: Oncolytics Biotech, SillaJen, Candel Therapeutics, Binhui Biopharmaceutical, Oryx GmbH, Oncolys Biopharma, EpicentRx, Theriva Biologics, Lokon Pharma, DNAtrix, Surv BioPharma Inc., Treovir, Immvira Pharma, Virogin Biotech, OrienGene Biotechnology, Apices Soluciones, Vyriad, Transgene, BioEclipse Therapeutics, Imugene, CG Oncology, Istari Oncology, Akamis Bio, Elicera Therapeutics, and others Key Oncolytic Virus Pipeline Therapies: Pelareorep, Pexa-Vec, CAN-2409, BS001, ParvOryx, Telomelysin, AdAPT-001, VCN-01, LOAd 703, DNX-2401, Surv.m-CRA-1, G207, MVR-T3011, VG161, OrienX010, AloCelyvir, Voyager-V1, TG6002, CRX-100, CF33-hNIS, CG0070, PVS-RIPO, NG-350A, ELC-201, and others Dive deep into rich insights for new oncolytic Virus treatments, visit @ Oncolytic Virus Drugs Table of Contents Related Reports Oncolytic Virus Therapies Market Oncolytic Virus Therapies Market Size, Target Population, Competitive Landscape, and Market Forecast – 2034 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key oncolytic virus therapies companies including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichi Sankyo, and others. Melanoma Market Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key melanoma companies including IO Biotech, Merck Sharp & Dohme, Eisai, Regeneron Pharmaceuticals, Iovance Biotherapeutics, Highlight Therapeutics, Linnaeus Therapeutics, Spring Bank Pharmaceuticals, Taiga Biotechnologies, Inc., Aivita Biomedical, Inc., Genentech, Inc., Dana-Farber Cancer Institute, BioMed Valley Discoveries, Inc, Amgen, Checkmate Pharmaceuticals, Astellas Pharma Inc, Galectin Therapeutics Inc., Eucure (Beijing) Biopharma Co., Ltd, Mologen AG, Ultimovacs ASA, Seagen Inc., MedImmune LLC, OnKure, Inc., Syntrix Biosystems, Inc., Anaveon AG, iOx Therapeutics, Portage Biotech, ModernaTX, Inc., Nektar Therapeutics, BioNTech SE, Sapience Therapeutics, HUYABIO International, LLC., Provectus Biopharmaceuticals, Inc., Cantargia AB, Turnstone Biologics, Corp., Aura Biosciences, F-star Therapeutics, Inc., Day One Biopharmaceuticals, Inc., Kinnate Biopharma, Xencor, Inc., HiFiBiO Therapeutics, and others. Colorectal Cancer Market Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key colorectal cancer companies, including Mirati Therapeutics, Exelixis, Enterome, Arcus Biosciences, Lyell Immunopharma, AstraZeneca, Novartis Pharmaceuticals, Surgimab, Numab Therapeutics, SOTIO Biotech, Amgen, Sichuan Baili Pharmaceutical, Qilu Pharmaceutical, Bristol-Myers Squibb, NGM Biopharmaceuticals, Takeda, PureTech, Pfizer, Kezar Life Sciences, Salubris, Biotherapeutics , and others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies including FibroGen, OSE Immunotherapeutics, Lokon Pharma, Oncotelic Inc., Tesaro, Inc., Helix BioPharma Corporation, Theradex, Tvardi Therapeutics, Incorporated, AIM ImmunoTech Inc., BioNTech SE, Prestige Biopharma Limited, HCW Biologics, Cantex Pharmaceuticals, XBiotech, Inc., Lumicell, Inc., CARsgen Therapeutics Co., Ltd., Panbela Therapeutics, Inc. , and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

临床结果临床2期免疫疗法快速通道临床3期

2025-12-17

·康和源免疫之家

81.8%疾病控制率！溶瘤病毒疗法YSCH-01获FDA“通行证”，复发胶质母细胞瘤患者迎来新希望

近日，元宋生物宣布其核心产品YSCH-01获得美国食品药品监督管理局（FDA）临床试验批准，将用于治疗复发胶质母细胞瘤（rGBM）。重组L-IFN腺病毒注射液（YSCH-01）是一款溶瘤病毒产品。溶瘤病毒是一种癌症治疗方法，利用介导抗肿瘤活性的病毒诱导免疫原性细胞死亡，从而产生对肿瘤的免疫力。2024年5月，知名学术期刊《癌症免疫治疗杂志》发表了YSCH-01在晚期实体肿瘤患者中的初步疗效。该试验共纳入13例实体瘤患者，其中肺癌患者5例，乳腺癌患者3例，黑色素瘤患者3例，卵巢癌和头颈癌患者各1例。结果显示：3例患者达到部分缓解（PR），6例患者病情稳定（SD），疾病控制率（DCR）为81.8%，中位无进展生存期（PFS）为4.97个月，中位总生存期（mOS）为8.62个月。该临床数据为后续溶瘤病毒的临床研究提供了积极信息。目前，康和源免疫之家有溶瘤病毒相关临床试验正在招募三阴乳腺癌患者，既往经过标准治疗失败的患者，可联系康和源免疫之家医学部（电话：400-880-3716），提交病例资料、治疗经历等进行初步筛选，符合条件的患者可入组免费接受治疗。关于溶瘤病毒溶瘤病毒是一类新兴的癌症治疗药物，这些经特殊设计的病毒可感染并杀死癌细胞。溶瘤病毒通过多种作用机制发挥抗肿瘤效果，包括在肿瘤细胞中选择性复制、诱导免疫原性细胞死亡，以及刺激宿主抗肿瘤免疫力。病毒杀死细胞与免疫系统杀死细胞之间存在很大的协同作用。如果能直接用病毒杀死细胞，就会引发抗原扩散并释放信息，这些信息会被免疫系统捕获。这正是细胞破裂、死亡或被这些方式摧毁时自然发生的机制。优势它们之所以成为一种极具前景的癌症治疗手段，主要基于以下几个原因： 1.癌细胞抗病毒防御能力较弱，使其更容易被病毒感染。 2.天然病毒可被基因改造，以增强其治疗优势，包括降低它们感染健康细胞的能力，以及赋予它们特异性地向肿瘤递送治疗有效载荷的能力，并在感染肿瘤细胞后产生免疫增强分子。 3.溶瘤病毒也可以作为病毒载体，将其他癌症疗法转运到肿瘤细胞中。例如，溶瘤病毒可用于将基因疗法送入癌细胞。病毒一旦到达目的地，其功能即会终止。 4.溶瘤病毒也可以与其他类型的细胞疗法结合使用。例如，工程化的T细胞可以成为溶瘤病毒的病毒载体。在黏液瘤病毒介导的（细胞死亡）过程中，治疗目标周围的癌细胞也会被消灭，这一过程被称为“旁观者杀伤效应”。这种效应能显著增强双重疗法对癌细胞的彻底清除能力，甚至对众所周知的难治性实体瘤也有效果。与某些副作用剧烈的癌症疗法不同，溶瘤病毒通常非常适合难以耐受传统治疗的患者，这使其成为老年患者或不适合接受激进治疗方案患者的宝贵选择。 T-VEC于2015年10月27日获得FDA批准，该批准适用于治疗某些无法手术切除的转移性黑色素瘤患者。然而，利用病毒治疗癌症的历史由来已久，在整个20世纪，学术界已陆续报道了各种病毒在癌症治疗中的案例研究和和小型临床试验。直到20世纪90年代，通过基因工程改造病毒以增强其溶瘤能力的研究时代才真正开启。首个被报道的基因工程溶瘤病毒基于单纯疱疹病毒1型（HSV-1）。此后，大量研究迅速跟进，利用多种病毒和肿瘤模型验证了这一方法的有效性。晚期实体瘤患者中观察到部分缓解与长期稳定 2023年12月，《Cancer Gene Therapy》发表了AdAPT-001在晚期实体瘤患者中的1期临床研究结果。第二部分共纳入23例患者，在15例可评估反应的患者中，5例患者有长期稳定的反应，2例患者部分缓解。该试验中1例64岁的男性患者，患有复发性骶索瘤转移至手臂、肝脏、肾脏和腹膜后，接受了骶骨放疗。2022年6月参加AdAPT-001的临床试验后，观察到他的手臂注射病灶减少了72.2%。复发性高级别胶质瘤患者中实现完全缓解与长期生存 2024年11月8日，《nature communications》发表了溶瘤病毒Ad-TD-nsIL12在复发性高级别胶质瘤患者中的I期研究结果。共纳入8例患者接受治疗，结果显示：4例患者病情稳定（SD），患者6达到完全缓解（CR），患者4部分缓解（PR），中位总生存期（OS）为18.9个月。其中一名患者持续8个月时间的头晕、左视力下降和失语异常，放疗和同步替莫唑胺治疗后，肿瘤出现进展，而Ad-TD-nsIL12治疗后肿瘤完全消失，并持续缓解至少18个月。综上可见，溶瘤病毒疗法是一种有前途的治疗选择。溶瘤病毒是一种前沿治疗选择。如果患者在国内经过多种治疗仍旧无效的话，可尝试前往国际顶尖癌症治疗机构寻求治疗或专家会诊。有出国就医意向或需要专家会诊的患者请联系康和源免疫之家医学部（400-880-3716）。结语 YSCH-01获得FDA批准进入临床试验，为复发胶质母细胞瘤患者提供了新的希望。未来，随着更多临床数据的积累，该疗法有望成为联合免疫治疗、放疗等手段的重要一环，为更多晚期癌症患者带来可持续的治疗选择。参考资料 1.https://acgtfoundation.org/news/oncolytic-virus-therapy-for-cancer/ 2.https://www.onclive.com/view/rp1-and-other-oncolytic-viruses-could-pave-a-new-treatment-pathway-in-advanced-melanoma 3.https://jitc.bmj.com/content/11/12/e007905 4.https://www.nature.com/articles/s41417-023-00720-0 5.https://www.nature.com/articles/s41467-024-53041-7 如果您在阅读本文后仍有困惑，或需要帮助，可通过康和源免疫之家医学部（400-880-3716）获取专业指导。您可以通过添加以下微信方式联系我们。曹老师微信：17801183037 谢老师微信：15810815293 康和源免疫之家 - 癌症患者的生命希望桥梁康和源免疫之家作为肿瘤诊疗服务平台，始终秉持“以患者为中心”的理念。在肿瘤治疗领域，患者面临着巨大的身心压力和复杂的治疗选择，康和源免疫之家深知患者的需求和困境，致力于为患者提供全方位、个性化的服务。为了实现这一目标，该平台整合了中国、美国、欧洲、日本、韩国等全球顶尖肿瘤专家资源。这些专家拥有丰富的临床经验和先进的治疗理念，能够为患者提供专业的诊断和治疗建议。同时，平台还与知名药企、创新药物研发机构建立了深度合作关系，这使得患者能够及时了解到前沿的抗癌药物和治疗技术，为治疗提供更多的选择。国际专家会诊服务肿瘤治疗具有复杂性和个体差异性，不同患者的病情和身体状况各不相同，因此需要个性化的治疗方案。康和源免疫之家通过国际专家会诊服务，可协调中美欧日韩等多国权威肿瘤专家，针对癌症开展跨国联合诊疗。对于那些需要第二诊疗意见的患者来说，国际专家会诊可以提供不同的视角和建议，帮助患者更全面地了解自己的病情和治疗方案。而对于寻求海外先进治疗方案的患者，平台的专业团队能够帮助他们获取国际前沿治疗指南，为患者制定更加科学、合理的治疗计划。临床试验作为连接患者与创新疗法的纽带，康和源免疫之家与全球领先药企及研发机构保持战略合作，持续提供涉及PD-1/L1抑制剂、CAR-T细胞治疗、ADC药物等领域的临床试验项目。这些临床试验项目代表了当前癌症治疗的前沿进展和研究方向，为患者提供了接触新型抗癌药物和治疗技术的机会。康和源免疫之家团队会根据患者的病情阶段、基因检测结果和治疗史，精准匹配适合的临床试验机会。这不仅提高了患者参与临床试验的成功率，也确保了患者能够接受更加适合自己的治疗。在康和源免疫之家，每个生命都被视为值得更好的医疗选择，无论是寻求国际顶尖专家的诊疗建议，还是尝试突破性的临床试验，平台都将竭诚为患者提供专业、可靠的全方位支持。让我们携手，在抗击肿瘤的征程上走得更远。 END 如果您或您身边的人正在遭受癌症的困扰，不妨拨打咨询电话400-880-3716，登录官网 https://www.myimm.net/ 或关注微信公众号“康和源免疫之家”（头条、知乎、百度、搜狐等自媒体同名），了解更多关于临床试验和肿瘤诊疗服务的信息。 🌿 抗癌，不仅是力量的抗争，更是精准的博弈。🌿 当亲人面对癌症，我们常问：“什么治疗方案更有效？会不会产生耐药？这种病会遗传给家人吗？” 这些关乎生存与未来的关键问题，答案可能就藏在每个人的基因里。 🧬 基因检测：为患者点亮精准治疗的“导航”，为家属揭开遗传风险的“谜底”。🧬 精准打击肿瘤，避免无效治疗肿瘤千差万别，用药也需“量体裁衣”。我们的基因检测能明确揭示肿瘤的基因突变靶点，就像为导弹装上“精确制导系统”，快速匹配更可能有效的靶向药物，避免在无效的化疗中消耗宝贵的生命与希望。评估遗传风险，为家人构筑健康防线部分癌症与遗传密切相关。通过基因检测，可以评估患者是否携带明确的遗传易感基因突变。这不仅解释了病因，更能为您的子女、兄弟姐妹等近亲提供至关重要的预警，让他们能及早干预，主动守护健康。 🔬康和源免疫之家，用基因图谱，守护您与家人的生命延续。🔬 我们提供的不仅是冰冷的报告，更是一份贯穿诊断、治疗与康复的“科学行动指南”。我们的医学专家将为您深度解读基因信息，在复杂的治疗选择中提供决策支持，并为整个家庭的健康风险管理提供专业建议。 📞 一人检测，可能惠及全家。立即拨打 400-880-3716，康和源免疫之家医学部，为您与家人的未来，提供一份科学的答案。让科学指引方向，让选择更有力量。扫描下方二维码，或者直接电话咨询康和源免疫之家医学部（400-880-3716），持续为您关注并分享癌症前沿消息。免责声明:文本参考来源于网络，版权归原作者所有。该文章仅供分享，如涉嫌侵犯您的著作权请联系我们删除，谢谢！

免疫疗法临床结果临床2期

2025-12-01

·可愈有道

攻克肉瘤新曙光！美国AdAPT-001溶瘤病毒疗法显疗效

/致力于帮助重疾患者寻找治愈之道/ 肉瘤是一类起源于间叶组织的恶性肿瘤，具有种类多样、病理表现复杂的特点。一直是临床治疗领域的棘手难题。尽管手术、放疗与化疗等传统治疗方式在病情控制方面发挥了一定作用，但对于晚期或转移性肉瘤患者而言，疗效往往有限，且伴随严重的毒副作用，患者生存质量亟待提升。随着肿瘤免疫治疗的飞速发展，一种名为AdAPT-001的溶瘤病毒疗法在近期的临床试验中展现出令人振奋的疗效，为肉瘤患者带来了攻克疾病的新曙光。图源：摄图网与传统化疗药物“不分敌我”的杀伤机制不同，AdAPT-001能精准识别肿瘤细胞表面的特定受体或利用肿瘤细胞活跃的增殖信号，选择性地在肿瘤细胞内复制。 2024年12月，美国食品药品监督管理局（FDA）已正式授予了溶瘤病毒疗法AdAPT-001联合PD-1抑制剂Nivolumab（纳武利尤单抗）或Atezolizumab（阿特珠单抗）用于治疗复发或难治性晚期及转移性软组织肉瘤患者的快速通道资格。这些患者先前至少接受过一线标准治疗，但病情仍持续进展，亟需更有效的治疗选择。 AdAPT-001是一种新型溶瘤病毒疗法，由美国生物制药公司EpicentRx开发的，作用机制是通过选择性感染并裂解肿瘤细胞，同时激发机体免疫反应。该药物在临床前及临床研究中显示出对多种实体瘤的治疗潜力，适应症范围包括软组织肉瘤、结直肠癌、乳腺癌以及肝细胞癌等。在涉及软组织肉瘤的临床试验里，使用AdAPT-001与免疫检查点抑制剂（如Nivolumab或者Atezolizumab）联合疗法的患者获得了积极的疗效数据。客观缓解率（ORR）达到21％，即超过五分之一的患者实现了肿瘤体积显著缩小或影像学完全消失。此外，在6个月时点的无进展生存率为38％，这表明有相当比例的患者在半年内病情保持稳定，未出现肿瘤进展或转移。图源：摄图网该快速通道认定的授予主要基于一项名为BETA-PRIME的临床研究数据支持。2024年在美国临床肿瘤学会（ASCO）年会上发布的研究结果表明：14例可评估的软组织肉瘤患者中，经AdAPT-001联合免疫检查点抑制剂治疗后，患者的客观缓解率为21％，而在研究者评估中这一比例达到36％。同时，6个月无进展生存率（PFS率）在独立评估中为38％，研究者评估中则高达54％，显示出该联合疗法在延缓疾病进展方面的潜在优势。值得指出的是，在这项临床研究里，软组织肉瘤患者的中位无进展生存期（mPFS）还未被达到，这意味着超过半数的入组患者在数据截止时仍未发生疾病进展，提示该治疗法可能具有持久的疾病控制效果。研究还记录到一些特殊的临床案例。1例脊索瘤患者和1例血管肉瘤患者即使在初步疾病进展后仍选择继续接受联合治疗，反映出该方案在某些难治性患者中可能具有独特的临床价值。截至到目前，尚有7名患者处于治疗阶段，这其中包括5例软组织肉瘤病例，提示该疗法具备良好的耐受性和治疗持续性。从安全性角度看，AdAPT-001在研究中未出现任何剂量限制性毒性反应，也没有报告与药物相关的严重不良事件。在接受免疫检查点抑制剂联合治疗的患者群体中，免疫相关不良反应的发生率较低，仅观察到1例相关病例。整体安全性可控。除注射部位可能出现暂时性反应外，该疗法未对周围正常组织造成显著毒性或损伤。大多数与AdAPT-001相关的不良反应为1级或2级，主要包括发热、乏力等类流感症状，表明其具备良好的临床安全性特征。图源：摄图网 AdAPT-001治疗相关的不良事件主要表现为发热和注射部位局部反应。在临床观察过程中，未检测到显著的鼻咽病毒脱落，这意味着没有发现明显的病毒从患者鼻咽部位释放或传播至体外，说明该治疗方法在安全性方面表现良好，未引发潜在的病毒扩散风险。此外，所有注射部位的病毒脱落或局部反应均在给药后的4周内完全清除，表明该药物具有较好的局部耐受性和迅速的清除能力，进一步印证了其临床使用的安全性及患者的良好耐受状况。由于AdAPT-001主要是利用经过基因工程改造的溶瘤腺病毒作为载体，将一种名为TGFβ抑制剂的治疗性分子精准递送至肿瘤组织内部。其作用机制包括高效“关闭”肿瘤微环境中过度表达的TGFβ信号通路。该通路被认为是促进肿瘤生长、侵袭以及免疫逃逸的关键因子；同时，AdAPT-001能够显著抑制调节性T细胞（Tregs）等具有免疫抑制功能的细胞亚群，从而解除肿瘤对免疫系统的压制，增强机体自身对抗癌细胞的能力。值得注意的是，当AdAPT-001与免疫检查点抑制剂联合应用时，可产生协同增效作用，显著提升抗肿瘤免疫应答的整体强度与持久性。图源：摄图网目前，AdAPT-001具有较为广泛的抗癌谱，目前已应用于多种实体瘤的治疗研究，包括软组织肉瘤、结直肠癌、乳腺癌以及肝细胞癌等。 AdAPT-001溶瘤病毒疗法在肉瘤治疗中展现的疗效，其意义远不止于为患者提供一种新的治疗选择。它标志着肉瘤治疗从传统的“物理清除”和“毒性杀伤”向“精准靶向”与“免疫激活”相结合的治疗模式迈出了重要一步。扫码立即开启与美国专家对话窗口海外专家第二诊疗意见定制个人治疗方案 ▼ 首先，它为那些处于绝望中的晚期肉瘤患者带来了切实的生存希望，打破了“无药可医”的困境。其次，AdAPT-001的成功为其他类型实体瘤的治疗提供了宝贵的借鉴经验，推动了溶瘤病毒疗法在更广泛肿瘤领域的探索。再者，该疗法研发过程融合了病毒学、分子生物学、免疫学等多学科前沿技术，其进展也将促进相关基础研究和转化医学的发展，加速更多创新疗法的诞生。图源：摄图网综上所述，AdAPT-001溶瘤病毒疗法在肉瘤治疗中展现出的显著疗效，无疑为攻克这一难治性肿瘤带来了新曙光。它不仅是肿瘤免疫治疗领域又一重要突破，更点燃了无数肉瘤患者战胜疾病的信心。随着研究不断深入和临床试验的持续推进，AdAPT-001及其他类似的溶瘤病毒疗法将在不久的将来成为肉瘤综合治疗体系中的关键一环，为提高患者生存率、改善生活质量贡献重要力量，推动人类在对抗癌症的道路上不断前行。参考来源： AdAPT-001 Gets FDA Fast Track Designation in Recurrent/Refractory Soft Tissue Sarcoma https://www.onclive.com/view/adapt-001-gets-fda-fast-track-designation-in-recurrent-refractory-soft-tissue-sarcoma ·END· 免责声明：公司所提供的信息均来源于网络上公开发表的文献或文章，仅供用户参考使用。本公司力求为用户提供准确、客观的信息资料与数据，用户据信息作出的选择和判断，公司不承担任何经济与法律责任。分享、收藏、点赞、在看安排一下？

100 项与 AdAPT-001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
软骨肉瘤	临床2期	美国	EpicentRx, Inc.	2021-03-29
软组织肉瘤	临床2期	美国	EpicentRx, Inc.	2021-03-29

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临床结果

适应症

分期

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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


NCT04673942 (BETA-PRIME, ASCO2025) 人工标引	临床2期	实体瘤	18	Prior Checkpoint Inhibitor	艱糧製簾窪窪遞膚窪衊(齋築製選膚艱鏇築鑰簾) = Treatment with AdAPT-001 was well tolerated and no new safety signals emerged. 遞選淵衊網廠廠製膚艱 (製艱鬱衊遞艱觸憲遞鬱 ) 更多	积极	2025-05-30
NCT04673942 (BETA-PRIME, ASCO2025) 人工标引	临床2期	实体瘤	18	AdAPT-001 + Checkpoint Inhibitor		积极	2025-05-30
Phase 1/2 clinical trial (AACR2025)	临床1/2期	肉瘤	25	AdAPT-001 plus checkpoint inhibitor	襯鬱遞積願築襯鑰衊壓(願襯觸鏇壓窪蓋糧鬱鑰) = 鏇窪憲觸窪窪願鏇選鏇醖艱壓繭壓網顧獵網顧 (窪淵繭艱醖願憲艱醖壓 ) 更多	积极	2025-04-27
NCT04673942 (BETA PRIME, SITC2024)	临床2期	实体瘤	25	AdAPT-001 + Checkpoint Inhibitor	繭廠製鹹廠選夢繭築壓(獵鬱廠選遞壓鹹廠鏇夢) = 1/25 (4.0%) developed immune-related hypophysitis 觸觸鬱鏇餘淵範膚願獵 (糧醖積艱糧製醖顧築遞 ) 更多	积极	2024-11-05
NCT04673942 (ASCO2024) 人工标引	临床2期	肿瘤	36	AdAPT-001 monotherapy	壓鹹願鑰繭糧壓繭獵齋(醖獵壓願餘簾鹹選繭鹽) = 顧齋顧憲艱積遞鹽糧廠糧淵築構願醖淵積範夢 (鬱艱壓觸鹽膚憲繭繭積 ) 更多	积极	2024-05-24
NCT04673942 (ASCO2024) 人工标引	临床2期	肿瘤	36	AdAPT-001 + CI combination	壓鹹願鑰繭糧壓繭獵齋(醖獵壓願餘簾鹹選繭鹽) = 遞鹹簾膚築襯簾鏇廠築糧淵築構願醖淵積範夢 (鬱艱壓觸鹽膚憲繭繭積 ) 更多	积极	2024-05-24
NCT04673942 (AACR2024) 人工标引	临床2期	肿瘤	36	AdAPT-001 +/- a checkpoint inhibitor	廠顧鹽願構鏇膚壓築網(窪醖簾構醖獵蓋鹹簾衊) = 齋艱願壓餘廠鹽繭簾遞築憲壓顧鹹憲糧積製壓 (網構製膚鑰網構鏇構鏇 ) 更多	积极	2024-04-05
NCT04673942 (BETA-PRIME, Pubmed \| Cancer Gene Ther) 人工标引	临床1期	实体瘤	28	AdAPT-001	顧網壓壓膚鹽糧鬱鬱窪(糧膚鹽網遞構獵壓鹽餘) = 醖鏇襯窪憲醖構網構遞簾構蓋衊衊襯觸鹹衊鏇 (願蓋鹽糧願選餘蓋糧鏇 ) 更多	积极	2024-04-01
NCT04673942 (BETA-PRIME, ASCO 12023 \| ASCO 22023) 人工标引	临床1期	实体瘤	19	AdAPT-001	餘淵網窪顧壓鹹製簾鹹(淵衊觸艱顧網顧積憲鏇) = 顧醖廠膚鏇構壓鹽餘襯襯鹹憲憲網網壓襯網製 (廠齋觸選襯廠積鹹願淵 ) 更多	积极	2023-05-26