A Phase 2 Study of Epcoritamab (Epco) Plus Physician's Choice of Platinum-Containing Chemotherapy Pre-Autologous Hematopoietic Cell Transplantation (AutoHCT) Followed by Post-AutoHCT Epco Consolidation/ Maintenance in Relapsed/ Refractory Large B-Cell Lymphoma (R/R LBCL)

This phase II trial tests how well epcoritamab in combination with standard of care (SOC) platinum-based chemotherapy (rituximab, ifosfamide, carboplatin, etoposide [RICE], rituximab, cytarabine, dexamethasone, oxaliplatin or carboplatin RDHAP/X] or gemcitabine and oxaliplatin [Gem/Ox]) and autologous hematopoietic cell transplant (HCT) works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab, a type of bispecific T-cell engager, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs, such as ifosfamide, etoposide phosphate, cytarabine, and gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. An autologous HCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving epcoritamab in combination with SOC platinum-based chemotherapy, such as RICE, RDHAP/X and Gem/Ox, and autologous HCT may kill more cancer cells in patients with relapsed or refractory LBCL.

开始日期2025-08-01

申办/合作机构

University of California, Davis

[+1]

NCT06820957

/ Not yet recruiting临床2/3期IIT

Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma

This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Ifosfamide, a type of alkylating agent and a type of antimetabolite, attaches to DNA in cells and may kill tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving VIrR/VDC/IE may be more effective than usual treatment with VDC/IE in treating patients with newly diagnosed metastatic Ewing sarcoma or other round cell sarcomas.

开始日期2025-07-15

申办/合作机构

The Children's Oncology Group Foundation, Inc.

NCT06835049

/ Not yet recruiting临床2期IIT

Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE). A Multicenter, Single Arm, Open Label, Phase II Trial

Soft tissue sarcomas (STSs) are rare cancers with a 5-year survival rate of 60%, and there is no standard treatment for high-risk extremity and trunk STSs (eSTS). A phase III trial suggests that adding moderate regional hyperthermia (HT) to anthracycline-based chemotherapy, followed by surgery and radiotherapy (RT), can improve 10-year overall survival by 10%. This trial aims to optimize treatment by combining the most effective regimens from chemotherapy, HT, RT, and surgery, and will evaluate the feasibility of this new total neoadjuvant treatment (TNT) approach.

开始日期2025-05-15

申办/合作机构

Swiss Group for Clinical Cancer Research

100 项与异环磷酰胺相关的临床结果

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100 项与异环磷酰胺相关的转化医学

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100 项与异环磷酰胺相关的专利（医药）

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9,831

项与异环磷酰胺相关的文献（医药）

2025-08-01·Journal of Pharmaceutical and Biomedical Analysis

Simultaneous analysis of various anticancer drugs by supercritical fluid chromatography-mass spectrometry. Part I: Optimization of chromatographic separation

Article

作者: Bonnabry, Pascal ; Rudaz, Serge ; Fleury-Souverain, Sandrine ; Guillarme, Davy ; Nguyen, Nathalie

This work presents a generic SFC-MS method for the simultaneous analysis of 22 anticancer drugs (fluorouracil, busulfan, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, docetaxel, doxorubicin, epirubicin, etoposide, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, paclitaxel, pemetrexed, raltitrexed, topotecan, treosulfan, vinblastine, vincristine). The separation conditions were optimized by screening nine stationary phases (2-picolylamine, bare hybrid silica, 2-ethylpyridine, fluoro-phenyl, octadecyl, diethylamine, diol, 1-aminoanthracene, zwitterionic modification), evaluating additives effects (2-5 % water, 20-50 mM ammonium formate, 0-1 mM ammonium fluoride), and adjusting the organic modifier composition (methanol, ethanol, isopropanol, acetonitrile). The optimized SFC-MS method successfully analyzed 22 anticancer drugs, along with 5 additional challenging compounds (azacitidine, mitomycin, cisplatin, oxaliplatin, carboplatin), in 12 min, using a diol column (100 × 3 mm, 1.7 µm) and a gradient of 2-100 % methanol containing 2 % water and 50 mM ammonium formate. To overcome overpressure generated by high organic solvent content, a backpressure gradient (110-150 bar) and a flow rate gradient (0.6-1.5 mL/min) were applied. The diol column was selected as the most promising based on five predefined chromatographic criteria. Additives with 5 % water or ammonium fluoride were excluded due to overpressure and signal loss, respectively. Increasing ammonium formate concentration improved peak symmetry by 29 %. For the organic modifier, pure methanol was chosen since ternary mixtures led to system overpressure without improving separation. Comparison with the LC-MS method using real samples confirmed the potential applicability of the SFC method, as the same trace compounds were detected with comparable concentrations. Sensitivity optimization and method validation will be discussed separately in a later paper.

2025-06-01·Analytical Science Advances

Simultaneous Determination of Residual Contamination of Eight Antineoplastic on Surfaces by HILIC Chromatography Coupled to High‐Resolution Spectrometry

Article

作者: Solgadi, Audrey ; Berriri, Sarra ; Safta, Fathi ; Caudron, Eric ; Kaouther, Zribi ; Mai Lê, Laetitia Minh ; Libong, Danielle

ABSTRACTResidual contamination by intravenous antineoplastic drugs on hospital surfaces remains a critical concern, as highlighted by numerous studies. This study presents a novel, rapid and highly sensitive analytical method for quantifying a wide range of antineoplastic drugs and detecting other potentially harmful molecules on wiped surfaces. Utilizing hydrophilic interaction liquid chromatography (HILIC) coupled with high‐resolution spectrometry, the method combines the quantification of eight commonly used antineoplastic drugs: 5‐fluorouracil, ifosfamide, cyclophosphamide, gemcitabine, doxorubicin, methotrexate, epirubicin and irinotecan, with the identification of unknown compounds offering a comprehensive solution for monitoring hospital surface contamination. While HILIC‐MS/MS has been extensively applied in various matrices, its use for surface contamination monitoring in healthcare settings has been relatively underexplored. Chromatographic separation was achieved using gradient elution on an HILIC ZORBAX 120 column (150 mm × 2.1 mm, 4 µm), enabling rapid analysis within 8 min. The method demonstrated exceptional sensitivity, achieving limits of quantification below 0.04 ng/cm2 for all targeted molecules. Applied to 28 surfaces in the day hospital of a medical oncology unit at a French hospital, the method revealed contamination on 22 surfaces with at least one antineoplastic drug. Additionally, unknown molecules, including a compound associated with cleaning detergents, were detected, highlighting the complexity of hospital surface contamination underscoring the ongoing risks faced by healthcare workers and patients. This innovative approach represents a significant advancement in analytical chemistry and hospital hygiene monitoring, providing a faster, more efficient and versatile alternative to traditional techniques, as it allows 5‐FU quantification within the same run time with other molecules. By addressing critical gaps in current methodologies, this study offers valuable insights into occupational safety and supports efforts to reduce exposure risks for healthcare workers and patients. Further research is needed to identify the unknown molecules detected and fully assess their potential risks.

2025-06-01·Biochemical Pharmacology

Ifosfamide alleviates autoimmune toxicity and enhances antitumor efficacy in melanoma immunotherapy

Article

作者: Gu, Chenyang ; Huang, Danping ; Yu, Xinping ; Liu, Xiuxing ; Tao, Tianyu ; Su, Wenru ; Gao, Yuehan ; Jia, Renbing ; Zhang, Chun ; Lv, Jianjie

Autoimmune toxicity affects up to 60 % of patients receiving immune checkpoint inhibitor (ICI) therapy for cancer, presenting a notable clinical obstacle that constrains its wider application. Hence, there is an imperative demand to develop novel strategies to manage immune-related adverse events (irAEs). Ifosfamide (IFO) shares structural and functional resemblances with cyclophosphamide (CPA). Despite the acknowledged dual anti-tumor and immunomodulatory effects of CPA, the specific effect of IFO on autoimmune conditions remains elusive. Here, we evaluated the efficacy of IFO on experimental autoimmune uveitis (EAU) mouse models and explored the cell-specific effects of IFO under autoimmune conditions using single-cell RNA sequencing. Our data indicated that IFO effectively alleviated inflammatory infiltration and reversed pathological alterations of EAU. Subsequent single-cell data analysis and in vivo experiments suggested IFO exerted broad suppressive effects on autoimmune responses, concurrently restoring the balance between Th17 and Treg populations. In addition, we observed that IFO enhanced CD8⁺ T cell activation and its cytotoxic immune responses, highlighting the cell-type-specific immunomodulatory effects of IFO. Moreover, we constructed EAU models on tumor-bearing mice under ICI treatment, and found that ICI exacerbated EAU symptoms. IFO not only possessed anti-tumor effects as monotherapy, but also augmented ICI efficacy by promoting CD8⁺ T cell-mediated immunity. Furthermore, we found that IFO alleviated EAU symptoms exacerbated by ICI treatment and effectively restored Th17/Treg balance. Our results elucidated the immunomodulatory effects of IFO treatment, providing evidence for the application of IFO in managing autoimmune conditions and irAEs.

107

项与异环磷酰胺相关的新闻（医药）

2025-05-04

·医药速览

常用抗肿瘤药物使用前预处理规范，一文总结（附速查表）

2023年《静脉用药安全输注药护专家指引》指出，未规范预处理的紫杉醇输液反应发生率高达41%，而预处理后骤降至2%-4%。这一数据背后，是无数因过敏反应、毒性损伤导致的治疗中断甚至患者死亡案例。预处理不仅是「流程」，更是肿瘤医生的「防弹衣」。一、预处理的核心目标与临床价值降低致命风险：过敏反应防控：紫杉醇类药物（如多西他赛）的聚氧乙烯蓖麻油溶剂、单抗类药物的外源蛋白成分，均可引发IgE介导的速发型过敏反应。毒性损伤规避：蒽环类药物的心脏毒性、环磷酰胺的出血性膀胱炎，均需通过预处理降低器官损伤风险。提升治疗依从性：预处理可减少化疗相关性恶心呕吐（CINV）、腹泻等2-3级不良反应，避免患者因无法耐受而放弃治疗。二、预处理的核心要义：从 “可选项” 转变为 “必选项”化疗药物在歼灭肿瘤细胞的同时，却可能借由超敏反应、器官毒性等途径对患者的生命构成威胁。规范落实预处理方案，乃是降低不良反应发生率、确保化疗安全的关键所在。1. 紫杉醇：5 分钟内可能骤起的过敏风暴风险数据：整体过敏发生率达 39%，严重过敏反应率为 2%，其中 90% 的严重过敏情况出现在首次用药的前 5 分钟。标准预处理方案：地塞米松：在化疗前 12 小时及 6 小时分别口服 10 mg（或静脉注射 10 mg）。苯海拉明：肌肉注射 50 mg（或使用异丙嗪 25 - 50 mg）。H2 受体拮抗剂：静脉注射西咪替丁 300 mg 或雷尼替丁 50 mg。简化方案适用情形：方案一（减量）：从第 3 周期起，地塞米松剂量减半，并逐次递减，直至减至 2 mg。方案二（停药）：第 3 周期停用地塞米松，仅保留抗组胺药物。特殊剂型注意要点：紫杉醇脂质体：依旧需要执行标准预处理流程。白蛋白结合型紫杉醇：通常无需预处理，但有既往过敏史的患者需密切观察监测。2. 多西他赛：体液潴留与过敏的双重隐患病理机制：聚山梨酯溶剂可诱发过敏反应，同时会致使毛细血管渗漏，进而引发全身水肿。预处理核心举措：地塞米松 8 mg 口服，从化疗前 1 天开始，每 12 小时服用一次，至少持续 3 天。3. 蒽环类药物：剂量累积性心脏毒性的防控要点心脏毒性数据：当阿霉素累积剂量达到 550 mg/m² 时，心力衰竭的发生风险高达 26%。预处理金标准方案：右丙亚胺（DZE）静脉给药，其剂量与蒽环类药物的比例为 10 - 20 倍（即 10:1 至 20:1）。4. 异环磷酰胺：出血性膀胱炎的预防策略关键干预手段：美司钠：剂量为异环磷酰胺的 60%，分 3 次给药，分别在化疗同时、4 小时后、8 小时后静脉注射。水化方案：每日静脉补液量应不少于 2000 ml，保持尿量大于 100 ml/h。5. 培美曲塞：叶酸代谢通路的双重保障预处理时间节点：叶酸：从化疗前 7 天开始口服（400 μg / 日），持续至末次化疗后 21 天。维生素 B12：化疗前 7 天肌肉注射 1000 μg，此后每 3 个月重复注射一次。6. 伊立替康：胆碱能危象与迟发性腹泻的管理策略分级防控方案：胆碱能综合征：化疗前预防性皮下注射阿托品 0.5 mg。迟发性腹泻：洛哌丁胺首剂口服 4 mg，之后每 2 小时口服 2 mg，直至末次稀便后 12 小时。7. 顺铂：肾毒性的水化与利尿准则水化方案严格要求：化疗前 6 小时开始输注生理盐水（1000 ml / 小时）。顺铂给药后持续输注，24 小时内不少于 2000 ml。甘露醇 125 ml 静脉注射，化疗前及化疗后各进行一次。呋塞米 20 - 40 mg 静脉注射，当尿量小于 100 ml/h 时启用。8. 博来霉素：肺纤维化的预警与干预措施肺功能监测要求：在基线以及每周期化疗前，检测 DLCO（一氧化碳弥散量）。预处理方案：化疗前 1 小时口服吲哚美辛 25 mg。9. 利妥昔单抗：乙肝病毒再激活的致命风险防范强制筛查与预防措施：所有患者在治疗前均需检测 HBsAg、抗 - HBc、HBV DNA。对于 HBsAg 阳性的患者，恩替卡韦等抗病毒治疗需在利妥昔单抗治疗前 1 - 2 周启动。输注前预处理操作：口服对乙酰氨基酚 500 mg。肌肉注射苯海拉明 50 mg。静脉注射地塞米松 5 - 10 mg（若为非激素化疗方案则加用）。10. 卡铂：不可轻视的骨髓抑制预防风险分层管理要点：计算 AUC 剂量时，需依据 Calvert 公式进行调整（肌酐清除率为核心参数）。当血小板低于 50×10⁹/L 时，考虑使用 IL - 11 或 TPO 进行支持治疗。结语从即时防控过敏反应，到长期管理器官毒性，预处理方案需贯穿化疗的整个过程。临床医师应依据药物特性、患者基础疾病以及既往治疗反应，灵活动态地调整预处理策略。建议医疗机构构建标准化的预处理流程，并借助信息化系统实现智能提醒与质量控制，最大程度降低治疗相关风险。参考文献：NCCN指南（2025）ASCO化疗安全共识（2024）中国抗癌协会化疗预处理专家共识（2024）推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。有问题可发邮件至yong_wang@pku.edu.cn获取更多信息。©2021 医药速览保留所有权利往期链接“小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记PROTAC技术| 抗体药物| 抗体药物偶联-ADC核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群加作者微信（yiyaoxueshu666）或者扫描公众号二维码添加作者，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

临床结果

2025-04-29

·GlobeNewswire-Health Care

Moleculin Announces New Pre-Clinical Data for Annamycin Demonstrating Market Expansion Potential Including Treatment for Pancreatic Cancer

Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025Annamycin is potentially a highly versatile drug capable of working synergistically with numerous mechanistically different FDA approved anticancer first line therapies both in vitro and in vivo HOUSTON, April 29, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced that an abstract and poster presentation regarding the Company’s next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, on April 28, 2025, at the McCormick Place Convention Center in Chicago, IL. “The case for expanding the potential markets for Annamycin continues to get stronger,” said Walter Klemp, Chairman and CEO of Moleculin. “In an environment where more and more cancer treatment regimens are combinations of two or more drugs, it is encouraging to see that Annamycin appears capable of generating synergistic results with so many commonly used drugs. The latest research continues to support our view that, in addition to hematological malignancies, solid cancers including sarcoma and pancreatic cancer also represent important expansion opportunities for Annamycin. These findings may help expand the clinical use of Annamycin and consequently make our drug candidate even more attractive to prospective future partners. With five previous or current investigator-initiated clinical trials supporting development of our drug candidates, we believe that our next investigator-initiated trials could be Annamycin for the treatment of pancreatic cancer or advance soft tissue sarcomas.” The study, presented in poster form, was designed to assess the efficacy of Annamycin in combination with approved anticancer agents in order to identify novel potentially highly efficacious clinical applications of Annamycin alone and with a therapeutic partner. Annamycin in its non-liposomal form (free drug; in vitro) and Liposomal Annamycin (L-ANN; in vivo) were tested in combination with selected US Food and Drug Administration (FDA) approved drugs. Usually, the most efficacious drug combinations from the in vitro studies were then tested using well developed in vivo models of leukemia and solid tumors, including sarcoma and pancreatic cancer. It should be noted that in a separate set of previous experiments, Annamycin activity was tested in vitro, and appeared to be highly active, against drug resistant cell lines, including cells resistant to cytarabine and venetoclax. The research shown in the AACR poster, described below, demonstrates that Annamycin is potentially a highly versatile drug capable of working synergistically with numerous mechanistically different FDA approved anticancer agents both in vitro and in vivo. Ongoing studies are working towards identifying new efficacious clinical applications of L-ANN drug combinations with the long-term goal of developing novel therapeutic strategies for treatment resistant cancers. Details of the poster presentation are as follows: Title: Combining Annamycin, a Non-cardiotoxic Potent Topo II Poison, with Azacitidine, Cytarabine, Gemcitabine, Ifosfamide, Trabectedin, or Vincristine to Synergize Anticancer Effects and Identify Potential Clinical ApplicationsTrack: Experimental and Molecular TherapeuticsSession: PO.ET02.03. Drug Combination Strategies for Cancer TreatmentAbstract Number: 1683/ 14Presenter: Waldemar Priebe, Ph.D., Department of Experimental Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer CenterFor more information, visit the AACR Annual Meeting website. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook. Forward-Looking StatementsSome of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of Annamycin to demonstrate in clinical trials the results from the animal models described in the poster. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775MBRX@jtcir.com

临床3期AACR会议

2025-04-28

·药研网

ASCO 2025热点速递 | 信达、荣昌、科伦集体登场!（附ADC/双/多抗最新进展一览表）

2025年美国临床肿瘤学会（ASCO）年会将于5月30日至6月3日在美国芝加哥举行。近期，ASCO官网已经公布所有中选的摘要标题。ADC和双抗的持续火热则延续了近年趋势。据药研网不完全统计，国内ADC领域已有28款产品的36项研究在ASCO上披露，涵盖HER2、EGFR、TROP2等热门靶点。本文提前扫描一下亮相ASCO的国产新药：部分呈现，后台回复“2025ASCO”可获取资料合集 pdf.科伦博泰六项临床研究结果四川科伦博泰将在本次大会公布其TROP2 ADC芦康沙妥珠单抗（sac-TMT）、抗PD-L1单抗塔戈利单抗（A167）以及RET抑制剂KL590586（A400/EP0031）的六项临床研究结果，相关研究摘要全文发布时间：美国当地时间 2025 年 5 月 22 日1.TROP2 ADC SKB264标题：芦康沙妥珠单抗（sac-TMT）用于经治的晚期EGFR突变非小细胞肺癌（NSCLC）患者的随机临床研究（OptiTROP-Lung03）结果摘要#：8507会议日期：美国当地时间2025年6月1日8:00-11:002.PD-L1单抗 A167+化疗标题：塔戈利单抗联合吉西他滨和顺铂对照安慰剂联合吉西他滨和顺铂一线治疗复发或转移性鼻咽癌（R/M NPC）的随机、双盲III期临床研究结果摘要#：6004会议日期：美国当地时间2025年5月31日13:15-16:153.TROP2 ADC+PD-L1 SKB264+A167标题：芦康沙妥珠单抗（sac-TMT）一线治疗不可切除的局部晚期或转移性三阴性乳腺癌（a/m TNBC）II期临床研究（OptiTROP-Breast05）的初步结果摘要#：1019会议日期：美国当地时间2025年5月30日14:45-16:154.TROP2 ADC+PD-L1 SKB264+A167标题：芦康沙妥珠单抗（sac-TMT）联合塔戈利单抗（抗PD-L1单抗）一线治疗晚期非小细胞肺癌(NSCLC)—II期临床研究（OptiTROP-Lung01）非鳞癌人群结果摘要#：8529会议日期：美国当地时间2025年5月31日13:30-16:305.TROP2 ADC SKB264标题：芦康沙妥珠单抗（sac-TMT）用于经治的EGFR罕见突变的局部晚期或转移性（LA/M）非小细胞肺癌（NSCLC）患者II期临床研究的初步结果摘要#：8615会议日期：美国当地时间2025年5月31日13:30-16:306. RET抑制剂 KL590586标题：KL590586用于晚期RET基因突变的甲状腺髓样癌患者的I期临床研究结果摘要#：6098会议日期：美国当地时间2025年6月2日9:00-12:00荣昌生物四项研究数据荣昌生物20余项肿瘤管线临床进展或阶段性数据入选口头报告、壁报或线上展示，其中包括维迪西妥单抗联合疗法一线治疗HER2表达胃癌、维迪西妥单抗联合RC148（PD-1/VEGF双抗）一线治疗三阴性乳腺癌、RC108（c-Met ADC）联合TKI二线治疗EFGR突变伴MET过表达非小细胞肺癌等临床研究。标题：维迪西妥单抗联合特瑞普利单抗及化疗/曲妥珠单抗一线治疗HER2表达局部晚期或转移性胃癌的临床研究摘要#：LBA4012会议日期：2025年6月2日（星期一）11:30-13:00标题：RC108联合伏美替尼治疗局部晚期或转移性EGFR突变伴MET过表达非小细胞肺癌（NSCLC）患者的Ib/II期临床研究摘要#：8592会议日期：2025年6月2日（星期一）11:30-13:00标题：维迪西妥单抗联合RC148对比白蛋白结合型紫杉醇±特瑞普利单抗治疗HR阴性、HER2低表达不可切除局部晚期或转移性乳腺癌的疗效和安全性：一项开放标签、随机、对照II期临床研究摘要#：TPS1139会议日期：2025年6月2日（星期一）9:00-12:00标题：维迪西妥单抗联合帕妥珠单抗±特瑞普利单抗新辅助治疗HER2阳性乳腺癌的安全性与疗效：一项开放标签II期临床研究摘要#：e12596映恩生物两项ADC研究数据映恩生物（9606.HK）将在以口头报告形式公布HER3 ADC DB-1310及B7H3 ADC DB-1311/BNT324的两项研究数据。相关研究摘要全文发布时间：美国当地时间（GMT-5) 2025 年 5 月23 日1.HER3 ADC DB-1310标题：DB-1310（HER3靶向抗体偶联药物）用于晚期实体瘤患者的1/2a 期研究初步结果摘要编号：#3000会议日期：美国当地时间（GMT-5）2025年5月30日14:45-14:572. B7H3 ADC DB-1311/BNT324标题：DB-1311/BNT324（新型B7H3靶向抗体药物偶联物）用于经多线治疗的去势抵抗性前列腺癌（CRPC）患者摘要编号：#5015会议日期：美国当地时间（GMT-5）2025年6月1日17:00-17:06 信达生物IBI363和IBI343多项口头报告信达生物将在 2025年美国临床肿瘤学会（ASCO）年会上公布肿瘤创新管线的一系列临床数据，包括IBI363（PD-1/IL-2α-bias）和IBI343(CLDN18.2 ADC)的多项口头报告。摘要标题：首创新型PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363在免疫治疗后的晚期肢端及黏膜黑色素瘤患者中的疗效与安全性摘要编号：2502展示时间：2025年5月31日下午3:00-6:00（美国中部时间）摘要标题：IBI363单药或联合贝伐珠单抗在晚期结直肠癌患者中的疗效与安全性摘要编号：104展示时间：2025年6月1日上午9:45-11:15（美国中部时间）摘要标题：首创新型PD-1/IL-2α-bias双特异性抗体IBI363在免疫治疗后的晚期非小细胞肺癌（NSCLC）患者中的应用摘要编号：8509展示时间：2025年6月3日上午9:45-11:15（美国中部时间）摘要标题：Claudin18.2（CLDN18.2）在胰腺导管腺癌（PDAC）中的表达与疗效：IBI343的I期剂量扩展队列研究结果摘要编号：4017展示时间：2025年6月2日上午11:30-下午1:00（美国中部时间）摘要标题：信迪利单抗（抗PD-1）联合异环磷酰胺、卡铂及依托泊苷（ICE）二线治疗经典霍奇金淋巴瘤（cHL）：一项多中心、随机、对照、双盲III期研究（ORIENT-21）摘要编号：7007展示时间：2025年5月30日下午2:45-5:45（美国中部时间）摘要标题：短程放疗联合信迪利单抗和CAPOX作为局部晚期直肠癌的全程新辅助治疗：一项前瞻性、随机对照试验（SPRING-01）摘要编号：3519展示时间：2025年6月1日上午11:30 -下午1:00 P（美国中部时间）摘要标题：动态肿瘤循环DNA驱动的鼻咽癌风险适应性系统治疗（卡培他滨/信迪利单抗）：EP-STAR试验摘要编号：6010展示时间：2025年6月2日下午3:00-4:30（美国中部时间）壁报摘要标题：PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363在黏膜及肢端黑色素瘤中的多中心、随机、对照、开放标签II期研究：进行中的研究摘要编号：TPS9594展示时间：2025年6月1日上午9:00-12:00（美国中部时间）摘要标题：抗HER2抗体-药物偶联物IBI354在局部晚期不可切除或转移性卵巢癌患者中的应用：I期研究更新结果摘要编号：5565展示时间：2025年6月1日上午9:00-12:00（美国中部时间）院摘要标题：IBI354（抗HER2抗体-药物偶联物[ADC]）在HER2阳性乳腺癌（BC）及其他实体瘤患者中的应用：I期研究更新摘要编号：1029展示时间：2025年6月2日上午9:00-12:00（美国中部时间）摘要标题：抗TROP2抗体-药物偶联物（ADC）IBI130在晚期三阴性乳腺癌（TNBC）及其他实体瘤患者中的安全性与疗效：I期研究结果摘要编号：1102展示时间：2025年6月2日上午9:00-12:00（美国中部时间）摘要标题：抗Claudin18.2（CLDN18.2）抗体-药物偶联物（ADC）arcotatug tavatecan（IBI343）在胃或胃食管结合部腺癌（G/GEJA）中的多区域、随机、对照、开放标签III期研究：进行中的研究摘要编号：TPS4201展示时间：2025年5月31日上午9:00-12:00（美国中部时间）摘要标题：一项经肝动脉化疗栓塞(TACE)联合信迪利单抗（抗 PD-1）、奥沙利铂和 S-1，以及曲妥珠单抗（HER-2 阳性）或阿帕替尼（HER-2 阴性）作为胃癌肝转移一线治疗的II期临床研究摘要编号：4050展示时间：2025年5月31日上午9:00-12:00（美国中部时间）总结2025年ASCO年会再次彰显了中国创新药企的显著进步与战略转型。相比以往主要依赖成熟靶点的跟进与同质化竞争，今年中国企业在靶点选择上更聚焦耐药机制和临床未满足需求，展现出从被动追随到主动定义临床标准的转变。头部企业如恒瑞医药、中国生物制药继续引领创新，在组合疗法和全球化布局上成绩斐然；同时，迪哲医药等新锐企业通过机制创新和双靶点抑制策略为行业探索出差异化突围路径。总体来看，2025年ASCO不仅是中国创新药企数量的爆发，更是质量与技术创新的实质跃升。参考来源：【1】2025ASCO官网【2】信达、荣昌、映恩、科伦博泰等企业官方发布End声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾1关张、破产、裁员 | 2024年生物药企的阴影2全球第一款司美格鲁肽咀嚼软糖上市！3中国首个男性HPV疫苗获批上市!

ASCO会议抗体药物偶联物临床结果临床1期临床3期

100 项与异环磷酰胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00343	异环磷酰胺	L01AA06	DB01181

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
骨组织肿瘤	日本	Shionogi & Co., Ltd.	2005-02-14
儿童恶性实体瘤	日本	Shionogi & Co., Ltd.	2005-02-14
性腺组织肿瘤	日本	Shionogi & Co., Ltd.	2004-12-14
出血性膀胱炎	美国	Baxter Healthcare Corp.	1987-08-14
骨肉瘤	日本	Shionogi & Co., Ltd.	1985-04-16
前列腺癌	日本	Shionogi & Co., Ltd.	1985-04-16
小细胞肺癌	日本	Shionogi & Co., Ltd.	1985-04-16
宫颈癌	日本	Shionogi & Co., Ltd.	1985-04-16
乳腺癌	法国	Baxter International, Inc.	1976-01-01
肺癌	法国	Baxter International, Inc.	1976-01-01
淋巴瘤	法国	Baxter International, Inc.	1976-01-01
卵巢癌	法国	Baxter International, Inc.	1976-01-01
肉瘤	法国	Baxter International, Inc.	1976-01-01
睾丸肿瘤	法国	Baxter International, Inc.	1976-01-01

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
难治性骨肉瘤	临床2期	中国	江苏恒瑞医药股份有限公司	2022-03-01
毒性	临床2期	中国	江苏恒瑞医药股份有限公司	2022-03-01
软骨肉瘤	临床前	法国	Atlanthera SASU	2018-07-27
尤文肉瘤	临床前	法国	Atlanthera SASU	2018-07-14

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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


NCT05364424 (GO43693, ASH2024) 人工标引	临床1期	弥漫性大B细胞淋巴瘤	41	Glofitamab inIfosfamideon CarboplatinEtoposide	(餘齋淵壓襯觸糧淵鬱觸) = 憲膚築蓋獵蓋鏇壓壓襯網窪鹹鹽顧夢廠選廠膚 (繭膚遞遞製觸壓膚糧鬱, 60.0 ~ 90.7) 更多	积极	2024-12-09
NCT04154189 (OLIE, Pubmed \| JAMA Oncol)	临床2期	复发性骨肉瘤二线	81	Lenvatinib + Ifosfamide and Etoposide	鑰獵廠憲淵鑰獵餘積壓(鹹窪選憲蓋鹹憲鹽蓋獵) = 鏇獵範繭齋鬱繭簾膚艱選鏇顧襯遞獵餘艱醖壓 (廠襯遞齋選遞醖鹹鹹齋, 59.3 ~ 86.9) 更多	不佳	2024-12-01
				Ifosfamide and Etoposide	鑰獵廠憲淵鑰獵餘積壓(鹹窪選憲蓋鹹憲鹽蓋獵) = 製蓋簾遞積築餘選醖觸選鏇顧襯遞獵餘艱醖壓 (廠襯遞齋選遞醖鹹鹹齋, 47.7 ~ 79.2) 更多
NCT03016871 (NICE, CTgov)	临床2期	难治性霍奇金淋巴瘤 \| 复发性霍奇金淋巴瘤	78	Laboratory Biomarker Analysis+Nivolumab+Etoposide+Carboplatin+Ifosfamide (Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin))	壓鹽糧觸選鬱鏇艱艱範(鹹築繭蓋觸糧鏇願遞積) = 製膚構襯遞鑰鏇醖繭顧繭觸築淵鬱窪顧襯顧壓 (鹹鏇鬱鑰衊顧膚夢膚膚, 繭願鑰遞憲糧構製夢鬱 ~ 鬱鏇齋艱膚醖構顧鏇繭) 更多	-	2024-10-09
				Laboratory Biomarker Analysis+Nivolumab+Etoposide+Carboplatin+Ifosfamide (Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin))	壓鹽糧觸選鬱鏇艱艱範(鹹築繭蓋觸糧鏇願遞積) = 夢膚遞顧遞艱觸衊齋廠繭觸築淵鬱窪顧襯顧壓 (鹹鏇鬱鑰衊顧膚夢膚膚, 觸顧鑰醖憲繭鑰壓窪簾 ~ 鹽積齋衊鑰顧繭願淵窪) 更多
ESMO2024 人工标引	临床2期	非精原细胞生殖细胞肿瘤	34	Paclitaxelnifosfamidecisplatin	(蓋醖鏇網糧淵淵夢範築) = 製餘廠鑰顧顧壓廠選齋構膚範鑰夢積遞製餘網 (蓋獵壓積製艱鬱蓋範淵 ) 更多	不佳	2024-09-15
NCT00936936 (CTgov)	临床2期	睾丸肿瘤 \| 生殖细胞和胚胎肿瘤	64	Bevacizumab (Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT)	(膚襯蓋齋簾鹹繭蓋齋構) = 簾築糧範積範構廠獵鏇憲鏇選鏇艱構觸糧鑰範 (構獵構觸鏇糧襯蓋築積, 壓蓋餘鏇餘製範鏇醖遞 ~ 網壓餘鬱簾範憲廠餘憲) 更多	-	2024-08-26
				Mesna+Etoposide+Carboplatin+Melphalan+Ifosfamide+Gemcitabine+Docetaxel (Cohort 2: HD GeM-DMC+ ICE for Refractory GCT)	(膚襯蓋齋簾鹹繭蓋齋構) = 鬱製蓋遞遞窪願製膚遞憲鏇選鏇艱構觸糧鑰範 (構獵構觸鏇糧襯蓋築積, 齋廠製顧艱襯範構簾獵 ~ 遞繭鏇壓醖繭蓋糧艱鑰) 更多
NCT04665765 (CTgov)	临床2期	原发性纵隔大B细胞难治性淋巴瘤 \| 复发性原发性纵隔大B细胞淋巴瘤 \| 难治性弥漫性大 B 细胞淋巴瘤 \| 复发性非霍奇金淋巴瘤 \| 难治性转化惰性 B 细胞非霍奇金淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	41	Etoposide+Polatuzumab Vedotin+Carboplatin+Ifosfamide+Rituximab	糧獵壓醖積窪構餘糧襯(積築構醖範構蓋餘獵醖) = 廠鬱壓鏇遞製顧鑰繭築願鑰鹹艱淵淵築淵鑰願 (選蓋簾網鏇廠齋築鬱繭, 淵蓋選窪鏇獵繭醖範壓 ~ 膚艱淵醖鑰衊鏇鬱鹽鹹) 更多	-	2024-08-26
NCT02375204 (TIGER, Pubmed) 人工标引	临床2期	生殖细胞和胚胎肿瘤二线	104	Paclitaxel, IIfosfamide anCisplatinin (TIP)	(鬱醖鏇廠鏇積鏇顧鏇夢) = 獵衊壓鑰範鏇襯遞繭夢齋糧襯獵憲觸鏇壓餘繭 (淵簾鏇獵網鹹遞艱鏇選, 59 ~ 77) 更多	积极	2024-07-19
				Paclitaxel + Ifosfamide + Cisplatin (patients had favorable risk factors)	(鬱醖鏇廠鏇積鏇顧鏇夢) = 繭廠壓壓網觸鬱鬱憲壓齋糧襯獵憲觸鏇壓餘繭 (淵簾鏇獵網鹹遞艱鏇選, 61 ~ 80) 更多
NCT02628405 (CTgov)	临床1/2期	原发性纵隔大B细胞难治性淋巴瘤 \| 复发性原发性纵隔大B细胞淋巴瘤 \| 难治性弥漫性大 B 细胞淋巴瘤 \| 复发性非霍奇金淋巴瘤 \| 难治性B细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤 \| 复发性B细胞淋巴瘤	30	Laboratory Biomarker Analysis+Lenalidomide+Etoposide+Carboplatin+Ifosfamide+Rituximab	(廠顧遞獵夢積糧淵顧獵) = 範構獵襯選醖鏇憲膚獵遞鏇膚積選鑰糧淵窪艱 (鹽糧艱願襯醖淵淵膚夢, 觸獵範艱鹹鬱壓願遞膚 ~ 鑰餘築餘顧獵簾蓋構壓) 更多	-	2024-07-01
NCT04947501 (N9, ASCO2024) 人工标引	早期临床1期	高风险神经母细胞瘤	15	cyclophosphamidehostopotecanopovincristineistifosfamidecarboplatinetoposide	(蓋積夢簾簾齋願艱餘繭) = 鬱選範簾簾廠廠鬱構鏇餘願願蓋願範淵醖網憲 (構網鑰齋願鹽蓋顧築繭 ) 更多	积极	2024-05-24
				cyclophosphamideplatopotecansidvincristineifosfamidecarboplatinetoposide	(願夢膚淵憲齋製壓積壓) = 鏇顧築艱餘膚襯選選製蓋網艱廠範蓋積鹹顧構 (簾範選鹽衊製鏇鹹範糧 ) 更多
ISN WCN2024	N/A	尿崩症 \| 肾小管性酸中毒	-	Ifosfamide 3g/m2	醖範鬱遞膚選壓襯鏇鹽(艱壓襯繭糧鑰構窪憲襯) = presented after the first cycle of chemotherapy 夢鑰糧襯鹹製襯壓壓築 (齋窪積衊願衊鹽壓遞範 ) 更多	-	2024-04-01