A Multicenter, Single-Arm, Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases

This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.

开始日期2024-09-26

申办/合作机构

北京键凯科技股份有限公司

NCT06581380

/ Not yet recruiting临床3期

A Multicenter, Randomized, Positive-Controlled, Open-label, Phase 3 Study of JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

This study was designed to compare the efficacy and safety of JK-1201I with Topotecan in patients with relapsed extensive stage small cell lung cancer (ES SCLC).

开始日期2024-09-16

申办/合作机构

北京键凯科技股份有限公司

NCT06575127

/ Recruiting临床2期IIT

Modified FOLFOXIRI Plus Target Therapy as a First Line Treatment for Advanced Colorectal Cancer a Prospective Phase Two Study

This prospective Phase II study aims to evaluate the efficacy and safety of a modified FOLFOXIRI regimen in the treatment of metastatic colorectal cancer (MCRC). FOLFOXIRI, though effective, is known for its high toxicity, necessitating close monitoring and dose adjustments. .
The primary endpoint is to assess the impact on the objective response rate and evaluate both acute and delayed toxicity. The secondary endpoints include studying the treatment's effectiveness as conversion therapy, along with disease-free survival (DFS) and overall survival (OS). The tertiary endpoint focuses on evaluating predictive and prognostic factors of significance.
This study seeks to balance the efficacy of FOLFOXIRI with a modified dose to minimize toxicity while maintaining therapeutic benefits, providing a potentially safer and effective option for patients with MCRC.

开始日期2024-08-17

申办/合作机构

Al-Azhar University

100 项与聚乙二醇伊立替康相关的临床结果

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100 项与聚乙二醇伊立替康相关的转化医学

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100 项与聚乙二醇伊立替康相关的专利（医药）

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项与聚乙二醇伊立替康相关的文献（医药）

2024-09-01·Cancer Medicine

Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer

Article

作者: Shi, Jinsheng ; Zhao, Xuan ; Li, Xuefei ; Zhao, Yanqiu ; Fang, Jian ; Nie, Ligong ; Yu, Guohua ; Zang, Aimin ; Long, Jieran ; Wu, Lin

Abstract:

Purpose:

To evaluate the safety, tolerability, and preliminary efficacy of multiple doses of pegylated irinotecan (JK1201I) as a second‐line monotherapy for treating small‐cell lung cancer (SCLC) patients.

Methods:

According to the “3 + 3” dose‐escalation principle, patients received intravenous JK1201I at 180 or 220 mg/m2 once every 3 weeks for four cycles. Progression‐free survival (PFS), overall survival (OS), median progression‐free survival (mPFS), and median overall survival (mOS) were evaluated. The Kaplan–Meier method was used to analyze PFS and overall OS. Brookmeyer and Crowley's method was used for mPFS and mOS.

Results:

This study included 29 patients with stage III–IV SCLC (stage IIIa, n = 1; stage IIIb, n = 1; and stage IV, n = 27). Of these, 26 patients were enrolled in the 180 mg/m2 dose group, and 3 patients were enrolled in the 220 mg/m2 dose group. No dose‐limiting toxicity (DLT) was noted during the first 28 days of treatment. Grade 3 or higher adverse events were recorded in the 180 mg/m2 group, including diarrhea (11.5%, 3/26), neutropenia (7.7%, 2/26), and leukopenia (7.7%, 2/26). In the 220 mg/m2 group, one patient (33.3%, 1/3) experienced neutropenia or leukopenia. In the 180 mg/m2 group, 38.5% (10/26) of patients achieved an objective response rate (ORR), with a disease control rate (DCR) of 73.1% (19/26). The mPFS and mOS were 3.4 and 12.1 months, respectively. In the 220 mg/m2 group, one patient had stable disease, and one had progressive disease (PD). The ORR, DCR, mPFS, and mOS were 0% (0/3) and 33.3% (1/3), 2.7 months and 2.7 months, respectively.

Conclusion:

JK1201I exhibits promising efficacy and relatively low toxicities as a second‐line monotherapy for SCLC, warranting further large‐scale clinical studies to evaluate its efficacy in greater detail.

2024-06-01·Journal of photochemistry and photobiology. B, Biology

Minocycline and photodynamic priming significantly improve chemotherapy efficacy in heterotypic spheroids of pancreatic ductal adenocarcinoma

Article

作者: Hasan, Tayyaba ; Pang, Sumiao ; Roberts, Harrison James ; Huang, Huang-Chiao ; Alburquerque, Jose Quilez ; Bano, Shazia

The prognosis for patients with advanced-stage pancreatic ductal adenocarcinoma (PDAC) remains dismal. It is generally accepted that combination cancer therapies offer the most promise, such as Folforinox, despite their associated high toxicity. This study addresses the issue of chemoresistance by introducing a complementary dual priming approach to attenuate the DNA repair mechanism and to improve the efficacy of a type 1 topoisomerase (Top1) inhibitor. The result is a regimen that integrates drug-repurposing and nanotechnology using 3 clinically relevant FDA-approved agents (1) Top1 inhibitor (irinotecan) at subcytotoxic doses (2) benzoporphyrin derivative (BPD) as a photoactive molecule for photodynamic priming (PDP) to improve the delivery of irinotecan within the cancer cell and (3) minocycline priming (MNP) to modulate DNA repair enzyme Tdp1 (tyrosyl-DNA phosphodiesterase) activity. We demonstrate in heterotypic 3D cancer models that incorporate cancer cells and pancreatic cancer-associated fibroblasts that simultaneous targeting of Tdp1 and Top1 were significantly more effective by employing MNP and photoactivatable multi-inhibitor liposomes encapsulating BPD and irinotecan compared to monotherapies or a cocktail of dual or triple-agents. These data are encouraging and warrant further work in appropriate animal models to evolve improved therapeutic regimens.

2024-06-01·Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]

A real-world analysis of second-line treatment option, gemcitabine plus anlotinib and anti-PD1, in advanced pancreatic cancer

Article

作者: Si, Haiyan ; Deng, Guochao ; Ma, Yue ; Dai, Guanghai ; Jia, Ru ; Fan, Mengjiao ; Wang, Zhikuan

BACKGROUND:

In the second-line treatment of advanced pancreatic cancer (APC), there is only one approved regimen based on the phase III NAPOLI-1 trial. However, for patients progressing after Nab-paclitaxel and Gemcitabine (Nab-P/Gem) or Nab-P combinations, second-line treatment were very limited.

METHODS:

This is a retrospective single-center analysis of patients. Our aim was to determine the effectiveness and tolerability of a novel regimen, gemcitabine plus Anlotinib and anti-PD1, in APC patients and to compare it with oxaliplatin, irinotecan, leucovorin, and fluorouracil (FOLFIRINOX) in the second-line setting who have failed on the first-line Nab-P combinations.

RESULTS:

In total, twenty-three patients received Gemcitabine plus Anlotinib and anti-PD1 in the second-line, 28 patients were treated with FOLFORINOX. There was no significant difference in overall survival (OS) or progression free survival (PFS) for either of the two sequences (p > 0.05). Patients who received Gemcitabine plus Anlotinib and anti-PD1 had a median PFS of 4.0 months (95% CI: 1.1-6.9) versus 3.5 months (95% CI 1.8-5.2) in FOLFORINOX group (p = 0.953). The median OS of Gemcitabine plus Anlotinib and anti-PD1 was 9.0 months (95% CI: 4.0-13.7) and 8.0 months (95% CI: 5.5-10.5) in FOLFORINOX group (p = 0.373). Grade ≥3 treatment-emergent adverse events (AEs) occurred for 13% of patients with Gemcitabine plus Anlotinib and anti-PD1 and 40% for FOLFORINOX.

CONCLUSION:

Our data confirms the effectiveness of Gemcitabine plus Anlotinib and anti-PD1 as a well-tolerated regimen in the second-line treatment of APC and extends available data on its use as a second-line treatment option when compared with FOLFIRINOX.

项与聚乙二醇伊立替康相关的新闻（医药）

2025-07-27

·梅斯医学

阿尔茨海默病（AD）一直被称为“最难攻克的医学堡垒”之一。近20年来，相关药物研发失败率高达98%，几乎成了新药的“滑铁卢”。传统治疗多聚焦于β-淀粉样蛋白（Aβ）或tau蛋白，但事实远比单一病理复杂得多——AD是神经元、胶质细胞、髓鞘等多种细胞类型协同“失控”的结果。近期，格莱斯顿研究所黄亚东研究员、加州大学旧金山分校 Yaqiao Li 博士等在国际顶尖学术期刊 Cell 上发表的重磅研究首次提出“细胞类型导向的网络校正疗法”，用两种老牌抗癌药——来曲唑（Letrozole）与伊立替康（Irinotecan）实现了多维度病理同步缓解，甚至在动物模型中逆转记忆损伤，揭示出一条全新的治疗路径。DOI：10.1016/j.cell.2025.06.035三大人源数据，精准锁定“药物重定位”组合研究的突破，源自一个跨尺度的人源数据整合平台。首先，团队汇集了三大AD单细胞转录组数据库（Mathys、Zhou、Lau），分析179,690个细胞核，排除未同时呈现Aβ与tau病理的样本，并利用Seurat算法消除批次效应，最终明确六类关键病变细胞，包括兴奋性/抑制性神经元、小胶质细胞、星形胶质细胞和少突胶质细胞及其前体。接着，他们调用CMap药物扰动数据库中1,300种药物的表达谱，开发“反转匹配”算法，筛选出可逆转AD特征的药物组合。最后，为了验证这些“候选药”，团队分析了加州大学系统144万份老年人电子病历，利用倾向评分匹配（PSM）控制混杂因素，计算药物暴露与AD风险的关系。通过单核转录组分析在人类阿尔茨海默病（AD）样本中揭示的共享和细胞类型特异性基因表达特征在人源数据中，研究者识别出AD存在两大病理集群：一是神经元-少突胶质细胞集群，富集雌激素/cAMP通路异常；二是胶质细胞集群，涉及突触组装与线粒体功能紊乱。正是在这两个维度上，来曲唑和伊立替康分别展现出靶向能力。具体来看，来曲唑对神经元显著有效（RR=0.466），其CMap评分在兴奋性神经元为-0.37，在抑制性神经元为-0.61，显示其可逆转APOE等关键致病基因的表达。而伊立替康在胶质细胞中的反转能力同样强劲（小胶质细胞-0.31，星形胶质细胞-0.29），并与其在EMR分析中观察到的显著风险降低（RR=0.195）相吻合。计算药物再利用的流程，该流程预测能够逆转阿尔茨海默病（AD）细胞类型特异性转录组特征的药物候选行为改善+病理缓解+细胞重塑三箭齐发另外，研究团队还构建了具有Aβ与tau双病理的5xFAD/PS19小鼠模型，进行3个月药物干预。结果令人惊喜：仅双药组在Morris水迷宫中表现出显著的短期与长期记忆改善。在病理层面，组合组的小鼠不仅Aβ斑块减少，还显著降低了磷酸化tau（AT8+）面积，且保护了海马CA1区的神经元结构。更妙的是，伊立替康还能独立抑制小胶质细胞活化，而组合治疗对星形胶质细胞的异常增生也有明显抑制。那么，这种协同效应从何而来？答案藏在小鼠海马区的单核RNA测序中。研究发现，组合疗法显著减少了抑制性神经元向星形胶质细胞发出的异常信号，同时在神经元中校正了APOE、SYT1等49个基因，在胶质细胞中调控了TREM2、GFAP等关键通路。更重要的是，这些变化并非简单“抹平”，而是激活了与保护相关的功能模块，如神经元中的树突形态发生（GO:0048813）和胶质细胞中的胆固醇代谢通路（KEGG:04979）。使用来曲唑（letrozole）和伊立替康（irinotecan）联合治疗能够挽救5xFAD/PS19小鼠的类AD记忆障碍从“对症治疗”迈向“对因干预”的范式转变这项研究的临床价值在于，它提供了一种多靶点、多细胞同步干预的范式。相比只针对Aβ的单靶点抗体疗法，来曲唑+伊立替康组合实现了五类病变细胞的整体“网络校正”。更令人振奋的是，这两种药原本就已获批用于癌症治疗，不仅已有丰富的人体安全性数据，还能穿透血脑屏障。当然，这项工作也并非没有挑战。CMap数据库基于癌细胞系，未必完全代表人脑环境；药效存在性别差异，雄性小鼠对单药敏感，雌性则需联用治疗，可能与雌激素调控机制有关；此外，目前双药联用患者样本较少，尚需前瞻性临床试验进一步验证疗效。但毫无疑问，这项研究为阿尔茨海默病的精准治疗打开了新纪元。研究团队已申请相关专利，并计划构建AI系统，根据患者分子分型定制个体化药物组合方案——譬如APOE4携带者或许更适合胶质靶向干预。随着单细胞组学和真实世界数据平台的进一步成熟，“一患一策”的AD精准治疗，或许真的不再遥远。参考资料：[1]Li Y, Pereda Serras C, Blumenfeld J, Xie M, Hao Y, Deng E, Chun YY, Holtzman J, An A, Yoon SY, Tang X, Rao A, Woldemariam S, Tang A, Zhang A, Simms J, Lo I, Oskotsky T, Keiser MJ, Huang Y, Sirota M. Cell-type-directed network-correcting combination therapy for Alzheimer's disease. Cell. 2025 Jul 15:S0092-8674(25)00737-8. doi: 10.1016/j.cell.2025.06.035. Epub ahead of print. PMID: 40695276.撰写：JY编辑：木白授权转载等事宜请联系梅斯学术管理员梅斯学术管理员微信bjy1689902068，备注学术转载点击“阅读原文”，即刻加入科研会员，限时折扣开通中

临床结果

2024-09-11

·GlobeNewswire-Health Care

BriaCell Reports Positive Overall Survival (OS) in Metastatic Breast Cancer

Median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitorOS of 15.6 months compares favorably with 6.7-9.3 months reported for similar patients in the literatureOngoing Phase 3 study investigating Bria-IMT™ in similar metastatic breast cancer populationNo drug related discontinuations to date PHILADELPHIA and VANCOUVER, British Columbia, Sept. 11, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce positive overall survival data of its Phase 2 clinical study of Bria-IMT™ in combination with an immune check point inhibitor (CPI) in late stage metastatic breast cancer. Median overall survival of 15.6 months is reported in BriaCell’s most recent patients (treated since 2022) vs. 6.7-9.3 months for similar patients reported in the literature (see table below). These patients are being treated with the same Bria-IMT™ formulation currently being used in BriaCell’s ongoing Phase 3 pivotal study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612) and represent patients enrolled post-COVID when full study activities resumed. This represents a substantial improvement over BriaCell’s 13.4 months median overall survival previously reported in December 2023. “Overall survival in patients with heavily pre-treated metastatic breast cancer is very poor,” stated Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutch Cancer Center and University of Washington and BriaCell medical advisory board member. “The BriaCell early data is quite encouraging from both efficacy and tolerability standpoints.” “We wanted to look at the Phase 2 data of those patients who most closely resemble the patients being treated in our ongoing phase 3 study and compare them to similar patients in the literature,” stated Dr. William V. Williams, BriaCell’s President and CEO. “The nearly two-fold overall survival benefit we are seeing with the Bria-IMT™ regimen, together with the similar previously reported approximate doubling of progression free survival, compared with literature controls, strongly support our belief that Bria-IMT™ could have a meaningful impact in the lives of heavily pre-treated metastatic breast cancer patients. We look forward to further clinical development of Bria-IMT™ with the goal of establishing it as a new standard of care for patients with metastatic breast cancer.” “The Bria-IMT™ regimen is the only investigational drug we have seen to show these impressive survival numbers in heavily pre-treated metastatic breast cancer patients who have failed numerous prior treatments including immune check point inhibitors and antibody drug conjugates,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “These survival and clinical benefit data support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™ and drive the ongoing pivotal study of our combination regimen in the treatment of metastatic breast cancer.” The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6) who were treated with the Bria-IMT™ regimen and an immune checkpoint inhibitor. Of these 54 patients, 37 were treated with the Phase 3 formulation and 25 of these were treated post-COVID when full study activities resumed. This data represents an additional six months of follow-up of the survival data presented at the San Antonio Breast Cancer Symposium in December 2023. Table 1. Comparative Median Overall Survival (OS) and Progression-Free Survival (PFS) in Similar Patients (Interim Analysis Using Kaplan-Meier Estimate) StudyPrior Lines of Therapy (median, range)Number of PatientsOS (months)PFS (months) BriaCell’s Phase 2 study patients who received pivotal Phase 3 study formulation (since 2022)5.5 (2-13)2515.64.1 BriaCell’s Phase 2 study patients who received pivotal Phase 3 study formulation (total)6 (2-13)3713.43.9 Bardia, A. et. al. 1 (TNBC)4 (2-14)2626.91.7 Tripathy D. et. al. 2 (Brain metastases)≥4 in 91%1787.5-7.81.9-2.8 O’Shaughnessy J. et. al. 3non-TNBC at initial diagnosis5 (2-14)766.72.3 O’Shaughnessy J. et. al. 3TNBC at initial diagnosis4 (2-10)1576.91.6 Cortes et. al. 44 (0-13)5949.1-9.31.9-2.5 References Bardia A, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29. PMID: 38422473.Tripathy D, et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022;8(7):1047-1052. doi:10.1001/jamaoncol.2022.0514.O’Shaughnessy J et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11. PMID: 35545724; PMCID: PMC9374646.Cortes J, Perez-Garcia J, Levy C, Gómez Pardo P, Bourgeois H, Spazzapan S, Martínez-Jañez N, Chao TC, Espié M, Nabholtz JM, Gonzàlez Farré X, Beliakouski V, Román García J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051. PMID: 29481630. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including statements about: the impact of Bria-IMT™ on patients with metastatic breast cancer; BriaCell’s further clinical development of Bria-IMT™; and the efficacy of immune check point inhibitors, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

临床3期免疫疗法临床2期临床结果

2024-07-18

·GlobeNewswire-Health Care

BriaCell Quadruples Progression Free Survival (PFS) in Patient with “Eye-Bulging” Metastatic Breast Cancer

Progression free survival (PFS) extended to 9.1 months in ADC resistant patient - quadruple the PFS of patients in similar studies 1, 2, 3Significant reduction of “Eye-Bulging” metastatic breast cancer tumor was previously reportedHeavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continues to receive BriaCell treatment PHILADELPHIA and VANCOUVER, British Columbia, July 18, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to report significantly higher PFS for its top responder patient in the Phase 2 study of BriaCell’s Bria-IMT™ regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer. The patient remains alive and she continues to receive BriaCell’s treatment regimen. “We are extremely pleased with the unprecedented survival benefit in this very-difficult-to-treat patient,” stated Dr. William V. Williams, BriaCell’s President and CEO. “This data represents a step forward in our efforts to build on our knowledge and successes to transform cancer care for patients. We expect to replicate this positive data in our ongoing Phase 3 study and bring relief to cancer patients whose medical needs remain unmet.” “Despite recent advances in cancer therapy, metastatic breast cancer remains an unmet medical need, as current treatments are limited by poor survival and harsh side effects,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “The Bria-IMT™ regimen produced a much longer than expected survival benefit in addition to its favorable safety and tolerability in this patient suggesting its potential as a therapeutic option for these cancer patients.” The patient had a large right orbital lesion (behind the right eye) and a right temporal lobe lesion (in the right side of the brain). The temporal lobe lesion is no longer detectable, while the orbital lesion has continued to shrink markedly (see figure showing resolution of proptosis post treatment (small arrows) with reduction in tumor indicated by the large arrows). In addition, her tumor markers (blood tests that correlate with the amount of tumor in the body) have markedly decreased from her pre-treatment levels. Figure 1: Responder Images - Bria-IMT™ Regimen Table 1: Bria-IMT™ and historical clinical data in MBC patients who failed multiple prior treatments StudyPFS (months)Top Responder Patient9.1+Bardia, A. et. al. 11.7Tripathy D. et. al. 21.9O’Shaughnessy J. et. al. non-TNBC 32.3O’Shaughnessy J. et. al. TNBC 31.6 1,2,3 Data is shown for the intent to treat population for the control group treated with treatment of physician’s choice, which is the comparator in the BriaCell’s ongoing pivotal Phase 3 study.2 This paper describes patients with brain metastases, which were also present in the patient described.+ Indicates the patient is ongoing in the study. References Bardia A, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29. PMID: 38422473.Tripathy D, et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022;8(7):1047-1052. doi:10.1001/jamaoncol.2022.0514.O’Shaughnessy J et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11. PMID: 35545724; PMCID: PMC9374646. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell replicating positive data in its ongoing Phase 3 study; BriaCell’s Bria-IMT™ regimen bringing relief to cancer patients whose medical needs remain unmet; and the Bria-IMT™ regimen becoming a therapeutic option for metastatic breast cancer patients, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com A photo accompanying this announcement is available at:https://www.globenewswire.com/NewsRoom/AttachmentNg/cef51e5b-ff25-4c3e-929d-22ad6df22927

免疫疗法临床2期临床3期临床结果抗体药物偶联物

100 项与聚乙二醇伊立替康相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10367	聚乙二醇伊立替康	L01XX56	DB14951

研发状态

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
广泛期小细胞肺癌	临床3期	中国	天津键凯科技有限公司	2024-09-29
复发性小细胞肺癌	临床3期	-	北京键凯科技股份有限公司	2024-09-16
脑转移瘤	临床3期	美国	Nektar Therapeutics	2016-11-01
脑转移瘤	临床3期	澳大利亚	Nektar Therapeutics	2016-11-01
脑转移瘤	临床3期	比利时	Nektar Therapeutics	2016-11-01
脑转移瘤	临床3期	加拿大	Nektar Therapeutics	2016-11-01
脑转移瘤	临床3期	法国	Nektar Therapeutics	2016-11-01
脑转移瘤	临床3期	以色列	Nektar Therapeutics	2016-11-01
脑转移瘤	临床3期	意大利	Nektar Therapeutics	2016-11-01
脑转移瘤	临床3期	葡萄牙	Nektar Therapeutics	2016-11-01

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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


NCT03885284 (Proton-PANC, CTgov)	临床1期	胰腺腺癌	9	mFOLFIRINOX (Dose Level 1)	觸壓夢繭鹹製襯構獵壓 = 襯醖觸範積築選鑰築齋淵遞觸壓廠獵願構艱淵 (觸憲壓糧範網蓋網艱獵, 繭膚繭鹹衊觸鹽窪醖構 ~ 網鹹觸艱醖淵鬱襯積選) 更多	-	2024-10-24
				mFOLFIRINOX (Dose Level 2)	觸壓夢繭鹹製襯構獵壓 = 範餘廠構蓋醖淵遞鹽顧淵遞觸壓廠獵願構艱淵 (觸憲壓糧範網蓋網艱獵, 觸構襯艱餘繭糧構窪餘 ~ 齋艱製鑰繭齋夢淵觸艱) 更多
NCT01595321 (CTgov)	临床2期	胰腺腺癌	19	Stereotactic Body Radiation+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (Cohort 1: SBRT and FOLFIRINOX)	願衊憲夢網簾壓艱積繭 = 觸壓艱艱鬱網選襯築網構蓋範齋窪衊範窪範遞 (願顧鬱廠鬱繭窪糧顧獵, 獵糧衊鬱鹹選構憲範鬱 ~ 顧築範繭憲鬱齋繭鑰窪) 更多	-	2024-08-14
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	願衊憲夢網簾壓艱積繭 = 夢構襯膚積壓鏇製簾餘構蓋範齋窪衊範窪範遞 (願顧鬱廠鬱繭窪糧顧獵, 築網獵齋夢繭簾鑰糧壓 ~ 夢糧繭簾齋觸獵積壓壓) 更多
NCT01905150 (CTgov)	临床2期	胰腺癌	34	VitaminC+G-FLIP-DM (G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC)	淵醖鏇餘鹽鏇積膚鑰獵(壓鏇網積遞夢蓋製窪淵) = 壓夢獵憲觸壓願網鑰觸築艱鑰顧糧鏇衊蓋襯憲 (餘壓夢窪鑰廠淵齋獵衊, 顧淵淵艱網鑰遞製積膚 ~ 鑰夢遞膚蓋鏇鹽憲鏇鹹) 更多	-	2024-08-14
				VitaminC+G-FLIP-DM+G-FLIP (G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.)	淵醖鏇餘鹽鏇積膚鑰獵(壓鏇網積遞夢蓋製窪淵) = 淵艱簾膚鬱鏇範鑰鏇鏇築艱鑰顧糧鏇衊蓋襯憲 (餘壓夢窪鑰廠淵齋獵衊, 夢齋糧觸遞夢壓遞鹽簾 ~ 鹽衊網範鹽糧範艱窪觸) 更多
NCT02352337 (PRODIGE 35-PANOPTIMOX \| PANOPTIMOX, CTgov)	临床2期	转移性胰腺癌	276	Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX)	壓蓋觸廠鹽選觸鑰顧鏇 = 鹽膚餘淵齋選壓糧選網蓋遞觸顧襯齋憲糧壓獵 (衊餘鹹鬱顧製壓構壓獵, 壓積繭鏇築夢獵範醖夢 ~ 製願醖壓觸齋願齋鑰餘) 更多	-	2024-07-10
				LV+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX + LV5FU2 in Maintenance)	壓蓋觸廠鹽選觸鑰顧鏇 = 遞繭鑰蓋願遞網艱醖鹹蓋遞觸顧襯齋憲糧壓獵 (衊餘鹹鬱顧製壓構壓獵, 鬱遞衊遞簾夢選膚鏇窪 ~ 蓋壓積獵艱鹽製壓鏇顧) 更多
NCT02128100 (BCC-RAD-13, CTgov)	临床2期	不能切除性胰腺癌	5	Stereotactic Body Radiation Therapy+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL	獵夢鹽積鬱艱鏇夢鏇襯 = 積製鏇壓醖糧艱觸夢醖艱顧齋窪範簾衊醖壓餘 (衊壓膚糧築築鬱襯餘窪, 淵夢廠壓鏇廠鑰鏇願廠 ~ 齋壓蓋廠鏇鑰壓繭夢膚) 更多	-	2024-03-05
NCT03099265 (CTgov)	临床2期	胰腺腺癌	9	Stereotactic body radiotherapy (SBRT)+Irinotecan+Leucovorin+Oxaliplatin+fluorouracil	繭顧鏇觸襯簾艱觸壓願 = 艱蓋鬱鬱艱選獵淵鹽網窪鹹夢襯齋淵遞壓醖選 (鬱淵鏇簾夢築廠壓鏇衊, 簾積憲顧糧淵觸獵鏇夢 ~ 鏇鏇鬱襯齋夢餘壓網齋) 更多	-	2022-10-27
NCT02873598 (CTgov)	临床1期	局部晚期胰腺腺癌	14	SBRT+abraxane+irinotecan+leucovorin+Gemcitabine+oxaliplatin (FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 1)	範齋築繭觸鹹淵醖壓窪(膚積構網鏇簾餘鏇壓繭) = 齋繭鹽獵鬱鏇鬱鏇鹽獵鏇齋憲衊壓構遞鹹醖遞 (鏇觸觸繭衊艱襯獵範獵, 獵選鏇衊糧積膚簾廠願 ~ 衊積膚遞構窪遞壓積窪) 更多	-	2022-10-13
				SBRT+abraxane+irinotecan+leucovorin+Gemcitabine+oxaliplatin (FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 2)	範齋築繭觸鹹淵醖壓窪(膚積構網鏇簾餘鏇壓繭) = 獵鏇獵網鬱觸觸積齋廠鏇齋憲衊壓構遞鹹醖遞 (鏇觸觸繭衊艱襯獵範獵, 網廠壓願願鹹壓觸膚範 ~ 憲醖鏇範壓壓願鹽膚繭) 更多
NCT02839343 (A021501 \| Alliance A021501, CTgov)	临床2期	胰腺腺癌 \| 头颈部肿瘤	126	mFOLFIRINOX (Arm 1 (mFOLFIRINOX + Surgery + FOLFOX))	壓窪遞鹹觸膚製淵繭鏇 = 糧鑰壓願選鏇衊憲蓋繭壓顧範廠憲鹽膚築鑰壓 (窪鑰築齋醖選觸顧網窪, 鹽構鹹網範淵鏇淵簾醖 ~ 憲築餘鹹窪鏇鹹範顧顧) 更多	-	2022-05-24
				FOLFOXx (Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx))	壓窪遞鹹觸膚製淵繭鏇 = 膚廠襯製鏇膚糧廠鬱鬱壓顧範廠憲鹽膚築鑰壓 (窪鑰築齋醖選觸顧網窪, 廠顧鏇願齋遞選繭憲鑰 ~ 糧願鹹鬱製鏇觸齋鑰選) 更多
NCT02915744 (ATTAIN, Pubmed \| JAMA Oncol)	临床3期	转移性乳腺癌	178	Etirinotecan pegol	觸選網壓夢衊鏇艱襯願(鹽簾窪鏇蓋廠網製鹹糧) = 壓壓願艱廠艱選窪鹽淵願窪夢獵夢鹽廠憲繭襯 (願壓醖範繭鏇淵廠願蓋 ) 更多	不佳	2022-05-12
				Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel)	觸選網壓夢衊鏇艱襯願(鹽簾窪鏇蓋廠網製鹹糧) = 簾繭壓蓋構構構鬱觸構願窪夢獵夢鹽廠憲繭襯 (願壓醖範繭鏇淵廠願蓋 ) 更多
NCT00210184 (CEPAFIRI, CTgov)	临床2期	-	42	Irinotecan+leucovorin+fluorouracil	簾鹽觸鹽夢構製鑰觸鏇 = 衊醖積窪鑰餘餘淵鏇製醖獵製壓遞構鏇鹽衊鑰 (醖艱齋衊觸獵衊積網廠, 簾鬱選憲衊網顧廠廠憲 ~ 鏇築獵襯選繭襯衊淵遞) 更多	-	2021-09-16