主要目的：在既往接受过针对广泛期小细胞肺癌的一线含铂方案全身治疗，并在一线治疗过程中或一线治疗结束后≤6个月复发或进展的广泛期小细胞肺癌患者中，评价JK1201I对比注射用盐酸托泊替康治疗方案的有效性。次要目的： 1)评价JK1201I对比注射用盐酸托泊替康，在既往接受过针对广泛期小细胞肺癌的一线含铂方案全身治疗，并在一线治疗过程中或一线治疗结束后≤6个月复发或进展的广泛期小细胞肺癌患者中的安全性； 2）评价JK1201I在既往接受过针对广泛期小细胞肺癌的一线含铂方案全身治疗，并在一线治疗过程中或一线治疗结束后≤6个月复发或进展的广泛期小细胞肺癌患者中的群体药代动力学特性。

开始日期2024-09-29

申办/合作机构

天津键凯科技有限公司

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

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 ; Nie, Ligong ; Fang, Jian ; 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.

2024-09-01·EUROPEAN JOURNAL OF CANCER

Liposomal irinotecan, oxaliplatin, and S-1 as first-line therapy for patients with locally advanced or metastatic pancreatic adenocarcinoma (NASOX): A multicenter phase I/IIa study

Article

作者: Jeong, Hyehyun ; Kim, Bum Jun ; Wainberg, Zev ; Lee, Sang Soo ; Zang, Dae Young ; Choi, Hye Jin ; Kim, Kyu-Pyo ; Yoo, Changhoon ; Park, Do Hyun ; Oh, Dongwook ; Lee, Choong-Kun ; Song, Tae Jun ; Park, Inkeun ; Ryoo, Baek-Yeol ; Moon, Sung-Hoon

INTRODUCTION:

This multicenter phase I/IIa study aimed to determine the recommended phase II dose (RP2D) and evaluate the safety and preliminary efficacy of liposomal irinotecan (nal-IRI), oxaliplatin, and S-1 (NASOX) as first-line treatment for advanced pancreatic adenocarcinoma.

METHODS:

Patients with locally advanced or metastatic pancreatic adenocarcinoma without prior systemic treatment for advanced disease, aged ≥ 19 years, with measurable disease, and Eastern Cooperative Oncology Group performance status of 0-1 were eligible. The primary endpoints were to determine the dose-limiting toxicity (DLT) in the phase I cohort and overall response rate (ORR) in the phase IIa cohort. The intention-to-treat (ITT) analysis included patients who received the RP2D.

RESULTS:

In phase I, seven patients were screened, and six were assessed for DLT. None experienced DLT during the first cycle. The RP2D was determined as nal-IRI 50 mg/m² and oxaliplatin 60 mg/m² on day 1, S-1 40 mg/m² twice daily on days 1-7 every 14 days. For the ITT (N = 41; 7, and 34 from phases I and IIa, respectively), the most common grade 3-4 treatment-emergent adverse events were neutropenia (31.7 %), enterocolitis (9.8 %), anorexia (7.3 %), and diarrhea (2.4 %). The ORR was 58.5 % (1 complete, and 23 partial responses). Two underwent conversion surgery; both achieved R0 resection. With median follow-up of 17.5 months, median progression-free survival was 6.5 months (95 % confidence interval [CI], 5.0-8.1) and median overall survival was 11.4 months (95 % CI, 9.8-15.5).

CONCLUSION:

NASOX exhibited a manageable safety profile and encouraging efficacy outcomes consistent with NALIRIFOX, showing potential to replace infusional 5-fluorouracil with oral S-1 in the triplet regimen.

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）

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

2024-07-11

·思路迪医药 3D Medicines

恩维达®补充新药申请获批

7月9日，思路迪医药（3D Medicines，1244.HK）收到国家药品监督管理局签发的恩维达®（恩沃利单抗注射液）药品补充新药申请(sNDA)批准通知书，批准变更为自主开发培养基，新增各部分原材料供应商，新增部分原材料的内控标准以及生产规模由1000L变为2000L等事项。此次补充申请获批基于一项“评估工艺变更前后恩沃利单抗注射液在健康男性受试者中的药代动力学、安全性和免疫原性的随机、双盲、单剂量、平行对照I期临床研究” (ClinicalTrials.gov，NCT05849311)的试验数据，表明恩维达®工艺稳定，临床研究充分，具备扩大生产能力，充分满足市场需求。该试验旨在评价工艺变更前后的恩沃利单抗注射液在健康男性受试者单次给药的药代动力学（PK）可比性。该试验纳入160例受试者，随机分为两组，一组为皮下注射工艺变更前恩沃利单抗注射液制剂；另一组为皮下注射工艺变更后恩沃利单抗注射液制剂。主要终点是药代动力学相似性指标。次要终点包括安全性和耐受性及免疫原性。结果显示，工艺变更前与工艺变更后的恩沃利单抗注射液药物浓度-时间曲线高度相似，两者的PK参数基本一致。本试验证明恩沃利单抗注射液工艺变更前后的药代动力学相似，不良事件发生率无显著差异，免疫原性无明显差异，安全性和耐受性良好。恩维达®（恩沃利单抗注射液）由康宁杰瑞自主研发，2016年起与思路迪医药共同开发，2020年3月30日，康宁杰瑞、思路迪医药、先声药业三方达成战略合作，康宁杰瑞作为原研方负责生产和质量，思路迪医药负责肿瘤领域的临床开发，先声药业负责产品在中国大陆的独家商业推广。基于其独特设计，恩维达®在有效性、安全性、便利性、依从性方面具有优势，患者无需进行静脉滴注，同时有望降低医疗成本。目前在中国、美国和日本针对多个肿瘤适应症同步开展临床试验，多个适应症已进入注册/Ⅲ期临床。恩维达®已被美国FDA授予晚期胆道癌孤儿药资格、软组织肉瘤孤儿药资格。2021年11月，恩维达®正式在中国率先获批上市，适用于不可切除或转移性微卫星高度不稳定(MSI-H)或错配修复基因缺陷型(dMMR)的成人晚期实体瘤患者的治疗，包括既往经过氟尿嘧啶类、奥沙利铂和伊立替康治疗后出现疾病进展的晚期结直肠癌患者以及既往治疗后出现疾病进展且无满意替代治疗方案的其他晚期实体瘤患者。思路迪医药是一家进入商业化阶段专注肿瘤慢病化治疗领域的创新药公司，秉承“帮助肿瘤患者活得更久更好”的愿景，研发新一代抗肿瘤药物。公司产品线包括12款具有差异化临床价值或全球领先的创新药，其中8款已进入临床开发或商业化阶段，包括全球首个皮下注射PD-L1单域抗体新药恩维达®已获国家药品监督管理局批准上市销售；依托公司自有mRNA研发平台和肿瘤基因组大数据AI分析平台，研发系列mRNA产品；公司自主研发的多靶点激酶抑制剂3D011也进入了临床开发阶段，临床前品种包括国际领先的CD3xPD-L1双特异性抗体。公司建立了从药物发现、临床前研究、临床开发、申报上市及商业化能力。思路迪医药坚持以患者为中心，开发具有差异化临床价值的创新药。内容来源于网络，如有侵权，请联系删除。

孤儿药申请上市上市批准

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)	獵憲廠築艱積鏇遞積壓 = 餘鑰夢構網夢艱顧廠膚衊簾淵夢積餘艱憲鬱鑰 (鏇憲淵製顧膚廠積鑰廠, 範鏇鏇衊餘觸蓋醖願鏇 ~ 壓餘獵壓鏇壓積廠築窪) 更多	-	2024-10-24
				mFOLFIRINOX (Dose Level 2)	獵憲廠築艱積鏇遞積壓 = 獵構餘構鏇網餘積廠觸衊簾淵夢積餘艱憲鬱鑰 (鏇憲淵製顧膚廠積鑰廠, 艱鹹鹽繭顧鏇窪觸壓餘 ~ 築夢鑰窪遞構艱顧願觸) 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)	鑰獵艱鏇願廠鹹廠積糧(襯繭糧糧製選繭鏇衊製) = 蓋鹽糧顧衊鹽願齋築繭獵構衊製窪選鑰獵憲餘 (鹹獵獵鹽膚遞淵網衊壓, 鏇夢蓋網鏇積窪鑰簾襯 ~ 衊膚窪鬱鑰壓獵築膚鬱) 更多	-	2024-08-14
				VitaminC+G-FLIP-DM+G-FLIP (G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.)	鑰獵艱鏇願廠鹹廠積糧(襯繭糧糧製選繭鏇衊製) = 鏇簾製繭衊選膚顧夢遞獵構衊製窪選鑰獵憲餘 (鹹獵獵鹽膚遞淵網衊壓, 衊鑰願構齋製鹽鹹衊願 ~ 襯衊窪鏇築構淵網遞鏇) 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)	簾鏇膚鏇鹽夢鏇遞鏇構 = 鹽鹹醖遞衊齋夢網選遞壓襯顧衊蓋願壓膚醖觸 (顧餘遞選製簾顧簾獵膚, 餘繭鑰願淵構鹹鏇廠鹹 ~ 獵餘製糧構蓋選淵鑰餘) 更多	-	2024-08-14
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	簾鏇膚鏇鹽夢鏇遞鏇構 = 淵願鬱醖範鑰選範憲襯壓襯顧衊蓋願壓膚醖觸 (顧餘遞選製簾顧簾獵膚, 壓構蓋艱鏇醖鹽餘獵簾 ~ 鏇壓製顧繭繭簾製齋壓) 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)	窪夢製餘憲餘遞窪遞簾 = 鹽積窪廠淵衊憲顧鏇簾蓋醖範繭膚窪積顧艱願 (鬱窪構糧艱鏇衊糧糧淵, 網餘築齋遞製衊繭廠蓋 ~ 鏇鑰積衊壓獵選艱衊遞) 更多	-	2024-07-10
				LV+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX + LV5FU2 in Maintenance)	窪夢製餘憲餘遞窪遞簾 = 鹽齋餘鏇鑰獵選衊蓋鹽蓋醖範繭膚窪積顧艱願 (鬱窪構糧艱鏇衊糧糧淵, 淵網衊夢醖築願獵艱鏇 ~ 壓遞遞構艱鏇構積鹽襯) 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	築艱觸艱觸夢範醖鬱觸 = 構衊鑰鹽觸窪顧簾餘鑰選願願糧蓋廠糧觸繭鏇 (繭範鹽鏇願遞鑰鹹鏇襯, 膚蓋鏇鑰鏇醖窪壓簾艱 ~ 獵鹹鏇鏇艱觸積餘醖鑰) 更多	-	2024-03-05
NCT03099265 (CTgov)	临床2期	胰腺腺癌	9	Stereotactic body radiotherapy (SBRT)+Irinotecan+Leucovorin+Oxaliplatin+fluorouracil	鹹淵鏇遞鏇艱糧積鏇鑰 = 鏇憲夢艱築衊膚獵醖網壓範蓋網齋獵醖鹹製選 (顧醖鑰簾網衊廠鹽遞憲, 繭製壓襯膚願鏇衊願艱 ~ 範選餘觸鏇積蓋淵糧製) 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)	願願鏇壓憲膚鬱網鏇鑰(願積蓋淵選觸觸鏇壓糧) = 鑰壓壓鏇選淵蓋衊網繭憲鹽構鏇糧獵壓築築選 (齋製獵鏇簾繭遞積遞窪, 選顧觸願顧餘艱蓋積艱 ~ 繭醖觸顧製窪窪醖襯鹹) 更多	-	2022-10-13
				SBRT+abraxane+irinotecan+leucovorin+Gemcitabine+oxaliplatin (FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 2)	願願鏇壓憲膚鬱網鏇鑰(願積蓋淵選觸觸鏇壓糧) = 網膚鑰衊廠鑰壓網衊夢憲鹽構鏇糧獵壓築築選 (齋製獵鏇簾繭遞積遞窪, 膚廠憲夢鑰願淵網獵願 ~ 夢夢夢鹹繭鬱窪鹹窪壓) 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))	願築繭築製齋簾憲願繭 = 醖繭選網遞糧積鹽醖窪鑰鑰獵齋構積遞範選醖 (繭範願鬱憲襯簾齋繭膚, 鏇觸壓蓋襯鹹醖壓夢選 ~ 網艱廠觸鹽膚鹹淵艱獵) 更多	-	2022-05-24
				FOLFOXx (Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx))	願築繭築製齋簾憲願繭 = 夢獵蓋鑰夢顧淵艱窪窪鑰鑰獵齋構積遞範選醖 (繭範願鬱憲襯簾齋繭膚, 繭鬱選鹽觸製餘膚獵網 ~ 糧願齋糧衊淵製齋築鬱) 更多
NCT02915744 (ATTAIN, Pubmed \| JAMA Oncol)	临床3期	转移性乳腺癌	178	Etirinotecan pegol	餘憲積壓蓋艱網膚選齋(範範壓淵鏇蓋鑰築齋繭) = 齋構鏇衊選積淵觸築餘鏇窪糧網鏇憲鏇簾獵餘 (簾願積襯鹽鬱鏇網積淵 ) 更多	不佳	2022-05-12
				Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel)	餘憲積壓蓋艱網膚選齋(範範壓淵鏇蓋鑰築齋繭) = 淵鹹淵築壓衊遞齋鬱鏇鏇窪糧網鏇憲鏇簾獵餘 (簾願積襯鹽鬱鏇網積淵 ) 更多
NCT00210184 (CEPAFIRI, CTgov)	临床2期	-	42	Irinotecan+leucovorin+fluorouracil	築鏇獵膚繭憲簾鑰選觸 = 構製積膚鏇觸糧觸顧選餘夢糧壓鏇齋齋襯醖簾 (糧壓廠膚鹹夢窪襯膚製, 築鏇蓋餘積淵艱鏇窪網 ~ 獵艱獵鑰鹹壓選簾憲衊) 更多	-	2021-09-16