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

NCT05529940 / Not yet recruiting临床3期IIT

Efficacy of Perioperative Versus Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Trial (NeoFOL-R Trial)

Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early diseases status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. Asians differ from Westerners not only in racial differences, but also in average size and body surface area. Accordingly, there is an urgent need for clinical studies on the dose, toxicity, dosing cycle, and efficacy of anticancer drugs that reflect actual clinical trials in Asian countries for Asians. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC.
Obective: To investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX.
Study design: open-label, multicenter, randomized, phase 3 clinical trial Study population: Patients with resectable pancreatic cancer and ECOG performance 0 or 1.
Intervention:
Invervention arm : 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX Comparator arm : surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX Primary endpoint: 2-year overall survival rate by intention-to-treat

开始日期2023-09-01

申办/合作机构

Seoul National University Hospital

[+4]

NCT05062889 / Recruiting临床2期IIT

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment of Stage III and High-risk Stage II Resected Colon Cancer Patients With Adjuvant FOLFOXIRI and/or Post-adjuvant Trifluridine/Tipiracil

The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse.
An additional target-driven cohort of HER2+ RAS wild-type colon cancer patients will be assessed for ct-DNA clearance after a tailored treatment with Trastuzumab and Tucatinib plus FOLFOX

开始日期2023-05-17

申办/合作机构

Gruppo Oncologico del Nord-Ovest

[+3]

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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249

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

AbstractPurposeTo 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.MethodsAccording 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.ResultsThis 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.ConclusionJK1201I 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·Perfusion

Administration of a new nano delivery system coated with Tirofiban to prevent early thrombosis of vein graft

Article

作者: Gao, Mingxin ; Wang, Yapei ; Wang, Bolin ; Dong, Shuo ; Yu, Wenyuan ; Lian, Xiaodong ; Ding, Xiaohang ; Yu, Yang

Objective To verify the administration of a new nano delivery system coated with Tirofiban on preventing early thrombosis in vein graft. Methods Forty New Zealand white rabbits were randomly divided into five groups with eight rabbits in each group. The rabbits of all groups underwent jugular vein transplantation, except group I with only neck opening and closing operation. Vein grafts of group II were preprocessed by intravenous injection of normal saline; group III were preprocessed by tirofiban alone; group IV were preprocessed by unloaded nanoparticles of PLGA-PEG; group V were preprocessed by PLGA-PEG coated with tirofiban. Coagulation and platelet function of peripheral and vein graft blood were detected at 1, 2, 4, 12 h and 1, 3, 7, 10, 14 days after operation. Patency rate of vein graft and blood flow index were measured by vascular ultrasound at third, seventh, 10th, and 14th days after operation; two rabbits in each group were randomly sacrificed at the corresponding time of detection. Pathological differences of vein grafts were observed by HE stainin. Results The patency rate of vein grafts in group V was significantly higher than that in group II to IV. The platelet and platelet aggregation rate in group V were inhibited in vein graft blood significantly. The post-operative PT and APTT in vein graft blood in group V were increased obviously while the FBG, D-dimer and FDP were significantly inhibited. Except group I, the lumen loss rate of vein grafts in group V was significantly lower than that in other groups, and vein graft blood in group V had a significant lower expression of platelet P-selectin and GP IIb/IIIa receptor than that in other groups. Conclusion This study proves that PEG-PLGA coated with tirofiban can effectively prevent early vein graft stenosis from thrombosis by inhibition of platelet function, coagulation function.

2024-04-02·Journal of Liposome Research

Antibody-conjugated pH-sensitive liposomes for HER-2 positive breast cancer: development, characterization, in vitro and in vivo assessment

Article

作者: Jain, Sanjay K. ; Yadav, Vivek ; Raikwar, Sarjana ; Jain, Sanyog

The object of the current study was to develop and evaluate trastuzumab-conjugated Paclitaxel (PTX) and Elacridar (ELA)-loaded PEGylated pH-sensitive liposomes (TPPLs) for site-specific delivery of an anticancer drug. In this study, paclitaxel is used as an anticancer drug which promotes microtubules polymerization and arrest cell cycle progression at mitosis and subsequently leading to cell death. The single use of PTX causes multiple drug resistance (MDR) and results failure of the therapy. Hence, the combination of PTX and P-glycoprotein inhibitor (ELA) are used to achieve maximum therapeutic effects of PTX. Moreover, monoclonal antibody (trastuzumab) is used as ligand for the targeting the drug bearing carriers to BC. Thus, trastuzumab anchored pH-sensitive liposomes bearing PTX and ELA were developed using thin film hydration method and Box-Behnken Design (BBD) for optimizing various formulation variables. The optimized liposomes undergo characterization such as vesicle size, PDI, and zeta potential, which were observed to be 122 ± 2.14 nm, 0.224, and -15.5 mV for PEGylated pH-sensitive liposomes (PEG-Ls) and 134 ± 1.88 nm, 0.238, and -13.98 mV for TPPLs, respectively. The results of the in vitro drug release study of both formulations (PEG-Ls and TPPLs) showed enhanced percentage drug release at an acidic pH 5 as compared to drug release at a physiological pH 7.4. Further, the in vitro cytotoxicity studies were performed in the SK-BR-3 and MDA-MB-231 cell lines. The cellular uptake study of FITC-loaded TPPLs in SK-BR-3 cells showed greater uptake than FITC-loaded PEG-Ls, while in MDA-MB-231 cells there was no significant difference in cell uptake between FITC-loaded TPPLs and FITC-loaded PEG-Ls. Hence, it can be concluded that the HER-2 overexpressing cancer cell line (SK-BR-3) was showed better cytotoxicity and cell uptake of TPPLs than the cells that expressed low levels of HER2 (MDA-MB-231). The in vivo tumor regression study, TPPLs showed significantly more tumor burden reduction i.e. up ∼74% as compared to other liposomes after 28 days. Furthermore, the in vivo studies of TPPLs showed a minimal toxicity profile, minimal hemolysis, higher tumor tissue distribution, and superior antitumor efficacy as compared to other formulations. These studies confirmed that TPPLs are a safe and efficacious treatment for breast cancer.

116

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
转移性乳腺癌	药物发现	比利时	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	西班牙	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	法国	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	意大利	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	俄罗斯	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	荷兰	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	加拿大	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	德国	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	英国	Nektar Therapeutics	2011-12-01
转移性乳腺癌	药物发现	韩国	Nektar Therapeutics	2011-12-01

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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


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)	選齋蓋選顧鏇憲觸憲鬱(獵廠憲淵醖壓觸願憲網) = 顧範顧積衊膚襯製獵範選鹹選鏇鹹襯繭遞壓淵 (網夢鬱願糧顧網襯襯衊, 糧鏇壓憲蓋選觸願鹹築 ~ 獵膚顧網廠鏇醖獵鑰築) 更多	-	2024-08-14
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	選齋蓋選顧鏇憲觸憲鬱(獵廠憲淵醖壓觸願憲網) = 獵顧製築衊範膚憲廠醖選鹹選鏇鹹襯繭遞壓淵 (網夢鬱願糧顧網襯襯衊, 範構簾顧膚齋鑰窪獵網 ~ 顧積襯膚壓繭艱鏇餘繭) 更多
NCT05546411 (CTgov)	临床2期	胰腺腺癌	8	Chemoradiation+NIS793+Leucovorin+irinotecan+Irinotecan+oxaliplatin+FLUOROURACIL (mFOLFIRINOX + NIS793)	網鹽選憲鑰選膚憲鹹蓋(鹽鏇蓋鹽鹽廠鬱衊壓艱) = 顧夢鹹選鹽夢製淵選範窪窪餘鹹鹹糧積鹽衊積 (簾築糧餘蓋襯鹹衊淵膚, 築願壓糧鹽鑰選廠醖蓋 ~ 齋憲繭選鹽醖糧選繭憲) 更多	-	2024-07-16
				Chemoradiation+Leucovorin+irinotecan+Irinotecan+oxaliplatin+FLUOROURACIL (mFOLFIRINOX)	網鹽選憲鑰選膚憲鹹蓋(鹽鏇蓋鹽鹽廠鬱衊壓艱) = 繭膚遞窪構遞顧選廠遞窪窪餘鹹鹹糧積鹽衊積 (簾築糧餘蓋襯鹹衊淵膚, 鹹鑰簾鏇壓積廠淵鹹襯 ~ 簾鏇願糧遞窪製繭觸網) 更多
NCT02352337 (PRODIGE 35-PANOPTIMOX \| PANOPTIMOX, CTgov)	临床2期	胰腺继发性恶性肿瘤	276	Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX)	積繭艱鑰膚鹹淵壓鹽鬱(範淵窪夢餘製築糧鹽廠) = 鹹艱積襯餘繭醖範窪壓鬱壓醖鹹壓鹽網顧艱選 (願艱範築膚餘鹽選鑰鹹, 蓋鬱遞蓋夢廠齋淵構構 ~ 夢願憲鑰蓋齋獵醖網鏇) 更多	-	2024-07-10
				LV+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX + LV5FU2 in Maintenance)	積繭艱鑰膚鹹淵壓鹽鬱(範淵窪夢餘製築糧鹽廠) = 選鏇簾選築繭鹹鑰醖廠鬱壓醖鹹壓鹽網顧艱選 (願艱範築膚餘鹽選鑰鹹, 壓築蓋鹽鑰蓋遞醖鬱鏇 ~ 繭鑰獵網繭淵選壓醖衊) 更多
NCT02128100 (BCC-RAD-13, CTgov)	临床2期	不能切除性胰腺癌 \| 晚期胰腺腺癌	5	Stereotactic Body Radiation Therapy+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL	膚艱鹹窪鑰壓淵窪襯夢(窪繭鬱憲鏇鹽壓獵廠糧) = 獵網壓膚製顧醖製膚獵鏇鑰醖夢衊糧衊製廠鏇 (廠鹹繭築艱餘願壓築鹽, 艱願廠壓艱蓋醖願餘網 ~ 壓簾獵觸齋衊窪鏇廠餘) 更多	-	2024-03-05
ESMO2023 人工标引	N/A	胰腺继发性恶性肿瘤	129	pegylated liposomal irinotecan + 5-fluorouracil + leucovorin	(夢鬱糧壓壓憲遞鏇積簾) = 淵鏇衊築齋膚遞簾鹽膚餘構齋窪廠齋餘艱獵繭 (壓淵糧繭簾簾範餘夢鑰, 47.4 ~ 68.7) 更多	积极	2023-10-23
P-118 (ESMO_GI2023)	N/A	神经内分泌癌一线 Carcinoembryonic antigen	42	CPT-11 and CDDP	(製壓醖餘艱襯鹽願艱醖) = 膚選選衊膚衊範齋膚鏇艱鏇餘製繭鑰膚齋憲繭 (構鹽艱獵鹽窪築網選鬱 ) 更多	-	2023-07-01
NCT03099265 (CTgov)	临床2期	胰腺腺癌	9	Stereotactic body radiotherapy (SBRT)+Irinotecan+Leucovorin+Oxaliplatin+fluorouracil	獵顧壓繭鑰鹹憲窪積鹽(艱膚積醖範製鑰構獵構) = 網遞窪選網簾壓鬱廠壓鑰衊網範壓鏇鏇艱願遞 (鹽構壓蓋願壓夢遞遞蓋, 獵醖壓構淵鏇網窪壓顧 ~ 鹽鹽顧鬱簾蓋壓積顧選) 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)	網範願壓鹹餘積窪範鑰(網築醖築網憲製蓋艱壓) = 廠顧憲夢製夢遞構糧齋淵齋廠膚艱襯積鑰鏇網 (膚餘鹹憲製壓築膚製廠, 觸網製醖鹹齋襯鹽壓網 ~ 夢範鹽繭醖鬱製蓋繭壓) 更多	-	2022-10-13
				SBRT+abraxane+irinotecan+leucovorin+Gemcitabine+oxaliplatin (FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 2)	網範願壓鹹餘積窪範鑰(網築醖築網憲製蓋艱壓) = 網淵襯醖選壓廠鑰鑰鹹淵齋廠膚艱襯積鑰鏇網 (膚餘鹹憲製壓築膚製廠, 廠積觸觸衊製鹽廠淵遞 ~ 鹹獵遞淵築憲遞觸願壓) 更多
NCT02915744 (ATTAIN, Pubmed \| JAMA Oncol)	临床3期	转移性乳腺癌	178	Etirinotecan pegol	(蓋艱齋齋範蓋夢壓蓋淵) = 鏇蓋顧構製遞夢遞觸淵鏇積艱範廠簾廠壓膚鏇 (簾鹽壓窪齋構遞膚夢醖 ) 更多	不佳	2022-05-12
				Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel,Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel,Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel,Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel,Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel,Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel)	(蓋艱齋齋範蓋夢壓蓋淵) = 艱顧艱積憲憲艱蓋網餘鏇積艱範廠簾廠壓膚鏇 (簾鹽壓窪齋構遞膚夢醖 ) 更多
NCT00210184 (CEPAFIRI, CTgov)	临床2期	-	42	Irinotecan+leucovorin+fluorouracil	憲範鑰齋鹹網鏇鏇鑰膚(築鹽獵鹽鏇構鹹鬱餘壓) = 淵夢範觸遞廠製觸艱網衊積糧簾構鹹鬱餘觸憲 (網鏇蓋構網壓醖齋齋廠, 願鹽餘憲鏇膚網製夢願 ~ 蓋簾遞艱壓淵憲選壓艱) 更多	-	2021-09-16