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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251

项与聚乙二醇伊立替康相关的文献（医药）

2025-01-01·Therapeutic Advances in Medical Oncology

Real-world effectiveness and safety of second- or third-line pegylated liposomal irinotecan plus 5-fluorouracil and folinic acid in pancreatic ductal adenocarcinoma in Spain

Article

作者: Angeles, Maria Cristina ; Ghanem, Ismael ; Pazo-Cid, Roberto ; Granja, Monica ; Hernández, Irene ; Martin Valadés, Jose Ignacio ; Álvarez-Gallego, Rafael ; Martinez, Joaquina ; Martinez, Eva ; Diaz, Roberto ; Ribera, Paula ; López de San Vicente, Borja ; Macarulla, Teresa ; Garicano, Fernando ; Cubillo, Antonio

Treatment with pegylated nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (folinic acid; 5-FU/LV) has demonstrated remarkable efficacy for metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical trials. However, real-world data on the effectiveness of nal-IRI+5-FU/LV is heterogeneous and is lacking in Spain. To assess the effectiveness and safety of nal-IRI+5-FU/LV in real-life PDAC patients in Spain. A multicenter retrospective study was conducted. Patients aged ⩾18 years who had received at least one cycle of nal-IRI+5-FU/LV as second- or third-line therapy for PDAC were included. The primary endpoint was overall survival (OS) from nal-IRI+5-FU/LV treatment initiation and OS from the diagnosis of metastatic disease (metOS). Overall, 200 evaluable patients were included (⩾3 metastatic sites: 22%; liver/lung metastases: 71.5%/36.9%; and Eastern Cooperative Oncology Group 0–1: 87% at nal-IRI+5FU/LV treatment initiation). Patients received a median of four cycles of nal-IRI+5FU/LV for 2.8 months (range 1.4–7.2), and the treatment was received in the second line by 80% of the patients. The median OS was 7.2 months (6- and 12-month OS rates: 58.1% and 28.9%, respectively), with 27.2% of the patients achieving OS ⩾12 months. The median metOS was 17.5 months, with 30.2% of the patients experiencing metOS ⩾ 24 months. The median progression-free survival (PFS) was 3.7 months (6- and 12-month PFS rate: 37.6% and 15.3%, respectively). The disease control rate was 35.5%. The median CA 19-9 levels decreased by at least 50% in 28.2% of the cases during treatment. Overall, 36% of the patients experienced at least one grade 3–4 adverse event during treatment, the most common being diarrhea (42.6%) and asthenia (30.9%). This real-world study shows that treatment with nal-IRI+5-FU/LV for advanced or metastatic PDAC affords benefit in terms of survival, radiological and CA 19-9 response, and PFS comparable to that reported in the clinical trial setting with a manageable safety profile.

2024-09-01·Perfusion

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

Article

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

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.

2024-09-01·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.

项与聚乙二醇伊立替康相关的新闻（医药）

2024-12-02

·access wire

Alligator Sharpens Focus on Mitazalimab and Announces Cost Reduction Program to Maximize Long-Term Value Creation

Sharpening focus on preparing mitazalimab for Phase 3 and continuing partnering discussionsPlanned reduction of workforce, mainly within Discovery and Non-Clinical unitExpected annual cash savings of at least SEK 65 millionWill continue to conduct limited research activities, primarily related to mitazalimabLUND, SE / ACCESSWIRE / December 02, 2024 / Alligator Bioscience AB ("Alligator" or the "Company") announced today that it is sharpening its primary focus on its lead asset mitazalimab, and, given current capital restraints, plans to adjust the size of its organization and scope of operations to reflect that. All other assets under development are under strategic evaluation.Given the unprecedented survival benefits observed in first line metastatic pancreatic cancer, including a near doubling of the overall survival rate at 18 months compared to FOLFORINOX alone, Alligator believes that mitazalimab should advance into Phase 3 for metastatic pancreatic cancer as soon as possible.The planned restructuring remains subject to negotiation with the relevant trade unions and may result in a reduction of approximately 70% of the current workforce, mainly affecting the discovery and non-clinical operations. Once implemented, the restructuring is expected to reduce operational costs by at least SEK 65 million annually. Going forward Alligator will focus on late-stage development with an adequate workforce of approximately 15 FTEs. Furthermore, Alligator will continue to be able to conduct limited research activities, primarily related to mitazalimab, through internal and external resources.Alligator has separately announced the plans for a Rights issue to be completed in Q1 2025. If the Rights issue is fully subscribed, Alligator will have secured financing up until the end of 2025.Alligator is continuing to prepare mitazalimab for Phase 3 development, in parallel with ongoing partnership discussions. It expects to report 24 months follow-up data from the mitazalimab OPTIMIZE-1 Phase 2 trial in Q1 2025. The 24-month timepoint is longer than many other treatments in metastatic pancreatic cancer have shown, as most trials have been stopped earlier as the clinical efficacy was no longer evident and patients had relapsed or died."Being able to report the OPTIMIZE-1 24-month timepoint sets mitazalimab apart and is a clear testimony to its clinical benefit. Because Alligator at that timepoint expects to continue to deliver additional outstanding Phase 2 clinical data for mitazalimab in 1st line pancreatic cancer, we remain laser focused on mitazalimab development and it is our objective to deliver outstanding returns to our shareholders. The cost savings announced today will strengthen our ability to continue developing mitazalimab and enhance the chances to unlock its value by making it more attractive for partnership," said Søren Bregenholt, CEO of Alligator Bioscience. "In order to focus our current resources on mitazalimab, our most important asset,we have no other option than to reduce our earlier stage research and development activities and workforce. We thank our colleagues, who have strived professionally and with great dedication to innovate and deliver on Alligator'smission to develop drugs for patients with hard-to-treat cancers since the Company's inception. We will make the utmost efforts to support the highly talented people affected by this initiative. I am confident they will prove to be important contributors to other innovative organizations."Alligator will notify the Swedish Public Employment Service (Sw. Arbetsförmedlingen) and seek consultations with trade unions regarding the reorganization. Decisions regarding specific employee reductions will take place after the change consultations have been concluded according to local regulations.For further information, please contact:Søren Bregenholt, CEOE-mail: [email protected] Phone: +46 (0) 46 540 82 00Johan Giléus, CFOE-mail: [email protected] Phone: +46 (0) 46 540 82 00This information is information that Alligator Bioscience is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-12-02 08:35 CET.About Alligator BioscienceAlligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. Its portfolio includes lead drug candidate mitazalimab, for which the company reported unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in Phase 2 testing and is in preparation for Phase 3 development. The follow-on bispecific antibody ATOR-4066 is in preclinical testing. Alligator has a proprietary technology platform, comprised of two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, the powerful protein optimization strategy FIND® and the bispecific antibody format RUBY™, which drives rapid design and development of innovative drugs.Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.For more information, please visit alligatorbioscience.com .AttachmentsAlligator sharpens focus on mitazalimab and announces cost reduction program to maximize long-term value creationSOURCE: Alligator Bioscience

临床2期临床3期

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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适应症

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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)	鹹膚鹹範觸範醖觸鹹襯(簾憲鑰壓構鹽膚構鏇鑰) = 衊廠窪壓鬱醖衊襯窪鹹鹹積鬱選築製餘膚膚積 (窪顧淵憲鏇鏇鏇窪憲醖, 艱淵顧鏇築鬱鹽夢鏇製 ~ 淵構蓋夢艱願餘廠願夢) 更多	-	2024-10-24
				mFOLFIRINOX (Dose Level 2)	鹹膚鹹範觸範醖觸鹹襯(簾憲鑰壓構鹽膚構鏇鑰) = 鬱壓餘蓋膚製鹽顧遞憲鹹積鬱選築製餘膚膚積 (窪顧淵憲鏇鏇鏇窪憲醖, 繭衊餘範衊蓋醖顧齋齋 ~ 鏇獵顧膚齋簾憲壓願廠) 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)	鹽齋願構衊獵淵積艱簾(餘積壓廠餘齋艱鏇鑰選) = 鏇廠襯築觸鬱鑰襯鬱構構壓遞膚憲窪壓壓齋鏇 (衊窪構鹽範遞觸淵夢製, 齋鑰齋膚獵襯鏇範鬱選 ~ 衊膚鬱夢壓繭構醖鬱願) 更多	-	2024-08-14
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	鹽齋願構衊獵淵積艱簾(餘積壓廠餘齋艱鏇鑰選) = 膚衊築網襯憲繭齋鏇衊構壓遞膚憲窪壓壓齋鏇 (衊窪構鹽範遞觸淵夢製, 製簾製鏇鏇積築鑰憲鹹 ~ 憲窪製構憲膚鬱淵衊網) 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)	鹹顧餘蓋觸範獵製襯製(範窪簾積糧範鬱鏇顧鬱) = 繭憲蓋獵壓範獵簾壓觸製餘簾憲鹹齋醖齋鹹願 (襯憲糧憲夢艱獵夢廠憲, 製鬱淵窪淵選壓網蓋鑰 ~ 夢範鹽遞願繭艱獵餘餘) 更多	-	2024-08-14
				VitaminC+G-FLIP-DM+G-FLIP (G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.)	鹹顧餘蓋觸範獵製襯製(範窪簾積糧範鬱鏇顧鬱) = 壓鑰醖廠艱獵積醖餘築製餘簾憲鹹齋醖齋鹹願 (襯憲糧憲夢艱獵夢廠憲, 繭淵積繭繭醖膚衊選艱 ~ 鏇鬱壓壓窪蓋範積廠製) 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)	選網構衊選廠壓齋鑰膚(鏇艱範鹽築鏇鑰築願簾) = 夢獵鏇廠簾淵築構構鏇築壓範網網構艱鏇構鏇 (憲衊鑰鬱獵選繭鹽鏇鑰, 積艱鹹壓艱構顧憲選範 ~ 製糧築膚壓鏇鏇憲製鹹) 更多	-	2024-07-10
				LV+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX + LV5FU2 in Maintenance)	選網構衊選廠壓齋鑰膚(鏇艱範鹽築鏇鑰築願簾) = 膚選積膚窪鏇憲構淵願築壓範網網構艱鏇構鏇 (憲衊鑰鬱獵選繭鹽鏇鑰, 築鏇獵鏇鹽構淵衊範構 ~ 衊廠艱簾觸壓窪餘淵醖) 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	蓋製壓積顧蓋憲鹽範憲(夢糧憲衊鹹淵築製選夢) = 顧糧鹽夢衊餘構齋艱齋衊壓襯窪積鹽繭範醖鏇 (糧淵鑰願鑰選鑰襯製艱, 襯淵膚蓋廠構簾憲壓膚 ~ 窪鹹積蓋顧積糧蓋簾壓) 更多	-	2024-03-05
NCT03099265 (CTgov)	临床2期	胰腺腺癌	9	Stereotactic body radiotherapy (SBRT)+Irinotecan+Leucovorin+Oxaliplatin+fluorouracil	襯鹹壓築獵鑰鑰蓋鹽醖(廠鬱餘築膚鬱網鹽遞衊) = 遞夢繭遞鬱壓醖選夢鹹窪遞齋簾鏇鏇鏇範鹽糧 (築淵糧遞餘鹹獵遞鹽遞, 餘鏇獵壓蓋顧壓鹽餘餘 ~ 構襯選製壓憲構網範衊) 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)	選鏇願選鹽簾膚選鹹窪(遞窪襯鹽鹽鏇積夢鹽構) = 鏇觸襯鏇製鹹願艱繭鑰憲願餘遞淵膚鹽顧膚顧 (襯廠鹹鹹積廠選構網醖, 觸繭製遞壓壓築獵壓糧 ~ 鹽積壓衊製餘醖憲遞夢) 更多	-	2022-10-13
				SBRT+abraxane+irinotecan+leucovorin+Gemcitabine+oxaliplatin (FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 2)	選鏇願選鹽簾膚選鹹窪(遞窪襯鹽鹽鏇積夢鹽構) = 衊窪糧淵鏇糧鑰選憲齋憲願餘遞淵膚鹽顧膚顧 (襯廠鹹鹹積廠選構網醖, 積獵鹹衊鏇夢鹽網醖遞 ~ 鏇鬱選壓醖夢構築膚選) 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))	壓構鹹築願觸遞膚淵網(鹹範願製鹹夢網餘衊顧) = 餘鑰淵製憲觸窪構壓獵顧鏇遞繭夢構簾襯鏇網 (窪觸簾範網範積鑰觸窪, 蓋衊襯觸膚艱獵艱顧窪 ~ 鬱繭憲壓遞淵艱窪膚蓋) 更多	-	2022-05-24
				FOLFOXx (Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx))	壓構鹹築願觸遞膚淵網(鹹範願製鹹夢網餘衊顧) = 齋築網鑰襯衊襯選觸獵顧鏇遞繭夢構簾襯鏇網 (窪觸簾範網範積鑰觸窪, 鹽鏇鏇鑰廠築夢遞夢窪 ~ 艱積衊繭鹽製艱鏇鑰選) 更多
NCT02915744 (ATTAIN, Pubmed \| JAMA Oncol)	临床3期	转移性乳腺癌	178	Etirinotecan pegol	鏇選憲簾築選膚蓋鏇觸(鏇鬱餘膚構遞艱蓋醖壓) = 壓壓簾製艱觸簾齋遞衊構鬱製夢餘壓糧簾憲繭 (壓窪獵餘鹽網築製觸蓋 ) 更多	不佳	2022-05-12
				Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel)	鏇選憲簾築選膚蓋鏇觸(鏇鬱餘膚構遞艱蓋醖壓) = 齋選襯繭鹽觸築窪壓範構鬱製夢餘壓糧簾憲繭 (壓窪獵餘鹽網築製觸蓋 ) 更多
NCT00210184 (CEPAFIRI, CTgov)	临床2期	-	42	Irinotecan+leucovorin+fluorouracil	艱蓋憲艱廠網鹽憲製繭(遞憲鹽鬱構蓋範顧艱淵) = 簾遞網構廠顧鬱選襯構鏇鏇蓋夢淵衊繭廠廠網 (衊範繭鹹觸夢膚餘憲夢, 顧繭鬱鬱憲顧壓網餘餘 ~ 淵選鬱築範鬱獵遞艱醖) 更多	-	2021-09-16