Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Efficacy and Safety of Vilamakitug in Participants With Active Axial Spondyloarthritis

The goal of this clinical trial is to find out if the study drug will work as a new therapy for axSpA patients. This study is placebo-controlled, and evaluates if study drug can treat symptoms of axSpA, including global disease activity, pain, function and inflammation.

开始日期2026-09-01

申办/合作机构

XBiotech, Inc.

NCT06590090

/ Not yet recruiting临床2期

Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate for the Treatment of Rheumatoid Arthritis

Approximately 108 subjects will be randomized in 2 arms in 2:1 ratio to receive weekly subcutaneous injections of either 400mg Natrunix + MTX weekly or placebo + MTX weekly for 14 weeks. At the week 14 visit subjects in both arms will undergo a safety follow up visit OR begin receiving biweekly subcutaneous injections of 400mg Natrunix for 14 weeks as part of an Open Label Extension (OLE).
The study will last for a maximum of 33 weeks, including: a screening period of up to 4 weeks, a 14-week double-blinded treatment phase followed by a 14-week open label extension phase and one-week follow-up.

开始日期2026-07-15

申办/合作机构

XBiotech, Inc.

NCT05363891

/ Completed临床2期

Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis

Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination with MTX (+Folate) for the Treatment of Rheumatoid Arthritis

开始日期2023-08-08

申办/合作机构

XBiotech, Inc.

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100 项与 Vilamakitug 相关的转化医学

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项与 Vilamakitug 相关的文献（医药）

2024-12-04·Future Oncology

Phase I/II study of trifluridine/tipiracil plus XB2001 versus trifluridine/tipiracil in metastatic colorectal cancer

Article

作者: Fumet, Jean-David ; Bertaut, Aurélie ; Mineur, Laurent ; Senellart, Hélène ; Thuillier, Frédéric ; Roussot, Nicolas ; Jary, Marine ; Rederstorff, Emilie ; Lepage, Come ; Hervieu, Alice ; Thibaudin, Marion ; Borg, Christophe ; Touchefeu, Yann ; Limagne, Emeric ; Labourey, Jean-Luc ; Chibaudel, Benoist ; Pernot, Simon ; Carnot, Aurélien ; Martin-Babau, Jérome ; Ghiringhelli, Francois ; Zanetta, Sylvie

Aim: Trifluridine/tipiracil-bevacizumab is a standard of care in metastatic colorectal cancer (mCRC) after chemotherapy failure. We aim to assess the addition of XB2001 (anti-IL-1 alpha monoclonal antibody) plus trifluridine/tipiracil-bevacizumab in mCRC refractory to standard chemotherapy.Methods: This multicenter, randomized, double blind, non-comparative Phase I-II study (ClinicalTrials.gov NCT05201352) will assess the efficacy and safety of trifluridine/tipiracil-bevacizumab and XB2001 in patients with mCRC previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, 5-FU, antiangiogenic and/or anti-EGFR if indicated. Primary end point of Phase I is the safety according to the Maximum Tolerated Dose (MTD) of XB2001. Primary end point of Phase II is the efficacy of trifluridine/tipiracil-bevacizumab + XB2001 in term of 6-month overall survival. Ancillary analysis will be performed.

2022-01-01·Journal of Innate Immunity2区 · 医学

IL-1 Mediates Tissue-Specific Inflammation and Severe Respiratory Failure in COVID-19

2区 · 医学

ArticleOA

作者: Kafousopoulos, Dionyssios ; Stylianakis, Emmanouil ; Droggiti, Dionysia-Eirini ; Simard, John ; Andriopoulou, Theano ; Giamarellos-Bourboulis, Evangelos J ; Netea, Mihai G ; Eugen-Olsen, Jesper ; Gkavogianni, Theologia ; Renieris, Georgios ; Karakike, Eleni ; Spanou, Victoria-Marina

Acute respiratory distress syndrome (ARDS) in COVID-19 has been associated with catastrophic inflammation. We present measurements in humans and a new animal model implicating a role in danger-associated molecular patterns. Calprotectin (S100A8/A9) and high-mobility group box 1 (HMGB1) were measured in patients without/with ARDS, and admission calprotectin was associated with soluble urokinase plasminogen activator receptor (suPAR). An animal model was developed by intravenous injection of plasma from healthy or patients with COVID-19 ARDS into C57/BL6 mice once daily for 3 consecutive days. Mice were treated with one anti-S100A8/A9 antibody, the IL-1 receptor antagonist anakinra or vehicle, and Flo1-2a anti-murine anti-IL-1α monoclonal antibody or the specific antihuman IL-1α antibody XB2001 or isotype controls. Cytokines and myeloperoxidase (MPO) were measured in tissues. Calprotectin, but not HMGB1, was elevated in ARDS. Higher suPAR indicated higher calprotectin. Animal challenge with COVID-19 plasma led to inflammatory reactions in murine lung and intestines as evidenced by increased levels of TNFα, IL-6, IFNγ, and MPO. Lung inflammation was attenuated with anti-S100A8/A9 pre-treatment. Anakinra treatment restored these levels. Similar decrease was found in mice treated with Flo1-2a but not with XB2001. Circulating alarmins, specifically calprotectin, of critically ill COVID-19 patients induces tissue-specific inflammatory responses through an IL-1-mediated mechanism. This could be attenuated through inhibition of IL-1 receptor or of IL-1α.

Signal Transduction and Targeted Therapy

Safety and efficacy of trifluridine/tipiracil +/− bevacizumab plus XB2001 (anti-IL-1α antibody): a single-center phase 1 trial

Article

作者: Bengrine, Leila ; Schmitt, Antonin ; Rageot, David ; Burlot, Chloé ; Roussot, Nicolas ; Fumet, Jean David ; Bellio, Hélène ; Derangère, Valentin ; Tharin, Zoé ; Peroz, Morgane ; Daumoine, Susy ; Thibaudin, Marion ; Huppe, Titouan ; Simard, John ; Bertaut, Aurélie ; Vincent, Julie ; Rederstorff, Emilie ; Hampe, Léa ; Ghiringhelli, Francois ; Truntzer, Caroline

Abstract:

In the tumour microenvironment, IL-1α promotes neoangiogenesis, matrix remodelling, tumour proliferation, chemoresistance, and metastases. Highly expressed in human colorectal cancers, IL-1α is associated with poor prognosis. XB2001, a fully human monoclonal antibody neutralizing IL-1α, was evaluated for safety and preliminary efficacy with trifluridine/tipiracil (FTD/TPI) and bevacizumab in metastatic colorectal cancer patients previously treated with oxaliplatin- and irinotecan-based chemotherapies. This single institution, phase 1 study used a 3 + 3 design to assess XB2001 at doses of 250 mg, 500 mg and 1000 mg every 14 days, associated with FTD/TPI 35 mg/m² (days 1–5 and 8-12, every 28 days) (NCT05201352). The Maximum Tolerated Dose of XB2001 + FTD/TPI was then associated in combination with bevacizumab (5 mg/kg, days 1 and 15). Safety, efficacy, pharmacokinetics and pharmacodynamics were assessed. Seventeen patients (median age: 67.4 years) were enroled. No patient exhibited dose-limiting toxicity at any dose. The most common treatment-related adverse events (TRAE) of any grade (G) were diarrhoea (35.3%), nausea (47.1%) and anaemia (35.3%). G3-4 TRAE were neutropenia (17.6%) hypertension and infection (5.9% each). The RP2D (recommended phase 2 dose) of XB2001 was 1000 mg. The disease control rate was 76%, with 23% of patients achieving an objective response, including one complete response. Response and longer progression-free survival were associated with a decrease in serum IL-6 levels during therapy. High intratumoral IL-1α expression at baseline and CD8/PD-L1 infiltration are associated with a better progression-free survival. The combination of XB2001 with FTD/TPI and bevacizumab is feasible and safe, and showed encouraging clinical activity in chemotherapy-resistant mCRC.

项与 Vilamakitug 相关的新闻（医药）

2026-10-19

·BioSpace

XBiotech Announces Positive Phase II Final Efficacy Results from Investigator-Sponsored TASKIN Trial in Refractory Metastatic Colorectal Cancer

Investigator-sponsored study funded by the French National Cancer Institute (INCa) meets pre-specified primary efficacy success criterion with 61.3% 12-month overall survival. Exploratory Subgroup analysis reveals significant survival benefit in right-sided tumors. AUSTIN, Texas, Oct. 19, 2026 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today announced positive final efficacy results from the randomized Phase II portion of the multicenter TASKIN clinical trial. The investigator-sponsored study—funded by the French National Cancer Institute (INCa) and coordinated by investigators at the Centre Georges-François Leclerc (CGFL) in Dijon, France—evaluated the addition of XBiotech’s anti-IL-1α monoclonal antibody, XB2001 (Natrunix™, vilamakitug), to standard-of-care trifluridine/tipiracil (TAS-102) with or without bevacizumab in patients with refractory metastatic colorectal cancer (mCRC). The TASKIN Phase II study met its pre-specified primary efficacy success criterion under a Simon two-stage design. At the 12-month landmark analysis, 49 of 80 evaluable patients (61.3%) in the vilamakitug experimental arm were alive, surpassing the protocol-defined threshold of 42 or more surviving patients required to establish efficacy. In the control arm (placebo plus standard chemotherapy), 44 of 79 evaluable patients (55.7%) were alive at 12 months. Professor François Ghiringhelli, M.D., Ph.D., Principal Investigator of the TASKIN study and Director of the Oncology Department at Centre Georges-François Leclerc, commented: "Patients with refractory metastatic colorectal cancer face severe therapeutic limitations and poor survival outcomes. Meeting our pre-specified primary milestone provides compelling evidence that targeting IL-1α plays a meaningful role in tumor biology. Most striking is the magnitude of benefit observed in right-sided colorectal cancers, which has been a historically aggressive disease subset with high unmet medical need. The alignment between this pronounced clinical survival advantage and elevated basal IL-1α tumor expression offers a clear biological rationale for this therapy." Summary of Overall Findings Time to Strategy Failure (TSF): The 12-month TSF rate, which captured the duration for which the overall treatment strategy remains viable, was 31.2% in the vilamakitug arm compared to 20.3% in the control arm (log-rank p = 0.17). Progression-Free Survival (PFS): Median PFS was 5.9 months for the vilamakitug arm versus 5.6 months for the control arm, with a 12-month PFS rate of 25.0% versus 21.0% (log-rank p = 0.42), with survival curves visibly separating after month 7. Safety & Treatment Adherence: Vilamakitug demonstrated high feasibility in combination with chemotherapy, showing a 96.4% mean compliance rate for trifluridine/tipiracil and only a 1.3% permanent discontinuation rate for vilamakitug/placebo Exploratory Endpoint Analysis, Efficacy in Right-Sided Primary Tumors A prospective exploratory analysis identified a statistically significant benefit in patients with right-sided (proximal) primary tumors (n = 37), a subtype characterized by aggressive tumor biology, high unmet medical need, and poor outcomes under standard therapies: Overall Survival (OS): Vilamakitug demonstrated a statistically significant 62% reduction in the risk of death compared to control (Hazard Ratio [HR] = 0.38; 95% CI: 0.14–0.99; Cox p = 0.047, log-rank p = 0.038) through 12 months. Time to Strategy Failure (TSF): Vilamakitug achieved a 61% reduction in the risk of treatment strategy failure compared to control (HR = 0.39; 95% CI: 0.18–0.85; Cox p = 0.017, log-rank p = 0.014) through 12 months. Sushma Shivaswamy, Ph.D., Chief Scientific Officer and Interim Chief Executive Officer of XBiotech, stated: "We are deeply grateful to Professor Ghiringhelli, the team at Centre Georges-François Leclerc, the French National Cancer Institute, and all the participating patients for advancing this important trial. By uncovering a biomarker-anchored patient population in right-sided disease that derives substantial clinical benefit from vilamakitug, TASKIN provides a focused and validated direction as we advance vilamakitug toward registrational clinical development." About the TASKIN Trial The TASKIN study (NCT05201352) is an investigator-sponsored clinical trial funded by the French National Cancer Institute (INCa) and sponsored by the Centre Georges-François Leclerc (CGFL) in Dijon, conducted across clinical cancer centers in France. The Phase I portion determined the safety and recommended Phase II dose of vilamakitug with trifluridine/tipiracil and bevacizumab. The double-blind Phase II portion enrolled heavily pre-treated refractory mCRC patients randomized 1:1 to receive standard-of-care trifluridine/tipiracil (± bevacizumab) in combination with either vilamakitug or placebo until disease progression or unacceptable toxicity. About vilamakitug (Natrunix™, XB2001) A True Human™ therapeutic monoclonal antibody developed solely by XBiotech. Vilamakitug is derived from a human donor that had a natural human immune response against interleukin1alpha (IL-1a). IL-1α is an apex mediator that creates the environment to support growth and emergence of malignant cells. IL-1a stimulates angiogenesis, cellular dysregulation, tissue matrix remodeling, tumor migration, adhesion, and invasion, hallmark physiological features of cancer. Remarkably, vilamakitug has been shown clinically to simultaneously reduce levels of each of VEGF-A, ErbB2/HER2, PDGF, and EGF in cancer patients. Rather than a simple cytotoxic agent that kills all growing tissue, vilamakitug therefore can target multiple aspects of the malignant disease process, facilitating anti-tumor effects while controlling the disease process and reducing disease morbidity. Dramatic reduction in incidence of cancer-related morbidity, reduced hospitalization, reduced duration of hospitalization, reduced symptoms such as diarrhea, fatigue and pain, reduced tumor burden, and longer progression free survival and overall survival have been observed in another study in advanced cancer. About XBiotech XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ discovery platform. XBiotech currently is advancing antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit . Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact: Wenyi Wei publicrelations@xbiotech.com tel. 737-207-4600

临床结果临床2期临床1期

2026-06-15

·BioSpace

XBiotech Launches Phase II Clinical Trial Evaluating Vilamakitug for the Treatment of Active Axial Spondyloarthritis

IND Application for V-SPINE Study Completes 30-Day FDA Review Without Clinical Hold, Clearing Path for U.S. Patient Enrollment AUSTIN, Texas, June 15, 2026 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today announced that its Investigational New Drug (IND) application for V-SPINE (PT064), a Phase II, double-blind, placebo-controlled, randomized study evaluating the efficacy and safety of vilamakitug in participants with active axial spondyloarthritis, has successfully completed the U.S. Food and Drug Administration’s (FDA) 30-day review period without a clinical hold. The study is now authorized to proceed with patient enrollment in the United States, marking the resumption of XBiotech’s rheumatology program. Study Chair and the Axial Spondyloarthritis Scientific Advisory Board The clinical protocol was developed under the leadership of Study Chair Marina Magrey, M.D., and with expert guidance from a distinguished panel of SPARTAN leaders and rheumatology experts. Dr. Magrey serves as Division Chief of Rheumatology at University Hospitals Cleveland Medical Center, Professor of Medicine at Case Western Reserve University School of Medicine, and Vice-Chair of the Spondyloarthritis Research and Treatment Network (SPARTAN). The advisory panel includes: Marina Magrey, M.D. — Division Chief of Rheumatology, University Hospitals Cleveland Medical Center; Professor of Medicine, Case Western Reserve University School of Medicine Atul Deodhar, M.D., M.R.C.P., FACR, FACP — Professor of Medicine and Medical Director of Rheumatology Clinics, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland Lianne S. Gensler, M.D. — Director of the UCSF Spondyloarthritis Research Program & Clinic; Professor of Medicine, University of California, San Francisco Walter P. Maksymowych, MB ChB, FRCP(C), FACP — Professor of Medicine, Division of Rheumatology, University of Alberta; Chief Medical Officer, CARE Arthritis Limited Michael A. Paley, M.D., Ph.D. — Assistant Professor of Medicine, Division of Rheumatology, Washington University in St. Louis John A. Carino, M.D., M.P.H., FACR — Vice-Chairman, Radiology and Imaging; Professor of Radiology, Weill Cornell Medicine About the V-SPINE Study PT064 will evaluate 400 mg of vilamakitug administered as 16 weekly subcutaneous injections versus placebo in 150 adult participants with active axial spondyloarthritis (axSpA). The primary endpoint is the proportion of participants achieving an ASAS40 response at Week 16. The study also includes a 12-week open-label extension in which all participants receive vilamakitug. Despite the availability of approved biologic therapies, a substantial proportion of patients continue to experience inadequate disease control, representing a significant and persistent unmet medical need. “The unmet need in axial spondyloarthritis remains real and substantial. IL-1α is a compelling upstream target, hypothesized to play a role in the inflammation, bone erosion, and chronic pain that define this disease. The PT064 protocol is rigorously designed to test whether targeting this upstream pathway translates into meaningful clinical benefit, and I am pleased to have contributed to its development. FDA clearance of the protocol is an important milestone, and I look forward to seeing this study advance for the benefit of patients.” — Marina Magrey, M.D., PT064 Study Chair “FDA clearance of the PT064 protocol is a significant step forward for our vilamakitug program and for patients living with axial spondyloarthritis. Vilamakitug is a True Human™ antibody indistinguishable from one naturally occurring in a healthy person with immunity to IL-1α, and we believe it represents a meaningful new approach to treating the inflammation that drives this disease. We are grateful to the members of our axSpA Scientific Advisory Board for their expert guidance in shaping this protocol, and we plan to move expeditiously into enrollment.” — Sushma Shivaswamy, Ph.D., Interim Chief Executive Officer and Chief Scientific Officer, XBiotech About Vilamakitug Vilamakitug (also known as XB2001 and Natrunix ™ ) is an IgG4 monoclonal antibody that neutralizes interleukin-1α (IL-1α), a proximal pro-inflammatory cytokine that can contribute to synovial and entheseal inflammation, osteoclast-mediated bone resorption, cartilage degradation, and inflammatory joint pain in spondyloarthritis. By targeting this upstream inflammatory mediator, vilamakitug is hypothesized to reduce both structural damage and disease activity, including in patients who have had an inadequate response to currently approved biologic therapies. About XBiotech XBiotech is a fully integrated, global biopharmaceutical company dedicated to pioneering the discovery, development, and commercialization of therapeutic antibodies. XBiotech currently is advancing a pipeline of therapies across inflammatory disorders, oncology, infectious disease, and dermatology by harnessing naturally occurring antibodies from patients with immunity to certain diseases. Utilizing natural human immunity as a source of new medicines offers the potential to redefine the standards of care for a wide range of diseases. XBiotech has a deep and continuing history in rheumatology. The Company previously developed and clinically advanced bermekimab, a True Human™ anti-IL-1α antibody evaluated across multiple inflammatory diseases. On December 30, 2019, XBiotech sold bermekimab in a transaction valued at up to $1.35 billion, retaining the right to develop True Human™ anti-IL-1α antibodies in all areas of medicine outside of dermatology. PT064 marks the continuation of that rheumatology legacy, as XBiotech advances vilamakitug — its next-generation True Human™ IL-1α antibody — into a pivotal Phase II study in axial spondyloarthritis. For more information, visit . About True Human™ Therapeutic Antibodies XBiotech's True Human™ antibodies are antibodies derived without modification from humans who possess natural immunity to certain diseases. XBiotech's True Human™ antibodies are directly sourced from the natural human immune response without modification. XBiotech's True Human™ antibodies have the potential to harness the body's natural immunity to fight disease. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. Forward-looking statements are not guarantees of future performance. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events, or otherwise, after the date of this press release. Contact Wenyi Wei publicrelations@xbiotech.com tel. 737-207-4600

临床2期上市批准并购

2025-01-06

·GlobeNewswire-Health Care

XBiotech Pauses Rheumatology program

Dec. 23, 2024 -- XBiotech (NASDAQ: XBIT) announced today data that it is halting its clinical program in rheumatological disease while it seeks to understand the outcome from its recently completed Phase II, Double-Blind, Placebo-Controlled, Randomized study in Rheumatoid Arthritis. The Phase II study failed to meet its primary endpoint amid substantial irregularities that make unequivocal interpretation of the findings difficult. XBiotech was planning launch of additional studies in arthritis as well as other areas of rheumatology, including ankylosing spondylitis, which are now on hold while recent findings are evaluated. About 230 subjects with moderate to severe rheumatoid arthritis were enrolled into the Phase II arthritis study, which examined the Company’s candidate drug, Natrunix, in combination with methotrexate (MTX). The study’s primary endpoint was the American College of Rheumatology (ACR) 20 response rate after 12 weeks of treatment. Various other rheumatological assessments were also performed, including NRS-pain scores, arthritic joint counts, quality of life assessments, and safety. The study population was randomized into three groups in a 1:1:1 ratio: 200 mg or 400mg Natrunix weekly in combination with MTX; or placebo weekly with MTX. Irregularities in the Phase II study involved the highest enrolling clinical sites, including numerous subjects being enrolled multiple times. Although the study did not meet efficacy endpoints, discrepancies found during data analysis suggest caution in interpreting results. Findings of the study are still being analysed in order to better understand the implications of the findings and determine how these results can be used to guide potential further rheumatology studies for Natrunix. XBiotech is pioneering the discovery and development of therapeutics based on its True Human™ antibody technology. The Company has several candidate products including Natrunix, which are cloned from individual donors who possess natural immunity against certain diseases. Located just minutes from downtown Austin, the XBiotech campus headquarters includes GMP manufacturing facilities, research and testing laboratories, infectious disease research facilities, quality control and clinical operations. For more information, visit www.xbiotech.com. The content above comes from the network. if any infringement, please contact us to modify.

临床2期临床结果

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适应症	最高研发状态	国家/地区	公司	日期
强直性脊柱炎	临床2期	-	XBiotech, Inc.	2026-09-01
非放射性轴性脊柱关节炎	临床2期	-	XBiotech, Inc.	2026-09-01
类风湿关节炎	临床2期	-	XBiotech, Inc.	2022-06-15
结直肠癌	临床2期	法国	XBiotech, Inc.	2022-04-28
胰腺癌	临床2期	美国	XBiotech, Inc.	2021-05-27

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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


NCT04825288 (1-BETTER, CTgov)	临床1/2期	胰腺癌	76	XB2001 (Phase I: XB2001 250 mg)	鹽鹹構淵製願餘鏇積觸 = 製製遞艱獵餘壓鹹餘網繭糧鏇鹽鏇膚積獵壓繭 (製憲築艱醖壓鬱壓鏇鬱, 觸蓋鏇蓋餘蓋膚簾憲窪 ~ 壓願築鑰顧艱衊糧壓構) 更多	-	2026-08-04
				XB2001 (Phase I: XB2001 500 mg)	鹽鹹構淵製願餘鏇積觸 = 醖製餘鏇構齋簾顧願鬱繭糧鏇鹽鏇膚積獵壓繭 (製憲築艱醖壓鬱壓鏇鬱, 製糧膚構膚構選築範觸 ~ 遞醖衊簾鏇蓋襯簾構鹽) 更多
NCT05201352 (Pubmed) 人工标引	临床1期	转移性结直肠癌	17	XB2001 + FTD/TPI + bevacizumab	觸窪築窪鏇繭鹽夢範範(構齋觸膚鹹艱構鬱選膚) = None 齋蓋願憲壓鹽鑰夢顧壓 (選鹹襯鹹醖製獵遞夢艱 ) 更多	积极	2025-01-17
NCT05201352 (TASKIN, ESMO_GI 12024 \| ESMO_GI 22024) 人工标引	临床1/2期	结直肠癌	17	FTD-TPI plus XB2001 and bevacizumab	醖選鏇夢鏇構繭齋鏇艱(繭鬱餘廠願憲遞膚膚壓) = None 選獵願鏇願願積繭鑰簾 (鹽鹽獵網夢蓋繭願簾齋 )	积极	2024-06-27
NCT04825288 (Company_Website) 人工标引	临床1/2期	胰腺癌二线 \| 三线	65	Natrunix+ONIVYDE (ON) + 5-Fluorouracil (5FU) + Leucovorin (LV)	範蓋網鬱齋齋觸夢糧鹹(鬱窪膚鏇鏇淵憲築醖醖) = This data highlights the observation that no subjects in the placebo ON+5FU+LV group (n=32) survived for longer than 330 days, whereas 8 subjects in the Natrunix ON+5FU+LV arm (n=33) were still alive as of day 330. 廠鑰鏇齋窪選鑰壓構鏇 (繭範醖糧繭築鹽鏇壓遞 )	积极	2024-06-18
				Placebo+ONIVYDE (ON) + 5-Fluorouracil (5FU) + Leucovorin (LV)