巴替利单抗(Balstilimab) - 药物靶点：PD-1_在研适应症：宫颈癌，晚期癌症，肝转移_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

BAL、Balstilimab (USAN/INN)、AGEN-2034

+ [2]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病消化系统疾病+ [7]

在研适应症

宫颈癌晚期癌症肝转移+ [45]

非在研适应症

晚期肾细胞癌HPV16阳性口咽癌乳头状瘤病毒感染+ [6]

原研机构

Agenus, Inc.

在研机构

Agenus, Inc.

City of Hope National Medical Center

Recepta Biopharma SA

+ [3]

非在研机构-

权益机构

VBI Vaccines, Inc.

Agenus, Inc.

贝达药业股份有限公司

+ [5]

最高研发阶段申请上市

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评快速通道 (美国)

登录后查看时间轴

结构/序列

Sequence Code 13223716L

来源: *****

Sequence Code 13223719H

来源: *****

关联

57

项与巴替利单抗相关的临床试验

NCT07595874

/ Recruiting临床2期IIT

A Phase II Novel Exploratory Study to Test Neoadjuvant Immunotherapy Combinations in Patients With Resectable Colon Cancer (NEST3)

This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.

开始日期2026-12-27

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07695311

/ Not yet recruiting临床1期IIT

Precision Analysis of Fusion Genes in Ewing Sarcoma (ES) and Desmoplastic Small Round Cell Tumor (DSRCT), Then EWSR1 (Ewing Sarcoma Gene Breakpoint Region 1 Gene) Immunotherapy Without or With Anti-CTLA-4 (Botensilimab) and Anti-PD1 (Balstilimab)

This study is for people who have high-risk Ewing sarcoma (ES), or a related Ewing's family tumor, desmoplastic small round cell tumor (DSRCT). The purpose of this study is to see if a new EWSR1 immunotherapy (a lipid nanoparticle coated with EWSR1 mRNA) which is given as a shot is safe and whether it can help the body's immune system better recognize and fight cancer.
This EWSR1 immunotherapy is designed to target a specific genetic change (EWSR1 fusion gene) that is found in cancer cells but not in normal, healthy cells. Because the EWSR1 gene is broken in cancer cells and the small protein it makes are only in the ES or DSRCT cancer cells, the goal of EWSR1 immunotherapy is to help the immune system identify and attack the cancer without harming normal cells. It is not yet approved by the Food and Drug Administration (FDA).
EWSR1 immunotherapy will be given as a shot into the muscle of the arm, leg, or buttock. If participants also receive botensilimab (4 doses after each EWSR1 immunotherapy shot) and balstilimab (an infusion every 2 weeks), these are given intravenously (IV) by a needle in the arm over 30 minutes. Participants in this study will receive treatment for about 6 months or until their cancer gets worse. Participants will remain in the study for follow-up for an additional year, for a total time of about 1.5 years in the study.

开始日期2026-10-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT07516366

/ Not yet recruiting临床2期IIT

Pilot Phase II Trial Evaluating Safety and Feasibility of Neoadjuvant Botensilimab and Balstilimab in Clear Cell Renal Cell Carcinoma (NEO RoBOT)

This phase II trial tests the effect of botensilimab and balstilimab before surgery (neoadjuvant) in treating patients with high-risk clear cell renal cell cancer that has not spread from where it first started to other areas of the body (non-metastatic). The current standard treatment for patients with non-metastatic clear cell renal cell cancer may include surgery to completely remove the tumor. This typically involves removing the kidney or part of the kidney (nephrectomy). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant botensilimab and balstilimab may be safe, tolerable, and/or effective in treating patients with high-risk non-metastatic clear cell renal cell cancer before undergoing a nephrectomy.

开始日期2026-08-21

申办/合作机构

National Cancer Institute

100 项与巴替利单抗相关的临床结果

登录后查看更多信息

100 项与巴替利单抗相关的转化医学

登录后查看更多信息

100 项与巴替利单抗相关的专利（医药）

登录后查看更多信息

112

项与巴替利单抗相关的文献（医药）

2026-03-01·Immuno-oncology technology

Refractory microsatellite-stable metastatic colorectal cancer: a comparison between botensilimab + balstilimab and current standard of care

Article

作者: Picone, V ; Bengala, E ; Santini, D

Background:

The combination of botensilimab + balstilimab demonstrated promising clinical activity in heavily pre-treated patients with microsatellite-stable metastatic colorectal cancer (mCRC) in a recently published phase I study (NCT03860272).

Patients and methods:

Our objective was to derive overall survival (OS), progression-free survival (PFS) and safety data from the trials of reference of the current standard of care for refractory mCRC and from the above-mentioned study, and to compare them. After a systematic search of PubMed, we selected four studies (SUNLIGHT, FRESCO-2, RECOURSE, CORRECT). Individual patient OS and PFS data were extracted from Kaplan-Meier curves and more frequent toxic effect rates were collected.

Results:

Immunotherapy showed higher efficacy in terms of median OS both compared with trifluridine-tipiracil plus bevacizumab [hazard ratio (HR) 0.62, 95% confidence interval (CI) 0.44-0.89] and to later lines of treatment: fruquintinib, regorafenib, and trifluridine-tipiracil alone. These results were confirmed by median PFS comparison of all the therapies except for the trifluridine-tipiracil + bevacizumab combination (HR 0.46, 95% CI 0.35-0.61 in favor of trifluridine-tipiracil + bevacizumab). As for treatment-related adverse events the most frequent with immunotherapy were fatigue and diarrhea. The other regimens were associated with hematologic toxic effects, nausea, hypertension, and dermatological toxicity.

Conclusion:

These findings suggest that the immunotherapy combination appears to be a potential option for patients with refractory mCRC while being associated with a completely different toxicity profile. However, confirmation of its efficacy awaits the results of randomized studies. Better comprehension of disease characteristics related to treatment response, such as metastatic sites and molecular biology, is warranted for patient selection.

2025-12-01·Journal for ImmunoTherapy of Cancer

Botensilimab (Fc-enhanced anti–CTLA-4 antibody) plus balstilimab (anti–PD-1 antibody) in patients with treatment-refractory ovarian cancer

Article

作者: Grossman, Joseph E ; Matulonis, Ursula A ; Wilky, Breelyn A ; Martynova, Anastasia ; Bockorny, Bruno ; Chand, Dhan ; Porter, Rebecca ; O’Day, Steven J ; Delepine, Chloe ; Gordon, Michael S ; Mahadevan, Daruka ; Hafez, Navid ; Corr, Bradley R ; Bourdelais, Sean ; Joshi, Bishnu ; Johnson, Benny ; El-Khoueiry, Anthony B ; Bullock, Andrea J ; Moser, Justin ; Wu, Wei ; Stebbing, Justin

Background:

Patients with platinum-resistant/refractory ovarian cancer (PROC) experience suboptimal outcomes, highlighting an immediate need for novel therapies. This phase 1b study investigated the safety and efficacy of botensilimab (BOT), a fragment crystallizable (Fc)-enhanced anti–cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody with differentiated mechanisms of action from first-generation CTLA-4 inhibitors, plus balstilimab (BAL; anti–programmed cell death protein 1 antibody), in an expanded cohort of patients with treatment-refractory ovarian cancer.

Methods:

BOT was administered intravenously at 1 mg/kg or 2 mg/kg every 6 weeks in combination with BAL intravenously at 3 mg/kg every 2 weeks (up to 2 years). The primary objectives were to assess safety and tolerability. Efficacy end points included objective response rate (ORR), duration of response (DOR), and progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1. Overall survival (OS) was an exploratory end point.

Results:

Overall, 44 patients were evaluable for safety (with a median of 3 prior lines of therapy; median follow-up 9.6 months (range, 0.6—36.6)), and 35 for efficacy. The most common treatment-related adverse event was diarrhea/colitis (43%; 16% grade 3) with no treatment-related deaths. RECIST-confirmed ORR was 23% (8/35; 95% CI 10% to 40%; one complete (CR), seven partial responses (PRs)) and clinical benefit rate (CR, PR, or stable disease ≥24 weeks) was 31% (11/35; 95% CI 17% to 49%). Median DOR was 9.7 months (95% CI 2.8 to not reached (NR)), median PFS was 2.8 months (95% CI 1.4 to 5.5), median OS was 14.8 months (95% CI 12.1 to NR), and 12-month OS was 75% (95% CI 55% to 86%). Immune phenotypic analyses and biomarker data revealed significantly higher FcγRIIIA+CD11c+ cells and higher programmed death-ligand 1 expression in responding patients, a strong association between T-cell infiltrated tumors and clinical benefit, and differences in immune architecture across histologic subtypes.

Conclusion:

The BOT/BAL combination demonstrated deep, durable responses and complete remissions in patients with treatment-refractory ovarian cancer where no standard treatments are currently available. RECIST under-represented clinical benefit with 11 patients achieving prolonged/clinically meaningful stable disease (or better) for ≥24 weeks. Toxicities were manageable and reversible. The encouraging clinical activity of BOT/BAL in heavily pretreated patients, as well as biomarker associations, warrants further investigation of this combination.

2025-04-10·JOURNAL OF CLINICAL ONCOLOGY

Botensilimab (Fc-enhanced anti–cytotoxic lymphocyte-association protein-4 antibody) Plus Balstilimab (anti–PD-1 antibody) in Patients With Relapsed/Refractory Metastatic Sarcomas

Article

作者: Jones, Robin L. ; Schwartz, Gary K. ; Bullock, Andrea J. ; Grossman, Joseph E. ; Trent, Jonathan C. ; Avagyan, Manushak ; O'Day, Steven ; Johnson, Benny ; Agulnik, Mark ; Chand, Dhan ; Delepine, Chloe ; Henick, Brian ; Gordon, Michael S. ; Singh, Arun ; El-Khoueiry, Anthony B. ; Wu, Wei ; Stebbing, Justin ; Mahadevan, Daruka ; Wilky, Breelyn A. ; Tsimberidou, Apostolia M.

PURPOSE:

Outcomes for patients with advanced sarcomas are poor and there is a high unmet need to develop novel therapies. The purpose of this phase I study was to define the safety and efficacy of botensilimab (BOT), an Fc-enhanced anti–cytotoxic lymphocyte-association protein-4 antibody, plus balstilimab (BAL), an anti–PD-1 antibody, in advanced sarcomas.

METHODS:

BOT was administered intravenously (IV) at 1 mg/kg or 2 mg/kg once every 6 weeks in combination with BAL IV at 3 mg/kg once every 2 weeks for up to 2 years. The primary end point was to determine dose-limiting toxicities during the dose-escalation period. Secondary end points include objective response rate (ORR), duration of response (DOR), disease control rate, and progression-free survival (PFS) by RECIST 1.1. Exploratory end points include assessing patient biomarkers including tumor mutational burden, cytokines, and PD-L1 expression.

RESULTS:

Overall, 64 patients with sarcoma were treated; all were evaluable for safety and 52 for efficacy. The most common treatment-related adverse event (TRAE) was diarrhea/colitis occurring in 35.9% of patients, with grade 3 in 6.3% of patients. No grade 4 or 5 TRAEs were reported. For all evaluable patients, ORR was 19.2% (95% CI, 9.6 to 32.5), and 27.8% (95% CI, 9.7 to 53.5) for evaluable patients with angiosarcoma (n = 18); 33.3% in visceral and 22.2% in cutaneous subtypes. Median PFS for evaluable patients was 4.4 months (95% CI, 2.8 to 6.1), with a 6-month PFS rate of 36% (95% CI, 22 to 50) and a median DOR of 21.7 months (95% CI, 1.9 to not reached).

CONCLUSION:

The combination of BOT/BAL demonstrated promising efficacy and safety in a large cohort of heavily pretreated sarcoma patients. This encouraging activity warrants further investigation (ClinicalTrials.gov identifier: NCT03860272 ).

264

项与巴替利单抗相关的新闻（医药）

2026-07-15

·今日头条

索赔约10亿元，凯赛生物提起诉讼；昭衍新药上半年业绩大增

凯赛生物提起诉讼。 7月14日，凯赛生物公告称，公司及全资子公司凯赛(金乡)生物材料有限公司作为共同原告，以侵害技术秘密纠纷为由，向北京市高级人民法院起诉王志洲、葛明华、曹务波、山东瀚霖生物技术有限公司、陈远童、傅深展、中国科学院微生物研究所、山东归源生物科技有限公司、宁夏中科生物科技股份有限公司、宁夏中科生物新材料有限公司。公司诉请被告立即停止侵害原告技术秘密，销毁涉及“生物发酵法工业化生产长链二元酸技术”相关技术秘密的产线、设备、图纸，并连带赔偿经济损失约9.67亿元及合理开支100万元。目前案件已立案受理，尚未开庭审理。猴子涨价效应。 7月14日，昭衍新药公告称，预计2026年半年度归属于上市公司股东的净利润为6.00亿元-9.00亿元，同比增长884.9%-1377.4%。报告期内生物资产市场价格上涨叠加自身自然生长增值，双重因素驱动其公允价值正向变动，为公司业绩做出积极贡献。信达生物再出海。 7月14日，信达生物宣布，Spero将获得第三代抗CD40L单抗IBI355在大中华区以外的全球独家开发、研究、生产和商业化权益。信达生物将获得首付款，并有资格获得开发、注册及商业化潜在里程碑付款，交易总额约11亿美元；同时还将获得未来基于该产品净销售额的梯度式销售分成。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 /市场速递 1）我国上半年创新药对外授权交易额超千亿美元 7月13日，新闻联播播报，今年1至6月，我国创新药对外授权交易总额约1100亿美元，达2025年全年总额的八成，再创历史新高。 2）迪哲医药与阿斯利康就舒沃哲®达成授权许可协议 7月14日，迪哲医药宣布，已与阿斯利康就舒沃哲®（舒沃替尼）达成授权许可协议。公司将授予阿斯利康在全球范围内的独家开发、商业化舒沃哲®的权利。 3）德琪医药收到优时比6000万美元首付款 7月13日，德琪医药宣布，已收到优时比支付的6000万美元首付款。该笔款项的支付依据为双方于2026年3月达成的CD19/CD3双特异性T细胞连接抗体ATG-201全球独家授权协议。 4）信达生物第三代抗CD40L单抗出海 7月14日，信达生物宣布，Spero将获得第三代抗CD40L单抗IBI355在大中华区以外的全球独家开发、研究、生产和商业化权益。信达生物将获得首付款，并有资格获得开发、注册及商业化潜在里程碑付款，交易总额约11亿美元；同时还将获得未来基于该产品净销售额的梯度式销售分成。 5）索赔约10亿元，凯赛生物提起诉讼 7月14日，凯赛生物公告称，公司及全资子公司凯赛(金乡)生物材料有限公司作为共同原告，以侵害技术秘密纠纷为由，向北京市高级人民法院起诉王志洲、葛明华、曹务波、山东瀚霖生物技术有限公司、陈远童、傅深展、中国科学院微生物研究所、山东归源生物科技有限公司、宁夏中科生物科技股份有限公司、宁夏中科生物新材料有限公司。公司诉请被告立即停止侵害原告技术秘密，销毁涉及“生物发酵法工业化生产长链二元酸技术”相关技术秘密的产线、设备、图纸，并连带赔偿经济损失约9.67亿元及合理开支100万元。目前案件已立案受理，尚未开庭审理。 / 02 /资本信息 1）昭衍新药预计上半年净利润同比增长885%-1377% 7月14日，昭衍新药公告称，预计2026年半年度归属于上市公司股东的净利润为6.00亿元-9.00亿元，同比增长884.9%-1377.4%。报告期内生物资产市场价格上涨叠加自身自然生长增值，双重因素驱动其公允价值正向变动，为公司业绩做出积极贡献。 / 03 /医药动态 1）中国生物制药BCL-2抑制剂拟纳入优先审评 7月14日，中国生物制药宣布，旗下公司正大天晴的BCL-2抑制剂TQB3909拟纳入优先审评，用于治疗既往经过至少包含BTK抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞性淋巴瘤（CLL/SLL）。 2）劲方医药GFH375片获临床许可 7月14日，据CDE官网，劲方医药GFH375片获临床许可，联合GFH276或GFS202A治疗KRAS G12D突变阳性的晚期实体瘤患者。 3）天衡药物TH5910获临床许可 7月14日，据CDE官网，天衡药物TH5910获临床许可，拟开展治疗急慢性呼吸道疾病（如急慢性支气管炎、肺炎等）。 4）坦蒂生物Cizutamig注射液获临床许可 7月14日，据CDE官网，坦蒂生物Cizutamig注射液获临床许可，拟开展治疗系统性自身免疫风湿性疾病相关间质性肺病的研究。 / 04 /海外药闻 1）Agenus停止一项CTLA-4+PD-1组合III期临床 7月13日，Agenus宣布达成最高3.4亿美元的私募融资协议，并发布了一项重大的临床开发战略调整。根据披露，Agenus将停止对CTLA-4+PD-1组合疗法botensilimab和balstilimab（BOT+BAL）针对晚期转移性微卫星稳定（MSS）结直肠癌（CRC）的III期研究BATTMAN的财政支持；转而将资源集中在BOT+BAL组合在MSS结肠癌新辅助治疗的III期临床试验。

2026-07-14

·佰傲谷BioValley

Agenus：停止一项CTLA-4+PD-1组合III期临床

2026年7月13日，Agenus宣布达成最高3.4亿美元的私募融资协议，并发布了一项重大的临床开发战略调整。根据披露，Agenus将停止对CTLA-4+PD-1组合疗法botensilimab和balstilimab（BOT+BAL）针对晚期转移性微卫星稳定（MSS）结直肠癌（CRC）的III期研究BATTMAN的财政支持；转而将资源集中在BOT+BAL组合在MSS结肠癌新辅助治疗的III期临床试验。受这一重大战略计划的影响，Agenus股票应声上涨，截止当日收盘，上涨82.69%。终止的III期临床被停止的BATTMAN研究是一项对照、随机的全球性III期试验，旨在评估BOT+BAL组合治疗难治性、不可切除的微卫星稳定或错配修复功能完整型转移性结直肠癌。根据clinicaltrials.gov显示，BATTMAN于2026年3月31日注册，预计招募834名患者。2026年4月，该研究完成首位患者入组。该研究才进行3个月，就已经停止。实际上，在2024年7月，FDA就拒绝了BOT+BAL组合用于复发/难治性微卫星稳定型结直肠癌的加速批准。FDA指出，其组合疗法在该适应症的响应率并不总是能转化为生存率，希望Agenus能开展一项生存率的III期临床试验以证明该组合疗法对该群体患者的获益。当时，Agenus因资金问题搁置了即时的全面III期研究。不过，Agenus表示将继续追踪II期临床数据的同时，并继续努力说服FDA重新考虑以及寻求欧洲监管机构的批准。后来，Agenus还是启动了针对微卫星稳定型结直肠癌的III期研究BATTMAN，作为验证性研究，旨在支持BOT+BAL组合用于该适应症的潜在监管申报。目前，该III期临床已经停止。Agenus表示将履行对正在接受治疗的患者的所有义务，并与所有研究人员密切合作，负责任地管理这一过渡。同时，这也代表Agenus放弃了对BOT+BAL组合用于微卫星稳定型结直肠癌。集中资源搞MSS结肠癌在这次临床开发战略调整中，Agenus将BOT+BAL组合用于MSS结肠癌新辅助治疗作为优先级，本次融资的净收益将全部用于支持该项目，包括推动BOT+BAL组合用于MSS结肠癌新辅助治疗的III期研究ROBBIN。这主要是基于在两项独立的II期临床试验NEST和UNICORN中，BOT+BAL组合在MSS结肠癌新辅助治疗中展现出深度且持续的疗效：约60%-70%的患者实现病理缓解，30%达到病理完全缓解（pCR），且在中位随访9至18个月内无复发病例。此外，该治疗效果在NEST和UNICORN的更新中持续存在，Agenus公司表示更多细节将在今年晚些时候发布。这一优异的治疗效果，以及在治疗期间观察到的循环肿瘤DNA（ctDNA）清除率，极大支持了Agenus公司对于BOT+BAL组合用于MSS结肠癌新辅助治疗的信心。因此，Agenus公司停止了BOT+BAL组合针对晚期转移性微卫星稳定（MSS）结直肠癌（CRC）的III期研究BATTMAN的财政支持，将资源投入BOT+BAL组合用于MSS结肠癌新辅助治疗上。为此，Agenus计划启动名为ROBBIN的全球注册性III期试验，入组850名未经治疗的高风险II/III期MSS结肠癌患者，对比新辅助BOT+BAL联合标准治疗与单纯标准治疗的无事件生存期（EFS）。该试验设计已与FDA达成一致。根据Agenus公司披露的ROBBIN研究时间表：III期研究ROBBIN的首位患者服药预计在2027年第一季度完成，预计于2027年下半年完成中期病理反应数据，预计于2029年下半年完成EFS中期分析，预计2030年下半年完成EFS最终分析。小结实际上，Agenus最核心的研发方向就是CTLA-4与PD-1的肿瘤免疫治疗组合，同时也是该公司最知名的项目。但是Agenus的BOT+BAL组合仍未获得任何监管批准，此前Agenus主动撤回针对宫颈癌的BLA，以及FDA拒绝批准针对复发/难治性微卫星稳定型结直肠癌。参考资料： 1.https://www.businesswire.com/news/home/20260713089967/en/Agenus-Announces-Oversubscribed-Private-Placement-of-Up-to-%24340-Million-to-Advance-Registrational-ROBBIN-Trial-of-Neoadjuvant-BOTBAL-in-MSS-Colon-Cancer 2.https://clinicaltrials.gov/study/NCT07152821?term=BATTMAN&viewType=Card&rank=1

临床3期临床2期加速审批临床失败临床结果

2026-07-13

·新药猎人笔记

Agenus大涨82%！融资3.4亿美元开发CTLA4/PD-1组合CRC新辅助治疗

7月13日，免疫肿瘤学公司Agenus（NASDAQ: AGEN）宣布了一项重大的战略调整：停止对晚期转移性微卫星稳定型（MSS）结直肠癌III期BATTMAN研究的资金支持，将全部资源转向高风险早期结肠癌的新辅助治疗。与此同时，公司完成了一笔最高可达3.4亿美元的私募融资，受此消息提振，其股价周一盘中涨幅一度超过100%。根据公告，此次融资由Commodore Capital领投，RA Capital、TCGX及Ligand Pharmaceuticals等机构参投，包括8500万美元的即时到账资金，以及未来通过行使认股权证可获得的2.55亿美元。若权证全部行权，这笔资金预计可支撑公司运营至2031年底，足以覆盖关键临床数据的读出节点。战略重心转移的背后，是Agenus对管线价值的重新评估。此前在NEST和UNICORN两项II期研究中，其核心组合疗法botensilimab联合balstilimab（BOT+BAL）在MSS结肠癌新辅助治疗中展现出令人瞩目的疗效：约60%-70%的患者实现病理缓解，30%达到病理完全缓解（pCR），且在中位随访9至18个月内无复发病例。为此，Agenus计划启动名为ROBBIN的全球注册性III期试验，入组850名未经治疗的高风险II/III期MSS结肠癌患者，对比新辅助BOT+BAL联合标准治疗与单纯标准治疗的无事件生存期（EFS）。该试验设计已与FDA达成一致，首位患者预计于2027年一季度入组，中期病理缓解数据有望在2027年下半年公布。对于仍在接受BATTMAN试验治疗的患者，Agenus表示将继续履行相关医疗义务。公司CEO Garo Armen强调，聚焦新辅助治疗是基于现有临床证据强度和患者获益最大化做出的决定，旨在抓住这一长期未被满足的临床需求。结语：相比之下，晚期转移性MSS结直肠癌的治疗窗口竞争更为激烈，而新辅助治疗领域在过去20余年尚无突破性疗法获批，美国市场潜在年销售额超70亿美元。

临床2期临床3期突破性疗法并购引进/卖出

100 项与巴替利单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11820	-	-	DB15676

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
宫颈癌	申请上市	美国	Recepta Biopharma SA	2022-01-30
不能切除的大肠癌	临床3期	加拿大	Agenus, Inc.	2026-03-31
肝转移	临床3期	法国	Agenus, Inc.	2025-12-08
转移性胃腺癌	临床3期	法国	Agenus, Inc.	2025-12-08
肛门肿瘤	临床3期	荷兰	Agenus, Inc.	2024-01-29
食管鳞状细胞癌	临床3期	荷兰	Agenus, Inc.	2024-01-29
MSI-H 实体瘤	临床3期	荷兰	Agenus, Inc.	2024-01-29
晚期癌症	临床3期	美国	Agenus, Inc.	2021-08-02
晚期癌症	临床3期	亚美尼亚	Agenus, Inc.	2021-08-02
子宫颈转移癌	临床3期	美国	Agenus, Inc.	2021-08-02

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT07227636 (ASCO2026)	临床2期	转移性微卫星稳定结直肠癌辅助 microsatellite-stable	54	balstilimabb + balstilimab (Stage III MSS CRC)	夢淵餘顧壓選觸鹽壓齋(餘糧廠鑰鏇築鑰襯構醖) = 遞遞壓製餘顧顧窪範齋淵鹽積窪積夢衊積淵鹹 (壓鑰鏇膚膚遞獵艱製製 )	积极	2026-05-29
NCT07152821 (CO.33/BATTMAN, ASCO2026)	临床3期	不能切除的大肠癌	834	botensilimabbalstilimabb + botensilimabbalstilimab	夢鑰簾鏇襯醖壓鏇築願(選願築糧鑰淵膚獵製獵) = 壓製簾積鬱觸願鬱鑰顧製鹹獵願憲遞選築網醖 (衊蓋積餘鹽鏇繭鹹鏇獵 )	积极	2026-05-29
NCT05571293 (NEST-1 \| NEST, CTgov)	临床2期	错配修复缺陷或微卫星高度不稳定性结直肠癌 \| 直肠癌 \| 结肠癌 ... 更多	26	Botensilimab+Balstilimab (Cohort A: Botensilimab and Balstilimab (Bot/Bal))	淵網積構繭鏇醖遞鑰願 = 觸夢積餘範廠鹹積鏇鹽築艱壓蓋簾製壓選製艱 (觸範醖艱網壓製築襯膚, 鹹壓襯鹹鏇壓廠觸淵築 ~ 糧願餘衊夢襯醖網襯網) 更多	-	2026-05-22
				Botensilimab+Balstilimab (Cohort B:)	淵網積構繭鏇醖遞鑰願 = 製憲鹹顧觸醖鑰繭積範築艱壓蓋簾製壓選製艱 (觸範醖艱網壓製築襯膚, 糧顧鏇顧遞壓遞選鹹積 ~ 繭膚艱鬱鏇構構壓繭網) 更多
NCT03860272 (C-800-01, Company_Website) 人工标引	临床1期	晚期癌症	341	botensilimab+balstilimab	築淵築範觸艱鑰壓膚願(觸襯構獵衊築顧鹹醖構) = 繭網積餘願壓鹽齋選鏇鹽襯襯築齋選鹽蓋夢艱 (遞網膚願窪糧積醖襯製 ) 更多	积极	2026-02-19
				botensilimab+balstilimab (imAEs within the first 12 weeks)	願艱壓鏇鏇鏇願範衊遞(衊簾願顧齋範鑰獵窪夢) = 壓遞願廠衊範夢蓋鬱衊繭鬱膚艱簾齋窪範範鹹 (構鏇蓋選獵糧淵製壓遞 )
NCT03860272 (C-800-01, J Immunother \| Company_Website) 人工标引	临床1期	难治性卵巢癌 \| 复发性铂耐药性卵巢癌	44	Botensilimab + Balstilimab	觸鏇齋構鏇膚壓鹽鑰築(獵鑰網夢遞鏇醖齋餘餘) = 蓋獵構築鏇製選鏇憲淵夢壓網築繭繭顧鑰淵夢 (餘鹽鏇網觸廠製選遞衊 ) 更多	积极	2025-12-23
NCT03894215 (RaPiDs, ESMO2025)	临床2期	复发性宫颈癌 PD-L1+	212	Balstilimab + zalfrelimab	範糧築構鹽願簾蓋顧構(憲選淵顧製範網壓繭選) = 艱餘夢獵鏇繭觸鏇糧鏇窪遞構製壓顧範範範艱 (顧鏇衊鬱醖壓網淵膚壓, 17 ~ 33) 更多	积极	2025-10-17
				Balstilimab + placebo	範糧築構鹽願簾蓋顧構(憲選淵顧製範網壓繭選) = 繭膚鑰顧顧衊觸構壓遞窪遞構製壓顧範範範艱 (顧鏇衊鬱醖壓網淵膚壓, 10 ~ 23) 更多
NCT03860272 (ESMO2025)	临床1期	晚期恶性实体瘤	343	Botensilimab + Balstilimab (IO naïve)	觸衊醖糧選觸觸鏇構繭(壓窪製觸窪獵壓構衊憲) = 淵醖糧鑰鬱艱襯獵願憲鹽製範鏇淵製鬱遞願鹽 (觸窪觸獵繭遞衊膚鬱齋 ) 更多	积极	2025-10-17
				Botensilimab + Balstilimab (IO refractory)	觸衊醖糧選觸觸鏇構繭(壓窪製觸窪獵壓構衊憲) = 製蓋簾願夢網積願積鏇鹽製範鏇淵製鬱遞願鹽 (觸窪觸獵繭遞衊膚鬱齋 ) 更多
NCT03104699 (Phase 2 study \| Phase I dose escalation, CTgov)	临床1/2期	局部晚期恶性实体瘤 \| 复发性宫颈癌 \| 子宫颈转移癌 ... 更多	211	Balstilimab (Phase 1: Balstilimab Dose 1)	鹽夢顧醖鹽衊繭齋願醖 = 齋鑰廠選襯鏇糧繭簾鹽艱願範艱顧艱鏇選觸顧 (窪簾廠鬱襯製築鏇廠顧, 獵衊襯廠襯蓋艱夢餘鏇 ~ 蓋積艱夢鏇艱鹽廠廠獵) 更多	-	2025-07-30
				Balstilimab (Phase 1: Balstilimab Dose 2)	鹽夢顧醖鹽衊繭齋願醖 = 觸夢鬱願壓窪築製獵鏇艱願範艱顧艱鏇選觸顧 (窪簾廠鬱襯製築鏇廠顧, 獵鏇鏇膚鬱範積醖鏇繭 ~ 餘鏇窪繭窪鹹夢繭範網) 更多
NCT03860272 (Pubmed \| J Clin Oncol) 人工标引	临床1期	肉瘤	64	Botensilimab + Balstilimab	獵觸願鹽構鹹鬱繭鏇築(積範構壓膚顧鹹蓋糧壓) = The most common treatment-related adverse event (TRAE) was diarrhea/colitis occurring in 35.9% of patients, with grade 3 in 6.3% of patients. 顧襯蓋顧鬱衊壓窪膚製 (觸構鑰糧艱範構憲觸壓 )	积极	2025-01-27
				Botensilimab + Balstilimab (angiosarcoma)
NCT05627635 (ASCO_GI2025)	临床1期	微卫星稳定型结直肠癌 MSS	14	Folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B)	鑰觸願觸鬱築觸壓淵選(構獵簾艱鑰窪構選範顧) = one pt at DL1 with transient G3 AST/ALT elevation and transient G2 colitis (resolved with steroids and infliximab), one pt at DL1 with G2 hypothyroidism and one patient at DL2 with G2 hyperthyroidism 廠憲簾鏇獵築範廠蓋襯 (鏇齋淵鹹醖選鑰齋憲範 ) 更多	积极	2025-01-23