Ficerafusp alfa(Ficerafusp alfa) - 药物靶点：EGFR x TGF-β_在研适应症：PD-L1阳性头颈部鳞状细胞癌，复发性头颈部鳞状细胞癌，转移性头颈部鳞状细胞癌_专利_临床

概要

基本信息

药物类型

单克隆抗体、抗体融合蛋白

别名

EGFR/TGFβ fusion monoclonal antibody、BCA 101

靶点

EGFR x TGF-β

作用方式

拮抗剂、抑制剂

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、TGF-β抑制剂(转化生长因子β抑制剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [3]

在研适应症

PD-L1阳性头颈部鳞状细胞癌复发性头颈部鳞状细胞癌转移性头颈部鳞状细胞癌+ [11]

非在研适应症-

原研机构

Bicara Therapeutics, Inc.

在研机构

Bicara Therapeutics, Inc.

非在研机构-

权益机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)-

特殊审评突破性疗法 (美国)

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结构/序列

Sequence Code 208411H

来源: *****

Sequence Code 208473L

来源: *****

关联

6

项与 Ficerafusp alfa 相关的临床试验

NCT07552558

/ Not yet recruiting临床1/2期IIT

Phase I/II Trial of Neoadjuvant Combination of Ficerafusp Alfa, Pembrolizumab, and SBRT for Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.

开始日期2026-09-30

申办/合作机构

Washington University School of Medicine

[+1]

NCT07807163

/ Recruiting临床2期

A Multicenter, Open-label, Randomized Phase 2 Study Evaluating Continuous Weekly Dosing of Ficerafusp Alfa (BCA101) in Combination With Pembrolizumab Versus an Alternative Ficerafusp Alfa Dosing Regimen for First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
The study aims to demonstrate that the antitumor activity of an alternative dosing regimen of ficerafusp alfa in combination with pembrolizumab is comparable to the weekly ficerafusp alfa regimen in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

开始日期2026-09-01

申办/合作机构

Bicara Therapeutics, Inc.

NCT07465276

/ Recruiting临床2期IIT

Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial

This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).
The names of the study drugs used in this research study are:
* ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein)
* pembrolizumab (a type of monoclonal antibody)

开始日期2026-03-26

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

100 项与 Ficerafusp alfa 相关的临床结果

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100 项与 Ficerafusp alfa 相关的转化医学

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100 项与 Ficerafusp alfa 相关的专利（医药）

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4

项与 Ficerafusp alfa 相关的文献（医药）

2026-06-20·JOURNAL OF CLINICAL ONCOLOGY

Ficerafusp Alfa (BCA101) With Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Two-Year Results of an Expansion Cohort of a Phase I/Ib Trial

Article

作者: Hanna, Glenn J. ; Chung, Christine H. ; Zandberg, Dan P. ; Raben, David ; O'Connell, Brenda C. ; Bohr, David ; Schulten, Jeltje ; Salazar, Rachel L. ; Hernando-Calvo, Alberto ; Wong, Deborah J. ; Sacco, Assuntina G. ; Reiners, Ralf D. ; Sherman, Eric ; Kaczmar, John ; Yilmaz, Emrullah

PURPOSE:

Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) have a poor prognosis, particularly those with human papillomavirus (HPV)–negative disease, in which elevated epidermal growth factor receptor and transforming growth factor-β impair tumor penetration of immune cells and lessen immunotherapy responses.

METHODS:

We present results from an expansion cohort of a first-in-human phase I/Ib trial (ClinicalTrials.gov identifier: NCT04429542 ) evaluating first-line treatment with ficerafusp alfa 1,500 mg once every week in combination with pembrolizumab 200 mg once every 3 weeks administered intravenously in patients with R/M HNSCC overexpressing PD-L1 (combined positive score ≥1). The primary end point was safety. Secondary end points included objective response rate (ORR), progression-free survival (PFS), duration of response (DOR), and overall survival (OS).

RESULTS:

Between February 2022 and April 2023, 42 patients received ≥1 dose of study drug and 39 were included in the efficacy-evaluable set (≥1 postbaseline scan). The median follow-up was 26.3 months. Nineteen of 42 patients (45%) had a grade 3 treatment-related adverse event (TRAE), and one (2%) had a grade 4 TRAE. The most common grade ≥3 TRAEs were anemia (14%) and acneiform dermatitis (12%). In efficacy-evaluable patients with HPV-negative (n = 28) or HPV-positive (n = 11) tumors, confirmed ORRs were 54% (complete response in 21%) and 27%, respectively. In the HPV-negative subgroup, median DOR was 21.7 months (95% CI, 6.0 to not estimable [NE]), median PFS was 9.9 months (95% CI, 4.4 to 22.7), and median OS was 21.3 months (95% CI, 9.9 to NE).

CONCLUSION:

Ficerafusp alfa plus pembrolizumab demonstrated favorable safety and tolerability with promising antitumor activity in the first-line treatment of R/M HNSCC, particularly in those with HPV-negative tumors.

2026-05-01·CURRENT OPINION IN ONCOLOGY

Recent highlights and breakthroughs in immunotherapy for head and neck cancers

Review

作者: Vuille, Joanna A ; Szturz, Petr

Purpose of review:

This review highlights recent advances in immunotherapy for head and neck oncology, focusing on pivotal studies, both early-stage and late-stage, published or presented in 2025.

Recent findings:

Noteworthy results were reported with immune checkpoint inhibitors in mucosal squamous cell carcinoma of the head and neck (SCCHN) (KEYNOTE-689 and NIVOPOSTOP trials evaluating pembrolizumab and nivolumab, respectively, in the perioperative setting); in nasopharyngeal carcinoma (DIPPER and DIAMOND trials evaluating camrelizumab and toripalimab, respectively, in the curative setting with radiotherapy, and tagitanlimab in recurrent and/or metastatic disease); in cutaneous squamous cell carcinoma of the head and neck region (C-POST trial in the adjuvant setting and the combination of avelumab with cetuximab in the palliative setting); and in BRAF V600E-mutated anaplastic thyroid carcinoma (pembrolizumab with dabrafenib and trametinib). Passive immunotherapy targeting tumor-associated antigens also showed encouraging activity in R/M-SCCHN (petosemtamab, ficerafusp-alfa, amivantamab, enfortumab vedotin) and in heavily pretreated R/M nasopharyngeal carcinoma (antibody-drug conjugates becotatug vedotin and izalontamab brengitecan [iza-bren]).

Summary:

Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.

2025-11-14·CLINICAL CANCER RESEARCH

Bridging EGFR/TGF-β Signaling to Bypass Resistance to Immune Checkpoint Blockade

Article

作者: Issaeva, Natalia ; Kothari, Aditi ; Bestvina, Christine M. ; Choudhury, Noura J.

Summary:

Although EGFR is a common target in squamous cancers, anti-EGFR monotherapies have shown modest success because of existing or acquired activation of other oncogenic pathways and tumor heterogeneity. A bifunctional fusion protein ficerafusp alfa in combination with pembrolizumab represents a potential solution to overcome resistance in early-phase clinical investigation.See related article by Hernando-Calvo et al., p. 4623

113

项与 Ficerafusp alfa 相关的新闻（医药）

2026-10-14

·药时代

股价跌超7%，PFS未达标！BioNTech肿瘤疫苗遇挫

正文共：2300字预计阅读时间：7分钟 2026年10月13日，BioNTech宣布其肿瘤疫苗BNT113联合K药，在晚期头颈鳞癌（HNSCC）患者中未能显著改善PFS。受此消息影响，BioNTech股价应声下跌。即便公告中称，独立数据监查委员会（IDMC）建议继续开展研究，评估另一主要终点OS数据。乾坤未定，且本次公告未披露HR、mPFS、ORR等详细数据。在无法判断PFS获益程度的情况下，公司股价盘后依跌超7%。原因为何？首先，是预期被打破。 BNT113依托于BioNTech的FixVac固定抗原平台，编码HPV16 E6/E7癌蛋白。E6/E7仅在肿瘤组织表达，正常细胞几乎不表达，是理想免疫靶点。理论上，诱导HPV16特异性T细胞应答，可与PD-1抑制剂形成协同。不仅如此，目前全球尚无获批HPV靶向疗法用于HPV16阳性HNSCC；该人群现有标准治疗易进展，中位OS仅20.7个月，患者需求明确。那么，一款靶点明确、肿瘤特异性强，且采用现货型mRNA设计，无需为每位患者单独定制的产品，自然被寄予厚望。 2026年1月，它获得FDA快速通道资格认定，被视为检验mRNA癌症疫苗能否走向商业化的重要项目之一。在本次失利的AHEAD-MERIT Ⅱ/Ⅲ 期研究中，A部分（初始非随机安全性导入阶段）也曾给出积极信号：联合方案在HPV16阳性HNSCC患者中具有免疫原性、耐受性良好。 BioNTech首席医学官Özlem Türeci在公告中亦表示，数据表明BNT113“正在发挥其预期的治疗机制”。 “奖池”越是叠加，PFS的失利带来的预期落差就越大。事实证明，抗原选择合理只是第一步：疫苗诱导产生特异性T细胞，不等于T细胞能够浸润肿瘤、克服肿瘤免疫抑制微环境、持续杀伤肿瘤细胞。叠加，本次公告未披露风险比、中位PFS或客观缓解率等数据。外界无法判断PFS结果获益的幅度与方向：是接近成功（数值上有利趋势但未跨过统计学门槛），还是彻底失败（两条生存曲线几乎没有实质分离）。信息缺口，就是不确定性；不确定性，就意味着风险。其次，未来不确定性大。 BioNTech把未来，都压在OS数据上。OS之所以仍是关键变量，是因为根据AHEAD-MERIT预先设定的统计学设计，即便PFS未达成，只要OS取得统计学显著改善，试验仍可判定为阳性。 IDMC建议试验继续推进，正是基于这一逻辑。支持者认为，免疫疗法的抗肿瘤效应可能随时间推移而累积和深化，因此PFS的早期失利未必预示OS的失败。历史确有先例：K药自身在HNSCC的一项III期试验中未达到PFS终点，但随后在一线治疗的KEYNOTE-048研究中显示出OS改善，并在五年随访中保持优势。首席医学官Özlem Türeci本人亦持此观点，强调“免疫介导的抗肿瘤效应随时间建立并加深”。但BMO Capital Markets分析师在致投资者的报告中指出，这种OS翻盘的可能性存在，但鉴于PFS失利，概率可能较低。毕竟，从既往临床证据看，PFS未达标而OS最终获益的案例实属少数，多数试验在OS评估中同样未能取得阳性结果。与此同时，HNSCC一线的竞争格局也在收紧。除BNT113外，Inhibrx的OX40激动剂INBRX-106、Merus的Petosemtamab、强生的Amivantamab、Bicara的Ficerafusp Alfa、艾伯维的Telisotuzumab adizutecan等多款双抗与ADC联合K药，均在同期开发一线复发/转移HNSCC适应症，其中INBRX-106已在HPV阳性亚组展现高ORR。 BNT113即便OS最终翻盘，也将面对一个日益拥挤的赛道。再者，也是最能煽动市场情绪的，就是同行对比。今年8月，Moderna宣布其与默沙东联合开发的个体化肿瘤疫苗mRNA-4157联合K药，在完全切除的IIB–IV期黑色素瘤辅助治疗III期研究中，达到主要终点无复发生存期（RFS）及关键次要终点无远处转移生存期（DMFS）。推荐阅读：股价暴涨177%！Moderna肿瘤疫苗III期临床成功这是个体化mRNA癌症疫苗，首次在随机III期研究中取得积极结果。此前IIb期研究的五年随访数据显示，联合方案将复发或死亡风险降低49%，将远处转移或死亡风险降低59%。相比之下，BioNTech拿下了mRNA肿瘤疫苗领域首个宣布失败III期研究。同样是与K药联用，同样基于mRNA平台，两家公司的阶段性答卷却截然不同。当然，只看结果是情绪的。仍需考虑两组研究在癌种、治疗阶段与临床场景上的本质差异。 Moderna选择的黑色素瘤，是典型的高突变负荷“热肿瘤”，对免疫治疗天然敏感；治疗场景为术后辅助，肿瘤负荷低，疫苗诱导的免疫反应有充分时间清除微小残留病灶。而BNT113面对的HPV16阳性HNSCC，尽管HPV16本身具有明确的外源抗原性，但晚期一线治疗所面临的肿瘤负荷与免疫抑制微环境，远比术后辅助场景更为复杂。 BNT113需在已形成的肿瘤微环境中实现即时控制，这对免疫反应的强度与速度提出了截然不同的要求。两条技术路线本身也各有优劣。个体化新抗原疫苗可匹配患者特有的肿瘤突变，理论上更有利于应对肿瘤异质性，但测序、定制与生产流程复杂，成本高昂；固定抗原疫苗靶点统一、可规模化量产、使用便捷，但依赖目标抗原在肿瘤中的稳定表达，且受个体免疫差异影响。因此，BNT113的挫折不能证明固定抗原策略的失败；Moderna的成功也不能证明个体化策略在所有癌种中的普适性。最后，则是对BioNTech公司本身的忧虑。 BNT113的PFS失利并非孤立事件。过去两个月，BioNTech接连遭遇mRNA肿瘤管线的挫折：8月，个体化新抗原疗法BNT122在结直肠癌辅助治疗的II期研究中因OS数值不平衡被终止；更早之前，固定抗原疫苗BNT111在黑色素瘤中的开发亦被搁置。接连的失败都发生在公司转型的敏感节点。随着新冠疫苗收入大幅回落，BioNTech正将战略重心全面转向肿瘤学。2026年上半年，公司营收仅2.24亿欧元，同比下降49.6%，净亏损扩大至13.5亿欧元。联合创始人Uğur Şahin与Özlem Türeci已宣布将于年底卸任，创办聚焦下一代mRNA技术的新公司Arife；新任CEO的交接预计在2027年初完成。推荐阅读：股价暴跌！BioNTech创始人夫妇离任与此同时，BioNTech正关闭德国三处生产基地，约1800个岗位面临裁撤，预计每年节约5亿欧元成本，再投资于肿瘤管线。值得注意的是，创始人与新公司Arife之间的资产与专利谈判仍存在不确定性。按照最初方案，BioNTech拟向Arife转移部分mRNA技术及早期项目，换取少数股权、里程碑付款及销售分成。但双方在专利估值、研发资产划分及人员安排上分歧明显，资产分割方案多次延期，不排除谈判破裂的可能。这又是一大变量。参考资料： 1.https://www.globenewswire.com/news-release/2026/10/13/3379487/0/en/biontech-provides-update-on-phase-2-3-clinical-trial-for-mrna-cancer-immunotherapy-candidate-bnt113-in-metastatic-hpv16-positive-head-and-neck-cancer.html 2.https://www.biospace.com/drug-development/biontech-faces-3rd-mrna-setback-as-head-and-neck-cancer-therapy-fails-to-improve-survival 3.https://pharmaphorum.com/news/keytruda-shows-promise-first-line-skin-cancer-treatment 4.雪球 5.BNT113的挫折：癌症疫苗可能需要重新定义自己的价值（未来生物资讯） 6.BioNTech mRNA癌症疫苗III期临床未达终点（生物技术小编） 7.BioNTech mRNA 癌症疫苗3期研究失利＆盘点mRNA疫苗（IO笔记） 8.mRNA先驱公司BioNTech关厂、裁员（药物递送） 9.BioNTech又摔一跤（同写意） 10.[新闻资讯] BioNTech创始人另起炉灶：专利与资产分割陷入僵局（Eurasian德国欧亚咨询） 11.其他公开资料图片来源：即梦AI BMS拿到两项III期临床成功大结果，怎么股价反而跌了？ 2026-10-13 张江落子：勃林格殷格翰如何把中国嵌入全球研发最前端 2026-10-12 2026-10-10 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！

疫苗免疫疗法临床3期信使RNA快速通道

2026-10-05

·GlobeNewswire-Health Care

Bicara Therapeutics Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

BOSTON, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced it awarded inducement grants on October 1, 2026 to two new employees as a material inducement to employment under Bicara’s 2026 Inducement Plan. The employees received, in the aggregate, non-qualified stock options to purchase 207,150 shares of Bicara’s common stock, par value $0.0001 per share, with an exercise price of $18.20 per share, equal to the closing price of Bicara’s common stock as reported by Nasdaq on October 1, 2026. One-fourth of the options vest on the first anniversary of the employee’s applicable start date, with the remaining options vesting in 12 equal quarterly installments thereafter, subject to the employee’s continued service with the company through each applicable vesting date. All of the above-described awards were granted outside of Bicara’s stockholder-approved equity incentive plans and are pursuant to Bicara’s 2026 Inducement Plan, which was adopted by Bicara’s board of directors in January 2026. The awards were approved by the compensation committee of Bicara’s board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Bicara in accordance with Nasdaq Listing Rule 5635(c)(4). About Bicara TherapeuticsBicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn and X. Contacts InvestorsRachel FrankIR@bicara.com MediaTim PalmerTim.Palmer@bicara.com

临床结果免疫疗法快速通道

2026-10-05

·BioSpace

Bicara Therapeutics Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4) - October 5, 2026

BOSTON, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced it awarded inducement grants on October 1, 2026 to two new employees as a material inducement to employment under Bicara’s 2026 Inducement Plan. The employees received, in the aggregate, non-qualified stock options to purchase 207,150 shares of Bicara’s common stock, par value $0.0001 per share, with an exercise price of $18.20 per share, equal to the closing price of Bicara’s common stock as reported by Nasdaq on October 1, 2026. One-fourth of the options vest on the first anniversary of the employee’s applicable start date, with the remaining options vesting in 12 equal quarterly installments thereafter, subject to the employee’s continued service with the company through each applicable vesting date. All of the above-described awards were granted outside of Bicara’s stockholder-approved equity incentive plans and are pursuant to Bicara’s 2026 Inducement Plan, which was adopted by Bicara’s board of directors in January 2026. The awards were approved by the compensation committee of Bicara’s board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Bicara in accordance with Nasdaq Listing Rule 5635(c)(4). About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit or follow us on LinkedIn and X. Contacts Investors Rachel Frank IR@bicara.com Media Tim Palmer Tim.Palmer@bicara.com

临床结果快速通道

100 项与 Ficerafusp alfa 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12768	-	-	-

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
PD-L1阳性头颈部鳞状细胞癌	临床3期	美国	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	日本	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	阿根廷	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	澳大利亚	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	奥地利	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	比利时	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	巴西	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	加拿大	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	捷克	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	法国	Bicara Therapeutics, Inc.	2025-01-28

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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


NCT06788990 (FORTIFI-HN01, ESMO2026)	临床2/3期	PD-L1阳性头颈部鳞状细胞癌一线 PD-L1-positive \| HPV-negative	650	Pembrolizumab 200 mgFicerafusp alfa (BCA101) 750 mg + Pembrolizumab 200 mgFicerafusp alfa (BCA101) 750 mg	鬱範鬱繭膚範獵鹹範蓋(壓糧鹹窪築範憲憲簾積) = 願鑰顧鬱憲壓鏇衊鏇衊鑰淵鑰鹽憲繭鹽糧壓構 (築餘鑰窪鏇積鑰醖觸憲 )	积极	2026-10-23
				Pembrolizumab 200 mg + Pembrolizumab 200 mg	鬱範鬱繭膚範獵鹹範蓋(窪襯網襯遞餘積齋襯壓) = 夢選艱窪簾鏇壓窪構窪壓艱醖選鏇壓構齋積鑰 (顧憲衊製壓獵獵淵衊衊 )
NCT04429542 (Pubmed \| J Clin Oncol)	临床1期	转移性头颈部鳞状细胞癌一线 PD-L1 \| HPV-negative \| HPV-positive	42	Ficerafusp alfa 1,500 mg + Pembrolizumab 200 mg	網憲鏇願鑰選簾鏇鑰鹹(簾餘艱簾膚遞衊願餘繭) = 鹽壓鬱鹹艱願遞齋觸壓顧築壓壓夢鹽鑰淵鹹廠 (積積繭窪鏇衊繭壓餘廠 ) 更多	积极	2026-06-20
				Ficerafusp alfa 1,500 mg + Pembrolizumab 200 mg (HPV-negative)	築憲獵鬱鹹遞艱蓋獵獵(鹹顧蓋艱艱獵鬱廠獵齋) = 範鏇範糧蓋願鬱壓蓋衊構遞壓淵積壓簾網鹹蓋 (鹽觸齋壓襯壓夢鑰廠廠 ) 更多
NCT06788990 (FORTIFI-HN01, ASCO2026)	临床2/3期	PD-L1阳性头颈部鳞状细胞癌一线 PD-L1-positive \| HPV-negative	650	Ficerafusp alfa (BCA101) + Pembrolizumab	鹽齋襯壓簾鏇願願築淵(糧鹹淵鑰醖襯製膚鹹鹽) = 製夢簾餘鑰衊窪鑰簾鬱鏇憲繭衊願膚餘選鬱網 (衊積繭衊獵襯餘願鏇簾 ) 更多	积极	2026-05-29
				Placebo + Pembrolizumab	鹽齋襯壓簾鏇願願築淵(糧鹹淵鑰醖襯製膚鹹鹽) = 築衊積願鑰簾憲淵鹽觸鏇憲繭衊願膚餘選鬱網 (衊積繭衊獵襯餘願鏇簾 ) 更多
NCT04429542 (ESMO_ASIA2025) 人工标引	临床1期	头颈部鳞状细胞癌 PD-L1 Expression (CPS >= 1)	31	Ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W	餘範製選餘構壓壓遞積(蓋遞夢餘鹹積齋鏇壓壓) = The most frequent TRAEs (any grade) were acneiform dermatitis (84%), pruritus (45%) and fatigue (39%). 廠艱衊窪鹽製鹹鹽淵鹽 (築壓襯蓋範遞衊願廠構 ) 更多	积极	2025-12-05
				Ficerafusp alfa 1500 mg QW + pembrolizumab
NCT04429542 (GlobeNewswire) 人工标引	临床1期	头颈部鳞状细胞癌一线 human papillomavirus (HPV)-negative	28	Ficerafusp alfa 1500mg + pembrolizumab (HPV-negative)	獵鹽衊艱築鏇觸願淵積(醖鬱襯鬱簾鏇範蓋築觸) = 壓網蓋鏇糧壓壓獵廠窪繭簾鏇膚積糧獵築獵鹹 (衊繭遞製膚選選繭網簾 ) 更多	积极	2025-08-12
NCT04429542 (ASCO2025 \| NEWS) 人工标引	临床1期	头颈部鳞状细胞癌	42	Ficerafusp alfa + Pembrolizumab	觸遞壓獵簾憲顧範製鬱(繭製蓋憲窪網壓鏇網衊) = 遞積夢廠膚窪鬱醖築構醖構願蓋網壓積獵網簾 (積鏇襯構築積蓋窪築選, 37 ~ 70) 更多	积极	2025-05-30
				Ficerafusp alfa + Pembrolizumab (HPV-negative)	觸遞壓獵簾憲顧範製鬱(繭製蓋憲窪網壓鏇網衊) = 範憲遞衊廠鬱願壓淵壓醖構願蓋網壓積獵網簾 (積鏇襯構築積蓋窪築選, 44 ~ 81) 更多
phase 1/1b trial (AACR2025)	临床1期	晚期皮肤鳞状细胞癌二线 anti-PD-1 therapy \| anti-EGFR antibodies	14	Ficerafusp alfa 1500 mg IV weekly	遞積夢繭餘鹽範鹽簾構(鏇鑰窪憲淵遞蓋鏇顧艱) = 鑰製構淵簾製齋膚艱顧憲製遞積襯鹽願糧糧鬱 (艱觸遞範網繭網糧築選, 15.2 ~ 72.3) 更多	积极	2025-04-28
NCT04429542 (Company_Website \| NEWS) 人工标引	临床1期	肛管鳞状细胞癌二线 \| 三线	28	Ficerafusp alfa Ficerafusp alfa + Pembrolizumab	鬱廠鹽醖鹽艱鹽齋齋簾(艱遞網鹽鹹繭願壓憲願) = the most common TRAE of any grade including, acneiform dermatitis (16/28 patients; 57.1%), epistaxis (14/28 patients; 50.0%), and pruritus (13/28 patients; 46.4%). 鬱觸製顧網醖繭鏇膚醖 (築顧觸淵餘鏇壓願艱範 )	积极	2025-01-27
NCT04429542 (ASCO_GI2025) 人工标引	临床1期	肛管鳞状细胞癌二线 \| 三线	26	Ficerafusp alfa + pembrolizumab	遞窪鬱糧網鏇鹹壓廠繭(簾繭鹹願蓋齋膚膚艱艱) = 觸夢艱衊獵窪繭網餘糧選齋廠蓋網鏇網遞窪網 (遞鬱憲鹹遞築繭獵鹽鬱 ) 更多	积极	2025-01-23
NCT04429542 (Biospace) 人工标引	临床1期	复发性头颈部鳞状细胞癌一线	39	Ficerafusp alfa (BCA101) + Pembrolizumab	積窪鏇願獵顧遞艱淵憲(鏇窪製製顧獵顧築蓋築) = acneiform rash (76%, with majority being Grade 1/2 in severity), fatigue (43%), and hypophosphatemia (38%). 餘夢願糧壓廠積獵壓構 (網膚壓積繭壓顧顧餘積 ) 更多	积极	2024-06-27
				Ficerafusp alfa (BCA101) + Pembrolizumab (HPV-negative)