A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, 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).
This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

开始日期2024-12-20

申办/合作机构

Bicara Therapeutics, Inc.初创企业

NCT04429542

/ Recruiting临床1期

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

开始日期2020-06-01

申办/合作机构

Bicara Therapeutics, Inc.初创企业

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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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项与 Ficerafusp alfa 相关的文献（医药）

2023-06-02·Cancer research

BCA101 Is a Tumor-Targeted Bifunctional Fusion Antibody That Simultaneously Inhibits EGFR and TGFβ Signaling to Durably Suppress Tumor Growth.

Article

作者: Kulkarni, Hanumant ; Reddy, Ram Bhupal ; Krishn, Shiv Ram ; Sharma, Pinky ; Govindappa, Nagaraja ; Bhatnagar, Jaya ; Boreddy, Srinivas Reddy ; Dhamne, Chaitrali ; Sagar, Milind ; Banerjee, Arindam ; Nair, Pradip ; Kuriakose, Anshu ; Kuriakose, Moni Abraham ; Shri, Meena ; Tiwari, Vinita ; Nair, Reshmi ; Dey, Chaitali ; Moole, Praveen Reddy ; Suresh, Amritha ; Tan, Seng-Lai ; Marigowda, Shivakumar Bhadravathi ; Sreenivas, Suma ; Patel, Sonal ; Ar, Madhukara ; Alke, Bhavna ; Periyasamy, Sankar ; Pandey, Prashant Kumar ; Mv, Prashantha Kumar ; Rao, Shruthi ; Bughani, Usha

The EGFR and TGFβ signaling pathways are important mediators of tumorigenesis, and cross-talk between them contributes to cancer progression and drug resistance. Therapies capable of simultaneously targeting EGFR and TGFβ could help improve patient outcomes across various cancer types. Here, we developed BCA101, an anti-EGFR IgG1 mAb linked to an extracellular domain of human TGFβRII. The TGFβ "trap" fused to the light chain in BCA101 did not sterically interfere with its ability to bind EGFR, inhibit cell proliferation, or mediate antibody-dependent cellular cytotoxicity. Functional neutralization of TGFβ by BCA101 was demonstrated by several in vitro assays. BCA101 increased production of proinflammatory cytokines and key markers associated with T-cell and natural killer-cell activation, while suppressing VEGF secretion. In addition, BCA101 inhibited differentiation of naïve CD4+ T cells to inducible regulatory T cells (iTreg) more strongly than the anti-EGFR antibody cetuximab. BCA101 localized to tumor tissues in xenograft mouse models with comparable kinetics to cetuximab, both having better tumor tissue retention over TGFβ "trap." TGFβ in tumors was neutralized by approximately 90% in animals dosed with 10 mg/kg of BCA101 compared with 54% in animals dosed with equimolar TGFβRII-Fc. In patient-derived xenograft mouse models of head and neck squamous cell carcinoma, BCA101 showed durable response after dose cessation. The combination of BCA101 and anti-PD1 antibody improved tumor inhibition in both B16-hEGFR-expressing syngeneic mouse models and in humanized HuNOG-EXL mice bearing human PC-3 xenografts. Together, these results support the clinical development of BCA101 as a monotherapy and in combination with immune checkpoint therapy.SIGNIFICANCEThe bifunctional mAb fusion design of BCA101 targets it to the tumor microenvironment where it inhibits EGFR and neutralizes TGFβ to induce immune activation and to suppress tumor growth.

项与 Ficerafusp alfa 相关的新闻（医药）

2025-02-02

·药明康德

疾病控制率100%的ADC疗法；潜在“first-in-class”多肽疗法早期临床结果积极…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 靶向TROP2的抗体偶联药物（ADC）OQY-3258在1期临床试验中表现亮眼，在初治三阴性乳腺癌患者中达到100%疾病控制率（DCR）。 2. 潜在“first-in-class”β连环蛋白多肽拮抗剂ST316在1期临床试验中获得作用机制验证。 3. 双功能性抗体疗法ficerafusp alfa与PD-1抑制剂pembrolizumab联用，在治疗二线及以上鳞状细胞肛管癌（SCAC）患者的1/1b期临床试验中，达到25.0%的确认客观缓解率（ORR）。药明康德内容团队整理 ST316：公布1期临床试验数据 Sapience Therapeutics公司汇报了在研潜在“first-in-class”β连环蛋白（catenin）多肽拮抗剂ST316的1期临床试验安全性和生物标志物数据。ST316通过破坏β连环蛋白与BCL9的相互作用，抑制Wnt/β-连环蛋白信号通路。数据显示，在所有测试剂量下，ST316均表现出良好的安全性和耐受性。接受ST316单药治疗的患者中所观察到的长期疾病稳定（SD）与ST316早期抗肿瘤活性信号相一致。接受治疗后，在7例接受评估的患者中，有4例显示β连环蛋白从细胞核转移至细胞质/膜，表明ST316能够进入肿瘤组织并成功与靶点结合。在1期试验中，ST316显著降低了患者的免疫抑制细胞表达，显示出潜在的免疫调节效应。 ETH47：公布1期临床试验顶线结果 Ethris公司宣布，其主打mRNA候选药物ETH47，在健康受试者中的进行的1期临床试验中获得积极的顶线数据。 ETH47旨在靶向哮喘急性加重的上游触发因素，它编码的干扰素λ（IFNλ）是一种在呼吸道抗病毒免疫中起关键作用的蛋白。本次试验数据显示，ETH47在鼻腔衬液中剂量依赖性诱导了IFNλ的产生，并且显著激活鼻拭子样本中抗病毒干扰素刺激基因mRNA的表达。安全性方面，ETH47在所有剂量水平上均表现出良好的安全性和耐受性。无严重或重度不良事件，也无因不良事件导致的试验中断。未检测到mRNA、IFNλ蛋白或专有脂类化合物的全身性吸收，这有效降低了脱靶效应的风险。 OQY-3258：1期临床试验结果公布 Vincerx Pharma和Oqory公司公布了在研抗体偶联药物OQY-3258用于治疗实体瘤患者的1a/1b期临床试验结果。OQY-3258又名ESG401，是一款靶向TROP2的抗体偶联药物。截至2024年8月，约150名实体瘤患者入组这一临床试验，在多种乳腺癌亚型患者中观察到可喜结果。在初治三阴性乳腺癌患者中（n=25），确认ORR为76%，疾病控制率为100%，中位缓解持续时间（DOR）和无进展生存期（PFS）尚未达到。截至2025年1月的最新数据显示确认ORR提高到80%。在HR阳性/HER2阴性乳腺癌患者中，确认ORR为39%，DCR为78%。中位PFS为7.4个月。 Ficerafusp alfa（BCA101）：公布1/1b期临床试验数据 Bicara Therapeutics公司公布了在研双功能性抗体疗法ficerafusp alfa与PD-1抑制剂pembrolizumab联用，治疗二线及以上鳞状细胞肛管癌患者的1/1b期临床试验的扩展队列试验数据。截至2024年12月5日，确认的ORR为25.0%（7/28例），其中包括6例部分缓解（PR）和1例完全缓解（CR）。此外，还有1例患者正在等待确认PR。中位PFS为2.9个月，在可评估的27例患者中，12个月的无进展生存率为40.7%。 SAB-142：1期临床试验结果公布 SAB BIO公司公布了在研人类抗胸腺细胞免疫球蛋白疗法SAB-142在健康志愿者中进行的1期临床试验的积极顶线结果。这一研究达到安全性和药代动力学活性的主要终点，支持SAB-142进入2b期临床开发阶段，用于治疗1型糖尿病。 1期临床试验数据显示，SAB-142表现出良好的安全性特征，支持长期给药。并且生物标志物研究显示SAB-142表现出持久的免疫调节作用。SAB-142是一种人类多克隆免疫球蛋白，可针对多种杀伤胰岛β细胞的免疫细胞，调节它们的活性，从而起到保护胰岛β细胞的作用。 TX45：公布1b期临床试验数据 Tectonic Therapeutic宣布，其主打候选药物TX45在1b期急性血流动力学临床试验中取得积极中期数据。在患有2型肺动脉高压合并射血分数保留型心力衰竭（PH-HFpEF）的患者中，单次静脉输注TX45可显著改善左心室功能和肺部血流动力学。在整个研究人群中，TX45使肺毛细血管楔压（PCWP）降低17.9%，PCWP已被证明与患者的运动耐受、发病率和死亡率相关。在合并毛细血管前肺动脉高压和毛细血管后肺动脉高压（CpcPH），且患者肺血管阻力（PVR）升高的患者亚组中，TX45使PVR降低超过30%，这一指标同PCWP一样，与患者的运动耐受及生存预后密切相关。 TX45是一款长效Fc-款松弛素（relaxin）融合蛋白。它的独特作用机制不仅改善肺部血流动力学，还能增强左心室功能。现有的肺动脉高压药物主要为肺血管扩张剂，尚未在PH-HFpEF患者中显示对左心室功能的改善。Tectonic Therapeutic官网表示，TX45具有成为“best-in-class”疗法的潜力。 CELZ-201-DDT：公布1/2期临床试验初步数据 Creative Medical Technology Holdings公司宣布，其基于干细胞的创新疗法CELZ-201-DDT，在治疗退行性椎间盘疾病（DDD）导致的慢性背痛的1/2期临床试验中取得积极的初步数据。首批患者共10例患者中8例接受CELZ-201-DDT的治疗，2例接受安慰剂治疗。安全性数据显示：未发生剂量限制性毒性，无严重不良事件。盲态数据分析显示，CELZ-201-DDT在缓解背痛和恢复功能方面表现出可喜的治疗潜力。在对首批数据进行全面安全性评估后，独立数据安全监测委员会（DSMB）建议按计划推进临床试验至下一患者队列。 CELZ-201-DDT是Creative Medical Technology Holdings研发的基于干细胞的治疗产品，旨在修复受损椎间盘组织、减轻慢性背痛并恢复患者功能。 ALLO-329：IND申请获FDA许可 Allogene Therapeutics公司宣布，在研同种异体CAR-T细胞疗法ALLO-329用于治疗多种自身免疫性疾病的1期临床篮子试验的IND申请已经获得美国FDA的许可。这项名为RESOLUTION的1期篮子试验将在系统性红斑狼疮、特发性炎症性肌病和系统性硬化症患者中评估ALLO-329的疗效和安全性，预计在2025年年中展开。 ALLO-329是一款靶向CD19和CD70两个靶点的CAR-T细胞疗法，可靶向CD19阳性B细胞和CD70阳性激活T细胞。这一策略可能同时针对B细胞和T细胞功能失常，从而带来更好的治疗效果。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] SAB BIO Announces Positive Topline Phase 1 Clinical Results. Retrieved January 28, 2025, from https://www.globenewswire.com/news-release/2025/01/28/3016248/0/en/SAB-BIO-Announces-Positive-Topline-Phase-1-Clinical-Results-with-Potentially-Disease-Modifying-T1D-Therapy-SAB-142.html [2] Allogene Therapeutics Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune Diseases. Retrieved January 28, 2025, from https://www.globenewswire.com/news-release/2025/01/28/3016394/0/en/Allogene-Therapeutics-Secures-U-S-FDA-IND-Clearance-for-ALLO-329-Advancing-its-Next-Generation-Allogeneic-CAR-T-into-Autoimmune-Diseases.html [3] Vincerx Pharma, Inc. and Oqory, Inc. Highlight Promising Data for Oqory’s TROP2 Antibody Drug Conjugate, OQY-3258. Retrieved January 29, 2025, from https://investors.vincerapharma.com/news-releases/news-release-details/vincerx-pharma-inc-and-oqory-inc-highlight-promising-data-oqorys [4] Bicara Therapeutics Presents Phase 1/1b Dose Expansion Results with Ficerafusp Alfa in Advanced Squamous Cancer of the Anal Canal at the 2025 ASCO Gastrointestinal Cancers Symposium. Retrieved January 29, 2025, from https://ir.bicara.com/news-releases/news-release-details/bicara-therapeutics-presents-phase-11b-dose-expansion-results [5] GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-3650, Second-Generation TriKE for the Treatment of Hematologic Malignancies. Retrieved January 29, 2025, from https://www.gtbiopharma.com/news-media/press-releases/detail/288/gt-biopharma-announces-first-patient-dosed-in-phase-1-trial [6] Sapience Therapeutics Presents ST316 Phase 1 Dose Escalation Data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium. Retrieved January 29, 2025, from https://sapiencetherapeutics.com/sapience-therapeutics-presents-st316-phase-1-dose-escalation-data-at-the-2025-american-society-of-clinical-oncology-asco-gastrointestinal-gi-cancers-symposium/ [7] Tectonic Therapeutic Announces Positive Interim Data from Phase 1b Trial for TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF. Retrieved January 30, 2025, from https://www.globenewswire.com/news-release/2025/01/30/3017839/0/en/Tectonic-Therapeutic-Announces-Positive-Interim-Data-from-Phase-1b-Trial-for-TX45-in-Patients-with-Group-2-Pulmonary-Hypertension-in-HFpEF.html [8] Tubulis Announces First Patient Dosed in Phase I/IIa Trial Evaluating ADC TUB-030 in Advanced Solid Tumors. Retrieved January 30, 2025, from https://www.businesswire.com/news/home/20250130888316/en [9] Creative Medical Technology Holdings Announces Positive Initial Safety, Tolerability, and Efficacy Data from First Cohort in Phase 1/2 Trial of CELZ-201-DDT for Chronic Back Pain. Retrieved January 30, 2025, from https://www.globenewswire.com/news-release/2025/01/30/3018142/0/en/Creative-Medical-Technology-Holdings-Announces-Positive-Initial-Safety-Tolerability-and-Efficacy-Data-from-First-Cohort-in-Phase-1-2-Trial-of-CELZ-201-DDT-for-Chronic-Back-Pain.html [10] Ethris Presents Positive Topline Phase 1 Data with mRNA Lead Candidate ETH47 for Uncontrolled Asthma. Retrieved January 30, 2025, from https://www.businesswire.com/news/home/20250130943965/en [11] Owkin Announces First Patient Dosed in Phase I AI-optimized Clinical Trial of OKN4395, a First-in-Class EP2/EP4/DP1 Triple Inhibitor for Patients with Solid Tumors. Retrieved January 30, 2025, from https://www.businesswire.com/news/home/20250130436779/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床1期抗体药物偶联物临床结果信使RNA

2025-02-01

·GlobeNewswire-Health Care

Bicara Therapeutics Presents Phase 1/1b Dose Expansion Results with Ficerafusp Alfa in Advanced Squamous Cancer of the Anal Canal at the 2025 ASCO Gastrointestinal Cancers Symposium

Jan. 27, 2025 -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the presentation of data from the Phase 1/1b dose expansion cohort of ficerafusp alfa in combination with pembrolizumab in patients with second line (2L) or later squamous cancer of the anal canal (SCAC). The results were presented in a poster session during the 2025 ASCO Gastrointestinal (GI) Cancers Symposium on Saturday, January 25, 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that 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), and is being evaluated in multiple solid tumor types. “We are encouraged by the preliminary data in SCAC, which demonstrate enhanced efficacy of the combination of ficerafusp alfa and pembrolizumab in a high-need patient population,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “The addition of ficerafusp alfa shows the potential to improve efficacy compared to historical data with pembrolizumab monotherapy in SCAC, with increased overall response rate, disease control rate, and 12-month progression-free survival, indicative of improved speed, depth, and durability of response. Importantly, responses were observed even in patients with liver metastases, which is a significant outcome in this setting. These data provide additional insights into the complimentary mechanisms of ficerafusp alfa and pembrolizumab, and support further development in squamous cell carcinomas, including first-line recurrent/metastatic head and neck squamous cell carcinoma.” “These early data with ficerafusp alfa and pembrolizumab suggest that ficerafusp alfa could play an important role in the future treatment of SCAC, underscoring the need for further investigation to assess the combination's potential in improving outcomes for patients,” said Van K. Morris, MD, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. Presentation Highlights: As of the data cut-off date of December 5, 2024, the single-arm, multicenter dose expansion cohort from an ongoing Phase 1/1b trial evaluated ficerafusp alfa in combination with pembrolizumab in 28 patients with immune checkpoint inhibitor-naive SCAC that was locally advanced/unresectable or metastatic, and who had received 1-2 prior lines of chemotherapy. The confirmed overall response rate was 25.0% (7/28 patients), irrespective of PD-L1 CPS score, including 6 partial responses (PR) and 1 complete response. In addition to the confirmed responses, there was 1 patient pending a confirmed PR. Median progression-free survival (PFS) was 2.9 months and the PFS rate at 12 months was 40.7% (27 evaluable patients). Tolerable safety profile with the most common treatment-related adverse events of any grade including, acneiform dermatitis (16/28 patients; 57.1%), epistaxis (14/28 patients; 50.0%), and pruritus (13/28 patients; 46.4%). Presentation Details: Title: Preliminary Phase 1/1b dose expansion results of the bifunctional EGFR/TGFβ inhibitor ficerafusp alfa (BCA101) with pembrolizumab in patients with squamous cell carcinoma of the anal canal Presenter: Van K. Morris, MD, Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center The poster presentation is available on the Bicara website under the Presentations & Publications section. Squamous cancer of the anal canal (SCAC) is the most common type of anal canal cancer, with an incidence in the United States. SCAC is typically associated with prior Human Papillomavirus (HPV) infection. Treatment is most commonly chemoradiation for patients with localized disease at diagnosis. Ficerafusp alfa is a first-in-class bifunctional antibody that 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 dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. 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 bifunctional antibody that 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 dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. 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 or X. The content above comes from the network. if any infringement, please contact us to modify.

临床结果免疫疗法ASCO会议

2025-01-27

·Endpoints

Bristol Myers shares IO combo data in colorectal cancer; Pfizer still waiting on Braftovi regimen survival figures

Several drugmakers shared new clinical data at this year’s ASCO GI Symposium in San Francisco, and Endpoints News has rounded up a handful of notable presentations from Bristol Myers Squibb, Pfizer, Exelixis and Bicara Therapeutics. 📡 Bristol Myers’ Opdivo plus Yervoy met the dual primary endpoint of progression-free survival in the Phase 3 CheckMate-8HW trial of people with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. The treatment cut the risk of disease progression or death by 38% versus Opdivo monotherapy at a median follow-up of 47 months. The Opdivo-Yervoy combo secured US approval for certain forms of pre-treated colorectal cancer in 2018, but the latest data came from a variety of patients, including those in the first-line setting. In December, the regimen was greenlit by the European Commission for first-line disease based on prior results from CheckMate-8HW comparing it with standard chemotherapy. Survival data will be shared at a later date. 💧 Pfizer presented results from its Phase 3 BREAKWATER study of Braftovi plus Eli Lilly’s Erbitux and the chemo cocktail fluorouracil, leucovorin and oxaliplatin in BRAF V600E-mutant metastatic colorectal cancer. Overall survival data for the treatment arm were not significant at the time of analysis, although the company stressed they were still immature. The control arm featuring chemotherapy with or without Roche’s Avastin hit its median OS, setting a benchmark of 14.6 months. The Braftovi regimen clinched FDA approval in first-line patients last month as part of the agency’s Project FrontRunner initiative, which is designed to improve accessibility to cancer drugs. The green light was based on response rates in BREAKWATER, but continued approval will depend on confirmatory PFS and OS results. Pfizer obtained Braftovi in 2019 when it bought the drug’s original developer Array Biopharma for $11.4 billion. 🗄️ Exelixis shared two updates at ASCO GI. The first was for its oral tyrosine kinase inhibitor zanzalintinib plus Roche’s Tecentriq in 107 patients with previously-treated metastatic colorectal cancer enrolled in a Phase 1b/2 test. The combo produced an ORR of 7.4% compared with 1.9% for zanzalintinib alone — a result that TD Cowen analysts described as “incrementally inferior” to Phase 1b data for Tecentriq plus Cabometyx in the same setting. But the zanzalintinib regimen did achieve a higher ORR of 18% in the subset of patients without liver metastases, which bodes well for the drugmaker’s ongoing Phase 3 STELLAR-303 trial, according to the analysts. That study is testing the treatment against Bayer’s Stivarga. In a separate presentation , Exelixis revealed that Cabometyx achieved 8.6 months of median PFS in a subset of 116 patients with extra-pancreatic neuroendocrine tumors (NETs) arising in the gastrointestinal tract enrolled in its Phase 3 CABINET trial. The test included a variety of patients with different types of NETs. Cabometyx is currently under FDA review for the disease, with a PDUFA date set for April 3. 🏆 Bicara reported that its EGFR-targeted antibody candidate ficerafusp alfa added to Merck’s Keytruda achieved a 25% ORR and 64.3% disease control rate in metastatic or locally advanced squamous cancer of the anal canal that has not been treated with checkpoint inhibitors. The combo results are “clearly superior” to Keytruda monotherapy, which is associated with an 11% ORR and 26% DCR in the same setting, TD Cowen analysts wrote in a separate note. Bicara’s Phase 1/1b trial enrolled 28 patients with one or two prior lines of chemotherapy. Also from the confab, Endpoints reported on mid-stage data for Agenus’ anti-CTLA-4/PD-1 regimen and ALX Oncology’s CD47-targeting candidate .

临床结果临床3期并购上市批准

100 项与 Ficerafusp alfa 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
复发性头颈部鳞状细胞癌	临床3期	美国	Bicara Therapeutics, Inc.初创企业	2024-12-20
转移性头颈部鳞状细胞癌	临床3期	美国	Bicara Therapeutics, Inc.初创企业	2024-12-20
肛管鳞状细胞癌	临床2期	美国	Bicara Therapeutics, Inc.初创企业	2023-03-10
结直肠癌	临床1期	加拿大	Bicara Therapeutics, Inc.初创企业	2020-06-01
结直肠癌	临床1期	美国	Bicara Therapeutics, Inc.初创企业	2020-06-01
结直肠癌	临床1期	澳大利亚	Bicara Therapeutics, Inc.初创企业	2020-06-01
胰腺癌	临床1期	澳大利亚	Bicara Therapeutics, Inc.初创企业	2020-06-01
胰腺癌	临床1期	美国	Bicara Therapeutics, Inc.初创企业	2020-06-01
胰腺癌	临床1期	加拿大	Bicara Therapeutics, Inc.初创企业	2020-06-01
鳞状细胞肺癌	临床1期	加拿大	Bicara Therapeutics, Inc.初创企业	2020-06-01

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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


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	(獵繭觸鹹製遞醖膚觸憲) = 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%). 願艱鹹餘構廠鬱製鏇鑰 (糧淵憲構顧顧餘夢糧鬱 )	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	(醖窪簾積衊夢選窪餘簾) = 醖齋淵簾簾憲積鑰範鬱鏇壓夢蓋獵蓋積鏇窪築 (選醖鬱鹹願網選製醖艱 ) 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	(憲簾簾醖夢廠遞選積鬱) = acneiform rash (76%, with majority being Grade 1/2 in severity), fatigue (43%), and hypophosphatemia (38%). 醖襯廠襯醖製夢積製鹽 (壓鹽膚繭顧觸蓋襯廠襯 ) 更多	积极	2024-06-27
				Ficerafusp alfa (BCA101) + Pembrolizumab (HPV-negative)
NCT04429542 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	头颈部鳞状细胞癌一线 PD-L1 \| HPV Negative	33	BCA101 1500 mg+pembrolizumab 200 mg	(範鹹觸顧鹹廠獵淵鏇夢) = 衊範膚鑰鑰繭鬱願繭獵簾遞鹹糧範範齋繭淵艱 (憲膚衊憲襯窪鏇壓獵廠 ) 更多	积极	2023-10-22
				BCA101 1500 mg+pembrolizumab 200 mg (HPV(-) pts)	(構鹹顧製鹽膚淵窪齋廠) = 繭齋壓壓觸獵鹹糧淵遞鏇顧網鏇蓋積齋鏇淵糧 (鑰廠製簾醖製繭醖襯獵 )
NCT04429542 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	转移性头颈部鳞状细胞癌一线	18	BCA101+pembrolizumab	(鬱簾蓋獵網鑰窪壓醖夢) = 構糧壓鏇築鏇憲鏇鑰廠鹽壓鏇製鹹遞鏇鹽憲齋 (憲膚繭簾艱鬱遞繭鑰鑰 ) 更多	积极	2023-05-26
				BCA101+pembrolizumab (HPV-neg)	(簾蓋築壓製網遞憲繭壓) = 齋糧壓觸遞鏇願網顧襯鏇範鏇獵願顧艱糧鹽窪 (淵簾築願夢遞觸鏇鑰餘 ) 更多
NCT04429542 (ESMO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	60	BCA101	(鑰齋廠鬱築積鏇繭膚襯) = Most common AEs attributed to BCA101 include rash (72%), fatigue (30%), pruritis (20%), and epistaxis (17%); all G2 or less 選廠築蓋窪齋齋糧壓繭 (淵鏇積構網廠繭醖製壓 ) 更多	积极	2022-09-10
				BCA101+pembrolizumab
NCT04429542 (ASCO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	60	BCA101	(餘餘壓鑰積廠壓遞遞夢) = Common adverse events (AEs) attributed to BCA101 include rash (70%), fatigue (23%), pruritis and epistaxis (17% each); all grade (G)2 or less 鏇願獵襯憲範鏇製鑰獵 (廠蓋築醖顧積鏇鹹範襯 ) 更多	积极	2022-06-02
				pembrolizumab+BCA101