Randomized Study to Compare First-line Treatment With Either Continuous or Intermittent Cetuximab Plus FOLFIRI in Patients With RAS/BRAF-wild-type Metastatic Colorectal Cancer (mCRC): AIO-KRK-0524 / FIRE-11

The goal of this clinical trial is to learn if the application of the chemotherapy FOLFIRI and cetuximab works better when given with scheduled breaks or continuously in adults with metastatic colorectal cancer. The main question it aims to answer is, whether worsening of disease after 12 months of treatment is lower when the treatment is given with breaks or given continuously. It will also answer the question whether the quality of life is better and side effects are less if chemotherapy is given with breaks.
Additionally, the treatment breaks will be controlled by blood tests and imaging examinations. A novel blood test will be introduced to investigate, whether worsening of the disease might be detected before the imaging, and whether a quicker reaction by re-starting the therapy would help the patients.
Participants will:
* receive an established chemotherapy mit FOLFIRI and cetuximab
* Receive blood tests every 4 weeks and imaging investigations every 12 weeks
* fill out questionnaires to report their quality of life

开始日期2026-01-01

申办/合作机构

Guardant Health, Inc.

NCT06418724

/ Not yet recruiting临床2期

Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma

The NEOPECS trial is a phase II prospective, single-arm, non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia.

开始日期2025-12-11

申办/合作机构

Melanoma & Skin Cancer Trials Ltd.

NCT05956821

/ Recruiting临床1/2期IIT

Phase I/II Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients < 22 years of age.

开始日期2025-11-01

申办/合作机构

University of Miami

100 项与西妥昔单抗相关的临床结果

登录后查看更多信息

100 项与西妥昔单抗相关的转化医学

登录后查看更多信息

100 项与西妥昔单抗相关的专利（医药）

登录后查看更多信息

8,322

项与西妥昔单抗相关的文献（医药）

2025-12-01·Journal of Gastrointestinal Cancer

Anti-EGFR Rechallenge in Metastatic Colorectal Cancer and the Role of ctDNA: A Systematic Review and Meta-analysis

Review

作者: da Silva, Luís Felipe Leite ; Peixoto, Renata D 'Alpino ; Saldanha, Erick Figueiredo ; da Conceição, Lucas Diniz ; Noronha, Mariana Macambira ; da Silva, Marcos Vinícius Martins Grangeiro

BACKGROUND:

Metastatic colorectal cancer (mCRC) remains a significant clinical challenge. While anti-EGFR inhibitors have improved survival rates, their long-term efficacy is limited by disease progression, which is often associated with the development of acquired resistance mutations. However, some patients may regain sensitivity to anti-EGFR agents after alternative therapies, suggesting a potential benefit for rechallenge strategies. Our study aims to conduct a systematic review and meta-analysis to comprehensively evaluate the efficacy and safety of EGFR rechallenge in patients with mCRC.

METHODS:

A systematic search of the MEDLINE, EMBASE, and Cochrane databases was conducted between October 28 and December 24, 2023, to identify clinical trials investigating treatment regimens incorporating panitumumab or cetuximab as a rechallenge strategy. Pooled proportions or hazard ratios (HR) were calculated using a random effects model. Inter-study heterogeneity was assessed using the I².

RESULTS:

Among the 2105 articles identified through the search, 13 met the predetermined inclusion criteria. Of these, 12 were phase II studies, encompassing 92.3% of the patient population. Cetuximab was administered to 302 patients (75.1%), whereas panitumumab was utilized in 100 patients (24.9%).A pooled analysis of eight studies demonstrated an objective response rate of 20.50% (95% CI 7.94 to 33.07) and a disease control rate of 67.35% (95% CI 58.60 to 76.09). The median progression-free survival was estimated at 3.5 months (95% CI 2.68-6.69), with a median OS of 9.8 months (95% CI 6.71-12.89). Patients exhibiting RAS wild-type status in circulating tumor DNA (ctDNA) analysis derived enhanced benefits from anti-EGFR rechallenge (HR: 0.41; 95% CI 0.28-0.60, I² = 60%). Common grade 3 or higher treatment-related adverse events included neutropenia (22.8%) and rash (14.9%).

CONCLUSION:

This meta-analysis underscores the efficacy and safety of anti-EGFR rechallenge as a promising therapeutic approach for a subset of patients afflicted with mCRC. The observed correlation between wild-type RAS status, as determined through ctDNA analysis, and improved OS signals the prospect of precision oncology in guiding treatment decisions.

2025-12-01·Journal of Gastrointestinal Cancer

Efficacy and Safety of Anti-EGFR Therapy Rechallenge in Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis

Review

作者: Burbano, Rommel Mario Rodríguez ; de Oliveira Rodrigues, Anna Luíza Soares ; de Moraes, Francisco Cezar Aquino ; Limachi-Choque, Jhonny ; Priantti, Jonathan N

BACKGROUND:

Colorectal cancer (CRC) represents the second leading cause of cancer-related mortality worldwide, with a significant portion of patients presenting with metastatic disease at diagnosis. Resistance to initial anti-EGFR therapy, a key treatment for RAS wild-type metastatic CRC, remains a major challenge. This study aimed to assess the efficacy and safety of rechallenge with anti-EGFR therapy in patients with metastatic CRC who have progressed after prior treatments.

METHODS:

A systematic search was conducted across PubMed, Web of Science, Cochrane, and Scopus. Studies were included if they were randomized controlled trials (RCTs) or observational studies involving patients with EGFR-mutated metastatic CRC who received anti-EGFR therapy as a rechallenge. Endpoints included objective response rate (ORR), disease control rate (DCR), and the incidence of adverse events. Statistical analyses were performed using the DerSimonian/Laird random effect model, with heterogeneity assessed via I² statistics. R, version 4.2.3, was used for statistical analyses.

RESULTS:

Fourteen studies were included with 520 patients; 50.3% were male, and the median age was 63 years old. The median progression-free survival (mPFS) ranged between 2.4 and 4.9 months, while the median overall survival (mOS) ranged from 5 to 17.8 months. Our pooled analysis demonstrated an objective response rate (ORR) of 17.70% (95% CI, 8.58-26.82%) and a disease control rate (DCR) of 61.72% (95% CI, 53.32-70.11%), both with significant heterogeneity (I², 84% and 80%, respectively; p < 0.01). In the subgroup analysis, cetuximab showed an ORR of 18.31% (95% CI, 4.67-31.94%), and panitumumab an ORR of 10.9% (95% CI, 0.00-26.82%), while the combination of both resulted in an ORR of 29.24% (95% CI, 0.00-65.84%). For DCR, cetuximab resulted in 62.1% (95% CI, 49.32-74.87%), panitumumab in 63.05% (95% CI, 52.13-73.97%), and the combination in 60.34% (95% CI, 31.92-88.77%), all with significant heterogeneity. Adverse events included anemia (15.39%), diarrhea (4.20%), hypomagnesemia (6.40%), neutropenia (22.57%), and skin rash (13.22%).

CONCLUSIONS:

Rechallenge with anti-EGFR therapy in metastatic CRC patients shows moderate efficacy with manageable safety profiles. These findings highlight the need for careful patient selection and monitoring to optimize outcomes. Further studies are warranted to refine strategies for maximizing the therapeutic benefits of anti-EGFR rechallenge.

2025-12-01·Journal of Gastrointestinal Cancer

Final Results of ERBIMOX: A Randomized Phase II Study of Modified FOLFOX7 With or Without Cetuximab as First-Line Treatment for KRAS Wild-type Metastatic Colorectal Cancer

Article

作者: Zirrgiebel, Ute ; Depenbusch, Reinhard ; Müller, Lothar ; Lerchenmüller, Christian ; Boller, Emil ; Niemeier, Beate ; Marschner, Norbert ; Sahm, Stephan ; Potthoff, Karin ; Tesch, Hans

BACKGROUND:

The combination of FOLFOX/FOLFIRI with an EGFR-antibody (cetuximab/panitumumab) is a first-line standard for RAS wild-type metastatic colorectal cancer (mCRC). The OPTIMOX stop-and-go regimen, which reduces oxaliplatin-induced neuropathy, and fluorouracil/folinic acid (FU/FA) were standard maintenance-therapies in the pre-antibody era. Whether an EGFR-antibody adds value to the OPTIMOX strategy in the RAS wild-type setting remains unknown.

METHODS:

In the open-label, randomized, multicenter phase II ERBIMOX trial, patients with KRAS wild-type mCRC received either first-line induction-therapy with 8 cycles of mFOLFOX7 followed by maintenance-therapy with FU/FA (OPTIMOX arm) or mFOLFOX7 + cetuximab followed by FU/FA + cetuximab (ERBIMOX arm). Primary objective was to demonstrate superiority of additional cetuximab to mFOLFOX7 during induction/maintenance-therapy. Primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The trial is registered at EudraCT (No.2006-002744-28).

RESULTS:

From 2006-2011, 138 patients with KRAS wild-type mCRC from 23 German sites were randomly assigned to either OPTIMOX (N = 63) or ERBIMOX (N = 75). ORR numerically favored the ERBIMOX arm (64.0% vs. 54.0%, P = 0.3071). Median PFS (ERBIMOX vs. OPTIMOX) was 9.6 vs. 8.8 months (P = 0.7612), median OS 25.6 vs. 30.9 months (P = 0.5821). Most common grade 3/4 adverse events (AEs) were skin reactions (21.9% vs. 2.1%) and gastrointestinal disorders (13.5% vs. 9.5%). No cetuximab-related deaths occurred.

CONCLUSION:

In treatment-naïve KRAS wild-type mCRC, adding cetuximab to mFOLFOX7 resulted in numerically higher ORR than mFOLFOX alone, but no statistically significant differences in ORR, PFS or OS; probably because of the premature stop due to poor recruitment. The safety profile was as expected, with few discontinuations.

1,074

项与西妥昔单抗相关的新闻（医药）

2025-06-30

·Biotech前瞻

2025CSCO结直肠癌指南丨国产KRAS抑制剂、EGFR单抗获得推荐

点击蓝字关注我们本期看点2025 CSCO指南会于 4月18日至19日在山东济南正式举办，国内肿瘤领域的知名专家将齐聚一堂，以讲座和报告的形式对指南内容进行全方位解读。作为国内高发的结直肠癌，自然是行业关注的重点。纵览更新要点，更加凸显出国产创新产品重新定义结直肠癌治疗格局的趋势，本文就这些更新要点进行梳理，以飨读者！本期内容01西妥昔单抗β注射液02KRAS G12C抑制剂03CSCO结直肠癌图谱04总结与展望【西妥昔单抗β注射液】更新要点：MSS/MSI-L/pMMR，RAS/BRAF野生型患者Ⅰ级推荐(左半)、Ⅱ级推荐(右半)增加西妥昔单抗β+FOLFIRI。2024年6月25日，先声药业集团旗下先声再明宣布，与迈博药业合作开发的恩立妥®（西妥昔单抗β注射液）获批中国市场。这是一款新一代EGFR抗体药物，适应症为一线治疗RAS/BRAF野生型转移性结直肠癌。该药物获批打破了中国结直肠癌EGFR靶向抗体药物市场长期依赖进口的局面。EGFR在多种肿瘤中高表达，是治疗重要靶点，尤其在RAS野生型患者中，使用EGFR抗体可显著延长生存期。此前中国市场仅有进口西妥昔单抗。恩立妥作为改良型生物新药，采用自主知识产权工艺，糖基化修饰更接近人类，有望降低过敏风险。其获批基于两项3期临床试验，数据显示显著延长患者无进展生存期和总生存期，提升客观缓解率。先声再明将负责产品商业化，其董事长表示，该药与公司已上市创新药有协同效应。目前，国内结直肠癌患者中，RAS/BRAF野生型占比约45%，但实际接受基因检测的患者不足半数，未来基因检测普及有望扩大市场空间。02 KRAS G12C抑制剂 KRAS G12C突变型晚期肠癌注释中增加国产KRAS G12C抑制剂研究进展。目前，全球已有5款KRAS G12C抑制剂获批上市。整理如下：信达生物/劲方医药丨氟泽雷塞片2024 年 8 月 21 日，NMPA附条件批准信达生物/劲方医药合作开发的KRAS G12C抑制剂氟泽雷塞片（GFH925/IBI351）上市，治疗至少接受过一种系统性治疗的KRAS G12C突变型的NSCLC成人患者。由此，氟泽雷塞片成为国内首款获批上市的KRAS G12C 抑制剂。艾力斯戈来雷塞（JAB-21822），已于2024年5月13日获得CDE优先审评，适用于既往接受过至少一线系统性治疗的KRAS G12C突变的局部晚期或转移性NSCLC成人患者的治疗。正大天晴/益方生物2024年11月8日，正大天晴/益方生物开发的格索雷塞（英文通用名：Garsorasib）已正式获得NMPA的上市批准，用于治疗至少接受过一种系统性治疗的KRAS G12C突变型的晚期NSCLC成人患者。安进丨Sotorasib 丨索托拉西布 2021年5月28日，FDA加速批准安进公司研发的索托拉西布（Sotorasib，商品名：Lumakras，药品编码：AMG-510）上市，用于治疗携带KRAS G12C突变的非小细胞肺癌患者，这些患者至少接受过一种全身性治疗。2021年1月12日，Sotorasib被NMPA入“拟突破性治疗药物品种”，国内合作企业为百济神州。施贵宝丨adagrasib丨阿达格拉西布2022年12月13日，美国FDA宣布加速批准Mirati公司（现已被施贵宝收购）KRAS G12C抑制剂Krazati（adagrasib）上市，这是FDA批准的第二款直接抑制KRAS突变体活性的靶向疗法。再鼎医药获得了adagrasib在大中华区的研究、开发、生产及独家商业权利。03 CSCO结直肠癌图谱04 总结与展望本次更新可以看出，国产创新药物逐步获得更多认可，也期望后续有更多创新产品重塑结直肠癌的治疗格局。 ★

CSCO会议上市批准优先审批临床3期申请上市

2025-06-26

·今日头条

中国NK疗法获FDA全球首个孤儿药认证！剑指肝癌、肺癌、乳腺癌等

据“先康达生命”官微消息，2025年5月15日，我国自主研发的PBMC来源同种异体NK细胞疗法——PANK疗法，获美国食品药品监督管理局（FDA）孤儿药资格认定，用于肝细胞癌（HCC）治疗。这是全球首个获FDA HCC适应症孤儿药认定的NK细胞疗法。 PANK疗法采用专有的细胞因子培养技术，从18~30岁健康成年人外周血中提取。与脐带血来源的NK细胞相比，其高表达CD16和NKG2D，抗肿瘤细胞杀伤活性更强；供体与受体间抑制性KIR（杀伤免疫球蛋白样受体）与HLA（人类白细胞抗原）的错配，进一步提升了杀伤效率。该疗法凭借“即用型”设计、强效肿瘤杀伤能力及高安全性等优势，为肝癌患者提供了创新治疗选择，更让世界看到中国创新疗法为全球癌症患者带来的希望。冲锋在抗癌前线的NK细胞，24小时不间断巡逻，扼制肿瘤萌芽自然杀伤（NK）细胞作为淋巴细胞的重要亚型，是人体免疫系统中无需预先致敏，即可非特异性杀伤肿瘤细胞和病毒感染细胞的 "先天防御尖兵"。其凭借快速响应的天然细胞毒性，在机体免疫监视中构筑起抵御癌症的第一道防线。NK细胞的抗肿瘤核心机制如下： 1、天然细胞毒性与快速响应：NK细胞是癌症的第一线防御者，无需预先致敏即可凭借天然细胞毒性发挥作用，通过介导抗体依赖的细胞毒性（ADCC）效应，成为抵御肿瘤的第一道屏障。其表面生殖系编码的受体可识别激活与抑制信号，当激活信号占优时，会启动直接杀伤靶细胞或重塑肿瘤微环境（如分泌细胞因子、介导细胞间作用）的双重途径。 2、多样化武器库：NK细胞拥有多样化抗癌“毒性武器库”，例如细胞毒分子、细胞因子或死亡配体等，可用于摧毁癌细胞。 ▼NK细胞细胞毒性武器库 ▲图源“Cell Death & Disease”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 3、连续杀伤力：区别于其他免疫细胞，NK 细胞具备 "连环杀手" 特性 —— 完成一个靶细胞破坏后，可迅速搜寻并攻击另一个靶细胞，这种“连续杀伤” 特性使其在抗肿瘤过程中保持持久战斗力。同种异体NK细胞让肝癌术后防复发有了“新武器”，三年无复发生存率达60%！肝切除术（LR）是单发性肝细胞癌（HCC）的根治性治疗手段，但术后的复发/转移难题也不容小觑。一项针对乙肝病毒相关孤立性HCC患者的MG4101研究（NCT02008929）证实，肝切除术后应用体外扩增同种异体自然杀伤（NK）细胞辅助治疗具有潜在临床价值。本次研究共入组5例接受肝切除术的乙肝相关肝细胞癌（HCC）患者，中位年龄为44.8岁（范围：36-54岁），肿瘤中位直径为2.2cm（2.1-8.2cm）。所有患者均接受了5个周期（术后4、6、8、12和16周）的体外扩增同种异体NK细胞治疗，中位随访期为43个月（范围，7-49个月）。结果显示：NK细胞输注后 3年无复发生存率（RFS）为60% ，总生存率（OS）为80% （详见下图）。肝切除术后1年存活的4例患者，至3年时仍全部存活。值得一提的是，其中一例患者（病例1）在根治性肝切除术后7个月，虽出现肝内复发。但经经射频消融（RFA）治疗后，连续42个月未再复发。 ▼接受NK治疗患者的RFS和OS ▲图源“AHPS”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 MD安德森重磅：AFM13-NK同种异体NK疗法缓解率达92.9% 据《自然医学》发表的I期临床试验（NCT04074746）数据显示，德克萨斯大学MD安德森癌症中心开发的AFM13-NK细胞疗法在治疗耐药性CD30+淋巴瘤中展现突破性成效。该疗法将脐带血来源的细胞因子预激活NK细胞与CD30/CD16A双特异性抗体AFM13复合，为对BrentuximabVedotin（BV）和PD-1抑制剂均耐药的患者带来新希望。 ▲截图源自“Nature medicine” 该研究共纳入42例患者，包括37例CD30阳性霍奇金淋巴瘤、5例T细胞淋巴瘤患者，既往接受过中位数为7种疗法，均对BV和PD-1抑制剂产生耐药。入组后先接受化疗，随后接受三种剂量水平的AFM13-NK细胞复合物输注。结果显示：全部入组患者的总缓解率（ORR）达92.9%，完全缓解率（CR）66.7% 。其中，霍奇金淋巴瘤患者ORR为97.3%、CR为73%，显著优于传统疗法。中位随访20个月时， 2年无事件生存率（EFS）为26.2%，总生存率（OS）为76.2% （详见下图）。 11例患者（5例未联合干细胞移植）维持CR达14-40个月，其中 5例无需后续治疗即可持续缓解。 ▲图源“Nature medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除综上，该疗法以“双特异性抗体桥接NK细胞”的创新模式，在难治性淋巴瘤中实现快速且持久的应答，不仅为霍奇金淋巴瘤提供新治疗范式，更验证了NK细胞与双特异性衔接剂联合应用的临床潜力。目前研究团队正持续评估该疗法对其他难治性恶性肿瘤的疗效，有望推动NK细胞免疫治疗在血液肿瘤及实体瘤领域的广泛应用，为攻克耐药性癌症开辟新路径。 NK细胞治疗2个月，复发性乳腺癌肿瘤体积缩小超10% 暨南大学研究团队开展的NK细胞治疗复发性乳腺癌临床研究（NCT02853903）中，共纳入36例病理确诊的复发性乳腺癌患者，其中一位46岁患者的显著疗效引发关注。该患者治疗前后的影像学变化尤为典型：治疗前 CT扫描显示，其右乳存在8.0×3.8×5.7cm的软组织肿块，边界模糊，增强CT呈中度不均匀强化；腋窝可见多处肿大淋巴结，最大者约2.9×1.7×3.8cm （详见下图A）。经NK细胞治疗2个月后，影像学复查显示肿块缩小至6.8×3.5×5.8cm ，强化程度减弱为轻度不均匀；腋窝肿大淋巴结亦显著缩小（详见下图B），展现出NK细胞疗法在复发性乳腺癌中的潜在抗肿瘤活性。 ▲图源“Dovepress”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除晚期肺癌不再绝望：NK细胞与西妥昔单抗“双剑合璧”，病灶显著缩小60% 《美国癌症研究杂志》发表的一项临床研究（NCT02845856）显示，自然杀伤细胞（NK 细胞）联合西妥昔单抗治疗晚期非小细胞肺癌（NSCLC）展现出潜在疗效，两例 IVA 期患者的肿瘤退缩情况尤为显著。其中一例是一位53岁的男性，确诊为IVA期非小细胞肺癌，治疗前，CT扫描显示右肺存在一3.5×3.5 cm的肿瘤（红色箭头标注）。 NK细胞联合治疗后，肿瘤显著缩小至1.7×1.3 cm，体积缩减超60% （详见下图）。 ▲图源“Am J Cancer Res”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除另一例是一位67岁患者，确诊为IVA期非小细胞肺癌，治疗前，CT扫描显示，右肺肿瘤大小为3.9×3.5 cm （红色箭头标注）。 NK细胞联合治疗后，肿瘤显著缩小至2.6×2.5 cm，影像学可见明显退缩（详见下图）。 ▲图源“Am J Cancer Res”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除综上，该研究通过影像学证据直观证实，NK 细胞疗法与西妥昔单抗的联合应用可诱导晚期 NSCLC 肿瘤快速退缩，为 IVA 期患者提供了免疫联合靶向治疗的新参考方向。尽管样本量有限，但其初步疗效为开展更大规模临床试验奠定了基础。小编寄语 NK细胞可在第一时间发现并启动人体的免疫防御机制，及时发现并将癌细胞扼杀在“摇篮”里，是公认的抗癌第一道防线。多项临床研究也表明，NK 细胞疗法具有很高的安全性和有效性，可以实现强效、通用和现成的免疫细胞疗法的前景，克服 CAR-T 疗法的部分缺点，是抗癌疗法中冉冉升起的新星！全球肿瘤医生网小编也希望通过这篇文章能让更多病友，了解到NK细胞疗法的前沿进展及其在实体瘤和血液肿瘤中的应用，为广大癌友带来新的希望与选择！参考资料 [1]Coënon L,et al.Natural Killer cells at the frontline in the fight against cancer[J]. Cell Death & Disease, 2024, 15(8): 614. https://www.nature.com/articles/s41419-024-06976-0 [2]Kim JM,et al.Adjuvant therapy using ex vivo-expanded allogenic natural killer cells in hepatectomy patients with hepatitis B virus related solitary hepatocellular carcinoma: MG4101 study. Ann Hepatobiliary Pancreat Surg. 2021 May 31;25(2):206-214. https://pmc.ncbi.nlm.nih.gov/articles/PMC8180393/ [3]Nieto Y,et al.Allogeneic NK cells with a bispecific innate cell engager in refractory relapsed lymphoma: a phase 1 trial[J]. Nature medicine, 2025: 1-7. https://www.nature.com/articles/s41591-025-03640-8 [4]Liang S,et al.Comparison of autogeneic and allogeneic natural killer cells immunotherapy on the clinical outcome of recurrent breast cancer. Onco Targets Ther. 2017 Aug 28;10:4273-4281. https://www.dovepress.com/comparison-of-autogeneic-and-allogeneic-natural-killer-cells-immunothe-peer-reviewed-fulltext-article-OTT [5]Liang S,et al.Cetuximab combined with natural killer cells therapy: an alternative to chemoradiotherapy for patients with advanced non-small cell lung cancer (NSCLC). Am J Cancer Res. 2018 May 1;8(5):879-891. https://pmc.ncbi.nlm.nih.gov/articles/PMC5992505/ 本文为全球肿瘤医生网原创，未经授权严禁转载

孤儿药细胞疗法临床研究抗体药物偶联物

2025-06-25

·PipelineReview

Verastem Oncology Announces First Patient Dosed with VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in a U.S. Phase 1/2a Trial in KRAS G12D Advanced Solid Tumors

Phase 1 dose-escalation study to evaluate VS-7375 in the U.S., with plans to expand as monotherapy into pancreatic cancer and non-small cell lung cancer cohorts, along with colorectal cancer in combination with cetuximab BOSTON, MA, USA I June 24, 2025 I Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the first patient has been dosed in VS-7375-101, the U.S. Phase 1/2a clinical trial evaluating VS-7375, a potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, in patients with advanced KRAS G12D mutant solid tumors. “We continue to make strong progress against our strategic priorities and key milestones that we set at the beginning of the year, including our recent FDA approval and commercial launch and our positive updated results and trial expansion in first-line metastatic pancreatic cancer. We are now excited to have achieved another milestone with the initiation of our first clinical trial and first patient dosed with VS-7375, a potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, in the U.S.,” said Dan Paterson, president and chief executive officer of Verastem Oncology. VS-7375-101 is a Phase 1/2a study being conducted in the U.S., with plans to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The monotherapy dose escalation phase of the study will use a starting dose of 400 mg, based on an efficacious dose identified in the Phase 1/2 study conducted in China by the Company’s partner, GenFleet Therapeutics. GenFleet announced encouraging initial safety and efficacy results from its Phase 1 dose-escalation phase of its study of VS-7375 (known as GFH375 in China) at the 2025 ASCO Annual Meeting. Verastem plans to dose-escalate across dose levels where encouraging initial safety and efficacy were observed in patients with advanced KRAS G12D mutant solid tumor cancers in GenFleet’s study. Upon successful completion of the dose-escalation phase, the Company will select a recommended Phase 2 dose and assess the efficacy and safety of monotherapy VS-7375 in expansion cohorts of patients with advanced pancreatic cancer and non-small cell lung cancer. In parallel with the monotherapy dose escalation, Verastem will evaluate VS-7375 in combination with cetuximab in advanced solid tumors. Subject to the results of the Phase 1 dose escalation combination of VS-7375 and cetuximab, Verastem plans to initiate a combination expansion cohort in colorectal cancer. “We are excited that the first patient has initiated treatment with VS-7375 in the U.S. We believe we can leverage VS-7375’s dual inhibition of both the ON/OFF states to improve on the efficacy seen to date with other KRAS G12D-selective agents. With the trial underway, we aim to accelerate the program’s development given the lack of FDA-approved, KRAS G12D-targeted treatments available to patients with KRAS G12D cancers,” said John Hayslip, M.D., chief medical officer of Verastem Oncology. “We are strongly encouraged by the anti-tumor activity seen in the updated Phase 1 data presented at the ASCO Annual Meeting from our partner GenFleet Therapeutics’ trial in China. We are advancing VS-7375 in the U.S. to target KRAS G12D mutant advanced solid tumors in areas of significant unmet need, such as pancreatic, colorectal, and lung cancers.” About KRAS G12D KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer. About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery, development, and commercialization collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared, and it initiated a Phase 1/2a clinical trial (NCT07020221), VS-7375-101, in May 2025. GenFleet’s IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and initial safety and efficacy results from the Phase 1 portion of the study were announced at ASCO 2025. In February 2025, GenFleet announced that the first patient was dosed in the Phase 2 portion of the study. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to developing and commercializing new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI™ FAKZYNJA™ CO-PACK in the U.S. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn . SOURCE: Verastem Oncology

临床1期临床申请ASCO会议临床2期

100 项与西妥昔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
D03455	西妥昔单抗	L01XC06	DB00002

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
RAS 野生型结直肠癌	澳大利亚	Merck Healthcare Pty Ltd.	2007-09-25
头颈部肿瘤	美国	Eli Lilly & Co.	2006-03-01
转移性结直肠癌	欧盟	Merck Europe BV	2004-06-29
转移性结直肠癌	冰岛	Merck Europe BV	2004-06-29
转移性结直肠癌	列支敦士登	Merck Europe BV	2004-06-29
转移性结直肠癌	挪威	Merck Europe BV	2004-06-29
头颈部鳞状细胞癌	欧盟	Merck Europe BV	2004-06-29
头颈部鳞状细胞癌	冰岛	Merck Europe BV	2004-06-29
头颈部鳞状细胞癌	列支敦士登	Merck Europe BV	2004-06-29
头颈部鳞状细胞癌	挪威	Merck Europe BV	2004-06-29
结直肠癌	瑞士	Merck & Co., Inc.	2003-12-01

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
结肠癌	临床3期	-	Merck Sharp & Dohme LLC	2025-07-17
KRAS G12C突变结直肠癌	临床3期	美国	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	中国	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	阿根廷	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	澳大利亚	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	奥地利	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	比利时	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	巴西	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	加拿大	Mirati Therapeutics, Inc.	2021-06-24
KRAS G12C突变结直肠癌	临床3期	哥伦比亚	Mirati Therapeutics, Inc.	2021-06-24

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


NCT04554836 (CTgov)	临床2期	直肠腺癌 \| RAS 突变结直肠癌 \| 结肠癌	6	Cetuximab+Leucovorin Calcium+Irinotecan Hydrochloride+Fluorouracil (FOLFIRI + Cetuximab)	願醖蓋蓋繭膚鹽餘鏇壓 = 襯衊築襯繭築衊糧廠範襯網鬱餘憲淵繭憲積壓 (觸醖獵憲憲鹽餘艱鏇積, 壓製廠齋壓製獵窪襯齋 ~ 夢膚餘膚壓壓鑰鹽築鬱) 更多	-	2025-06-08
				Leucovorin Calcium+Irinotecan Hydrochloride+Fluorouracil (FOLFIRI)	願醖蓋蓋繭膚鹽餘鏇壓 = 艱鑰選廠壓鏇繭齋遞鏇襯網鬱餘憲淵繭憲積壓 (觸醖獵憲憲鹽餘艱鏇積, 鬱鹽襯鏇範衊蓋獵製窪 ~ 淵構憲餘鑰蓋積鏇蓋衊) 更多
NCT04607421 (BREAKWATER, ASCO2025) 人工标引	临床3期	BRAF V600E突变结直肠癌一线 BRAF V600E	637	encorafenib + cetuximab	蓋蓋顧選鹹築醖簾選觸(觸構壓餘膚窪築夢鑰窪) = 顧壓夢遞淵夢繭鏇壓繭遞醖窪窪醖網繭衊蓋選 (壓製蓋鹹製鹽積範淵構, 5.7 ~ 8.3) 更多	积极	2025-05-30
				encorafenib + cetuximab + mFOLFOX6	蓋蓋顧選鹹築醖簾選觸(觸構壓餘膚窪築夢鑰窪) = 齋艱築製簾製膚鬱襯壓遞醖窪窪醖網繭衊蓋選 (壓製蓋鹹製鹽積範淵構, 11.2 ~ 15.9) 更多
CL01002062 (ASCO2025)	临床1期	EGFR	118	RPH-002	窪糧壓糧夢壓積鹹顧願(膚鏇顧顧鏇鑰範蓋範鬱) = 醖網艱蓋窪鬱獵獵構醖夢淵製選鹹築鹽鬱鑰構 (遞鏇積獵窪顧襯觸淵衊, 54.10 ~ 78.19) 更多	积极	2025-05-30
				Erbitux	窪糧壓糧夢壓積鹹顧願(膚鏇顧顧鏇鑰範蓋範鬱) = 積餘範淵鏇餘獵餘襯構夢淵製選鹹築鹽鬱鑰構 (遞鏇積獵窪顧襯觸淵衊, 66.09 ~ 86.27) 更多
ChiCTR2200062002 (ASCO2025)	临床2期	局部晚期直肠癌新辅助 pMMR \| RAS/BRAF wild-type	25	Standard chemoradiotherapy	淵簾窪網齋糧艱艱壓選(醖糧顧鹽淵獵廠淵繭積) = 餘襯壓憲膚選襯繭範膚築鏇顧窪願廠膚築鬱窪 (膚顧選淵積醖鬱遞鏇鹽 )	积极	2025-05-30
NCT00716391 (TTCC-2007-01, ASCO2025)	临床3期	局部晚期不可切除癌 TP53 \| HPV+	-	cetuximab (RT/CDDP arm)	窪蓋餘積鹹鹽繭窪廠鏇(選構遞願遞膚艱餘積壓) = 選壓壓窪衊膚衊鬱構餘鹽衊範範窪糧醖鑰簾範 (壓夢醖衊膚艱鹹餘願願, 25.6 ~ 105.4) 更多	积极	2025-05-30
				cetuximab (RT/CET arm)	窪蓋餘積鹹鹽繭窪廠鏇(選構遞願遞膚艱餘積壓) = 鹹獵遞鏇壓衊窪鑰夢淵鹽衊範範窪糧醖鑰簾範 (壓夢醖衊膚艱鹹餘願願, 14.3 ~ 59.2) 更多
NCT02979977 (Phase 2 trial of dual EGFR inhibition with cetuximab and afatinib, ASCO2025)	临床2期	复发性头颈部鳞状细胞癌 p16 positive \| p16 negative	-	Cetuximab and Afatinib Combination	襯鏇淵築願艱夢顧範醖(獵鹹選鏇觸繭鏇築憲網) = 築遞衊選齋鹹齋餘鹽顧鏇糧積簾衊艱壓憲鹽選 (繭範獵簾選糧襯艱壓網, 12.3% ~ 38) 更多	积极	2025-05-30
NCT04607421 (BREAKWATER, Pubmed \| N Engl J Med)	临床3期	BRAF V600E突变结直肠癌 \| 转移性结直肠癌一线	-	Encorafenib plus Cetuximab (EC)	遞鏇窪齋遞顧鏇糧範餘(繭鑰遞衊醖獵膚顧構獵) = The incidence of serious adverse events during treatment was 46.1% with EC+mFOLFOX6 and 38.9% with standard care 積簾鏇選憲齋觸糧夢餘 (糧餘蓋繭觸夢網壓鑰觸 ) 更多	积极	2025-05-30
				Standard care (chemotherapy with or without bevacizumab)
NCT04853043 (APK Mutant, CTgov)	临床2期	转移性结直肠癌	7	Cetuximab	蓋構廠糧齋窪網築淵顧(膚艱製壓選簾繭遞遞襯) = 願獵餘憲選範蓋範憲構淵膚淵繭觸鑰遞製艱廠 (選網範鑰夢襯醖齋餘蓋, 窪獵糧壓窪廠構網鹽夢 ~ 襯構艱膚鹽衊襯醖構鏇) 更多	-	2025-05-06
NCT00956007 (Postoperative Radiotherapy ± Cetuximab, Pubmed \| J Clin Oncol)	临床3期	头颈部鳞状细胞癌 high epidermal growth factor receptor expression \| human papillomavirus (HPV)-negative	702	Intensity-modulated RT + Cetuximab	廠窪築糧餘繭淵鹽餘獵(憲簾淵繭鏇廠衊憲淵淵) = 壓鹹蓋鏇鏇遞網獵鹹繭簾鹽憲壓憲齋窪獵觸廠 (鏇憲製簾製觸繭構襯鑰 ) 更多	积极	2025-04-20
				Intensity-modulated RT alone	廠窪築糧餘繭淵鹽餘獵(憲簾淵繭鏇廠衊憲淵淵) = 鏇顧襯窪鏇製襯獵觸網簾鹽憲壓憲齋窪獵觸廠 (鏇憲製簾製觸繭構襯鑰 ) 更多
NCT05756153 (KROCUS, Company_Website) 人工标引	临床2期	KRAS G12C突变非小细胞肺癌一线 KRAS G12C	47	Fulzerasib 600mg BID + Cetuximab 500 mg/m2 Q2W	網蓋鏇醖繭顧壓獵積獵(膚鏇壓鬱糧顧淵範範築) = 遞範鹽鏇蓋遞鹽願艱鹽淵膚鹽鬱築獵衊糧窪襯 (觸衊糧糧廠夢鹹衊艱糧 ) 更多	积极	2025-03-28