A Phase 1a/1b, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers

The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.
*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.

开始日期2021-10-15

申办/合作机构

Institut de Recherches Intern Servier

[+1]

NCT04195373

/ Withdrawn临床1期

A Phase I Open-label, Safety Study of Intra-tumoral Application of TMV-018 in Combination With 5-FC or Anti-PD-1 Therapy in Patients With Tumors of the Gastrointestinal Tract

This study aims to determine the safety and tolerability of TMV-018 when given alone or in combination with the prodrug 5-Fluorocytosine (5-FC) or an anti-PD-1 checkpoint inhibitor in patients with gastrointestinal tumors. Furthermore, the maximum tolerated dose (MTD) and recommended Phase II dose of TMV-018 shall be determined.

开始日期2020-11-23

申办/合作机构

Themis Bioscience GmbH

[+2]

NCT04672434

/ Completed临床1期

A Phase 1, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of Sym024 (Anti-CD73) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies

The primary purpose of this study is to see if Sym024 is safe and tolerable as monotherapy and in combination with Sym021 in patients with solid tumor malignancies.

开始日期2020-11-19

申办/合作机构

Servier Symphogen A/S

100 项与 Sym-021 相关的临床结果

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100 项与 Sym-021 相关的转化医学

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100 项与 Sym-021 相关的专利（医药）

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项与 Sym-021 相关的文献（医药）

2026-05-01·Journal for ImmunoTherapy of Cancer

Phase 1 multicenter study of the NKG2A targeting antibody S095029 as a single agent and in combination with anti-PD-1 in patients with advanced malignancies

Article

作者: Ianopoulos, Xenophon ; Hemon, Agnes ; Naing, Aung ; Patnaik, Amita ; Drean, Pauline ; Spreafico, Anna ; Skartved, Niels Jorgen ; He, Peng ; Barve, Minal ; Askoxylakis, Vasileios ; Lakhani, Nehal ; Kantari-Mimoun, Chahrazade

Background:

NKG2A is a C-type lectin that heterodimerizes with CD94 creating an inhibitory immunoreceptor. S095029 is a fully human monoclonal IgG1 anti-NKG2A antibody with attenuated Fc-effector functions that specifically binds the NKG2A/CD94 heterodimer, blocking the interaction with its ligand HLA-E. Sym021 is an anti-programmed cell death protein 1 (PD-1) IgG1 antibody. Preclinical data demonstrated that S095029 combined with Sym021 increases antitumor activity.

Methods:

This first-in-human, open-label, multicenter study ( NCT05162755 ) evaluated safety, tolerability, preliminary efficacy, pharmacokinetics and pharmacodynamics (PD) of S095029 as monotherapy or in combination with Sym021 in patients with advanced solid tumors. Monotherapy regimen included two doses of S095029 every 2 weeks (Q2W) followed by single-agent Sym021 (Q2W). Adverse events were defined per Common Terminology Criteria for Adverse Events V.5.0. Antitumor activity was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) V.1.1. Cytokine secretion as PD markers and target engagement/receptor occupancy were assessed in peripheral blood. Selected immune markers were assessed by multiplex immunofluorescence on tumor biopsies.

Results:

As of July 25, 2025, 21 patients with heavily pretreated solid tumors were treated with S095029 as a single agent (10, 30, 100, 300, 750 and 1,500 mg) and 20 patients were treated with S095029 (30, 100, 300, 750 and 1,500 mg) in combination with Sym021 (200 mg). S095029 was well tolerated without dose-limiting toxicities for both monotherapy and combination with anti-PD-1. A maximum tolerated dose was not reached. Two patients (9.5%; uterine sarcoma, porocarcinoma) who received one cycle of S095029 monotherapy followed by Sym021 and two patients (10%; leiomyosarcoma, squamous cell carcinoma of unknown primary) who received S095029 in combination with Sym021 showed confirmed partial responses. None of these patients had received prior anti-PD-1 treatment. The clinical benefit rate (complete response+partial response+stable disease ≥6 months) by RECIST V.1.1 in all enrolled patients was 19.5%. S095029 serum concentrations increased with dose for both monotherapy and combination with Sym021. Full receptor occupancy was achieved starting at 30 mg Q2W. Increases in levels of monokine induced by gamma interferon, macrophage inflammatory protein 1-beta and tumor necrosis factor-α in peripheral blood were detected following treatment with S095029+Sym021 suggesting immune cell activation on treatment.

Conclusions:

The anti-NKG2A antibody S095029 in combination with anti-PD-1 Sym021 demonstrated a favorable safety profile and exhibited signal of antitumor activity in unselected, heavily pretreated patients with advanced malignancies.

Trial registration number:

NCT05162755 .

2026-03-01·Journal for ImmunoTherapy of Cancer

Phase Ib multicenter study of anti-TIM-3 (S095018/Sym023) in combination with anti-PD-1 (Sym021) in patients with advanced/metastatic recurrent biliary tract cancer

Article

作者: Skartved, Niels ; Lakhani, Nehal ; Geronimi, Julia ; Darcel, Pauline ; Rodrigues, Christelle ; Rodon Ahnert, Jordi ; Harouki, Najah ; Kim, Richard ; Askoxylakis, Vasileios ; Raimbourg, Judith ; Hald, Rikke ; Ianopoulos, Xenophon ; Kaplon, Hélène ; Marron, Thomas ; Moreno, Irene ; Liao, Chih-Yi ; Macarulla, Teresa ; He, Peng ; Davis, Sarah Lindsey ; Jakobsen, Janus Schou ; Ghiringhelli, Francois ; Abdul Razak, Albiruni ; Mahipal, Amit ; Lopez-Ravnborg, Daleen

Background:

T-cell immunoglobulin and mucin-domain containing 3 (TIM-3) is an inhibitory receptor linked to decreased antitumor activity of immune cells. S095018 is a human anti-TIM-3 IgG2 antibody that blocks the binding of phosphatidyl serine to TIM-3. Sym021 is a humanized IgG1 antibody that inhibits the binding of programmed cell death protein-1 (PD-1) to its ligands programmed death-ligand 1 (PD-L1) and PD-L2.

Methods:

S095018 in combination with Sym021 was tested in patients with advanced/metastatic biliary tract cancers (BTC) whose disease progressed under treatment with at least 1 line of systemic therapy and who had not received prior treatment with PD-(L)1 inhibitors ( NCT04641871 ). Patients received 3 mg/kg of Sym021 and 10 mg/kg of S095018 once every 2 weeks. Primary endpoints included overall response rate and incidence/severity of adverse events. Key secondary endpoints included pharmacokinetics, immunogenicity assessment, progression-free survival (PFS) and overall survival (OS).

Results:

35 patients with stage IV BTC received S095018 in combination with Sym021. A partial response was achieved in 2 patients (5.7%) and stable disease in 11 patients (31.4%) for a disease control rate of 37%; 4 patients were not evaluable for response. Median PFS and OS were 1.9 months (90% CI 1.8 to 3.7) and 13.4 months (90% CI 8.2 to 27.1), respectively. The most common treatment-emergent adverse events of any grade included fatigue, pruritus, infusion-related reaction, and increases in amylase (8.6% each). Exploratory biomarker analyses in paired tumor biopsies showed an increase in intratumoral CD8 T-cell density and an upregulation of gene signatures related to interferon-γ signaling, antigen presentation, and T-cell activation with treatment without, however, clear association with efficacy endpoints.

Conclusions:

Dual PD-1/TIM-3 inhibition was tolerable but exhibited modest antitumor activity in patients with advanced/metastatic recurrent BTC who had not received prior anti-PD-(L)1 treatment.

2024-09-20·Nan fang yi ke da xue xue bao = Journal of Southern Medical University

[High RNF7 expression enhances PD-1 resistance of non-small cell lung cancer cells by promoting CXCL1 expression and myeloid-derived suppressor cell recruitment via activating NF-κB signaling].

Article

作者: Zhong, N ; Geng, B ; Sun, Z ; Zhao, W ; Wang, H

OBJECTIVE:

To investigate the mechanism of RNF7 for regulating myeloid-derived suppressor cells (MDSCs) in nonsmall cell lung cancer (NSCLC).

METHODS:

TIMER2.0 database and immunohistochemistry were used to analyze RNF7 expression level and its correlation with immune cell infiltration in non-small cell lung cancer. The impact of RNF7 expression levels on prognosis of lung cancer patients was analyzed using Kaplan-Meier survival analysis. CMT-167 cells with RNF7 overexpression or knockdown were inoculated subcutaneously in C57BL/6 mice, and the mice in RNF7 knockdown group were treated with anti-PD-1 or IgG isotype control 7 days after the inoculation. The tumor tissues were harvested after 30 days for tumor volume measurement, detection of S100A8+A9 and Gr-1 expressions with immunohistochemistry, and analysis of MDSC infiltration. Gene set enrichment analysis (GSEA) was performed to identify the potential pathways regulated by RNF7 in NSCLC. Western blotting and luciferase assays were used to assess the impact of RNF7 on the NF-κB signaling pathway. ELISA and RT-qPCR were used to measure chemokine (C-X-C motif) ligand 1 (CXCL1) expression.

RESULTS:

RNF7 expression was significantly upregulated in NSCLC, and high RNF7 expression levels were associated with poor prognosis of the patients (P < 0.001). TIMER2.0 analysis revealed a positive correlation between RNF7 expression and MDSC infiltration (P < 0.001). GSEA suggested that RNF7 was enriched in the NF-κB signaling pathway. In NSCLC cells, RNF7 knockdown significantly inhibited NF-κB activation and reduced CXCL1 expression. In the tumor-bearing mice, RNF7 overexpression significantly increased MDSC infiltration in the tumor tissue, and RNF7 knockdown obviously reduced MDSC infiltration and enhanced the efficacy of anti-PD-1 therapy.

CONCLUSION:

High expression of RNF7 in NSCLC cells promotes CXCL1 expression by activating the NF-κB signaling pathway, thus leading to the chemotactic recruitment of MDSCs, which contributes to tumor resistance to antiPD-1 therapy.

项与 Sym-021 相关的新闻（医药）

2026-06-03

·国际干细胞与免疫细胞研究

全球首例菌群三药方案出炉，难治患者病灶全消，实现病理CR！

点击蓝字关注我们结直肠癌（CRC）是全球第三大常见恶性肿瘤，仅次于乳腺癌与肺癌。免疫检查点抑制剂（ICI）在晚期或转移性结直肠癌（mCRC）治疗中展现出巨大潜力，尤其对有错配修复缺陷（dMMR）和微卫星不稳定性高（MSI-H）的患者疗效显著；但对于错配修复功能良好（pMMR）、微卫星稳定（MSS）或微卫星不稳定性低（MSI-L）的患者，ICI响应率极低。因此，为这类患者寻找新的治疗策略迫在眉睫。多项研究提示，肠道菌群调节或可改善CRC患者对ICI的耐药问题。在此基础上，我国研究人员取得突破性进展——《Cureus》期刊报道了全球首例“替雷利珠单抗+贝伐珠单抗+FMT胶囊”联合治疗IV期pMMR/MSS转移性结直肠癌的病例，该方案成功将肿瘤缩小至可根治性手术范围，最终实现病理完全缓解（pCR）！全球首例！粪菌移植联合替雷利珠单抗+贝伐珠单抗三管齐下，助晚期结直肠癌患者病灶全缩小，肿瘤标志物骤降该患者是一位57岁中国男性，确诊为升结肠错配修复充分（pMMR）晚期转移性结直肠癌（mCRC），伴继发性肝脏恶性肿瘤，近半个月来反复出现腹痛、大便性状异常等症状。基因检测显示KRAS/NRAS/BRAF均为野生型，临床分期为cT4bN2M1b Ⅳb期。患者先后接受三次治疗：首次入组Ⅱ期临床试验，采用CPGJ602+mFOLFOX6（奥沙利铂+氟尿嘧啶+亚叶酸钙）方案，疗效不佳；随后改为贝伐单抗联合FOLFOXIRI（奥沙利铂+伊立替康+亚叶酸钙）方案，完成3个周期后CT评估达部分缓解（PR），但因高强度化疗引发消化道反应、骨髓抑制等严重副作用，患者拒绝继续该方案，且病情暂不适合根治性手术，最终接受第三次治疗——口服肠道菌群胶囊联合替雷利珠单抗+贝伐单抗。治疗后疗效显著，结果显示如下： 1、肿瘤标志物大幅下降：癌胚抗原（CEA）从入院时的30.1μg/L骤降至4.3μg/L，CA19-9从62.64kU/L降至23.97kU/L。 2、病灶全面缩小并达PR：相较于第二次治疗后“结肠及淋巴结病灶缩小、肝转移灶无变化”的情况，此次所有病灶均明显缩小——CT显示结肠肿瘤从3.7cm×3.1cm缩小至2.1cm×1.7cm，腹膜后淋巴结转移灶从5.2cm×4.3cm缩小至2.3cm×1.4cm，肝脏肿瘤从3.9cm×3.2cm缩小至2.9cm×2.3cm（详见下图）。肿瘤缩小至可手术切除的程度。术后，患者获得病理完全缓解（pCR）。 ▼该患者第二次治疗后，腹部轴向CT图像 ▲图源“Cureus”，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 ▼该患者第三次治疗后，腹部轴向CT图像 ▲图源“Cureus”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除益生菌的前世今生，开启全新抗癌模式肠道中的天然菌群大部分由益生菌构成，其中乳酸菌较为常见，此外还涵盖肠球菌、迷走球菌、魏斯氏菌、明乳球菌、链球菌、四联球菌、双歧杆菌、肉杆菌、酒球菌、片球菌、乳杆菌、大肠杆菌以及酵母菌等。需要注意的是，同一物种的细菌并非都具备相同特性，且可能会对生物体产生不同影响，而且并非所有菌株都属于益生菌范畴。益生菌是一类“活的、非病原性微生物”，在适量摄入的情况下，可为宿主提供多种有益影响。早在益生菌被明确认知之前，奶酪、面包、葡萄酒、啤酒等发酵产品就因其具备营养和治疗功效而被广泛应用。早期对于益生菌的研究，主要聚焦于其作为食品或膳食补充剂时所发挥的营养作用。然而，近期的研究重点则转向了益生菌在医学和治疗领域的功能，其中在癌症领域的作用尤为突出。益生菌在癌症防治方面的作用广泛，其抗癌作用主要体现在以下三个方面： 1、多项研究显示，益生菌能够提高机体免疫功能，对改善肝癌、肺癌、肾癌、结直肠癌等多种癌种的预后具有积极意义，有望成为癌症和免疫治疗领域的热门研究方向之一。 2、微生物群可参与多种癌症的致癌进程，妇科癌症便是其中之一。以宫颈癌为例，菌群失调已被证实会通过影响人乳头瘤病毒（HPV）的感染、清除及持续状态，进而影响HPV感染情况，同时还会通过改变TGFβ1等免疫系统蛋白的水平，对宿主免疫反应产生影响。 3、益生菌还可用作辅助药剂，以增强或调节其他诊断和治疗手段的效果。例如，全身化疗常引发腹泻这一副作用。研究表明，益生菌丁酸梭菌能够减轻肺癌患者因化疗导致的腹泻症状，同时缓解全身炎症反应。小编寄语在癌症治疗的漫漫征程中，积极调节肠道菌群已然强势崛起，成为继癌症疫苗、免疫细胞疗法之后的又一“抗癌新星”。肠道菌群作为人体内部生态的关键“守护者”，与癌症防治紧密交织，恰似为抗癌之战精心构筑的一道 “隐形防线”。通过科学有效的调节举措，不仅能为患者的整体健康状况筑牢根基、添砖加瓦，更能显著提升抗癌及免疫治疗的 “战斗力”，巧妙化解手术与放化疗带来的诸多副作用 “难题”，宛如在荆棘满布的抗癌路上，铺就一条更为平坦、顺遂的通途，小编也希望未来能实现“无痛抗癌”的美好愿景。但小编温馨提示，癌症患者由于疾病的高度复杂性，建议在专业营养师或有执照的医疗保健人员的指导下，选择私人订制版个体化益生菌，这类益生菌是根据不同病种筛选出的特定菌种组成，可针对患者的自身病情，辅助肠道建立优势菌种架构，并能排除毒素和有害菌、重整肠道环境，从而促进疾病显著改善，以达到预期的应答水平。《柳叶刀》也曾指出“个体化益生菌群可能是未来癌症免疫治疗的策略”。想了解定制益生菌更多内容或寻求益生菌帮助的患者，可扫文末二维码，通过国际干细胞与免疫细胞研究医学部，咨询权威的营养专家。参考资料 [1]Cheng X,et al.Shen T. Successful Treatment of pMMR MSS IVB Colorectal Cancer Using Anti-VEGF and Anti-PD-1 Therapy in Combination of Gut Microbiota Transplantation: A Case Report. Cureus. 2023 Jul 24;15(7):e42347. https://pmc.ncbi.nlm.nih.gov/articles/PMC10445052/ 本文为“国际干细胞与免疫细胞研究”原创，转载需授权干细胞与免疫细胞研究入群免费领取抗癌细胞资讯｜新技术｜新药研发｜权威专家资料求分享求收藏求点击求在看

2026-05-28

·德琪医药

Antengene Receives CDE Endorsement for Pivotal Phase III CLINCH-3 Study of ATG-022 in CLDN18.2+ Advanced Gastric/GEJ Cancer

Shanghai and Hong Kong, PRC, May 28, 2026 — Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, today announced that following review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), the company has received CDE endorsement to conduct the pivotal Phase III CLINCH-3 study of ATG-022, a Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The study is expected to be initiated in China first and is planned as a multi-regional clinical trial (MRCT). Dr. Jay Mei Founder, Chairman and Chief Executive Officer of Antengene “Receiving CDE endorsement to conduct the pivotal Phase III CLINCH-3 study represents a defining milestone for Antengene. This achievement underscores Antengene’s fully integrated R&D capabilities, from the design and discovery of novel molecules to clinical translation and registrational development. The Breakthrough Therapy Designation previously granted by CDE provided an important basis for our regulatory discussions on this pivotal study and enabled efficient feedback from CDE. We are highly encouraged by the potential of ATG-022 to address the significant unmet medical needs of patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma, and we look forward to working closely with investigators to advance this important study.” The CLINCH-3 study will be led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator’s choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. As a pivotal registrational study, CLINCH-3 is intended to support a future marketing approval application for ATG-022 as monotherapy for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The primary endpoints of the study are progression-free survival as assessed by independent review committee (PFS by IRC) and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety, and other measures. The initiation of this pivotal study is supported by encouraging results from the Phase I/II CLINCH study, which showed that ATG-022, as monotherapy, demonstrated a differentiated efficacy and safety profile in patients with advanced gastric or gastroesophageal junction adenocarcinoma. As of December 25, 2025, among patients whose tumors had CLDN18.2 expression of IHC 2+ >20%, ATG-022 achieved ORRs of 46.7% and 40.0% at 1.8 mg/kg and 2.4 mg/kg, respectively, with corresponding DCRs of 86.7% and 90.0%. Median PFS (mPFS) was 6.97 months and 5.09 months, respectively, while median OS (mOS) was not yet reached in the 1.8 mg/kg cohort and was 14.72 months in the 2.4 mg/kg cohort. In the 1.8 mg/kg cohort, the incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was 19.4%, highlighting a highly differentiated safety profile for an ADC. Together with its robust antitumor activity, encouraging survival outcomes and favorable tolerability, these data position ATG-022 as a potential best-in-disease therapy for gastric cancer or gastroesophageal junction adenocarcinoma. Prof. Lin Shen Professor of Peking University Cancer Hospital, principal investigator of the CLINCH-3 study “Advanced gastric and gastroesophageal junction adenocarcinoma remains one of the most difficult solid tumors to treat, and the challenge is particularly acute in the 3L setting, where current options, including chemotherapy, anti-angiogenic agents and immunotherapy, provide limited efficacy, low objective response rates and insufficient survival benefit. ATG-022 has shown a compelling clinical profile as monotherapy at 1.8 mg/kg, with strong anti-tumor activity, meaningful survival benefit and a favorable safety profile. The CDE endorsement to conduct this pivotal Phase III study represents an important step toward potentially transforming the treatment landscape for patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. I am pleased to lead CLINCH-3 and look forward to working with Antengene to bring this promising therapy to more patients.” Antengene will continue to advance a comprehensive clinical development strategy for ATG-022 across multiple settings, including its pivotal monotherapy study in advanced gastric or gastroesophageal junction adenocarcinoma, ongoing combination studies with anti-PD-1 therapy and chemotherapy in the 1L gastric cancer setting, and further exploration in other CLDN18.2+ solid tumors, including tumor types beyond the digestive system where encouraging efficacy signals with confirmed tumor responses, have been observed. Through this strategy, the company aims to maximize the clinical potential of ATG-022 and bring innovative, impactful therapies to patients in China and around the world. About Antengene Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages, with key investigational candidates including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 x 4-1BB bispecific antibody), ATG-125 (B7-H3 × PD-L1 bispecific ADC), ATG-207 (αCD3-TGF-β bifunctional fusion protein), as well as T cell engager (TCE) programs developed using Antengene’s proprietary AnTenGager® platform. AnTenGager®, is Antengene’s proprietary TCE 2.0 platform, featuring “2+1” bivalent binding for low expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune disease, solid tumors and hematological malignancies, with programs targeting CD19 x CD3 (ATG-201 for B cell-related autoimmune diseases; partnered with UCB), CDH6 x CD3 (ATG-106 for ovarian cancer and kidney cancer), ALPPL2 x CD3 (ATG-112 for gynecological tumors, digestive system malignancies, bladder cancer and NSCLC), LY6G6D x CD3 (ATG-110 for microsatellite-stable colorectal cancer), GPRC5D x CD3 (ATG-021 for multiple myeloma), LILRB4 x CD3 (ATG-102 for acute myeloid leukemia and chronic myelomonocytic leukemia) and FLT3 x CD3 (ATG-107 for acute myeloid leukemia). To date, Antengene has obtained 32 investigational new drug (IND) approvals in the U.S. and Asia, and obtained new drug application (NDA) approvals in 10 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor), is approved in the Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company’s Annual Report for the year ended December 31, 2025, and the documents subsequently submitted to the Hong Kong Stock Exchange.

2026-05-26

·国际干细胞与免疫细胞研究

黑色素瘤一线治疗再添猛将，FMT联手PD-1抑制剂，斩获65%高缓解率！

点击蓝字关注我们粪便微生物移植（FMT）是克服难治性黑色素瘤患者对免疫检查点抑制剂耐药的潜在策略，但它在一线治疗中的作用尚未明确。为填补这一空白，研究人员开展了一项I期临床研究（NCT03772899），旨在评估FMT联合PD-1抑制剂[纳武单抗（nivolumab）或帕博利珠单抗（pembrolizumab）]用于一线治疗的临床疗效。结果令人振奋：该联合方案的客观缓解率高达65%，为晚期黑色素瘤患者带来了新的治疗希望与选择！这一突破性数据不仅证实了FMT与免疫治疗联用在一线场景的巨大价值，更让肿瘤患者在治疗之初就拥有了更高效的对抗方案，为战胜癌症点亮了更明亮的曙光！ ▲截图源自“Nat Med” 肠道菌群成抗癌关键！粪菌移植（FMT）联合PD-1抑制剂，一线治疗黑色素瘤，ORR高达65% 该研究（NCT03772899）共纳入20名一线接受抗PD-1治疗的黑色素瘤患者，所有患者在启动抗PD-1单药治疗前至少1周，均接受了一次来自健康志愿者的口服胶囊剂型粪便微生物移植（FMT）。结果显示，该联合方案的客观缓解率达65%（20例中13例），其中4例（20%）实现完全缓解；同时，应答者体内免疫原性细菌显著增多，有害细菌则明显减少。 ▲图源“Nat Med”，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，该研究结果证实，来自健康供体的FMT在黑色素瘤一线治疗中具有良好的安全性，其与免疫检查点抑制剂的联合应用价值值得深入探索。肠道菌群：人体的“第二基因组” 人体肠道内栖息着数以万亿计的微生物，它们构成复杂精妙的生态系统，即肠道菌群。这些微生物的基因总量远超人类自身基因数量，因此肠道菌群被形象地称为人体的“第二基因组”。长期以来，肠道菌群被认为主要参与食物消化与营养吸收，而越来越多的研究证实，其在人体健康诸多方面均发挥关键作用，尤其在免疫系统调节与癌症治疗领域意义重大。肠道菌群可通过以下方式调节： 1、益生菌：作为“活的、非病原性微生物”，益生菌在适量摄入时能为宿主带来多种益处。多项研究显示，它可提升机体免疫功能，对改善肝癌、肺癌、肾癌、结直肠癌等多种癌种的预后具有积极意义，有望成为癌症与免疫治疗领域的热门研究方向。 2、粪便微生物组移植（FMT）：从健康个体捐献的粪便中分离菌群，以菌液或胶囊形式，通过内窥镜灌注或口服等方式移植到患者肠道，从而重建新的肠道菌群、恢复微生物多样性（详见下图）。 ▲图源“Curr Treat Options Oncol”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除肠道菌群的检测申请流程 1、样本提交：按标准采集并提交粪便样本； 2、权威检测：由国际干细胞与免疫细胞研究送专业机构进行高通量测序； 3、精准解读检测结果：如发现异常，国际干细胞与免疫细胞研究医学部，协助患者对接肿瘤免疫权威专家制定调节方案。小编寄语在癌症治疗与康复过程中，营养支持治疗扮演着举足轻重的角色。及时、恰当补充各类营养素，对改善患者营养状况、增强机体免疫力、提高治疗耐受性及减轻治疗副作用均大有裨益。然而，肿瘤患者的营养基础、个人情况、癌种、分期及治疗方式存在显著差异，对应的饮食调理方案也需个体化制定。建议患者秉持均衡营养、健康饮食的原则，结合自身病情与癌种特点，筛选特定菌种以辅助肠道建立优势菌群基础，同时改善肠道环境、排除毒素及有害菌，进而促进病情改善、达到预期治疗应答。如果您想了解定制益生菌或更多营养评估和健康指导信息，可可扫文末二维码，将治疗经历、近期影像学及病理检查结果等资料，提交至国际干细胞与免疫细胞研究医学部，咨询权威的肿瘤营养专家。参考资料 [1]Routy B,et al. Fecal microbiota transplantation plus anti-PD-1 immunotherapy in advanced melanoma: a phase I trial[J]. Nature medicine, 2023, 29(8): 2121-2132. https://www.nature.com/articles/s41591-023-02453-x 本文为“国际干细胞与免疫细胞研究”原创，转载需授权干细胞与免疫细胞研究入群免费领取抗癌细胞资讯｜新技术｜新药研发｜权威专家资料求分享求收藏求点击求在看

100 项与 Sym-021 相关的药物交易

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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
晚期恶性实体瘤	临床1期	美国	Institut Servier de Medecine Translationnelle SARL	2021-10-15
晚期恶性实体瘤	临床1期	加拿大	Institut Servier de Medecine Translationnelle SARL	2021-10-15
胆管癌	临床1期	美国	Servier Symphogen A/S	2020-10-12
胆管癌	临床1期	加拿大	Servier Symphogen A/S	2020-10-12
胆管癌	临床1期	法国	Servier Symphogen A/S	2020-10-12
胆管癌	临床1期	西班牙	Servier Symphogen A/S	2020-10-12
Vater壶腹癌	临床1期	美国	Servier Symphogen A/S	2020-10-12
Vater壶腹癌	临床1期	加拿大	Servier Symphogen A/S	2020-10-12
Vater壶腹癌	临床1期	法国	Servier Symphogen A/S	2020-10-12
Vater壶腹癌	临床1期	西班牙	Servier Symphogen A/S	2020-10-12

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临床结果

适应症

分期

评价

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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


NCT05162755	临床1期	实体瘤末线 \| 二线 \| 三线	41	Sym025	構餘憲簾糧鏇獵餘築築(鹹憲蓋獵構艱襯壓願鬱) = 憲齋鬱蓋選襯鹽遞觸醖築蓋願衊膚鏇廠憲選壓 (鹹廠淵衊觸膚網鹹鏇構 ) 更多	积极	2024-11-05
				Sym021+Sym025	構餘憲簾糧鏇獵餘築築(鹹憲蓋獵構艱襯壓願鬱) = 簾餘選簾餘選構憲夢膚築蓋願衊膚鏇廠憲選壓 (鹹廠淵衊觸膚網鹹鏇構 ) 更多
NCT03489343 \| NCT03311412 \| NCT03489369 (ESMO2020)	临床1期	转移性肿瘤 \| 晚期恶性实体瘤 \| 淋巴瘤	-	Sym021	醖網積廠獵膚獵網繭憲(襯淵廠製構膚鹹鑰積淵) = Sym021, Sym022 and Sym023 alone and Sym021 in combination with either Sym022 or Sym023 were well tolerated with AE profiles typical of immune checkpoint inhibitors 獵積製製鏇顧壓餘顧憲 (餘膚窪蓋窪願鹽襯膚壓 )	-	2020-09-20
				Sym022
AUA2020	N/A	泌尿生殖系统肿瘤 HLA-I genotypes \| HLA-C genotypes \| KIR ligands ... 更多	51	anti-PD-1 drugs (HLA-A2 supertype)	鑰憲艱憲壓衊醖鏇繭壓(襯窪獵夢願構淵衊願鏇) = 築襯醖範鹽夢衊窪糧範範鏇鏇淵積遞淵製獵膚 (廠窪願糧衊淵憲網顧夢 )	-	2020-04-01
				anti-PD-1 drugs (Patients without HLA-A2 supertype)	鑰憲艱憲壓衊醖鏇繭壓(襯窪獵夢願構淵衊願鏇) = 壓顧鏇壓鑰膚壓製顧夢範鏇鏇淵積遞淵製獵膚 (廠窪願糧衊淵憲網顧夢 )