Phase IIb, Randomized, Active-Controlled, Parallel-Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AST-3424 in Patients With AKR1C3-High Expressing Advanced Hepatocellular Carcinoma Who Progressed After Systemic Therapy With Immune Checkpoint Inhibitors

The goal of this clinical trial is to learn if drug AST-3424 works to treat AKR1C3 high expressing advanced hepatocellular carcinoma after failure of systemic therapy with immune checkpoint inhibitors. The main question it aims to answer is:
Does AST-3424 prolong survival in patients with AKR1C3-high Expressing advanced Hepatocellular Carcinoma who have progressed after immune checkpoint inhibitors based therapies?
Researchers will compare AST-3424 to regorafenib (current optional therapy for target patients) to see if AST-3424 works.
Participants will:
Receive AST-3424 infusion on Day 1 and Day 8 of each 21-day treatment cycle or take regorafenib once a day on Day 1 -Day 21 of each 28-day treatment cycle.

开始日期2026-01-01

申办/合作机构

浙江海正药业股份有限公司

ChiCTR2500114071

/ Not yet recruiting临床2期IIT

A Randomized, Positive-Controlled, Multicenter Phase IIb Trial of AST-3424 in Patients with AKR1C3-High Expression Advanced Hepatocellular Carcinoma Previously Treated with Immune Checkpoint Inhibitor-Based Therapy

开始日期2025-10-01

申办/合作机构-

CTR20201908

/ Recruiting临床1期

评价AST-3424 治疗复发或难治性急性淋巴细胞白血病患者的安全性、耐受性、药代动力学、初步疗效以及疗效与AKR1C3 酶表达相关性的临床研究

主要目的：评估AST-3424静脉给药的安全性和耐受性；评估AST-3424及其代谢产物的药代动力学特征；评估ALL受试者接受AST-3424单药治疗的给药方案；次要目的：初步评估AST-3424单药治疗复发或难治性ALL的血液学缓解情况，判定标准为ORR= CR+PR（其中CR包括CR和CRi）；评估患者的总生存期（OS）；评估患者的无进展生存期（PFS）（PFS定义为从首次用药开始到疾病进展或任何原因导致的死亡的时间）；评估CR/CRi患者的微小残存病变（MRD）的阴性率（MRD阴性定义为流式细胞术检测< 0.01%）；评估CR/CRi患者微小残存病变（MRD）首次达到阴性的时间；评估CR/CRi患者MRD阴性持续的时间（从达到CR/CRi后MRD首次评估阴性到MRD转为阳性或CR/CRi后复发的最早日期时间）；探讨患者外周血和骨髓中经PCR-荧光探针法确定的AKR1C3酶的表达与疗效之间的关系。探索性目的：探索DNA损伤修复相关基因突变的表达。

开始日期2021-04-06

申办/合作机构

深圳艾欣达伟医药科技有限公司

100 项与 AST-3424 相关的临床结果

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100 项与 AST-3424 相关的转化医学

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100 项与 AST-3424 相关的专利（医药）

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项与 AST-3424 相关的文献（医药）

2025-01-15·INTERNATIONAL JOURNAL OF CANCER

Enhanced pharmacological activities of AKR1C3‐activated prodrug AST‐3424 in cancer cells with defective DNA repair

Article

作者: Duan, Jianxin ; Meng, Fanying ; Liu, Xing ; Jung, Don ; Li, Anrong ; Qi, Tianyang ; Cai, Xiaohong ; Wang, Yizhi ; Lu, Zhaoqiang ; Yu, Jibing

Abstract:

AST‐3424 is a novel and highly tumor‐selective prodrug. AST‐3424 is activated by AKR1C3 to release a toxic bis‐alkylating moiety, AST 2660. In this study, we have investigated the essential role of DNA repair in AST‐3424 mediated pharmacological activities in vitro and in vivo. We show here that AST‐3424 is effective as a single therapeutic agent against cancer cells to induce cytotoxicity, DNA damage, apoptosis and cell cycle arrest at G2 phase in a dose‐ and AKR1C3‐dependent manner in both p53‐proficient H460 (RRID:CVCL_0459) and p53‐deficient HT‐29 cells (RRID:CVCL_0320). The combination of abrogators of G2 checkpoint with AST‐3424 was only synergistic in HT‐29 but not in H460 cells. The enhanced activity of AST‐3424 in HT‐29 cells was due to impaired DNA repair ability via the attenuation of cell cycle G2 arrest and reduced RAD51 expression. Furthermore, we utilized a BRCA2 deficient cell line and two PDX models with BRCA deleterious mutations to study the increased activity of AST‐3424. The results showed that AST‐3424 exhibited enhanced in vitro cytotoxicity and superior and durable in vivo anti‐tumor effects in cells deficient of DNA repair protein BRCA2. In summary, we report here that when DNA repair capacity is reduced, the in vitro and in vivo activity of AST‐3424 can be further enhanced, thus providing supporting evidence for the further evaluation of AST‐3424 in the clinic.

2023-08-10·British journal of cancer

Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, and clinical activity of OBI-3424 in patients with advanced or metastatic solid tumors

Article

作者: Verschraegen, Claire F ; Hsu, Pei ; Wesolowski, Robert ; Pearce, Tillman E ; Shia, Chi-Sheng ; Tsimberidou, Apostolia Maria

Abstract:

Background:

Report of a Phase 1 dose-escalation study of OBI-3424 monotherapy in patients with advanced solid tumors (NCT03592264).

Methods:

A classic 3 + 3 design was used to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of OBI-3424 administered intravenously, as a single agent, at doses of 1, 2, 4, 6, 8, or 12 mg/m2 (days 1 and 8 of a 21-day cycle, Schedule A) or 8, 10, 12, or 14 mg/m2 (day 1 of a 21-day cycle, Schedule B).

Results:

Dose-limiting hematologic toxicities at 12 mg/m2 in Schedule A led to dose and schedule modifications (Schedule B). In Schedule B, maximum tolerated dose was not reached at the maximum dose tested (14 mg/m2). Grade ≥3 anemia was noted in 3/6 patients treated at 14 mg/m2; the RP2D was 12 mg/m2 (Schedule B). Grade ≥3 treatment-emergent adverse events were experienced by 19/39 (49%) and included anemia (41%) and thrombocytopenia (26%); three patients experienced serious treatment-emergent adverse events (grade ≥3 anemia and thrombocytopenia). One patient had a partial response and 21/33 (64%) had stable disease.

Conclusions:

The RP2D is 12 mg/m2 once every 3 weeks. OBI-3424 was well tolerated; dose-dependent, noncumulative thrombocytopenia and anemia were dose-limiting.

2023-01-01·American journal of cancer research

Erratum: A novel selective AKR1C3-activated prodrug AST-3424/OBI-3424 exhibits broad anti-tumor activity.

作者: Qi, Tianyang ; Wang, Chun-Chung ; Meng, Fanying ; Jung, Donald ; Hsu, Ren-Yu ; Duan, Jianxin ; Hsieh, Yin-Cheng ; Li, Wan-Fen ; Shia, Chi-Sheng

[This corrects the article on p. 3645 in vol. 11, PMID: 34354865.].

项与 AST-3424 相关的新闻（医药）

2026-01-16

·海正药业

海正药业HSE-001项目IIb期临床试验完成首例受试者入组

2026年1月16日，浙江海正药业股份有限公司（以下简称：海正药业，股票代码:600267）开展的“HSE-001（AST-3424）用于既往接受过含免疫检查点抑制剂系统治疗失败进展的AKR1C3高表达的晚期肝细胞癌的有效性和安全性的随机、阳性药平行对照、全国多中心的IIb期临床研究”，在广西医科大学附属肿瘤医院完成首例患者入组，标志着该项目取得里程碑式进展。本研究由南京天印山医院和复旦大学附属中山医院共同牵头，国内著名肿瘤专家秦叔逵教授与樊佳教授共同担任主要研究者。 HSE-001是海正药业于2025年9月从深圳艾欣达伟医药科技有限公司引进的具有潜在全球首创(First-in-Class，FIC)的小分子偶联靶向药物（SMDC）。公司引进后快速推进并达成首例入组这一重要里程碑节点，项目的高效推进展现出海正药业扎根创新药研发的决心与临床转化实力。作为一款依赖AKR1C3酶活化的SMDC，HSE-001通过醛酮还原酶家族1成员C3(AKR1C3)选择性裂解成具有细胞毒性的活性形式，以实现肿瘤细胞精准杀灭，同时最大限度地减少对正常组织的损伤。 HSE001研究全国Co-leading Pl、南京天印山医院荣誉院长、首席专家秦叔逵教授表示：“当前免疫检查点抑制剂已成为晚期肝细胞癌治疗的重要手段，但多数患者接受治疗后仍会面临疾病进展，且尚无后线标准治疗方案，临床亟需创新药物突破治疗困境。HSE-001的靶点选择精准契合肝癌发病机制，前期临床数据显示出优异的疗效与安全性优势，该药物有望为晚期肝细胞癌的后线治疗提供新的突破，我们期待通过这项临床试验，能够进一步验证其在患者中的疗效和安全性。” 海正药业董事长、总裁肖卫红表示：“HSE-001项目IIb期临床研究首例患者入组，标志着该药物的临床开发取得重要进展，有望为肝癌患者带来新的治疗选择。海正药业始终秉持‘以科学为基、以患者为先’的理念，依托SMDC这一潜力赛道构建起差异化竞争壁垒，全速推进创新管线的研发进程，加速科研成果转化，通过构建具有国际竞争力的创新产品管线，为守护生命健康贡献海正力量。” 关于海正药业海正药业（股票代码：600267）始创于1956年，是一家国有控股的综合性医药健康产业集团。公司专注于创新药、生物药、仿制药和高端原料药的研发、生产、销售，并布局了动保、大健康、医美等新兴领域。同时依托自身产业技术转化和产能优势，前瞻布局合成生物学，成为该领域的先行者。公司始终坚持对海正品质的卓越追求，积极承担国家战略需求，持续打造具有全球影响力的民族医药健康品牌。如需了解更多信息，请访问www.hisunpharm.com或关注公司官微：海正药业

2026-01-12

·BioSpace

OBI Pharma and TegMine Therapeutics Sign Exclusive Global License Agreement for Glycan-Targeting ADC

Successful Delivery of Commissioned ADC Candidate to Advance the Collaboration Between OBI and TegMine TAIPEI, TW / ACCESS Newswire / January 12, 2026 / OBI Pharma (4174.TWO) announced that it has entered into a commercial license agreement with TegMine Therapeutics, Inc. (TegMine), a San Francisco-based biopharma focused on developing antibodies targeting cancer-associated glycans and glycoproteins, for a glycan-targeting ADC. Under the terms of the agreement, OBI is eligible to receive an upfront payment as well as development and commercial milestones. Following product launch, OBI will also receive royalties based on a tiered percentage of annual net sales. While the detailed financial terms are not disclosed in accordance with the confidentiality provisions, the overall deal economics are broadly comparable to those of recent similar licensing transactions in the market. TegMine will obtain the exclusive global rights to develop and commercialize the ADC under the license agreement. This international licensing collaboration reflects the potential value of products generated using OBI's Obrion ™ ADC technologies. The licensed ADC candidate is derived from a high-affinity anti-glycan antibody provided by TegMine and was developed into an ADC by OBI using the Obrion ™ ADC technology family, including the GlycOBI ® glycan-conjugation technology, the dual-function enzymatic EndoSymeOBI ® , and the highly hydrophilic linker HYPrOBI ® . The ADC candidate generated with this proprietary site-specific glycan conjugation is homogeneous and scalable for manufacturing. Heidi Wang, Ph.D. Chief Executive Officer of OBI Pharma, said, "This strategic collaboration leverages the complementary strengths of both organizations. It not only supports the advancement of OBI's ADC product development but also expands opportunities for strategic partnerships using our innovative ADC technologies such as GlycOBI ® . We look forward to working closely with TegMine to further develop this novel ADC that may benefit patients with urgent medical needs." "The transition from our successful Master Services Agreement to this global license agreement is a major milestone for TegMine," said Jeff Bernstein, Ph.D., Chief Executive Officer of TegMine Therapeutics. "By combining OBI's site-specific GlycOBI ® conjugation with our proprietary antibodies discovered via the TegMiner ™ platform, we have generated an ADC with exceptional tumor specificity. This TegMine program demonstrates the power of targeting cancer-specific glycan signatures to deliver potent payloads while sparing healthy tissue. We are excited to advance this program rapidly into the clinic." About GlycOBI ® OBI has developed a unique glycan-based ADC technology (GlycOBI ® ), designed in a Plug and Play format that is compatible with any antibodies, linkers, and payloads, and supports various drug-antibody ratios (DAR). Powered by OBI's proprietary dual-function enzymatic technology EndoSymeOBI ® and its hydrophilic linker technology HYPrOBI ® , GlycOBI ® , a core component of OBI's Obrion ™ ADC technology family, enables the generation of site-specific and homogeneous ADCs with an efficient and scalable process under GMP conditions. During the conjugation process, GlycOBI ® avoids disrupting the antibody structure and ensures that the resulting ADC retains biophysical characteristics comparable to the native antibody. In addition, OBI's linker technology improves payload conjugation efficiency and reduces the propensity for aggregation or degradation, further supporting a stable and well-controlled ADC manufacturing process. GlycOBI ® has overcome limitations commonly associated with traditional ADC approaches and has demonstrated improved antitumor activity and stability in various in vivo studies. About OBI Pharma OBI Pharma is a clinical-stage global oncology company established in 2002 and headquartered in Taiwan. Together with its subsidiary OBI Pharma USA, Inc., the company is dedicated to developing innovative cancer therapeutics to provide new treatment options for patients with urgent medical needs. OBI's research efforts center on novel antibody-drug conjugates (ADC). Through its patented next-generation conjugation technology platform, Obrion™, OBI has established diverse ADC design modalities. The platform integrates proprietary conjugation and linker technologies, including GlycOBI ® , GlycOBI DUO ® , EndoSymeOBI ® , HYPrOBI ® , and the novel cysteine-conjugation technology ThiOBI ® , to advance next-generation ADC solutions. OBI has developed a next-generation suite of ADC programs. These include monospecific ADCs such as OBI-902 (TROP2) and OBI-904 (Nectin-4); a bispecific single-payload ADC, OBI-201 (HER2 x TROP2); and a bispecific dual-payload ADC, OBI-221 (cMET x HER3). In addition to its ADC programs, OBI's assets include OBI-3424, a first-in-class AKR1C3-targeted small-molecule prodrug that selectively releases a potent DNA-alkylating agent in the presence of the aldo-keto reductase 1C3 enzyme, which is highly expressed in certain tumors. Additional information can be found at . GlycOBI ® , EndoSymeOBI ® , ThiOBI ® , HYPrOBI ® , and GlycOBI DUO ® are registered trademarks of OBI. Obrion ™ is a trademark under registration. About TegMine Therapeutics TegMine is redefining precision oncology by targeting highly expressed glycans and glycoproteins that drive cancer aggressiveness and immune evasion. Our mission is to eradicate cancer by identifying unique tumor antigens that are consistently prevalent across the tumor while being largely absent from healthy tissues. The company's proprietary TegMiner ™ platform utilizes glyco-engineered cell lines and advanced mass spectrometry to identify previously inaccessible, cancer-specific glycan epitopes. This discovery engine is designed to generate high-specificity antibodies that deliver maximum therapeutic impact across numerous treatment modalities, including antibody-drug conjugates (ADCs) and other next-generation antibody formats. For more information, please visit . Forward-Looking Statements Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma's reports and presentations, including OBI Pharma's filings with the Taiwan Securities and Futures Bureau. COMPANY CONTACT: Kevin Poulos, Chief Business Officer OBI Pharma USA, Inc. +1 (619) 537 7698, ext. 102 kpoulos@obipharma.com Jeff Bernstein, Chief Executive Officer TegMine Therapeutics, Inc. jeff@tegminetx.com SOURCE: OBI Pharma USA, Inc. View the original press release on ACCESS Newswire

引进/卖出抗体药物偶联物

2026-01-08

·道尽瘤子

AST-3424：免疫进展肝癌患者的精准治疗新突破

一、引言：免疫耐药后的治疗困境与新希望在晚期肝细胞癌的治疗历程中，免疫联合靶向治疗方案（如“T+A”方案：阿替利珠单抗+贝伐珠单抗）的出现，曾为无数患者带来了新的生存希望。然而，一个不可避免的临床现实是：免疫治疗最终会耐药。当免疫联合方案失效后，患者往往陷入“无标准方案可用”的困境，只能在不同机制相似、疗效有限的选择中艰难抉择，眼睁睁看着宝贵的治疗时间在尝试中流逝。正是在这一临床需求迫切而标准方案空缺的背景下，一种全球首创的小分子偶联药物——AST-3424，以其独特的作用机制和精准的治疗理念，为免疫治疗进展后的晚期肝癌患者带来了新的曙光。更令人振奋的是，高达85%的肝细胞癌患者存在其作用靶点AKR1C3的高表达，这意味着绝大多数患者都有潜在获益的机会。二、理解AKR1C3：肝癌治疗的新兴“精准靶点”1. AKR1C3的生物学特性基本功能：醛酮还原酶家族1成员C3 参与类固醇激素代谢和前列腺素合成在多种正常组织中低表达在肝癌中的异常：高表达率：85%的肝细胞癌患者中高表达预后意义：表达水平与肿瘤侵袭性、耐药性和不良预后密切相关治疗价值：成为理想的治疗靶点2. 为何选择AKR1C3作为靶点？高选择性：肿瘤组织高表达，正常组织低表达实现“肿瘤特异性”治疗减少对正常组织的损伤检测便利：通过简单的免疫组化（IHC）即可检测无需复杂的基因测序费用相对较低，可及性强广泛适用：覆盖绝大多数肝癌患者为精准治疗提供可靠依据三、AST-3424：智能激活的小分子偶联药物1. 创新机制：从“前药”到“智能炸弹” 传统化疗的局限：无差别杀伤快速分裂细胞毒性大，副作用明显治疗窗口狭窄 AST-3424的革命性设计：第一步：精准递送 AST-3424本身是无活性前药通过血液循环到达全身第二步：智能激活在AKR1C3高表达的肿瘤细胞内被AKR1C3酶特异性裂解仅在肿瘤细胞内激活第三步：强力杀伤释放活性成分AST-2660 AST-2660是强效DNA烷化剂与DNA结合形成不可逆交联导致肿瘤细胞死亡2. 技术优势：小分子偶联药物（SMDC）与传统ADC的区别：特性抗体偶联药物（ADC）小分子偶联药物（SMDC）AST-3424载体部分抗体（大分子）小分子配体靶向机制抗体-抗原结合酶-底物特异性反应穿透性相对较差优异，易于穿透肿瘤组织制备难度复杂，成本高相对简单免疫原性可能存在基本无 AST-3424的独特优势：高穿透性：小分子易进入肿瘤深部高选择性：依赖AKR1C3酶的特异性激活高稳定性：在循环中保持稳定，减少提前释放四、临床数据：疗效与安全性的双重验证1. CSCO 2024公布的II期研究数据研究概况：患者类型：晚期肝细胞癌样本量：30例患者特征： 76.7%接受过≥2线系统治疗 90%在前一线治疗中疾病进展代表真实世界难治人群疗效数据：疾病控制率（DCR）：60% 意味着超过一半患者疾病稳定或缩小对于多线治疗失败患者，这是显著疗效生存数据：中位总生存期（OS）：10.8个月 6个月OS率：71.7% 9个月OS率：67.2% 临床意义：在免疫治疗进展后的难治患者中，显示出有希望的生存获益横向对比：传统二线治疗（如瑞戈非尼）在类似人群中的中位OS约7-8个月 AST-3424的10.8个月显示出潜在优势2. 安全性数据不良事件特征：主要毒性：血液学毒性贫血、血小板减少、白细胞减少多数为轻中度可通过支持治疗管理非血液学毒性：恶心、蛋白尿、ALT升高可控可逆关键安全信息：无5级治疗相关不良事件报告总体安全性可控优于传统化疗的毒性谱五、当前临床试验详情 1. 试验设计特点研究标题：AST-3424用于免疫治疗进展的AKR1C3高表达晚期肝癌的IIb期研究创新设计：双剂量探索：设置4mg和6mg两个剂量组活性对照：以瑞戈非尼作为对照组随机分配：采用2:2:1的随机比例目的明确：确定最佳剂量，验证疗效优势2. 入组人群精准定义核心纳入标准：疾病类型：经病理确诊的晚期肝细胞癌治疗史：既往接受过系统治疗关键要求：免疫联合治疗后进展接受过PD-1/PD-L1抑制剂联合其他治疗（如靶向、化疗）治疗期间或之后疾病进展生物标志物：AKR1C3高表达免疫组化检测2+或3+ 阳性率高达85%，大多数患者符合检测安排：提供1年内的肿瘤组织进行AKR1C3检测研究组可能协助安排检测 2+或3+表达即可入组排除情况：既往使用过瑞戈非尼治疗确保对照组的科学性3. 治疗与随访安排治疗方案：试验组：AST-3424静脉输注 4mg剂量组 6mg剂量组对照组：瑞戈非尼口服治疗周期：21天为一个周期随访评估：定期影像学评估疗效安全性监测和不良事件管理生存随访4. 开展中心当前开放：江苏省扩展计划：其他中心陆续开放中地理位置：方便华东地区患者参与六、AST-3424的核心治疗优势1. 针对明确的临床未满足需求当前治疗困境：免疫联合治疗进展后无标准方案现有选择疗效有限患者急需新机制药物 AST-3424的定位：专门为免疫治疗进展患者设计提供全新作用机制的替代选择填补临床治疗空白2. 精准的伴随诊断策略检测简单可行：免疫组化检测，非基因检测费用相对较低结果快速可得高阳性率保障： 85%的肝癌患者阳性绝大多数患者有机会获益减少“检测后无药可用”的失望3. 优于传统化疗的安全性特征毒性对比：毒性类型传统化疗 AST-3424消化道反应严重恶心呕吐轻度恶心骨髓抑制重度，恢复慢轻中度，可控肝毒性常见且严重轻度ALT升高神经毒性常见罕见脱发常见罕见生活质量影响：更轻的毒性意味着更好的生活质量减少住院和支持治疗需求更适合多线治疗后体质虚弱的患者七、适合人群与自我评估1. 明确的目标人群特征如果您符合以下所有条件，应重点考虑：确诊为晚期肝细胞癌（HCC）既往接受过免疫联合治疗（如“T+A”方案）治疗期间或之后疾病进展有可用的肿瘤组织样本（1年内）未使用过瑞戈非尼治疗年龄18-75岁，身体状况可接受进一步治疗2. 关键检测：AKR1C3表达评估检测重要性：决定是否符合入组资格预测潜在治疗效果为精准治疗提供依据检测流程建议：咨询主治医生是否可安排AKR1C3检测如有近期活检组织，可用于检测如无可用组织，可能需要重新活检检测结果通常1-2周可得3. 治疗史梳理重点需要明确记录：所有既往治疗方案及时间免疫治疗的具体药物和联合方案最佳疗效和进展时间治疗相关不良反应及处理八、患者参与的十大获益1. 获得全球首创创新治疗接触first-in-class小分子偶联药物，走在肝癌治疗最前沿。2. 精准匹配治疗靶点基于AKR1C3生物标志物的精准治疗，提高疗效可能性。3. 填补免疫耐药后治疗空白专门针对免疫治疗进展患者，满足迫切临床需求。4. 免费接受创新药物治疗临床试验期间所有药物及相关检查费用全免。5. 可能获得优于标准治疗的疗效早期数据显示60%疾病控制率和10.8个月中位OS的潜力。6. 相对良好的安全性相比传统化疗，毒性更可控，生活质量影响更小。7. 专业团队的全程管理由肝癌领域专家提供全面治疗和监测。8. 贡献中国原创新药研发参与全球首创药物的临床开发，帮助未来更多患者。9. 获得交叉治疗机会如分到对照组且疾病进展，可能有机会接受AST-3424治疗。10. 在多线治疗后重燃希望在治疗选择有限时，获得全新的治疗机制和机会。九、科学认识IIb期临床试验1. IIb期研究的设计意义研究目的：在特定人群中验证初步疗效探索最佳给药剂量为III期确证性研究提供依据设计特点：随机对照设计，提高证据等级设置活性对照组（瑞戈非尼）双剂量组探索最优剂量2. 参与临床试验的科学认知不是“试验小白鼠”：所有治疗都有充分的临床前和早期临床数据支持严格的安全监测体系保障患者安全伦理委员会全程监督保护患者权益理性看待疗效数据： II期数据不能完全预测最终疗效个体反应可能存在差异需综合评估获益风险比十、肝癌治疗格局与AST-3424的定位1. 肝癌系统治疗的发展脉络传统治疗时代：索拉非尼（一线标准十余年）仑伐替尼（一线新选择）免疫治疗革命： “T+A”方案成为一线新标准其他免疫联合方案陆续获批后免疫治疗时代挑战：免疫耐药后缺乏有效方案急需新机制药物突破瓶颈2. AST-3424的治疗地位当前定位：免疫治疗进展后的精准治疗选择基于生物标志物的个体化治疗小分子偶联药物的先行者未来潜力：可能成为免疫耐药后的标准治疗可能探索与其他药物的联合应用可能扩展至其他AKR1C3高表达肿瘤十一、给患者和家属的实用建议1. 积极进行生物标志物检测主动询问医生AKR1C3检测事宜保留肿瘤组织样本以备检测了解检测结果的意义2. 系统整理治疗资料建立完整的治疗时间线保存所有影像学和病理报告记录治疗反应和不良反应3. 理性评估治疗选择了解当前所有可选方案权衡各方案的获益与风险在医生指导下做出决策4. 关注临床试验动态了解新药研发进展评估参与临床试验的时机选择正规渠道获取信息结语：在精准治疗时代抓住新机遇 AST-3424的出现，代表了肝癌治疗从“一刀切”到“精准打击”的重要转变。它不仅仅是一种新药，更是一种治疗理念的革新——基于生物标志物选择最可能获益的患者，利用肿瘤特有的酶激活机制实现精准杀伤。对于免疫治疗进展的晚期肝癌患者，每一次新的治疗机会都弥足珍贵。AST-3424临床试验的开启，为这些患者提供了一条基于科学、立足精准的新路径。在抗癌这条漫长道路上，新药的不断涌现提醒我们：医学的进步永不停歇，希望永远在前方。了解新机制、检测新靶点、评估新疗法——这是在精准医疗时代，每一位患者都应掌握的抗癌智慧。当标准治疗走到尽头时，创新疗法可能就是照亮前路的那束光。请关注微信公众号：【道尽瘤子】目前有肺癌、肝癌、肾癌、胃癌、肠癌、胰腺癌、妇瘤、泌尿肿瘤、血液肿瘤......等几乎涵盖所有癌种的临床试验正在招募患者！扫描下方二维码添加医学助理一对一咨询！道尽瘤子与您同行，共创健康未来。参与临床试验，获取国际前沿新药免费使用机会！更有一线专家团队为您的治疗保驾护航！ end 北肿健康病友交流群，为您提供全方位的支持与交流平台: 具体包括：呼吸系统肺癌病友交流群：小细胞肺癌，非小细胞肺癌（肺腺癌、肺鳞癌）... 消化系统癌症病友群：胃癌、肠癌、肝癌、胆管癌、胰腺癌、胆囊癌、食管癌、贲门癌... 妇科癌症病友群：乳腺癌、宫颈癌、卵巢癌、外阴癌、子宫内膜癌、输卵管癌... 泌尿系统癌症病友群：肾癌、前列腺癌、膀胱癌、尿路上皮癌、睾丸癌。阴茎癌... 头颈癌病友群：鼻咽癌、甲状腺癌，舌癌、口腔癌、胶质瘤... 血液癌病友群：淋巴瘤、白血病交流群... 罕见病病友群：胸腺瘤、平滑肌瘤，恶性脂肪瘤、黑色素瘤…… end 您的赞+在看+分享是我更新的动力！也能帮到更多病友，积极关注、分享能积福接好运哦！愿每个人都能早日康复！分享收藏点赞在看

抗体药物偶联物免疫疗法临床结果

100 项与 AST-3424 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16057

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
晚期肝细胞癌	临床2期	中国	深圳艾欣达伟医药科技有限公司	2025-12-25
急性髓性白血病	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23
膀胱癌	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23
结直肠癌	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23
子宫内膜癌	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23
食管癌	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23
结外NK-T细胞淋巴瘤	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23
高危骨髓增生异常综合征	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23
非小细胞肺癌	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23
外周T细胞淋巴瘤	临床2期	中国	深圳艾欣达伟医药科技有限公司	2022-06-23

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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


Pediatric Preclinical In Vivo Testing Consortium (PIVOT) (AACR2025)	临床2期	肝母细胞瘤 AKR1C3	-	OBI-3424	網繭遞艱繭淵窪遞構夢(製鹹壓壓網憲築壓鹹遞) = 積糧簾鏇淵範鹹繭襯簾構餘壓範築淵膚壓餘選 (遞窪鑰壓獵簾艱積築蓋 )	积极	2025-04-30
	临床2期	肝母细胞瘤 AKR1C3	-	Vehicle	網繭遞艱繭淵窪遞構夢(製鹹壓壓網憲築壓鹹遞) = 衊餘窪窪獵積簾製蓋鏇構餘壓範築淵膚壓餘選 (遞窪鑰壓獵簾艱積築蓋 )	积极	2025-04-30
NCT06239155 (AST-3424-001, Company_Website) 人工标引	临床2期	肝细胞癌 AKR1C3强阳性表达	30	AST-3424	繭衊鹹鏇蓋鹽範簾繭遞(繭艱鏇網窪簾齋鏇壓淵) = 選襯鹹壓選淵廠淵遞憲鑰鹽窪鹹獵糧獵憲夢製 (鹽觸餘淵顧夢鬱艱簾鹽 ) 更多	积极	2024-09-27
NCT06239155 (AST-3424-001, Company_Website) 人工标引	临床2期	肝细胞癌 AKR1C3强阳性表达	30	AST-3424 (TP53基因野生型)	繭衊鹹鏇蓋鹽範簾繭遞(繭艱鏇網窪簾齋鏇壓淵) = 淵醖製齋鹹餘鏇夢餘積鑰鹽窪鹹獵糧獵憲夢製 (鹽觸餘淵顧夢鬱艱簾鹽 ) 更多	积极	2024-09-27
NCT06239155 (ASCO2024)	临床1期	晚期恶性实体瘤 AKR1C3 expression	21	AST-3424 8 mg/m2	構鑰餘窪願廠淵衊願選(廠觸醖膚壓鹹鏇觸醖壓) = 夢遞顧膚餘窪遞艱窪窪鬱糧範鹽簾製選餘鹽醖 (夢壓廠鑰簾壓膚衊鏇繭 ) 更多	积极	2024-05-24
NCT03592264 (Pubmed)	临床1期	转移性实体瘤	39	OBI-3424	顧顧構糧糧網構鑰簾艱(簾鏇淵遞艱餘廠艱鹹齋) = 範窪鹽鹹鹹顧製蓋選淵網構蓋鑰蓋衊鑰壓襯鹹 (觸選鑰糧憲糧製製觸鑰 )	-	2023-05-12
NCT03592264 \| NCT04315324 (AACR2022)	临床1/2期	胰腺腺癌 \| HR阳性/HER2低表达实体瘤 \| 难治性 T 急性淋巴细胞白血病	-	OBI-3424	遞艱壓膚廠鑰鹽夢憲窪(鬱鏇選鏇憲襯鑰遞襯願) = 膚餘襯範淵窪壓壓齋遞製鏇蓋艱積鹹範遞積範 (觸廠網鏇網範鑰襯積廠 )	-	2022-06-15
NCT03592264 \| NCT04315324 (AACR2022)	临床1/2期	胰腺腺癌 \| HR阳性/HER2低表达实体瘤 \| 难治性 T 急性淋巴细胞白血病	-	Pembrolizumab	遞艱壓膚廠鑰鹽夢憲窪(鬱鏇選鏇憲襯鑰遞襯願) = 襯蓋製構選範構鬱廠醖製鏇蓋艱積鹹範遞積範 (觸廠網鏇網範鑰襯積廠 )	-	2022-06-15
NCT03592264 (ASCO2022)	临床1期	转移性实体瘤	39	OBI-3424	製餘憲齋衊鑰積築廠獵(憲憲憲鑰獵遞夢構鏇壓) = 選顧鹹糧築醖齋壓簾齋遞製鹽餘範鏇製鹽膚簾 (糧簾襯遞憲鏇鏇襯衊艱 ) 更多	-	2022-06-02