The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies:
* Metastatic HER2+ breast cancer (MBC) - randomized 1:1 to one of two arms (evorpacept + standard of care therapy vs. standard of care only)
* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs
* Recurrent/metastatic head and neck cancer (HNSCC) - note that this substudy will not be open at the time of study initiation

开始日期2025-04-28

申办/合作机构

ALX Oncology, Inc.

NCT05467670

/ Recruiting临床2期IIT

Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Patients with Recurrent Platinum-resistant Ovarian Cancer: Phase II Study

Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).

开始日期2023-03-30

申办/合作机构

University of Pittsburgh

[+2]

NCT05868226

/ Recruiting临床1期

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.

开始日期2023-02-15

申办/合作机构

Quantumleap Healthcare Collaborative

100 项与 Evorpacept 相关的临床结果

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100 项与 Evorpacept 相关的转化医学

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100 项与 Evorpacept 相关的专利（医药）

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项与 Evorpacept 相关的文献（医药）

2024-07-01·CURRENT OPINION IN ONCOLOGY

State of the art and upcoming trends in HER2-directed therapies in gastrointestinal malignancies

Review

作者: Lee, Jaeyop ; Ku, Geoffrey

Purpose of review:

This review critically evaluates the evolution and current status of human epidermal growth factor receptor 2 (HER2)-directed therapies in upper gastrointestinal (GI) malignancies, a timely and relevant inquiry given the dynamic shifts in therapeutic strategies over the past decade. Initial enthusiasm following the Trastuzumab for Gastric Cancer (ToGA) study's demonstration of trastuzumab's efficacy, however, encountered hurdles due to subsequent trials showing limited progress, underscoring the necessity for a reevaluation of therapeutic approaches and the exploration of novel agents.

Recent findings:

The review highlights significant breakthroughs in the form of immune checkpoint inhibitors and innovative therapeutic technologies, which have redefined treatment paradigms and shown promising efficacy in HER2-positive cases. Emerging treatments such as trastuzumab deruxtecan (T-DXd), zanidatamab and evorpacept further illustrate the ongoing efforts to leverage unique mechanisms of action for improved HER2-positive antitumor activity.

Summary:

The advancements in HER2-directed therapies underscore a pivotal era in the management of upper GI malignancies. These developments not only reflect the profound impact of integrating novel therapeutic combinations but also highlight the critical role of ongoing research in overcoming resistance mechanisms and tailoring treatment to individual disease profiles.

2024-01-01·TRANSFUSION MEDICINE AND HEMOTHERAPY

Evorpacept-Induced Interference and Application of a Novel Mitigation Agent, Evo-NR, in Pretransfusion Testing

Article

作者: Yoon, Eungjun ; Kim, Tae Yeul ; Kim, Hyungsuk ; Cho, Duck

Introduction: Evorpacept is a CD47-blocking agent currently being developed for the treatment of various cancers. Interference by evorpacept in pretransfusion compatibility testing has been reported at limited plasma concentrations. Although various mitigation strategies have been proposed, none are practical. This in vitro study assessed evorpacept-induced interference at extended concentrations and investigated the capability of a novel mitigation agent, Evo-NR. Methods: Antibody screening tests were performed on evorpacept-spiked plasma with (anti-E and anti-Jk^a) or without alloantibodies at evorpacept concentrations up to 2,000 μg/mL using manual gel cards and automated analyzers. Evorpacept-coated red blood cells (RBCs) (rr [ce/ce], Fy[a+b−], S−s+) were tested by direct antiglobulin testing (DAT) and antigen typing using anti-Fy^b and anti-S reagents at indirect antiglobulin testing (IAT) phase. Evo-NR was used to resolve the interference in plasma and RBC samples. Flow cytometry was used to assess the mitigation effects. Results: Evorpacept-spiked plasma showed panreactive interference in antibody screening tests using manual gel cards (2+ to 3+) and automated analyzers (4+). A carryover effect was also observed in the automated analyzers. The use of a 3- to 6-fold molar excess of Evo-NR effectively resolved the interference in the plasma and enabled accurate alloantibody identification. Although the reduction in evorpacept binding to RBCs was identified via flow cytometry, Evo-NR was incapable of resolving the serologic interference observed in DAT and antigen typing at IAT phase. Discussion: Evorpacept showed constant panreactivity and a carryover effect at high concentrations. Evo-NR successfully resolved the interference in the plasma samples and could be considered a practical and efficient mitigation solution. Implementation of Evo-NR has the potential to support RBC transfusion for patients undergoing evorpacept treatment.

2021-12-01·The Lancet. Oncology1区 · 医学

Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study

1区 · 医学

Article

作者: Patricia LoRusso ; Hyun Cheol Chung ; Hong I Wan ; Keun-Wook Lee ; Nehal J Lakhani ; Pierre Squifflet ; Wells A Messersmith ; Justin F Gainor ; Yung-Jue Bang ; Jaume Pons ; Frank Stephen Hodi ; Won Seog Kim ; Laura Q M Chow ; Jeeyun Lee ; Philip Fanning ; Sophia S Randolph ; Feng Jin ; Rafael Santana-Davila ; Tracy C Kuo

BACKGROUND:

Both innate and adaptive immune responses are important components of anticancer immunity. The CD47-SIRPα interaction could represent an important pathway used by tumour cells to evade immune surveillance. We aimed to evaluate the safety, pharmacokinetics, pharmacodynamics, and anticancer activity of evorpacept (also known as ALX148), a high-affinity CD47-blocking protein with an inactive IgG Fc region in patients with solid tumours.

METHODS:

We did a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study at nine hospitals and one clinic in the USA and Korea. Eligible patients for the dose-escalation and safety lead-in phases were aged 18 years or older with histological or cytological diagnosis of advanced or metastatic solid tumours with no available standard therapy, measurable or unmeasurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status score of 0 or 1. In the dose-escalation phase, which used a 3 + 3 design, patients received intravenous evorpacept at either 0·3, 1, 3, or 10 mg/kg once per week in 21-day cycles, or 30 mg/kg once every other week in 28-day cycles. In the safety lead-in phase, patients were given the maximum tolerable dose of evorpacept from the dose-escalation phase plus either intravenous pembrolizumab (200 mg administered once every 3 weeks) or intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks). In the dose-expansion phase, additional patients aged 18 years or older with second-line or later-line advanced malignancies were enrolled into three parallel cohorts: those with head and neck squamous cell carcinoma (HNSCC) and those with non-small-cell lung cancer (NSCLC) were given the maximum tolerated dose of evorpacept plus intravenous pembrolizumab (200 mg administered once every 3 weeks), and patients with HER2-positive gastric or gastroesophageal junction cancer were given the maximum tolerated dose of evorpacept plus intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg once every 3 weeks) until disease progression, voluntary withdrawal from the study, or unacceptable toxicity. The primary endpoint was the maximum tolerated dose of evorpacept administered as a single agent and in combination with pembrolizumab or trastuzumab, measured by the occurrence of dose-limiting toxicities during the first cycle, and was assessed in all patients who had received at least one dose of evorpacept. Secondary outcomes included the safety, tolerability, and antitumour activity of evorpacept, alone or in combination with pembrolizumab or trastuzumab. The primary outcome, safety, and tolerability were assessed in all patients who had received at least one dose of evorpacept, and antitumour activity was assessed in those who recieved at least one dose of study treatment and underwent at least one post-baseline tumor assessment. This trial is registered with ClinicalTrials.gov, NCT03013218.

FINDINGS:

Between March 6, 2017, and Feb 21, 2019, 110 patients received single-agent evorpacept (n=28), evorpacept plus pembrolizumab (n=52), or evorpacept plus trastuzumab (n=30), and were included in the safety analysis. Median follow-up was 29·1 months (95% CI not calculable [NC]-NC) in the single-agent cohort, 27·0 months (25·1-28·8) in the evorpacept plus pembrolizumab cohort, and 32·7 months (27·0-32·7) in the evorpacept plus trastuzumab cohort. Two (7%) dose-limiting toxicities in the first cycle were reported in patients who received single-agent evorpacept; neutropenia with an associated infection in one patient with gastroesophageal junction cancer who received 3 mg/kg once per week, and thrombocytopenia with associated bleeding in one patient with pancreatic cancer who received 30 mg/kg once every other week. No maximum tolerated dose was reached; the maximum administered doses were 10 mg/kg once per week or 30 mg/kg once every other week. The 10 mg/kg once per week dose was used in the expansion cohorts in combination with pembrolizumab or trastuzumab. The most common grade 3 or worse treatment-related adverse events were thrombocytopenia with single-agent evorpacept (two [7%] patients) and evorpacept plus pembrolizumab (two [4%]), and thrombocytopenia (two [7%]) and neutropenia (two [7%]) with evorpacept plus trastuzumab. In patients who received single-agent evorpacept, four treatment-related serious adverse events were reported. Five serious treatment-related adverse events related to evorpacept plus pembrolizumab were reported, and one serious adverse event related to evorpacept plus trastuzumab was reported. In response-evaluable patients in the dose-escalation phase (n=15) receiving single-agent evorpacept once per week, four (27%) had a best overall response of stable disease (two received 0·3 mg/kg, one received 3 mg/kg, and one received 10 mg/kg); in the 11 patients who received single-agent evorpacept at the highest dose of 30 mg/kg once every other week, two (18%) had stable disease. In the dose-expansion cohort, overall responses were recorded in four (20·0%; 95% CI 5·7-43·7) of 20 patients with HNSCC who received evorpacept plus pembrolizumab, in one (5·0%; 0·1-24·9) of 20 patients with NSCLC who received evorpacept plus pembrolizumab, and in four (21·1%; 6·1-45·6) of 19 patients with gastric or gastroesophageal junction cancer who received evorpacept plus trastuzumab.

INTERPRETATION:

The safety findings support the use of evorpacept in combination with pembrolizumab or trastuzumab for patients with advanced solid tumours. Preliminary antitumour activity results support future investigation of evorpacept combined with pembrolizumab or trastuzumab in patients with HNSCC, gastric or gastroesophageal junction cancer, and NSCLC.

FUNDING:

ALX Oncology.

165

项与 Evorpacept 相关的新闻（医药）

2025-06-16

·创药网

近一个月药物研究进展概览

本文梳理了近一个月（2025年4月16日～2025年5月15日）在研药物的临床试验取得不佳（研发成功率降低）进展的情况，同时，对部分药物的研究情况进行简述和分析，供研发人员参考。据统计，在检索时间范围内，共有2个药物的临床试验数据进展不佳（表1），均处于暂停阶段。适应症涉及头颈癌和非小细胞肺癌。以下对这2个药物的研究进展不佳原因进行简要介绍。表1：近一个月（2025年4月16日～2025年5月15日）临床试验数据不佳的药物Evorpacept01Evorpacept是一款SIRPα-Fc融合蛋白，旨在阻断CD47与其受体SIRPα结合，促使巨噬细胞攻击肿瘤细胞。Evorpacept也是目前少数还在开发的CD47抑制剂之一。根据ALX肿瘤公司报告的最新进展，Evorpacept与K药联用的两项Ⅱ期临床试验ASPEN-03和ASPEN-04皆未达到主要终点目标，结果显示，相比Keytruda单药，Evorpacept+Keytruda联用未能提高晚期头颈部鳞状细胞癌患者的客观缓解率（ORR）。从机制上来看，CD47是一种在正常细胞中广泛表达的膜糖蛋白，当CD47结合到巨噬细胞表面的SIRPα之后，会提供一种“别吃我”信号。当细胞表面的CD47蛋白表达水平较高时，巨噬细胞便会进行规避，从而避免对正常细胞造成“误伤”。而CD47成为肿瘤免疫治疗潜在靶标的理论基础，则在于肿瘤细胞也会通过高表达CD47来屏蔽巨噬细胞的吞噬功能。因此，只要阻断肿瘤细胞中的CD47与巨噬细胞中的SIRPα的结合作用，启动巨噬细胞对肿瘤细胞的吞噬，便可以达到抗癌的效果。基于以上机制，CD47也被称为肿瘤免疫治疗的“下一代PD-1”。在我国，宜明昂科靶向CD47的IMM01（Timdarpacept/替达派西普）是一款潜力药物，主要针对骨髓增生异常综合征（MDS）、经典霍奇金淋巴瘤（cHL）和慢性粒单核细胞白血病（CMML）3个适应症。根据2024年ASCO大会上，宜明昂科披露的MDS和cHL两个适应症数据来看，IMM01联合AZA作为一线治疗高风险MDS患者的Ⅱ期临床试验的最新结果显示，51名患者可评估疗效，完全缓解率（CR）达到33.3%，总体反应率达到64.7%；在治疗超过4个月的34名患者中，CR达到50.0%，ORR达到85.3%；而在治疗超过6个月的29名患者中，CR达到58.6%，ORR达到89.7%。此外，目前CD47靶标上，我国诸多药企在开发双抗路线，如信达的CD47/PD-L1双抗，康方的Claudin 18.2/CD47双抗，德昇济医药的HER2/CD47双抗，有望在保证安全性的同时，保持一定的肿瘤杀伤效果。Belrestotug02近日，葛兰素史克（GSK）和iTeos Therapeutics宣布，由于中期临床试验数据未能达到预期效果，双方决定终止合作开发TIGIT（T细胞免疫球蛋白和ITIM结构域）抗体Belrestotug。Belrestotug是一种针对TIGIT靶标的实验性免疫疗法，旨在通过阻断TIGIT蛋白来增强免疫系统对肿瘤的攻击能力。TIGIT是一种共抑制性受体，广泛存在于T细胞和自然杀伤细胞（NK细胞）上（图1），被认为能够抑制免疫反应，因此，成为继PD-1/L1之后的热门免疫检查点靶标。TIGIT可竞争性抑制CD226与CD155的结合，损害CD226介导的T细胞和自然杀伤（NK）细胞活化。TIGIT与其配体CD155结合会在T细胞和NK细胞中激活抑制信号。TIGIT与抗原呈递细胞（APCs）上的CD155结合会促使白细胞介素-10（IL-10）产生，减少白细胞介素-12（IL-12）生成，并间接抑制T细胞。最后，TIGIT信号传导会增强调节性T细胞（Tregs）的免疫抑制功能（图2）。图1：TIGIT、CD226、CD96和CD112R在T细胞和NK细胞中表达图2：TIGIT在免疫反应调节中的作用根据双方披露的信息，关键Ⅱ期试验结果显示，Belrestotug与抗PD-1抑制剂Jemperli联合治疗PD-L1高表达的非小细胞肺癌患者时，虽然ORR作为主要终点持续改善，但PFS（无进展生存期）未达到开发者设定的临床意义阈值。另一项针对PD-L1阳性头颈部鳞状细胞癌的Ⅱ期试验中期分析也显示，联合治疗组的疗效趋势低于预期响应率阈值，进一步加剧了研发困境。基于上述数据，GSK和iTeos决定终止所有包含belrestotug的临床试验队列，包括一项正在进行的Ⅲ期研究——该研究原计划评估Belrestotug联合Jemperli作为一线疗法在局部晚期或转移性非小细胞肺癌患者中的疗效。这一行动直接导致双方终止四年前达成的合作协议，GSK此前为此支付了6.25亿美元的预付款。TIGIT作为继PD-1/PD-L1之后的新一代免疫检查点，曾被寄予厚望。四年前GSK与iTeos达成合作时，该领域正处于热度巅峰，百时美施贵宝、吉利德、默沙东和罗氏等巨头均积极布局，试图通过阻断TIGIT-PVR信号通路扩大免疫治疗受益人群。然而，早期临床研究中观察到的疗效优势未能转化为生存获益。♡♡♡♡♡♡♡♡♡♡【参考资料】1. Informa数据库, 检索日期: 2025年5月21日.2. Insight数据库, 检索日期: 2025年5月21日.3. 药渡数据库, 检索日期：2025年5月23日.4. 药明康德、医药魔方、学术经纬、fiercebiotech、bioSeedin柏思荟、新药猎人笔记等网络公开资源.本文其它内容请见《全球药物创新快讯》2025年第4期（总第151期）。

ASCO会议临床2期免疫疗法临床1期临床结果

2025-06-02

·佰傲谷BioValley

被要求与DS8201对照，没戏的CD47

近日，ALX Oncology公布了第一季度的财报，并提供了公司的业务更新。根据公司这份公告披露，公司寻求其CD47抑制剂Evorpacept在“HER2阳性胃癌”这个适应症的上市批准可能没戏了。根据FDA的反馈，由于标准护理的改变，其SPEN-06临床试验已不符合加速批准的条件，基于此，ALX Oncology选择不在美国寻求监管批准。此外，ALX Oncology还宣布将对公司进行精简（具体未公布），以将现金跑道延长至2026年第四季度。需要与DS8201 PKEvorpacept是一款SIRPα-Fc融合蛋白，旨在阻断CD47与其受体SIRPα结合，促使巨噬细胞攻击肿瘤细胞。HER2阳性胃癌是ALX Oncology寄托批准希望的适应症，这一厚望主要来自于名为ASPEN-06 Ⅱ期临床试验的激励。2023年10月，ALX Oncology公布发ASPEN-06的中期分析结果显示，相较于对照组，Evorpacept联用组在客观缓解率 (ORR) 显著提升（52% vs 22%）。这一临床数据令市场大受鼓舞，公司股价开盘大涨了70%。虽然在之后公布的顶线数据中（2024年7月），Evorpacept联用组的ORR相比对照组有所下降（40.3% VS 26.6%），但并未动摇公司的信心，ALX Oncology还称Evorpacept为首个在前瞻性随机临床试验中显示出持久临床益处且耐受性良好的CD47阻断剂。在今年3月的研发日活动中，公司便表示，将基于ASPEN-06临床数据与FDA讨论Evorpacept在该适应症中的监管路径，具体结果会在今年第二季度对外公布。但是，SPEN-06并未能得到FDA的认可，FDA认为SPEN-06不符合其获得加速批准的条件，因为Enhertu现在是HER2阳性胃癌的标准治疗方案，FDA指出，Evorpacept想要获得监管批准，需要开展与Enhertu对照的Ⅲ期临床试验。而ALX Oncology现在不打算按照FDA的要求来，放弃在美国开展Ⅲ期临床试验，那这也意味着公司现在放弃寻求该适应症在美国的上市批准。多次临床失败作为少数能挺到现在的CD47抑制剂，Evorpacept已经遭受了不少打击。最初，ALX Oncology的开发重点和吉利德、天境生物等一样，首推的适应症主要是MDS（骨髓增生异常综合征）和AML（急性髓细胞性白血病）。不过，结局也吉利德一样，ALX Oncology在这个两个适应症上也失败了，2023年8月，ALX Oncology终止了Evorpacept分别针对MDS和AML的两项临床试验ASPEN-02和ASPEN-05，原因是在ASPEN-02试验中，对比Azacitidine单药历史疗效，Evorpacept+Azacitidine联用并没有取得显著改善，同时基于Azacitidine在MDS和AML中的作用机制类似，AML也因此被一同放弃开发。实体瘤也不例外。今年4月，ALX Oncology宣布Evorpacept与K药联用的两项Ⅱ期临床试验ASPEN-03和ASPEN-04皆未达到主要终点目标，结果显示，相比Keytruda单药，Evorpacept+Keytruda联用未能提高晚期头颈部鳞状细胞癌(HNSCC)患者的ORR。基于此，ALX Oncology便宣布放弃Evorpacept+K药在该适应症中的开发。失败的还有尿路上皮癌（UC)，在这次的财报中，公司还宣布决定停止Evorpacept联合Padcev（Nectin-4 -ADC）临床试验，因为对SPEN-07临床试验进行最终分析后发现，加入Evorpacept并未能提高Padcev的疗效。下一步打算几大适应症的接连失败，基本上把ALX Oncology打回原地。现在公司把希望放在了新的临床试验上，根据公司披露的开发计划，公司将在今年年中启动两项新的临床试验，包括联合trastuzumab治疗HER2阳性乳腺癌的Ⅱ期临床试验ASPEN-Breast，以及联合cetuximab用于治疗结直肠癌（CRC）的Ⅰ期临床试验ASPEN-CRC 。另外，现在公司还在重点推进的管线为其EGFR ADC管线ALX2004，此前已经获得FDA的IND批准，公司计划今年年中启动临床试验。总结作为目前少数还在坚持开发CD47抑制剂的Biotech，ALX Oncology一路走来实属不易，经历了MDS和AML、HNSCC、UC等多个适应症失败，现在几乎是从头再来，只是公司的资金经得起消耗么？参考出处https://ir.alxoncology.com/news-releases/news-release-details/alx-oncology-reports-first-quarter-2025-financial-results-andhttps://endpts.com/alx-oncology-wont-seek-approval-for-cd47-drug-in-gastric-cancer-korro-bios-layoffs/········

临床2期财报临床3期加速审批临床失败

2025-05-20

·ir.alxoncology.com

ALX Oncology Highlights Differentiated Design, Preclinical Data and Development Plans for EGFR-Targeted ADC, ALX2004, in R&D Webcast Event

- A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window by reducing toxicity - Following recent IND clearance from U.S. FDA, ALX2004 will enter clinical studies mid-year 2025 with initial safety data anticipated in 1H 2026 - Trials evaluating the Company’s lead investigational therapy, CD47-blocker evorpacept, in breast and colorectal cancers planned to initiate in mid-2025 with multiple key inflection points from evorpacept and ALX2004 development programs anticipated in 2026 SOUTH SAN FRANCISCO, Calif., May 20, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, provides an overview of the clinical development program for its highly-differentiated antibody-drug conjugate (ADC), ALX2004, at the Company’s R&D webcast event today. ALX Oncology leadership will discuss the unique design profile, preclinical data and clinical development plans for ALX2004, a potential best- and first-in-class ADC for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, that is planned to enter Phase 1 studies in mid-year 2025. "ALX Oncology is driving a new, highly differentiated approach to the treatment of EGFR-expressing tumors, harnessing our proprietary linker-payload platform to bring forward an ADC candidate that we believe may be able to overcome challenges seen with EGFR-ADCs in the past and drive a best-in-class molecule forward," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "As we advance ALX2004 into the clinic, we are excited to share the development program and highlight how we rigorously designed all components of this ADC with an optimized, validated payload and antibody to maximize its potential for success across a variety of tumor types." The Company’s ALX2004 R&D webcast event will include presentations on: ALX2004 Unique Design: Optimized for Anti-Tumor Activity and Improved Outcomes Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor payload and linker-payload platform, ALX2004 has been rigorously designed to maximize the therapeutic window and overcome toxicity challenges observed in this class. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary linker-Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload. Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. Initiation of Phase 1 Clinical Development Program The U.S. Food and Drug Administration (FDA) cleared ALX Oncology’s Investigational New Drug (IND) application for ALX2004 in April 2025. ALX Oncology will provide an overview of its Phase 1 clinical trial design for ALX2004 planned to initiate mid-2025. The Company anticipates initiating a Phase 1 dose escalation trial in EGFR-expressing solid tumors, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma and esophageal squamous cell carcinoma, targeting patients with relapsed/refractory cancers. The Company anticipates initial safety data in the first half of 2026. ALX2004 Webcast Information The virtual event will be webcast live and a replay will be available after the event by visiting the "Investors" section of ALX Oncology’s website and selecting "Events and Presentations." Date & Time: Tuesday, May 20, 2025, 8:00 a.m. PT/11:00 a.m. ET Webcast Access: https://edge.media-server.com/mmc/p/ohnn53h5 About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and is anticipated to enter Phase 1 trials mid-2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Investor Relations Contact: Elhan Webb, CFA, IR Consultant ewebb@alxoncology.com Media Contact: Audra Friis, Sam Brown Healthcare Communications audrafriis@sambrown.com (917) 519-9577

临床申请抗体药物偶联物临床1期

100 项与 Evorpacept 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12193	-	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HER2表达胃腺癌	临床3期	美国	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	美国	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	日本	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	日本	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	澳大利亚	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	澳大利亚	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	比利时	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	比利时	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	捷克	ALX Oncology, Inc.	2022-01-15
HER2表达胃腺癌	临床3期	捷克	Eli Lilly & Co.	2022-01-15

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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


NCT05025800 (AACR2025) 人工标引	临床1期	非霍奇金淋巴瘤	20	Evorpacept + lenalidomide + rituximab	餘製鏇壓範製鹹齋範壓(膚積範鏇艱夢糧築顧遞) = 鏇網餘遞繭鏇糧鑰鬱蓋壓蓋顧壓製壓築築築窪 (築獵範蓋觸鬱範淵選範 ) 更多	积极	2025-04-29
NCT04675294 (ASPEN-03, Company_Website) 人工标引	临床2期	晚期头颈部鳞状细胞癌一线 PD-L1 Positive	-	Evorpacept + pembrolizumab	繭製製願製襯鑰醖淵齋(願鹽顧築積鬱艱築獵選) = Not Meet Primary Endpoints 鬱鬱構遞齋願繭醖顧獵 (積遞選醖積鬱餘顧蓋鏇 ) 未达到	不佳	2025-04-25
				pembrolizumab
NCT04675333 (ASPEN-04, Company_Website) 人工标引	临床2期	晚期头颈部鳞状细胞癌	-	evorpacept + pembrolizumab + chemotherapy	願鹽觸糧糧膚鹽窪廠願(製觸網糧鬱壓鬱網製範) = Not Meet Primary Endpoints. 夢選鹽選糧窪衊鑰選構 (蓋築壓鏇夢壓鑰製憲衊 ) 未达到	不佳	2025-04-25
				pembrolizumab + chemotherapy
NCT05002127 (ASPEN-06, ASCO_GI2025) 人工标引	临床2/3期	HER2阳性胃食管腺癌 \| HER2阳性胃癌 HER2+	127	EvorpaceptEvorpacept (ALX148) + Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鹽蓋鬱餘鹽觸衊簾範獵(窪築艱憲壓襯衊鹽鬱糧) = 範願襯鑰廠鹽積壓構夢觸繭網構簾鬱艱醖襯壓 (壓鹽襯遞糧淵鑰衊餘鏇 ) 更多	积极	2025-01-23
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鹽蓋鬱餘鹽觸衊簾範獵(窪築艱憲壓襯衊鹽鬱糧) = 製蓋鹹夢繭齋築蓋顧襯觸繭網構簾鬱艱醖襯壓 (壓鹽襯遞糧淵鑰衊餘鏇 ) 更多
NCT05002127 (ASPEN-06, Corporate Publications) 人工标引	临床2/3期	HER2阳性胃食管交界处癌 \| HER2阳性胃癌 HER2 Positive	127	Evorpacept + Trastuzumab + Ramucirumab + Paclitaxel	獵築簾構淵網簾範鏇構(夢構鏇憲顧壓糧顧鹹鬱) = 淵衊餘夢觸願構醖製積艱廠鬱網築夢廠築範顧 (餘鹹糧鏇鏇夢簾壓構構, 29.0 ~ 54.4) 更多	积极	2025-01-23
				Trastuzumab + Ramucirumab + Paclitaxel	獵築簾構淵網簾範鏇構(夢構鏇憲顧壓糧顧鹹鬱) = 齋獵製製選衊鹽淵鹹築艱廠鬱網築夢廠築範顧 (餘鹹糧鏇鏇夢簾壓構構, 16.3 ~ 39.1) 更多
NCT05002127 (ASPEN-06, Company_Website) 人工标引	临床2/3期	HER2阳性胃癌 \| HER2阳性胃食管结合部腺癌 HER2 Positive	127	Evorpacept + trastuzumab + CYRAMZA + paclitaxel	遞觸製遞醖淵鏇築鏇壓(艱餘製顧襯鏇窪選鹹製) = 鑰醖構淵壓鏇齋齋遞願壓淵願簾鹹築壓簾築鏇 (憲齋窪淵簾網憲壓觸廠 ) 更多	积极	2024-07-31
				Trastuzumab + CYRAMZA + paclitaxel	遞觸製遞醖淵鏇築鏇壓(艱餘製顧襯鏇窪選鹹製) = 顧選齋壓窪顧鏇醖繭願壓淵願簾鹹築壓簾築鏇 (憲齋窪淵簾網憲壓觸廠 ) 更多
NCT05167409 (ASCO2024) 人工标引	临床2期	转移性微卫星稳定结直肠癌 Microsatellite Stable (MSS)	16	Evorpacept (E) 15 mg/kgcetuximabpembrolizumab	積醖範顧觸廠蓋夢觸積(鹹鏇製齋積艱齋鑰襯憲) = 齋齋積廠齋糧繭選壓齋範製選壓遞選夢鏇齋艱 (憲網糧壓鏇壓糧壓淵艱 ) 更多	不佳	2024-05-24
NCT05524545 (ASCO2024) 人工标引	临床1期	局部晚期尿路上皮癌 \| 转移性尿路上皮癌	20	Evorpacept 20 mg/kgenfortumab vedotin	鏇鏇選淵積範齋構糧積(觸窪襯積築觸願鏇繭蓋) = Not observed. 鏇餘構壓觸醖廠繭醖醖 (醖製齋艱齋窪衊蓋艱選 ) 更多	积极	2024-05-24
NCT05025800 (AACR2024) 人工标引	临床1期	非霍奇金淋巴瘤	20	Evorpacept+rituximab+lenalidomide	製選糧廠顧遞艱艱鹹廠(顧範膚願衊構廠範範膚) = 構鏇壓鹹鬱觸衊顧製簾網廠餘遞淵齋蓋糧艱膚 (淵網艱繭蓋鑰廠鑰襯窪 ) 更多	积极	2024-04-05
NCT05002127 (ASPEN-06, NEWS) 人工标引	临床2期	转移性 HER2 阳性胃食管结合部癌 \| HER2阳性胃癌二线 HER2 Positive	54	Evorpacept 30 mg/kg+trastuzumab + CYRAMZA + paclitaxel	鑰齋範鹽範鏇簾願夢膚(顧膚遞鹹膚齋夢蓋糧窪) = 網鏇淵築齋網窪齋獵醖齋網遞衊憲壓簾糧夢鏇 (鏇製齋膚觸窪構窪觸餘 ) 更多	积极	2023-10-03
				trastuzumab + CYRAMZA + paclitaxel	鑰齋範鹽範鏇簾願夢膚(顧膚遞鹹膚齋夢蓋糧窪) = 網鬱醖獵積醖夢膚鬱憲齋網遞衊憲壓簾糧夢鏇 (鏇製齋膚觸窪構窪觸餘 ) 更多