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

NCT05524545

/ Recruiting临床1期

A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)

AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.

开始日期2022-11-02

申办/合作机构

ALX Oncology, Inc.

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 ; Keun-Wook Lee ; Hong I Wan ; 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 ; Sophia S Randolph ; Philip Fanning ; Feng Jin ; Tracy C Kuo ; Rafael Santana-Davila

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.

152

项与 Evorpacept 相关的新闻（医药）

2025-04-07

·PipelineReview

ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate

SOUTH SAN FRANCISCO, CA, USA I April 07, 2025 I ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, today announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company’s potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors. Based on this clearance, ALX Oncology will initiate a single-agent dose-escalation and expansion Phase 1 clinical trial for ALX2004 in mid-2025. “Clinical advancement of our first ADC and the first drug candidate developed on our proprietary linker-payload platform is an important milestone in our mission to deliver breakthrough therapies that will help transform the future of cancer treatment,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “We meticulously designed all aspects of ALX2004 – the antibody backbone, linker and payload – to optimize the targeted delivery of a powerful chemotherapy payload to tumor cells while minimizing systemic toxicity. The resulting, highly differentiated molecule has demonstrated potent anti-tumor activity in preclinical models and is a strategic addition to our clinical pipeline, which also includes multiple trials evaluating our lead therapeutic candidate, evorpacept.” EGFR is a transmembrane protein located on the surface of cells that regulates cell growth; overexpression occurs across various tumor types, including breast cancer, colorectal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer. EGFR is clinically validated as a therapeutic target with several FDA-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs. Early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads. Utilizing the company’s proprietary, highly differentiated topoisomerase I inhibitor payload platform, ALX Oncology scientists designed ALX2004 to optimize ADC-based mechanisms of anti-tumor activity and improve outcomes in patients with EGFR-expressing tumors. The ALX2004 molecule, created entirely in ALX Oncology labs, comprises an antibody backbone engineered to optimize anti-EGFR activity, a linker with enhanced stability and a proprietary topoisomerase I payload that can generate an enhanced bystander effect. ALX Oncology plans to conduct an R&D call focused on ALX2004 in Q2 2025 and to initiate a Phase 1 clinical trial of the investigational therapy in mid-2025. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system 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. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology . SOURCE: ALX Oncology

临床申请抗体药物偶联物免疫疗法

2025-04-07

·ir.alxoncology.com

ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate

ALX2004 is a potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors that was created from ALX Oncology’s proprietary linker-payload platform ALX2004, the company’s first ADC, was fully designed and developed in-house by ALX Oncology scientists Company expects to initiate Phase 1 clinical trials of ALX2004 in mid-2025, with initial safety data available in 1H 2026 SOUTH SAN FRANCISCO, Calif., April 07, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, today announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company’s potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors. Based on this clearance, ALX Oncology will initiate a single-agent dose-escalation and expansion Phase 1 clinical trial for ALX2004 in mid-2025. “Clinical advancement of our first ADC and the first drug candidate developed on our proprietary linker-payload platform is an important milestone in our mission to deliver breakthrough therapies that will help transform the future of cancer treatment,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “We meticulously designed all aspects of ALX2004 – the antibody backbone, linker and payload – to optimize the targeted delivery of a powerful chemotherapy payload to tumor cells while minimizing systemic toxicity. The resulting, highly differentiated molecule has demonstrated potent anti-tumor activity in preclinical models and is a strategic addition to our clinical pipeline, which also includes multiple trials evaluating our lead therapeutic candidate, evorpacept.” EGFR is a transmembrane protein located on the surface of cells that regulates cell growth; overexpression occurs across various tumor types, including breast cancer, colorectal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer. EGFR is clinically validated as a therapeutic target with several FDA-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs. Early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads. Utilizing the company’s proprietary, highly differentiated topoisomerase I inhibitor payload platform, ALX Oncology scientists designed ALX2004 to optimize ADC-based mechanisms of anti-tumor activity and improve outcomes in patients with EGFR-expressing tumors. The ALX2004 molecule, created entirely in ALX Oncology labs, comprises an antibody backbone engineered to optimize anti-EGFR activity, a linker with enhanced stability and a proprietary topoisomerase I payload that can generate an enhanced bystander effect. ALX Oncology plans to conduct an R&D call focused on ALX2004 in Q2 2025 and to initiate a Phase 1 clinical trial of the investigational therapy in mid-2025. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system 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. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary note regarding forward-looking statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations Contact: Elhan Webb, CFA, IR Consultant ewebb@alxoncology.com Media Contact: Audra Friis, Sam Brown, Inc. audrafriis@sambrown.com (917) 519-9577

抗体药物偶联物临床申请

2025-03-10

·佰傲谷BioValley

CD47群星陨落，这款能行吗？

小编有话说 y 在前几年，“别吃我”信号通路CD47-SIRPα，可谓是最热门的开发领域之一。随着诸多管线的临床推进安全性问题频发，吉利德、天境医药等先锋企业的先后撤离，CD47靶向药物的开发仿佛按下了减速键。但是CD47所代表的巨大前景，还是在吸引着广大企业前赴后继。在CD47群星陨落的时代下，ALX Oncology显露出其野心。 2025年3月5日，ALX Oncology公司在其研发日活动中，透露出希望通过加速批准路径将其CD47阻断剂Evorpacept推进上市。但此前曾数次失利 Evorpacept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。但是Evorpacept的开发也一路波折：首先，2023年8月，ALX Oncology终止了Evorpacept分别针对MDS和AML的两项临床试验，原因是疗效未有显著改善。延伸阅读：跌落的CD47，又一家企业削减项目其次，2024年7月，Evorpacept针对HER2阳性胃癌的2期临床ASPEN-06的数据更新出现反差。根据2023年10月所披露的数据显示，Evorpacept联合治疗组的客观缓解率 (ORR) 显著高于对照组（52% vs 22%）；但是2024年7月更新的数据显示，Evorpacept联合治疗组的ORR下降至40.3%，而对照组上升至26.6%。这一数据更新也直接导致当时ALX Oncology公司股价大跌30%。尽管先后经历了MDS和AML失败，ALX Oncology公司仍然将未来押注在Evorpacept上。仍被看好的Evorpacept 在研发日活动期间，ALX Oncology公司披露了Evorpacept接下来的开发策略，包括：在2025年上半年启动Evorpacept联合曲妥珠单抗治疗HER2阳性乳腺癌、和Evorpacept联合西妥昔单抗治疗结直肠癌（CRC）的临床计划；将于2025第二季度公布Evorpacept两项针对晚期头颈部鳞状细胞癌的2期试验ASPEN-03和ASPEN-04的顶线结果，以及Evorpacept联合PADCEV治疗尿路上皮癌的1期临床试验ASPEN-07的最新结果；将于2025年下半年公布Evorpacept联用ENHERTU治疗乳腺癌的1b期临床试验I-SPY的顶线结果；将基于Evorpacept的ASPEN-06数据，与FDA进行沟通讨论，预计将于2025年第二季度提供胃癌注册路径的监管指南。在ASCO 2025年会上，ASPEN-06数据更新显示：Evorpacept联合治疗在通过新鲜活检或ctDNA her2阳性证实her2阳性表达的患者中，确认客观缓解率（cORR）为48.9%，中位缓解持续时间（mDOR）为15.7个月，而对照组的ORR和mDOR分别为24.5% 和9.1个月，无进展生存期风险比为0.64。另外，ALX Oncology在研发日上还推出了一款新型EGFR ADC候选药物ALX2004。ALX2004在临床前显示出积极的抗肿瘤活性，该公司计划在2025年第一季度向FDA提交ALX2004的IND申请。同时，为了支持Evorpacept的乳腺癌和CRC新计划，ALX Oncology进行了战略优先排序和资源优化活动，大幅减少了临床前研究，包括主要在临床前研究职能部门进行裁员30%，将现金流延长至2026年第四季度。小结事实上，尽管CD47靶向药物的开发命途多舛，多款管线折戟。但CD47仍是充满希望的靶标。国内多家企业都有相关布局，其中宜明昂科的四大核心管线全部围绕CD47，并且进度最快的IMM01已经推进2期临床开发。延伸阅读：苦头吃尽，吉利德终放弃CD47 参考资料： 1.https://www.globenewswire.com/news-release/2025/03/05/3037351/0/en/ALX-Oncology-Highlights-Focused-Evorpacept-Development-Plan-Clinical-Progress-and-Corporate-Updates-at-R-D-Day-Webcast-Event.html 2.https://ir.alxoncology.com/static-files/f504366f-7bdf-49f2-8e22-31b983b588ae 3.https://www.fiercebiotech.com/biotech/alx-lays-30-staff-pay-more-trials-cd47-blocker 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

临床结果临床2期ASCO会议临床1期抗体药物偶联物

100 项与 Evorpacept 相关的药物交易

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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	ALX Oncology, Inc.	2022-01-15
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	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	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	捷克	Eli Lilly & Co.	2022-01-15
HER2表达胃腺癌	临床3期	捷克	ALX Oncology, Inc.	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


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	襯糧鹹鹹願網齋艱憲鑰(淵鹹製鏇膚淵鑰醖鬱獵) = 觸構衊膚構鹹顧範積醖醖餘選餘鏇鬱獵鹹製蓋 (構廠鹽鑰製憲繭製鹹獵, 29.0 ~ 54.4) 更多	积极	2025-01-23
				Trastuzumab + Ramucirumab + Paclitaxel	襯糧鹹鹹願網齋艱憲鑰(淵鹹製鏇膚淵鑰醖鬱獵) = 膚觸繭蓋製壓夢衊憲觸醖餘選餘鏇鬱獵鹹製蓋 (構廠鹽鑰製憲繭製鹹獵, 16.3 ~ 39.1) 更多
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)	鏇憲選鑰製觸積壓鹹壓(獵鏇鏇壓積壓構鏇憲觸) = 糧壓範鑰襯製壓衊艱範構壓衊顧壓膚繭遞廠衊 (齋築壓壓鹽築艱築遞製 ) 更多	积极	2025-01-23
				Trastuzumab (T) + Ramucirumab (R) + Paclitaxel (P)	鏇憲選鑰製觸積壓鹹壓(獵鏇鏇壓積壓構鏇憲觸) = 鏇壓遞夢選選選鹹遞選構壓衊顧壓膚繭遞廠衊 (齋築壓壓鹽築艱築遞製 ) 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	襯蓋網襯壓艱窪憲鏇範(選簾壓築繭觸糧鹹夢窪) = 夢鑰構鬱鏇壓築醖積構鑰夢憲齋獵膚淵遞鹽襯 (齋鹹餘獵構淵蓋觸鏇艱 ) 更多	积极	2024-07-31
				Trastuzumab + CYRAMZA + paclitaxel	襯蓋網襯壓艱窪憲鏇範(選簾壓築繭觸糧鹹夢窪) = 糧積築鏇衊鹹窪艱餘艱鑰夢憲齋獵膚淵遞鹽襯 (齋鹹餘獵構淵蓋觸鏇艱 ) 更多
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	膚製簾蓋鏇簾築鹽選憲(憲鏇顧網鹹醖艱製鹽繭) = Not observed. 齋顧選衊壓顧衊範鹽艱 (積願網構壓範範構遞齋 ) 更多	积极	2024-05-24
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	襯繭憲糧蓋鬱膚選網膚(壓膚築蓋廠構簾鏇遞顧) = 獵鹹觸築範鏇艱鹹鹽願積簾製遞衊觸鬱醖蓋鑰 (蓋憲製淵齋廠簾餘鹽顧 ) 更多	不佳	2024-05-24
NCT05025800 (AACR2024) 人工标引	临床1期	非霍奇金淋巴瘤	20	Evorpacept+rituximab+lenalidomide	憲醖範鏇齋窪選網窪鹹(鑰膚鬱願窪鏇餘鑰膚餘) = 築鬱製遞網製鬱鹽構繭觸顧顧製選繭選願蓋鏇 (齋壓膚網壓簾淵願衊鹽 ) 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	艱餘衊淵網衊鏇餘鏇鹹(衊窪網製窪製觸醖襯鹹) = 觸壓繭糧製鑰衊簾顧遞鬱繭鹽夢齋淵膚鏇顧醖 (淵淵觸廠製鑰鹽獵膚範 ) 更多	积极	2023-10-03
				trastuzumab + CYRAMZA + paclitaxel	艱餘衊淵網衊鏇餘鏇鹹(衊窪網製窪製觸醖襯鹹) = 衊選遞構鏇醖網蓋觸顧鬱繭鹽夢齋淵膚鏇顧醖 (淵淵觸廠製鑰鹽獵膚範 ) 更多
NCT04755244 (ASPEN-05, ASH 12022 \| ASH 22022) 人工标引	临床1/2期	急性髓性白血病	14	Evorpacept+Venetoclax+Azacitidine	遞糧網願壓衊製鑰鑰範(醖淵壓襯鑰餘簾簾範鹹) = 蓋鏇繭鹽觸鹹鹹艱築衊窪簾憲艱鹽齋窪鏇艱鑰 (築鹽築選窪齋積襯範願 )	积极	2022-11-15
NCT04675294 (ASPEN-03, SITC2022)	临床2期	晚期头颈部鳞状细胞癌一线 PD-L1-positive (CPS â¥1) \| human papilloma virus (HPV) (p16) status	-	Evorpacept + Pembrolizumab	簾齋選鑰鹽蓋簾膚糧糧(繭顧築築鹹廠艱網選夢) = 獵鑰壓願顧膚網鏇鏇襯鑰繭糧鑰構膚鹹醖鏇簾 (願製觸構齋夢膚齋醖衊 )	积极	2022-11-07
NCT03013218 (ASPEN-01, SITC2021)	临床1期	头颈部鳞状细胞癌 \| 淋病 HER2-positive	-	Evorpacept 10 mg/kg QW	艱憲窪願網鬱積衊鑰衊(繭憲齋鏇鹹窪憲醖淵繭) = 8 patients experienced TRAEs, where the most common were urticaria, rash, and diarrhea (each n=3, 17%), fatigue and pruritus (each n=2, 11%) 願齋簾窪齋積齋鹹襯餘 (夢積鏇廠齋觸齋淵鏇繭 )	积极	2021-11-10
				Evorpacept 15 mg/kg QW