预约演示
更新于：2026-07-22
Evorpacept
更新于：2026-07-22
概要
基本信息
药物类型 Fc融合蛋白 |
别名 CD47/SIRPa-blocking Agent ALX 148、SIRPa Variant ALX 148、ALX 148 + [2] |
靶点 |
作用方式 抑制剂 |
作用机制 CD47抑制剂(分化群47抑制剂) |
在研适应症 |
非在研适应症 |
非在研机构 |
最高研发阶段临床2/3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
Sequence Code 19364417
来源: *****
关联
13
项与 Evorpacept 相关的临床试验NCT07007559
Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
NCT05787639
Neoadjuvant Radiation and Evorpacept (ALX148) in Combination With Pembrolizumab In Patients With Previously Untreated Locally Advanced, Resectable, HPVOPC (Human Papilloma Virus Oropharynx Cancer)
NCT05467670
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
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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8
项与 Evorpacept 相关的文献（医药）2026-06-01CLINICAL CANCER RESEARCH
Zanidatamab, a Dual HER2-Targeted Bispecific Antibody, in Patients with Unresectable Locally Advanced or Metastatic HER2-Positive Salivary Gland Cancer: A Combined Analysis of Early-Phase Studies
Article
作者: Yeung, Kay T. ; Shah, Kavita V. ; Meric-Bernstam, Funda ; Doi, Toshihiko ; Lee, Keun-Wook ; Elimova, Elena ; Loro, Emanuele ; Shpektor, Diana ; Fuller, Douglas S. ; Samuel Nached, Theresa ; Beeram, Muralidhar ; Oh, Do-Youn
Abstract:
Purpose::
Human epidermal growth factor receptor 2 (HER2) overexpression occurs in various subtypes of salivary gland cancers (SGC) and can be associated with treatment challenges and poor clinical outcomes. Zanidatamab is a dual HER2-targeted, bispecific antibody that has demonstrated antitumor activity across multiple HER2-positive tumor types. This combined analysis aimed to assess the efficacy and safety of zanidatamab in HER2-positive SGC.
Patients and Methods::
Adult patients with previously treated, unresectable locally advanced or metastatic HER2-positive SGC were enrolled in three early-phase trials of zanidatamab: a first-in-human phase I study (NCT02892123), a phase I study of patients in Japan (JRCT2031210161), and a phase Ib/II study evaluating zanidatamab plus evorpacept, a high-affinity CD47 inhibitor (NCT05027139). Confirmed objective response rate (cORR) and progression-free survival (PFS) were measured in each study. Outcomes with zanidatamab monotherapy were pooled for summary analysis.
Results::
Ten patients with HER2-positive SGC were enrolled across trials; six patients were previously treated with HER2-targeted therapy. Among patients who received zanidatamab monotherapy (n = 9), seven experienced zanidatamab-related adverse events (all grade 1/2), the most common being diarrhea and infusion-related reactions. The cORR [95% confidence interval (CI)] was 44% (14%–79%), the median (95% CI) PFS was 10.1 (3.8–not estimable) months, and the median (range) duration of response was not reached (9.4 to 42.3+ months). All patients experienced a reduction in tumor size. One patient who received zanidatamab plus evorpacept experienced a confirmed partial response and 18.4 months of PFS.
Conclusions::
Although the sample size is small, these findings support the clinical benefit of zanidatamab treatment for HER2-positive SGC.
2025-11-01Cancer research communications
Phase II Clinical Trial and Preclinical Evaluation of a Novel CD47 Blockade Combination in Refractory Microsatellite-Stable Metastatic Colorectal Cancer
Article
作者: Messersmith, Wells A. ; Balmaceda, Nicole ; Hochster, Howard S. ; Van Bokhoven, Adrie ; Spencer, Kristen ; Scott, Aaron J. ; Pitts, Todd M. ; Jordan, Kimberly R. ; Binns, Cameron A. ; Bagby, Stacey M. ; Lentz, Robert W. ; Kim, Sunnie S. ; Lieu, Christopher H. ; Hu, Junxiao ; Wadlow, Raymond C. ; Dominguez, Adrian T.A. ; Davis, S. Lindsey ; Robinson, Hannah R. ; Blatchford, Patrick ; Lang, Julie ; Baiyee, Emily ; Boland, Patrick M. ; Leal, Alexis D.
Abstract:
Purpose::
In this preclinical human immune system patient-derived xenograft (HIS-PDX) model and phase II clinical trial, we assessed evorpacept (anti-CD47 engineered fusion protein with inactive Fc), cetuximab, and pembrolizumab (triple therapy) in microsatellite-stable (MSS) colorectal cancer.
Patients and Methods::
HIS BALB/c-Rag2nullIl2rγnullSirpαNOD mice with PDXs were treated with triple therapy or its components. Patients with refractory MSS colorectal cancer were treated with triple therapy in a safety run-in (stage 1) followed by expansion (stage 2, planned N = 42). The co-primary objectives were to determine the recommended dose of evorpacept and objective response rate (vs. historic control).
Results::
In HIS-PDX mice, triple therapy decreased the growth of MSS colorectal cancer tumors and increased tumor-infiltrating CD8+ T cells. Sixteen patients were treated on the clinical trial across two evorpacept dose levels: N = 12 in stage 1 and N = 4 in stage 2. Trial enrollment was terminated early because of safety concerns (one treatment-related grade 5 event each of hemophagocytic lymphohistiocytosis and cytokine release syndrome). Otherwise, the adverse event profile was as expected. Among all patients, the objective response rate was 6.3%; formal hypothesis testing was not performed. The disease control rate was 12.5%, the median progression-free survival was 2.3 months, and the median overall survival was 10.9 months. Blood- and tumor-based clinical trial correlative analyses identified innate and adaptive immune system activation.
Conclusions::
Whereas triple therapy demonstrated evidence of efficacy in refractory MSS colorectal cancer, safety concerns halted enrollment. Further investigation is necessary to determine the optimal use of CD47-targeted therapies in MSS colorectal cancer.
Significance::
Evorpacept, cetuximab, and pembrolizumab demonstrated antitumor activity in a preclinical HIS-PDX model and clinical trial in refractory MSS colorectal cancer; however, immune-related adverse events prompted early termination of study enrollment. Evidence of innate and adaptive antitumor immune activation was identified. The role of SIRPα/CD47 blockade in the treatment of MSS colorectal cancer needs to be further elucidated in future trials.
2025-10-01CLINICAL CANCER RESEARCH
A Phase I Trial of Evorpacept, Lenalidomide, and Rituximab for Patients with B-Cell Non-Hodgkin Lymphoma
Article
作者: Neelapu, Sattva S. ; McChesney, Elizabeth ; Strati, Paolo ; English, Noel ; Henderson, Jared ; Sheehan, Elizabeth ; Chihara, Dai ; Tyshevich, Andrey ; Ahmed, Sairah ; Flowers, Christopher R. ; Dent, Kylie ; Fayad, Luis E. ; Shavronskaya, Darya ; Alesse, Julia ; Syzrantsev, Nikita ; Feng, Lei ; Westin, Jason R. ; Nesmelov, Alexander ; Zhuang, Tony Z.
Abstract:
Purpose::
SIRPα+ macrophages can mediate resistance to lenalidomide and rituximab in patients with B-cell non-Hodgkin lymphoma (B-NHL). Evorpacept (ALX148) is a novel CD47 blocker that abrogates interactions between lymphoma cells and SIRPα+ macrophages.
Patients and Methods::
Adult patients with B-NHL who had received at least two prior lines of systemic therapy were included in this single-arm phase I study (NCT05025800). Evorpacept was administered intravenously, in a 28-day cycle, until progression at two dose levels (DL): 30 mg/Kg on day (D) 1 and D15 (DL1) or 60 mg/Kg on day 1 (DL2); rituximab 375 mg/m2 i.v. was given weekly during cycle 1 and on D1 during cycles 2 to 6; and lenalidomide 20 mg was given orally from D1 to D21 during cycles 1 to 6. Single-cell RNA sequencing was performed on tumor biopsies collected before treatment and during cycle 1.
Results::
Twenty patients were included in this study. The median age was 61 (27–85) years, and 18 patients (90%) had indolent B-NHL. Three patients were treated at DL1, 17 at DL2, and no dose-limiting toxicity was observed. The most common grade 3 to 4 adverse events included neutropenia (60%), infections (30%), and alanine transferase increase (15%). Sixteen (80%) patients achieved complete response, and after a median follow-up of 28 months, 2-year progression-free survival rate was 69%. During treatment, a significant increase in T cells and macrophages was observed, and macrophage pathways associated with anti-tumoral activity were upregulated.
Conclusions::
Evorpacept plus lenalidomide and rituximab has a safe toxicity profile and promising anti-tumoral activity, and induces favorable biological effects on the tumoral immune microenvironment.
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
10 条进展最快的记录, 后查看更多信息
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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 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 美国 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 日本 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 日本 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 澳大利亚 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 澳大利亚 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 比利时 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 比利时 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 捷克 | 2022-01-15 | |
| HER2表达胃腺癌 | 临床3期 | 捷克 | 2022-01-15 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 24 | 積鬱衊齋膚膚築築製窪(艱憲願鬱餘淵淵鹽鹹顧) = 製顧願壓餘鹹製構襯壓 築夢淵製積築憲築網鏇 (蓋齋獵觸膚蓋鏇鏇製憲 ) 更多 | 积极 | 2025-12-06 | |||
临床2期 | HER2阳性转移性乳腺癌 HER2-positive | 80 | 糧觸築鹹鹽膚齋膚窪構(衊醖顧鏇衊築壓蓋遞構) = 鬱壓餘鏇鏇憲鹽選艱構 壓廠願範選製繭蓋廠簾 (鹽艱範範網鏇膚壓齋艱 ) | 积极 | 2025-10-17 | ||
临床2期 | PD-L1阳性头颈部鳞状细胞癌 PD-L1 positive | 181 | 膚範襯衊憲繭範鑰鬱廠(膚廠鹽廠觸艱淵鑰膚鹽) = 築淵獵願繭築遞簾構膚 壓鬱醖襯憲衊衊選壓觸 (壓襯鹹製膚簾鹽餘鑰簾, 18.8 ~ 35.2) | 不佳 | 2025-10-17 | ||
膚範襯衊憲繭範鑰鬱廠(膚廠鹽廠觸艱淵鑰膚鹽) = 襯繭夢鏇鹽鬱願獵鏇網 壓鬱醖襯憲衊衊選壓觸 (壓襯鹹製膚簾鹽餘鑰簾 ) | |||||||
临床2期 | 165 | 艱窪齋蓋網鏇襯獵顧繭(顧網願廠願鹽鑰膚醖襯) = 簾餘願艱選壓範鹹衊齋 獵膚顧醖衊鹽餘憲餘糧 (壓築鑰廠餘築鏇窪醖願, 28.2 ~ 47.0) | 不佳 | 2025-10-17 | |||
Pembrolizumab + Chemotherapy | 艱窪齋蓋網鏇襯獵顧繭(顧網願廠願鹽鑰膚醖襯) = 憲窪觸遞艱鑰憲艱鏇選 獵膚顧醖衊鹽餘憲餘糧 (壓築鑰廠餘築鏇窪醖願, 32.0 ~ 59.4) | ||||||
临床2期 | 27 | evorpacept (Neoadjuvant SBRT) | 衊顧願窪鏇繭鏇窪簾廠(蓋糧顧積淵壓醖鹽廠製) = 遞醖鏇鬱廠選鏇鹽鹽襯 獵遞齋積鹽廠鑰製網衊 (觸夢願鹽範網憲鹹醖齋 ) | 积极 | 2025-05-30 | ||
临床1期 | 20 | 築網獵膚鹹製鏇醖網構(窪糧蓋鬱淵艱艱觸餘製) = 積膚醖願獵顧範遞窪衊 醖淵鏇衊鑰顧醖蓋淵範 (製蓋醖鹹鬱醖鑰醖鏇蓋 ) 更多 | 积极 | 2025-04-29 | |||
临床2期 | - | 鏇選鏇艱製淵獵簾獵醖(憲鏇餘獵築獵餘艱獵鏇) = Not Meet Primary Endpoints 糧繭鹽蓋壓獵艱餘願網 (繭鏇襯積獵壓觸遞網齋 ) 未达到 | 不佳 | 2025-04-25 | |||
临床2期 | - | 構獵選顧蓋製鑰範鏇鬱(窪範顧鹽繭構製齋鹽糧) = Not Meet Primary Endpoints. 壓積獵鑰醖繭繭積餘獵 (積夢襯顧繭顧鬱艱積夢 ) 未达到 | 不佳 | 2025-04-25 | |||
pembrolizumab + chemotherapy | |||||||
临床2/3期 | 127 | 獵製衊壓衊築積願鹹鹽(鹽獵窪觸餘衊繭壓衊廠) = 醖憲遞膚遞鏇繭築廠鏇 簾淵鏇範醖遞鏇鹽糧築 (糧鬱糧糧糧糧觸簾壓糧, 29.0 ~ 54.4) 更多 | 积极 | 2025-01-23 | |||
獵製衊壓衊築積願鹹鹽(鹽獵窪觸餘衊繭壓衊廠) = 構醖觸艱鏇憲廠獵糧鑰 簾淵鏇範醖遞鏇鹽糧築 (糧鬱糧糧糧糧觸簾壓糧, 16.3 ~ 39.1) 更多 | |||||||
临床2/3期 | 127 | 衊願糧鏇壓醖製網積繭(製鬱願憲鹽壓糧選衊願) = 築獵願範構蓋糧鬱壓鏇 選願糧鏇鑰積遞獵獵廠 (夢遞蓋網製壓蓋築糧願 ) 更多 | 积极 | 2025-01-23 | |||
衊願糧鏇壓醖製網積繭(製鬱願憲鹽壓糧選衊願) = 鹽齋壓繭繭願願蓋簾積 選願糧鏇鑰積遞獵獵廠 (夢遞蓋網製壓蓋築糧願 ) 更多 |
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