This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).
The names of the study drugs involved in this research study are:
* Venetoclax (a type of BCL-2 inhibitor)
* Azacitidine (a type of Demethylating Agent)
* Eganelisib (a type of PI3K-gamma inhibitor)

开始日期2026-04-13

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06533761

/ Recruiting临床1期

A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS).
The study consists of 2 parts:
* Part 1: Dose Escalation (DE) in both monotherapy and in combination.
* Part 2: Dose Optimization

开始日期2025-04-28

申办/合作机构

Stelexis Therapeutics LLC

NCT03795610

/ Completed临床2期IIT

Phase 2 Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer.
Patients will be treated with 2 weeks of IPI-549, a specific PI3K? inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.

开始日期2020-03-06

申办/合作机构

University of California San Diego

[+1]

100 项与 Eganelisib 相关的临床结果

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100 项与 Eganelisib 相关的转化医学

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100 项与 Eganelisib 相关的专利（医药）

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项与 Eganelisib 相关的文献（医药）

2026-12-31·CANCER BIOLOGY & THERAPY

PI3Kγ inhibition drives M1 macrophage differentiation and synergizes with PD-L1 blockade to improve survival in poorly immunogenic head and neck squamous cell carcinoma

Article

作者: Oghumu, Steve ; Lamenza, Felipe F. ; Mo, Xiaokui ; Roth, Peyton ; Ryan, Nathan M. ; Anderson, Kelvin ; Jordanides, Pete P. ; Jagadeesha, Sushmitha ; Kehres, Reegan ; Siddiqui, Arham ; Pracha, Sherefuddin H. ; Bopp, Anna R. ; Shrestha, Suvekshya ; Upadhaya, Puja

BACKGROUND:

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer globally with high mortality rates, highlighting the urgent need for novel therapeutic strategies. We investigated the efficacy of combining phosphoinositide 3-kinase gamma (PI3Kγ) inhibition with programmed death-ligand 1 (PD-L1) blockade in a poorly immunogenic HNSCC model.

MATERIALS AND METHODS:

Mouse bone marrow-derived macrophages (BMDMs) were differentiated and polarized in the presence or absence of the PI3Kγ inhibitor IPI-549 or culture supernatants from MOC2 cells treated with or without IPI-549. MOC2 cells were orthotopically injected into C57BL/6 mice, and treated with anti-PD-L1, IPI-549, combined anti-PD-L1 and IPI-549 or vehicle control. Tumor burden, survival, and immunological responses were evaluated.

RESULTS AND CONCLUSION:

Dual inhibition of PI3Kγ (using IPI-549) and PD-L1 demonstrated nearly significant reduction in primary tumor burden and significantly increased survival compared to single or control treatments. PI3Kγ inhibition promoted macrophage differentiation toward an antitumoral M1 phenotype. In the bone marrow, dual therapy significantly increased MHC-II expression across various myeloid cell subsets and effectively normalized myelopoiesis. Notably, combination therapy increased CD8+ T-cell infiltration into tumors while decreasing T-cell exhaustion marker (LAG-3, CTLA-4, and TIM-3) and protumoral cytokine (IL-4). Combined PI3Kγ and PD-L1 inhibition offers a promising strategy for treating poorly immunogenic HNSCC by simultaneously targeting multiple immunosuppressive mechanisms. These findings provide a strong rationale for combining PI3Kγ and PD-L1 inhibitors as a therapeutic strategy for poorly immunogenic HNSCC, potentially improving clinical outcomes for patients.

2026-10-01·INTERNATIONAL JOURNAL OF BIOCHEMISTRY & CELL BIOLOGY

Targeting PI3Kγ/AKT1-OCT4/SOX2 axis with eganelisib suppresses tumor growth and prevents ovarian failure in malignant ovarian germ cell tumors

Article

作者: Ji, Yijie ; Yi, Li ; Liu, Bingbing ; Shen, Xinghui ; Xu, Yanning ; Li, Hanbo ; Chen, Quanyu ; Chen, Ling ; Li, Shuangshuang ; Gong, Xue ; Liu, Jinzhu ; Liu, Wenbiao

OBJECTIVE:

Malignant ovarian germ cell tumors (MOGCTs) predominantly affect children and young women. Cisplatin-based chemotherapy is effective but frequently causes premature ovarian failure (POF). The PI3K/AKT pathway drives both MOGCT pathogenesis and chemotherapy-induced ovarian damage, yet no strategy simultaneously targets both. This study investigates whether the selective PI3Kγ inhibitor eganelisib can exert dual antitumor and ovarian-protective effects by modulating the AKT1-OCT4/SOX2 axis.

METHODS:

In this study, we tried to observe eganelisib antitumor effects on the human embryonal carcinoma cell line NCCIT in vitro and in vivo. Ovarian fertility was assessed by estrous cycle, hormone levels, follicular development, embryonic development, and fertility outcomes in mice treated with eganelisib compared with cisplatin. AKT1 overexpression and knockdown were performed to validate functional dependency. Protein interactions between AKT1 and OCT4/SOX2 were evaluated by co-immunoprecipitation.

RESULTS:

In vitro, eganelisib suppressed NCCIT cell proliferation, migration, invasion, and stemness via AKT1-dependent disruption of the AKT1-OCT4/SOX2 axis. In vivo, eganelisib achieved antitumor efficacy comparable to cisplatin while preserving ovarian reserve, maintaining hormone balance, and protecting fertility. Mechanistically, eganelisib upregulated PTEN and enhanced GSK3β activity in the ovary without activating stress-related FOXO3/mTOR pathways.

CONCLUSION:

Our findings suggest that selective PI3Kγ inhibition with eganelisib may partially dissociate antitumor activity from gonadotoxicity by targeting the shared AKT1-OCT4/SOX2 signaling axis. This dual-purpose strategy offers a promising mechanism-based approach for fertility-concurrent cancer therapy in young patients with MOGCTs.

2026-06-15·FASEB JOURNAL

Polyphosphates Attenuate Interleukin‐12 Production in Macrophages Infected With Legionella pneumophila

Article

作者: Echahidi, Fedoua ; Mimmler, Maximilian ; Platten, Johannes ; Bosmann, Markus ; Roewe, Julian ; Kaya, Ziya ; Zamboni, Dario S. ; Reinhardt, Christoph ; Xu, Shuang ; Kilroy, Jonathan ; Vasilew, Kara ; Josinsky, Sarah ; Jayaraman, Archana

ABSTRACT:

Polyphosphates are evolutionarily conserved linear chains of phosphate residues present in all living cells. Bacteria accumulate polyphosphates under stress and starvation for energy and phosphate storage, protein folding, and stress adaptation. During infection, bacteria release polyphosphates that may impair host responses, although the exact mechanisms remain elusive. In this study, polyphosphates were found to be elevated in bronchoalveolar lavage fluids from patients with Legionnaires' disease, in Legionella pneumophila cultured alone, or during infection of bone marrow‐derived macrophages (BMDMs) from C57BL/6J mice. We performed RNA‐sequencing of infected BMDMs co‐incubated with or without long‐chain, bacterial‐type polyphosphates. Among nearly 500 differentially expressed genes, Il12b (p40) showed the strongest suppression among highly expressed genes. IL‐12p40 protein release was dose‐dependently reduced by long‐chain polyphosphates (~P i 700), but not by short‐chain, mammalian‐type polyphosphates (~P i 70), indicating a specific bacterial mechanism targeting innate immune signaling. In contrast, IL‐18, processed by inflammasome activation and synergizing functionally with IL‐12, was not consistently suppressed. Polyphosphates predominantly inhibited LPS/TLR4 signaling, with Legionella ‐induced IL‐12 relying on the MyD88 pathway, but not TRIF. RAGE and P2Y1, previously implicated in polyphosphate biology, were not required for IL‐12 suppression. However, PI3K/AKT signaling appeared to mediate polyphosphate effects, which were reversed by the PI3K inhibitors, LY294002, copanlisib, and eganelisib. Finally, long‐chain polyphosphates suppressed IL‐12 release also from human monocyte‐derived macrophages exposed to L. pneumophila or LPS. In summary, our findings identify a selective inhibition of IL‐12 by long‐chain bacterial polyphosphates, suggesting that these molecules act as bacterial effectors capable of suppressing protective innate immune responses.

项与 Eganelisib 相关的新闻（医药）

2026-07-13

·优在生物

Nature Cancer | 巴黎大学Puissant团队创制PROTAC降解剂靶向髓系特异性PI3Kγ治疗急性髓系白血病

导语急性髓系白血病老年患者五年生存率不足10%，常规化疗耐受性差，维奈克拉单药易产生耐药。现有泛PI3K抑制剂因全身广泛靶点抑制，存在剂量限制性毒性，限制临床长期给药。髓系特异性PI3K亚型靶向策略有望降低脱靶损伤，但相关靶点依赖机制尚未完整阐明。既往PI3Kγ小分子抑制剂仅可逆阻断激酶活性，长期用药后AML细胞可通过代偿通路重启AKT信号，无法实现持久肿瘤抑制。同时学界缺少可稳定降解PI3Kγ的靶向分子，缺乏能协同维奈克拉的新型联合治疗方案，临床转化存在明显空白。 2024年1月，巴黎大学Alexandre Puissant联合杜克大学Kris C. Wood、蒙彼利埃大学Anthony R. Martin团队在Nature Cancer发表论文Targeting a Lineage-Specific PI3Kɣ/AKT Signaling Module in Acute Myeloid Leukemia Using a Heterobifunctional Degrader。该研究证实PIK3CG/PIK3R5异二聚体是AML髓系谱系特有生存靶点，阐明其持续驱动AKT通路激活的分子环路，合成首个选择性PI3Kγ双功能降解剂ARM165，验证ARM165单药及联合维奈克拉在细胞、类器官、多种小鼠模型的强效抗白血病活性，为低毒高效AML靶向治疗提供全新先导化合物与联合策略，对血液肿瘤代谢靶向药物研发具备重要参考价值。正文研究人员首先依托TCGA、GTEx、BEAT-AML公共队列数据库，结合CRISPR基因依赖谱、染色质开放组数据，系统解析PIK3CG与调控亚基PIK3R5的组织表达及AML细胞依赖特征。多组学数据显示二者仅在髓系细胞特异性高表达，单核系FAB4/5亚型患者表达水平显著上调，造血干祖细胞、淋巴系肿瘤几乎无高转录信号。敲除筛选证实，仅沉默PIK3CG或PIK3R5会大幅抑制多株AML细胞增殖与集落形成，敲除PIK3CA、PIK3CB、PIK3CD无明显杀伤效果。体内NSG移植模型验证，PIK3CG敲除白血病细胞体内负荷显著下降。互作质谱实验发现PIK3R5可结合TORC2、RTK家族蛋白，介导GPCR下游AKT1/2持续磷酸化，PIK3CG-PIK3R5复合物是AML细胞AKT通路唯一髓系特异性调控单元。进一步药物敏感性关联分析证明，PIK3CG高表达患者对维奈克拉天然耐药，基因层面抑制该二聚体可下调MCL1，显著提升维奈克拉细胞杀伤效率。为解决传统PI3Kγ可逆抑制剂药效短暂的缺陷，团队对比IPI-549、AZ2两类小分子抑制剂长效信号抑制能力，探究降解策略的独特优势。体外实验显示，AZ2处理72小时后AML细胞AKT磷酸化水平恢复至接近基线，可逆抑制无法持久阻断通路代偿激活。研究基于AZ2骨架，通过五步化学合成偶联CRBN招募配体，构建异双功能PROTAC分子ARM165。系列生化实验验证，ARM165依赖CRBN与蛋白酶体途径介导PI3Kγ完全降解，突变泛素化赖氨酸位点、敲除CRBN均可完全消除降解活性。转录组测序证实，ARM165与AZ2调控通路差异巨大，ARM165显著激活凋亡、p53通路，抑制氧化磷酸化与AKT/mTOR信号，而AZ无明显转录扰动。多株AML细胞、原代患者样本药效实验证实，ARM165增殖抑制活性远优于母药AZ2，非髓系肿瘤细胞对ARM165不敏感，具备理想谱系选择性。研究人员进一步开展体外协同实验与多层体内动物模型验证，明确ARM165联合维奈克拉的协同抗白血病潜力，并评估药物体内安全性。体外BLISS协同分析显示，ARM165与维奈克拉在9例原代患者样本均存在显著协同杀伤，该组合可大幅降低白血病干细胞频率。体内实验选用同基因Cbfb-MYH11小鼠、患者来源PDX移植模型，单药ARM165可显著降低骨髓、脾脏白血病浸润负荷，联用维奈克拉可进一步缩小肿瘤并大幅延长小鼠生存期。安全性检测提示，ARM16短期给药仅轻微影响正常造血祖细胞，无明显体重下降与严重造血毒性。机制层面，ARM165降解PI3Kγ持续阻断AKT活化，下调抗凋亡蛋白MCL1，解除AML细胞对维奈克拉的耐药屏障。研究同时指出本研究局限为ARM165水溶性与体内生物利用度不足，后续可优化分子结构推动临床前转化。 PIK3CG 降解剂 ARM165 的合成路线总结总的来说，该研究完整定义AML髓系特异性PIK3CG/PIK3R5-AKT生存轴，揭示传统可逆PI3Kγ抑制剂存在持久通路代偿缺陷，自主合成选择性PROTAC降解剂ARM165，在细胞、原代样本、多种免疫缺陷及同基因小鼠模型中验证单药及维奈克拉联合的强效抗白血病作用，证实谱系特异性蛋白降解可实现低脱靶、长效靶向抑制，同时阐明PI3Kγ-AKT-MCL1介导维奈克拉耐药的完整分子机制，梳理该先导化合物临床优化方向。该工作首次将PROTAC降解技术应用于髓系谱系依赖的急性髓系白血病靶点，突破传统激酶抑制剂耐药瓶颈，开辟血液肿瘤谱系选择性降解药物研发新思路，为老年不耐受化疗、维奈克拉耐药AML患者提供全新可联合治疗方案，同时为其他组织特异性PI3K亚型靶向药物开发提供完整研究范式。论文链接： https://www.nature.com/articles/s43018-024-00782-5 END 内容为【优在生物】公众号原创，转载请写明来源于【优在生物】版权声明：本公众号标注原创的文章系作者个人学习心得，若有版权争议或标注差错，请联系我们。免责声明：本文内容仅供学术交流参考，不构成任何建议或承诺，优在生物不对因使用本文信息导致的任何后果负责。

蛋白降解靶向嵌合体临床结果临床1期

2026-06-07

·药明康德

小分子KRAS G12D抑制剂获积极临床进展；针对多种实体瘤，创新ADC展现治疗潜力…… | 一周盘点

本期看点： 1. 在研口服选择性KRAS G12D抑制剂RNK08954用于治疗KRAS G12D突变转移性非小细胞肺癌（NSCLC）的1期临床试验获积极数据，疾病控制率（DCR）为95.7%。 2. 靶向5T4的抗体药物偶联物（ADC）JK06在5种肿瘤类型中展现治疗潜力，包括NSCLC、乳腺癌、胃癌、宫颈癌后和子宫内膜癌。 RNK08954：公布1期临床试验的初步数据珃诺生物（Ranok Therapeutics）宣布，其在研口服选择性KRAS G12D抑制剂RNK08954用于治疗KRAS G12D突变转移性NSCLC的1期临床试验获积极数据。RNK08954具有独特的药代动力学特性，旨在实现深层、持续的靶点抑制。RNK08954目前正作为单药及与化疗和/或其他靶向药物联合，针对NSCLC、胰腺导管腺癌（PDAC）及其他实体瘤患者开展临床试验。此次公布的结果显示，在转移性NSCLC患者队列（N=47）中，RNK08954表现出增强的抗肿瘤活性。在所有测试剂量下，可评估患者的客观缓解率（ORR）为42.6%，DCR为95.7%。在推荐2期剂量（RP2D）下，RNK08954的临床活性增强，未接受过紫杉烷类药物治疗的患者的ORR为50.0%。安全性方面，RNK08954耐受良好，并展现出差异化的安全性特征。 JK06：公布1/2期临床试验的新数据 Salubris Biotherapeutics公司公布了其靶向5T4的抗体药物偶联物JK06用于治疗不可切除的局部晚期或转移性实体瘤的1/2期研究最新数据。JK06是一款潜在“first-in-class”的四价双表位ADC，可选择性靶向在多种实体瘤中高表达的5T4蛋白，并携带MMAE有效载荷。该药物对5T4具有皮摩尔级亲和力，且双表位设计增强了内化作用。截至2026年5月12日，已有173名患者接受了JK06治疗，5种肿瘤类型的患者获得客观缓解。在可评估的鳞状NSCLC患者中，确认的ORR为35%（4.5 mg/kg剂量组达50%），DCR为94%；在可评估的EGFR突变NSCLC患者中，确认的ORR为43%，DCR为86%。在可评估的激素受体阳性乳腺癌和三阴性乳腺癌患者中，确认的ORR分别为30%和25%，DCR分别为60%和69%。此外，继NSCLC、乳腺癌、胃癌和宫颈癌后，在子宫内膜癌患者中也观察到1例确认的部分缓解（PR）。在安全性方面，JK06总体耐受性良好，治疗相关不良事件多为低级别且可控。 JADE101：公布1期临床试验的中期数据 Jade Biosciences公司宣布，其用于治疗IgA肾病的新型在研抗APRIL单克隆抗体JADE101在1期临床试验中取得积极的中期结果。JADE101采用超高结合亲和力设计，可选择性阻断驱动致病性IgA产生的关键因子APRIL。该1期试验是一项双盲、安慰剂对照研究，截至2026年4月14日已招募32名健康成人受试者。此次公布的结果显示，单次给药JADE101 700 mg后，IgA水平较基线平均降低70%，且该效果在12周内得以维持。模拟结果显示，在单次700 mg诱导剂量之后，采用每12周一次350 mg的皮下注射维持方案，在稳态下可实现＞70%的IgA降低。此外，观察到JADE101展现出比第一代抗APRIL单抗或双靶点抑制剂更快、更深且更持久的IgA降低效果。安全性方面，JADE101在所有评估剂量下均表现出良好的耐受性。 TTX-MC138：公布1a期临床试验的新数据 TransCode Therapeutics公司宣布，其候选疗法TTX-MC138用于治疗转移性癌症的1a期临床试验取得积极进展，并计划推进至2a期临床开发，针对完成根治性治疗后循环肿瘤DNA（ctDNA）呈阳性的结直肠癌患者。TTX-MC138旨在抑制促转移RNA——microRNA-10b，它被认为是多种晚期实体瘤转移的主要调节因子。该研究达到了主要安全性终点，未观察到剂量限制性毒性。在疗效上，根据RECIST标准评估，14名可评估患者中有9名（64%）实现了至少持续6个月的疾病稳定，其中一名转移性甲状腺癌患者病情已稳定12个月，且其肿瘤标志物（甲状腺球蛋白）水平出现显著下降。目前仍有3名患者继续留在试验中接受治疗。血浆药代动力学分析显示，该药物的生物利用度与早期临床前研究一致。 ▲接受TTX-MC138治疗患者的无进展生存率（图片来源：参考资料[21]）参考资料： [1] ReST Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for RST-101 for the Early Treatment of Post-Traumatic Stress Disorder (PTSD). Retrieved June 5, 2026, from https://secure.businesswire.com/news/home/20260527908676/en/ReST-Therapeutics-Announces-U.S.-FDA-Acceptance-of-Investigational-New-Drug-IND-Application-for-RST-101-for-the-Early-Treatment-of-Post-Traumatic-Stress-Disorder-PTSD [2] Immunocore presents updated Phase 1 data of brenetafusp in patients with heavily pretreated advanced melanoma. Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/05/31/3303917/0/en/immunocore-presents-updated-phase-1-data-of-brenetafusp-in-patients-with-heavily-pretreated-advanced-melanoma.html [3] Orion Pharma announces first results from Phase 1/2 TEADES trial with TEAD inhibitor ODM-212 in patients with advanced solid tumours. Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/05/30/3303898/0/en/orion-pharma-announces-first-results-from-phase-1-2-teades-trial-with-tead-inhibitor-odm-212-in-patients-with-advanced-solid-tumours.html [4] Tune Therapeutics Presents Positive Phase 1b/2a Proof of Concept Data on TUNE-401: a First-in-Class Epigenetic Silencer for Patients with Hepatitis B at EASL 2026. Retrieved June 5, 2026, from https://secure.businesswire.com/news/home/20260530052195/en/Tune-Therapeutics-Presents-Positive-Phase-1b2a-Proof-of-Concept-Data-on-TUNE-401-a-First-in-Class-Epigenetic-Silencer-for-Patients-with-Hepatitis-B-at-EASL-2026 [5] Salubris Biotherapeutics Announces Updated Phase 1/2 Data for JK06, a 5T4-Targeted Antibody Drug Conjugate, at the 2026 American Society of Clinical Oncology Annual Meeting. Retrieved June 5, 2026, from https://secure.businesswire.com/news/home/20260530902647/en/Salubris-Biotherapeutics-Announces-Updated-Phase-12-Data-for-JK06-a-5T4-Targeted-Antibody-Drug-Conjugate-at-the-2026-American-Society-of-Clinical-Oncology-Annual-Meeting [6] Salubris Biotherapeutics Announces Updated Phase 1/2 Data for JK06, a 5T4-Targeted Antibody Drug Conjugate, at the 2026 American Society of Clinical Oncology Annual Meeting. Retrieved June 5, 2026, from https://secure.businesswire.com/news/home/20260530902647/en/Salubris-Biotherapeutics-Announces-Updated-Phase-12-Data-for-JK06-a-5T4-Targeted-Antibody-Drug-Conjugate-at-the-2026-American-Society-of-Clinical-Oncology-Annual-Meeting [7] Kelonia Therapeutics Presents Updated First-in-Human Data from Phase 1 inMMyCAR Study of KLN-1010 in vivo BCMA CAR-T Therapy at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 5, 2026, from https://secure.businesswire.com/news/home/20260531412768/en/Kelonia-Therapeutics-Presents-Updated-First-in-Human-Data-from-Phase-1-inMMyCAR-Study-of-KLN-1010-in-vivo-BCMA-CAR-T-Therapy-at-the-2026-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting [8] Skyhawk Therapeutics Announces Twelve-Month Interim Results from Phase 1/2 Clinical Trial of SKY-0515 in Huntington's Disease. Retrieved June 5, 2026, from https://www.prnewswire.com/news-releases/skyhawk-therapeutics-announces-twelve-month-interim-results-from-phase-12-clinical-trial-of-sky-0515-in-huntingtons-disease-302786696.html [9] Voyager Receives FDA IND Clearance for VY1706, First Gene Therapy Approach to Reducing Tau Production in the Brain for Alzheimer’s Disease. Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/06/01/3304289/36461/en/voyager-receives-fda-ind-clearance-for-vy1706-first-gene-therapy-approach-to-reducing-tau-production-in-the-brain-for-alzheimer-s-disease.html [10] Iovance Biotherapeutics Announces Clearance of Investigational New Drug (IND) Application for IL-12 Tethered TIL Therapy IOV-5001. Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/06/01/3304233/0/en/iovance-biotherapeutics-announces-clearance-of-investigational-new-drug-ind-application-for-il-12-tethered-til-therapy-iov-5001.html [11] Promising Phase 1 Data for Servier's Emiltatug Ledadotin (Emi-Le) in Adenoid Cystic Carcinoma (ACC) Presented at ASCO 2026. Retrieved June 5, 2026, from https://www.prnewswire.com/news-releases/promising-phase-1-data-for-serviers-emiltatug-ledadotin-emi-le-in-adenoid-cystic-carcinoma-acc-presented-at-asco-2026-302786700.html [12] NextCure Presents Positive SIM0505 Phase 1 Dose Escalation Data in Patients with Gynecologic Cancers at ASCO 2026. Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/06/01/3304283/0/en/nextcure-presents-positive-sim0505-phase-1-dose-escalation-data-in-patients-with-gynecologic-cancers-at-asco-2026.html [13] SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO. Retrieved June 5, 2026, from https://www.prnewswire.com/news-releases/systimmune-reports-phase-1-data-for-bl-m14d1-demonstrating-promising-activity-in-small-cell-lung-cancer-at-asco-302786503.html [14] Jade Biosciences Announces Positive Interim Phase 1 Results for JADE101 Demonstrating Potential Best-in-Class Profile and Every-12-Week Dosing in IgA Nephropathy. Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/06/01/3304176/0/en/jade-biosciences-announces-positive-interim-phase-1-results-for-jade101-demonstrating-potential-best-in-class-profile-and-every-12-week-dosing-in-iga-nephropathy.html [15] Ranok Therapeutics Announces Positive Interim Phase 1 Data Of Its KRAS G12D Inhibitor RNK08954 In Patients With KRAS G12D-Mutated Metastatic Non-Small Cell Lung Cancer Presented At ASCO 2026. Retrieved June 5, 2026, from https://www.prnewswire.com/news-releases/ranok-therapeutics-announces-positive-interim-phase-1-data-of-its-kras-g12d-inhibitor-rnk08954-in-patients-with-kras-g12d-mutated-metastatic-non-small-cell-lung-cancer-presented-at-asco-2026-302786577.html [16] Aprea Therapeutics Presents Updated Phase 1 Data on WEE1 Inhibitor APR-1051 at ASCO 2026, Demonstrating Early Monotherapy Activity and Manageable Tolerability in Advanced Solid Tumors. Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/06/01/3304318/0/en/aprea-therapeutics-presents-updated-phase-1-data-on-wee1-inhibitor-apr-1051-at-asco-2026-demonstrating-early-monotherapy-activity-and-manageable-tolerability-in-advanced-solid-tumo.html [17] Avenzo Therapeutics Presents Updated Results from the Phase 1/2 Study of AVZO-021, a Potentially Differentiated CDK2 Inhibitor, at the 2026 American Society of Clinical Oncology Annual Meeting. Retrieved June 5, 2026, from https://secure.businesswire.com/news/home/20260601127731/en/Avenzo-Therapeutics-Presents-Updated-Results-from-the-Phase-12-Study-of-AVZO-021-a-Potentially-Differentiated-CDK2-Inhibitor-at-the-2026-American-Society-of-Clinical-Oncology-Annual-Meeting [18] Legend Biotech Announces Late-Breaking Oral Presentation at EHA 2026 Showcasing Initial Phase 1 In Vivo CAR-T Data with LB2501 in Non-Hodgkin Lymphoma (NHL). Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/06/02/3305321/0/en/legend-biotech-announces-late-breaking-oral-presentation-at-eha-2026-showcasing-initial-phase-1-in-vivo-car-t-data-with-lb2501-in-non-hodgkin-lymphoma-nhl.html [19] JJP Biologics Announces Positive Interim Phase 1b Data for Nebaprubart (JJP-1212), an Anti-CD89 Antagonist, in Linear IgA Disease (LAD). Retrieved June 5, 2026, from https://www.globenewswire.com/news-release/2026/06/03/3305764/0/en/jjp-biologics-announces-positive-interim-phase-1b-data-for-nebaprubart-jjp-1212-an-anti-cd89-antagonist-in-linear-iga-disease-lad.html [20] Stelexis BioSciences Announces Positive Phase 1 Data for Eganelisib in Relapsed/Refractory AML and Higher-Risk MDS in an Oral Presentation at ASCO 2026. Retrieved June 5, 2026, from https://www.prnewswire.com/news-releases/stelexis-biosciences-announces-positive-phase-1-data-for-eganelisib-in-relapsedrefractory-aml-and-higher-risk-mds-in-an-oral-presentation-at-asco-2026-302788731.html [21] TransCode Therapeutics Successfully Completes Phase 1a Clinical Trial, Reports Safety and Stabilization Data for TTX-MC138 in Metastatic Cancer. Retrieved June 5, 2026, from https://www.prnewswire.com/news-releases/transcode-therapeutics-successfully-completes-phase-1a-clinical-trial-reports-safety-and-stabilization-data-for-ttx-mc138-in-metastatic-cancer-302789380.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

2026-06-05

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Stelexis BioSciences宣布eganelisib治疗复发/难治性急性髓系白血病（AML）及高危骨髓增生异常综合征（MDS）的1期临床数据积极，相关结果将于2026年ASCO年会上作口头报告Stelexis BioSciences Announces Positive Phase 1 Data for Eganelisib in Relapsed/Refractory AML and Higher-Risk MDS in an Oral Presentation at ASCO 2026

Eganelisib induced complete remissions and hematologic improvements as a single-agent via myeloid differentiation in a Phase 1 study in relapsed/refractory patients with myeloid malignancies (MDS/AML) who show high expression of PI3K-gamma in bone marrow blasts. 在一项针对骨髓原始细胞PI3K-γ高表达的复发/难治性髓系恶性肿瘤（MDS/AML）患者的1期研究中，艾加列司布作为单药通过髓系分化诱导了完全缓解与血液学改善。The improved overall survival in patients with high expression of PI3K-gamma in this Phase 1 study is internally consistent with the observed responses and is externally validated by the TCGA database, which suggests a poor prognosis for patients with high expression of PI3K-gamma. 本项I期研究中，PI3K-γ高表达患者总生存期的改善与观察到的疗效在内部保持一致，并得到了TCGA数据库的外部验证，该数据库表明PI3K-γ高表达患者预后较差。Eganelisib generated a striking efficacy signal while demonstrating a favorable safety and tolerability profile in this Phase 1 study. 在这项1期研究中，Eganelisib显示出显著的疗效信号，同时展现出良好的安全性和耐受性。WALTHAM, Mass. 沃尔瑟姆，马萨诸塞州, ，June 2, 2026 2026年6月2日/PRNewswire/ -- Stelexis BioSciences, Inc. (Stelexis) today announced results from a Phase 1 clinical trial (NCT06533761) of eganelisib, an oral, first-in-class PI3K-gamma inhibitor, in 21 patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS). /美通社/ -- Stelexis BioSciences公司（Stelexis）今日公布了eganelisib（一种口服、首创的PI3K-γ抑制剂）在一项针对21例复发/难治性（R/R）急性髓系白血病（AML）或高危骨髓增生异常综合征（HR-MDS）患者的1期临床试验（NCT06533761）中的结果。The data were presented in an oral session at the 2026 ASCO Annual Meeting by Mendel Goldfinger, M.D., of Montefiore Einstein Comprehensive Cancer Center.. 这些数据由来自蒙蒂菲奥里爱因斯坦综合癌症中心的门德尔·戈尔德芬格（Mendel Goldfinger）医学博士在2026年美国临床肿瘤学会（ASCO）年会口头报告环节中进行展示。Key Findings 主要发现The trial recruited a heavily pretreated patient population that was uniformly characterized by features that convey an unfavorable prognosis: 该试验招募的患者人群均接受过大量既往治疗，且均具有提示预后不良的特征：29% TP53-deleted or -mutated 29% TP53缺失或突变90% abnormal cytogenetics 90% 细胞遗传学异常76% received more than two prior therapies 76%接受过两种以上既往治疗。76% received prior venetoclax 76% 既往接受过维奈克拉治疗A modified objective response rate (defined as CR + Stable Disease with neutrophil count improvement) was achieved in: 改良客观缓解率（定义为CR+伴中性粒细胞计数改善的疾病稳定）在……中达到：50% (6/12) of patients with high PI3K-gamma expression vs. 50%（6/12）的PI3K-γ高表达患者与……相比0% (0/8) of patients with low PI3K-gamma expression (p<0.05, Fisher's exact test), using immunohistochemical staining of bone marrow biopsies 通过对骨髓活检标本进行免疫组织化学染色，0%（0/8）的患者呈低 PI3K-γ 表达（p<0.05，Fisher精确检验）。Responses included molecular and major cytogenetic remissions in two patients in CR 应答包括2例完全缓解（CR）患者达到分子学缓解和主要细胞遗传学缓解。Five of six responding patients had severe or life-threatening neutropenia at baseline, and all five patients demonstrated rapid neutrophil count improvements, including a rapid 六名有应答的患者中有五名在基线时患有重度或危及生命的中性粒细胞减少症，且这五名患者均表现出中性粒细胞计数的快速改善，包括快速的normalization 标准化（或归一化/规范化/正常化，视具体领域而定）of neutrophil counts in four patients, consistent with induction of myeloid differentiation ……四名患者的中性粒细胞计数，与诱导髓系分化一致Median overall survival (OS) was 27 weeks in PI3K-gamma-high patients vs. 9.9 weeks in low expressors (HR 0.22; 95% CI 0.07–0.75) PI3K-γ高表达患者的中位总生存期（OS）为27周，而低表达患者为9.9周（HR 0.22；95% CI 0.07–0.75）。Based on historical patient data from the publicly available TCGA database, PI3K-gamma-high expression is an adverse prognostic factor for OS in patients receiving conventional therapy, thereby supporting a substantial clinical benefit observed following treatment with eganelisib in this study. 基于公开的TCGA数据库历史患者数据，在接受常规治疗的患者中，PI3K-γ高表达是总生存期（OS）的不良预后因素，从而印证了本研究中观察到的eganelisib治疗所获得的显著临床获益。Eganelisib was well tolerated at both dose levels (45 mg and 60 mg, once daily) with no dose-limiting toxicities and no intrinsic hematologic toxicity. This is consistent with the myeloid-restricted expression of PI3K-gamma, and with the observation that PI3K-gamma is dispensable for normal hematopoiesis (Gu et al., Blood 2024).. Eganelisib在两种剂量水平（45 mg和60 mg，每日一次）下均表现出良好的耐受性，未出现剂量限制性毒性，亦无固有的血液学毒性。这与PI3K-γ的髓系限制性表达相符，并与PI3K-γ对正常造血非必需的观察结果一致（Gu等，《Blood》2024）。The majority of adverse events in this study were disease-related rather than treatment-related, consistent with the underlying patient population. Treatment-related AEs were predominantly low-grade with no Grade 5 related AEs. Of note, no eganelisib-related SAEs were observed and no patient discontinued treatment due to an eganelisib-related AE.. 本研究中大多数不良事件与疾病相关而非与治疗相关，这与该患者人群的特征相符。治疗相关不良事件主要为低级别，且无5级相关不良事件。值得注意的是，未观察到与伊加奈利西布（eganelisib）相关的严重不良事件，且无患者因伊加奈利西布相关不良事件而终止治疗。Published outcomes for patients with relapsed/refractory disease who failed frontline venetoclax and hypomethylating agent therapy have shown a median overall survival of approximately 2.4 months (Maiti et al., Haematologica 2021), underscoring the high unmet need in this population. 已发表的针对一线维奈克拉联合去甲基化药物治疗失败的复发/难治性疾病患者的数据显示，其中位总生存期约为2.4个月（Maiti等，《Haematologica》2021），这凸显了该人群巨大的未满足临床需求。'The preliminary data generated by eganelisib in patients with heavily pretreated AML and higher-risk MDS is encouraging,' said Konstantinos N. Aprilakis, M.D., Board Member at Stelexis and Partner at Deerfield Management. 'In addition to a favorable safety and tolerability profile, Stelexis has observed evidence of biologic and clinical activity for eganelisib in a particularly difficult-to-treat patient population. “eganelisib在经多线前期治疗的急性髓系白血病（AML）和高危骨髓增生异常综合征（MDS）患者中取得的初步数据令人鼓舞，”Stelexis董事会成员兼Deerfield Management合伙人康斯坦丁诺斯·N·阿普里拉基斯医学博士表示。“除具备良好的安全性和耐受性外，Stelexis还在这一治疗难度极高的患者群体中，观察到了eganelisib具有生物学和临床活性的证据。”I am especially delighted that Stelexis has identified a biomarker that may be used to identify patients most likely to benefit from treatment with eganelisib. These clinical data suggest that eganelisib has the potential to be effective across multiple hematologic malignancies of high unmet need.'. 我尤为欣喜的是，Stelexis 已发现一种生物标志物，可用于识别最有可能从 eganelisib 治疗中获益的患者。这些临床数据表明，eganelisib 有望在多种高度未满足临床需求的血液系统恶性肿瘤中展现疗效。'For nearly 20 years now, the field has been searching for therapies that offer a better prognosis to MDS-patients than hypomethylating agents alone. For far too long, clinicians had to primarily rely on classifying and selecting patients for investigational treatment based on prognostic scores or bone marrow blast counts, alone. 近20年来，该领域一直在寻求能为MDS患者提供优于单用去甲基化药物预后的治疗方案。长期以来，临床医生在分类和筛选患者接受试验性治疗时，往往只能单纯依赖预后评分或骨髓原始细胞计数。It is time we begin to classify patients based on disease-specific, functional, biological vulnerabilities and offer therapies that selectively target those biological vulnerabilities' said Manuel Aivado, MD, PhD, President and Chief Executive Officer of Stelexis BioSciences. 'We believe that myeloid malignancies may find in PI3K-gamma an analog to HER2 in breast cancer, and we are thrilled that the ground-breaking discoveries of our co-founders have paved Stelexis' way to this doorstep.'. Stelexis BioSciences 总裁兼首席执行官 Manuel Aivado 医学博士、哲学博士表示：“是时候开始根据疾病特异性、功能性和生物学脆弱性对患者进行分类，并提供能够选择性靶向这些生物学脆弱性的疗法了。我们认为，PI3K-γ 有望成为髓系恶性肿瘤中类似于乳腺癌 HER2 的靶点。我们深感振奋，联合创始人的突破性发现已为 Stelexis 铺平了通往这一目标的大门。”Based on these results, Stelexis plans to advance eganelisib into a randomized expansion cohort with hypomethylating agents in treatment-naïve, PI3K-gamma-high MDS patients with an IPSS-R category of intermediate, high, or very-high risk or with CMML-2. 基于上述结果，Stelexis计划将eganelisib推进至一项随机扩展队列研究，联合去甲基化药物，用于治疗初治、PI3Kγ高表达且IPSS-R风险分层为中危、高危或极高危的骨髓增生异常综合征（MDS）患者，或慢性粒单核细胞白血病2型（CMML-2）患者。About Eganelisib 关于艾加尼利西布Eganelisib is a first-in-class, oral, highly potent, and isoform-selective inhibitor of PI3K-gamma, the myeloid-restricted isoform of the PI3K kinase family. PI3K-gamma is dispensable in normal hematopoiesis and lymphocytes, differentiating it from delta-class PI3K inhibitors that have been associated with significant immune-mediated adverse events.. Eganelisib 是一种同类首创的口服、高效且具有亚型选择性的 PI3K-γ 抑制剂，PI3K-γ 为 PI3K 激酶家族中的髓系限制性亚型。PI3K-γ 在正常造血和淋巴细胞中并非必需，这一特性使其区别于已知会引发严重免疫介导不良反应的 PI3K-δ 抑制剂。In myeloid malignancies, PI3K-gamma signaling reinforces the differentiation block characteristic of AML and higher-risk MDS through PAK1, identifying PI3K-gamma as a therapeutic target whose inhibition can re-engage myeloid differentiation without imposing intrinsic myelosuppression or lymphoid toxicity.. 在髓系恶性肿瘤中，PI3K-γ信号通路通过PAK1强化了急性髓系白血病（AML）和较高危骨髓增生异常综合征（MDS）特征性的分化阻滞，表明PI3K-γ是一个治疗靶点，抑制该靶点可在不引起固有骨髓抑制或淋巴细胞毒性的情况下重新激活髓系分化。About Stelexis 关于 StelexisStelexis BioSciences, Inc. is a privately held clinical-stage biopharmaceutical company developing targeted therapies for myeloid malignancies. Stelexis was founded by Deerfield Management and is headquartered in Waltham, Massachusetts. Stelexis BioSciences, Inc. 是一家私营的临床阶段生物制药公司，致力于开发针对髓系恶性肿瘤的靶向疗法。Stelexis 由 Deerfield Management 创立，总部位于马萨诸塞州沃尔瑟姆。Stelexis' Co-Founders discovered that PAK1 is a key kinase maintaining the malignant stem cell phenotype responsible for the maturation block in patients with MDS or AML (Pandolfi et al., Blood 2015), later they identified PI3K-gamma as a core vulnerability in myeloid malignancies, and eventually showed that eganelisib-mediated inhibition of PI3K-gamma acts via inhibition of PAK1 to exert its therapeutic effects (Luo et al., Nature 2024).. Stelexis的联合创始人发现，PAK1是一种关键激酶，负责维持导致MDS或AML患者成熟阻滞的恶性干细胞表型（Pandolfi等，《Blood》2015）；随后，他们鉴定出PI3K-gamma是髓系恶性肿瘤的核心脆弱性，并最终证明，eganelisib介导的PI3K-gamma抑制是通过抑制PAK1来发挥治疗作用的（Luo等，《Nature》2024）。Stelexis is advancing eganelisib as a first-in-class treatment for HR-MDS and AML, and Stelexis is developing a potential best-in-class anti-IL-1RAP antibody for the treatment of Lower-Risk MDS, and other indications. Stelexis正在推进eganelisib作为治疗HR-MDS和AML的同类首创药物，同时Stelexis正在开发一种潜在的同类型最优抗IL-1RAP抗体，用于治疗低危MDS及其他适应症。For more information, please visit 如需更多信息，请访问www.stelexis.com www.stelexis.com. 。SOURCE Stelexis BioSciences, Inc. 来源：Stelexis BioSciences, Inc.21 二十一% 百分号more press release views with 通过……获得更多新闻稿浏览量Request a Demo 申请演示

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KEGG	Wiki	ATC	Drug Bank
D11896	Eganelisib	-	DB16296

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
晚期头颈癌	临床2期	美国	University of California San Diego	2020-03-06
HPV相关鳞状细胞癌	临床2期	美国	University of California San Diego	2020-03-06
局部晚期头颈部鳞状细胞癌	临床2期	美国	University of California San Diego	2020-03-06
局部晚期透明细胞肾细胞癌	临床2期	美国	Infinity Pharmaceuticals, Inc.	2019-12-17
转移性透明细胞性肾细胞癌	临床2期	美国	Infinity Pharmaceuticals, Inc.	2019-12-17
三阴性乳腺癌	临床2期	美国	Infinity Pharmaceuticals, Inc.	2019-12-17
晚期癌症	临床2期	美国	Infinity Pharmaceuticals, Inc.	2019-09-25
晚期癌症	临床2期	捷克	Infinity Pharmaceuticals, Inc.	2019-09-25
晚期癌症	临床2期	法国	Infinity Pharmaceuticals, Inc.	2019-09-25
晚期癌症	临床2期	意大利	Infinity Pharmaceuticals, Inc.	2019-09-25

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临床结果

适应症

分期

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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


NCT06533761 (ASCO2026)	临床1期	急性髓性白血病 \| 高危骨髓增生异常综合征 TP53 mutation	15	Eganelisib 45 mg	願襯壓繭鬱簾廠淵構鹹(製鹹顧築窪簾範鹹鬱選) = 鏇淵餘鹽選廠醖壓淵餘廠壓製壓簾簾積衊淵願 (鑰範齋鏇遞顧獵築築鬱 )	积极	2026-05-29
NCT03795610 (CTgov)	临床2期	晚期头颈癌 \| HPV相关鳞状细胞癌 \| 局部晚期头颈部鳞状细胞癌	16	IPI-549	觸顧廠齋鏇襯壓糧醖鏇 = 簾糧選鏇鑰齋築齋蓋艱夢壓簾鑰窪糧衊繭顧鑰 (繭餘蓋鹹壓範積廠廠範, 積構願糧齋遞獵淵遞選 ~ 願糧顧夢簾願糧夢製範) 更多	-	2025-07-25
MARIO-3 (SABCS2022)	临床2期	三阴性乳腺癌一线 PD-L1 positive	43	Eganelisib 30 mg + Atezolizumab + Nab-paclitaxel	鑰窪廠構繭鏇獵醖窪獵(範鹽選襯鏇觸膚繭淵選) = 獵鏇淵築願齋簾顧齋構選鏇餘鹹餘顧鑰夢壓壓 (鏇鏇遞蓋願窪積鏇網構 ) 更多	积极	2022-02-15
NCT03961698 (MARIO-3, Corporate Publications) 人工标引	临床2期	三阴性乳腺癌 \| 尿路上皮癌一线 Triple Negative	49	Atezolizumab+Albumin-Bound Paclitaxel+Eganelisib	鬱襯簾網餘夢廠糧製艱(製壓網範窪獵觸鏇醖淵) = 積遞繭壓衊鹹選襯鹹廠鏇齋範憲餘顧鬱醖築淵 (鹽願鹽齋糧蓋齋艱蓋鹽 ) 更多	积极	2021-07-27
NCT03980041 (MARIO-275, Corporate Publications) 人工标引	临床2期	三阴性乳腺癌 \| 尿路上皮癌 Triple Negative	49	Nivolumab+Placebo	願鑰夢選顧衊夢艱鏇艱(艱餘觸鬱願願醖網糧選) = the most common ≥Grade 3 TEAEs across all doses, all causality, were disease progression (27.3%), anemia (12.1%), and hepatic AEs including hepatotoxicity (15.2%), increased ALT (12.1%) and increased AST (12.1%) with no Hy’s Law. 蓋餘鑰範窪齋廠醖範夢 (獵繭蓋鹽窪蓋網廠鹹網 ) 更多	积极	2021-07-27
NCT03980041 (MARIO-275, Corporate Publications) 人工标引	临床2期	三阴性乳腺癌 \| 尿路上皮癌 Triple Negative	49	Nivolumab+eganelisib		积极	2021-07-27
NCT03980041 (MARIO-275, ASCO_GU 12021 \| ASCO_GU 22021) 人工标引	临床2期	晚期尿路上皮癌	-	nivolumab+IPI 549	糧鑰壓夢齋積膚壓膚範(鬱築醖繭遞積繭齋廠衊) = 鏇鏇繭構艱築餘糧範鹽選蓋餘窪顧醖鏇夢壓醖 (簾壓憲醖獵鹹積淵壓選 ) 更多	积极	2021-02-20
NCT03980041 (MARIO-275, ASCO_GU 12021 \| ASCO_GU 22021) 人工标引	临床2期	晚期尿路上皮癌	-	placebo+nivolumab	糧鑰壓夢齋積膚壓膚範(鬱築醖繭遞積繭齋廠衊) = 範簾鏇簾構蓋衊膚獵築選蓋餘窪顧醖鏇夢壓醖 (簾壓憲醖獵鹹積淵壓選, 1 ~ 91) 更多	积极	2021-02-20
NCT03719326 (ARC-2, AACR2021) 人工标引	临床1期	卵巢癌 \| 转移性三阴性乳腺癌	29	AB928 150 mg + pegylated liposomal doxorubicin (Doublet)	餘廠範顧糧夢繭簾遞廠(製窪鑰淵壓觸糧積顧廠) = Four pts reported 6 Gr ≥3 SAEs 蓋鑰製糧鬱選積範憲網 (網鹹鹽網積壓繭顧網範 ) 更多	积极	2021-02-15
NCT03719326 (ARC-2, AACR2021) 人工标引	临床1期	卵巢癌 \| 转移性三阴性乳腺癌	29	IPI-549 40 mg + AB928 150 mg + pegylated liposomal doxorubicin (Triplet)		积极	2021-02-15
NCT03961698 (Mario-3, SABCS2021)	临床2期	三阴性乳腺癌一线	6	Eganelisib 30 mg	糧築築獵觸廠蓋鏇淵膚(鑰襯遞鹽觸齋觸淵鏇製) = 鏇顧繭醖顧簾餘積醖蓋鏇膚艱鑰遞鹹製艱餘餘 (網網蓋選餘網窪壓鏇鹽 )	积极	2021-02-15
NCT02637531 (IPI-549-01, SITC2020)	临床1期	头颈部鳞状细胞癌	180	Eganelisib 40 mg QD PO + Nivolumab 240 mg Q2W IV	網範鑰膚鬱選憲淵窪簾(蓋簾廠築醖憲範範憲簾) = 22.8% of patients experienced anemia 遞鹹醖範鏇繭衊顧選顧 (窪淵簾觸獵網夢膚蓋廠 ) 更多	积极	2020-12-10
NCT02637531 (IPI-549-01, SITC2020)	临床1期	黑色素瘤	180	Eganelisib 40 mg	餘廠廠衊衊襯蓋範壓願(製選繭遞願蓋選壓鹹夢) = 22.8% of patients treated with eganelisib + nivolumab experienced anemia 繭醖製廠遞築鹽廠鏇壓 (膚憲願網願醖壓網構鑰 ) 更多	积极	2020-11-09