A Phase I/II Open-Label, Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to an Approved JAK Inhibitors (HEMA-MED)

The goal of this clinical trial is to learn how roginolisib works in comparison to standard treatment in adult patients with Myelofibrosis. The main questions it aims to answer is to evaluate the safety and tolerability of roginolisib when administered in combination with ruxolitinib.

开始日期2025-11-17

申办/合作机构

iOnctura SA

NCT07018752

/ Recruiting临床1/2期IIT

A Platform Trial, Evaluating New Drugs or Combination in Relapsed or Refractory Peripheral T-cell Lymphomas

This study is a platform trial for the evaluation of new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas.
The objective of the study is to generate exploratory data on new drugs or combination of drugs to treat refractory/relapse peripheral T-cells lymphoma to better identify the population of interest and design future correct clinical trials.
Primary objectives of the different sub-studies :
* phase 1 sub-studies: determine the safety and tolerability of escalating doses of the sub-study treatment
* phase 2 sub-studies: identify drugs that will improve significantly the outcome in target patients Secondary objectives of both sub-studies: analyze the response rate, the clinical benefit rate, the progression-free survival, the duration of response, the time to next treatment or death, the overall survival, the rate of transplantation following study treatment and the safety profile of the drugs used

开始日期2025-08-20

申办/合作机构

Le LYSARC

[+3]

100 项与 Roginolisib 相关的临床结果

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100 项与 Roginolisib 相关的转化医学

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100 项与 Roginolisib 相关的专利（医药）

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项与 Roginolisib 相关的文献（医药）

2024-07-22·Journal of Chemical Information and Modeling

Challenging Complexity with Simplicity: Rethinking the Role of Single-Step Models in Computer-Aided Synthesis Planning

Article

作者: Lai, Luhua ; Lin, Kangjie ; Pei, Jianfeng ; Li, Junren

Computer-assisted synthesis planning has become increasingly important in drug discovery. While deep-learning models have shown remarkable progress in achieving high accuracies for single-step retrosynthetic predictions, their performances in retrosynthetic route planning need to be checked. This study compares the intricate single-step models with a straightforward template enumeration approach for retrosynthetic route planning on a real-world drug molecule data set. Despite the superior single-step accuracy of advanced models, the template enumeration method with a heuristic-based retrosynthesis knowledge score was found to surpass them in efficiency in searching the reaction space, achieving a higher or comparable solve rate within the same time frame. This counterintuitive result underscores the importance of efficiency and retrosynthesis knowledge in retrosynthesis route planning and suggests that future research should incorporate a simple template enumeration as a benchmark. It also suggests that this simple yet effective strategy should be considered alongside more complex models to better cater to the practical needs of computer-assisted synthesis planning in drug discovery.

2024-05-01·Translational oncology

The highly selective and oral phosphoinositide 3-kinase delta (PI3K-δ) inhibitor roginolisib induces apoptosis in mesothelioma cells and increases immune effector cell composition

Article

作者: Joanna Kopecka ; Karolina Niewola-Staszkowska ; Francesca Finotello ; Roger Falkenstern-Ge ; German Ott ; Michael Lahn ; Lars van der Veen ; Julia Schüler ; Chiara Riganti ; Giusy Di Conza ; Claudia Kalla

Targeting aberrantly expressed kinases in malignant pleural mesothelioma (MPM) is a promising therapeutic strategy. We here investigated the effect of the novel and highly selective Phosphoinositide 3-kinase delta (PI3K-δ) inhibitor roginolisib (IOA-244) on MPM cells and on the immune cells in MPM microenvironment. To this aim, we analyzed the expression of PI3K-δ by immunohistochemistry in specimens from primary MPM, cell viability and death in three different MPM cell lines treated with roginolisib alone and in combination with ipatasertib (AKT inhibitor) and sapanisertib (mTOR inhibitor). In a co-culture model of patient-derived MPM cells, autologous peripheral blood mononuclear cells and fibroblasts, the tumor cell viability and changes in immune cell composition were investigated after treatment of roginolisib with nivolumab and cisplatin. PI3K-δ was detected in 66/89 (74%) MPM tumors and was associated with reduced overall survival (12 vs. 25 months, P=0.0452). Roginolisib induced apoptosis in MPM cells and enhanced the anti-tumor efficacy of AKT and mTOR kinase inhibitors by suppressing PI3K-δ/AKT/mTOR and ERK1/2 signaling. Furthermore, the combination of roginolisib with chemotherapy and immunotherapy re-balanced the immune cell composition, increasing effector T-cells and reducing immune suppressive cells. Overall, roginolisib induces apoptosis in MPM cells and increases the antitumor immune cell effector function when combined with nivolumab and cisplatin. These results provide first insights on the potential of roginolisib as a therapeutic agent in patients with MPM and its potential in combination with established immunotherapy regimen.

2023-12-01·International journal of toxicology

Non-Clinical Toxicology Evaluation of the Novel Non-ATP Competitive Oral PI3 Kinase Delta Inhibitor Roginolisib

Article

作者: Deken, Marcel A. ; Lahn, Michael ; van der Veen, Lars ; Schmitt, Michael

Roginolisib (IOA-244) is a novel, non-ATP competitive phosphoinositide-3-kinase (PI3K) delta inhibitor that regulates Akt/mTOR signaling. Roginolisib was administered once daily to rats and dogs in dose-range finding (DRF) and 4-week GLP toxicology studies. Free plasma levels of roginolisib exceeded the cellular target engagement IC90 for PI3Kδ for ≥12 hours at doses of 5 mg/kg, the IC90 for PI3Kβ for ≥2 hours at doses ≥15 mg/kg, and the IC50 for PI3Kα for ≥2 hours at dose levels ≥45 mg/kg. Toxicity in rats occurred at doses ≥100 mg/kg. In dogs, we observed dose-dependent skin and gastrointestinal toxicity and doses ≥30 mg/kg had a greater incidence of mortality. Lymphoid tissue toxicity occurred in both species. Toxicities in dogs observed at the ≥15 mg/kg dose, affecting the digestive mucosa, liver, and skin, cleared after treatment cessation. Doses ≤75 mg/kg were tolerated in rats and the no-observed-adverse-effect-level (NOAEL) in rats was 15 mg/kg. Due to mainly epithelial lesions of the skin at 5 mg/kg and necrotizing damage of the intestinal epithelia at ≥15 mg/kg, no NOAEL was determined in dogs. However, the adverse effects observed in dogs at 5 mg/kg were considered monitorable and reversible in patients with advanced malignancies. Furthermore, the PK profile subsequently proved to be a decisive factor for achieving selective PI3Kδ inhibition without the toxicities observed in dogs. As the result of the unique PK profile of roginolisib, patients were able to take daily roginolisib without dose modification and showed pharmacodynamic PI3Kδ inhibition over several months without gastrointestinal or dermatologic toxicities.

项与 Roginolisib 相关的新闻（医药）

2026-02-04

·动脉网

瑞士生物技术公司获得两项出版物和FDA快速通道指定Two publications and an FDA fast track designation for Swiss biotechs

MoonLake Immunotherapeutics has received FDA Fast Track designation for the treatment of palmoplantar pustulosis with its novel IL-17 inhibitor, speeding up drug development. Meanwhile, Alys Pharmaceuticals and iOnctura both published high-impact papers confirming the potential of their lead assets.. MoonLake Immunotherapeutics公司已获得FDA快速通道资格，用于其新型IL-17抑制剂治疗掌跖脓疱病，加速了药物开发。同时，Alys Pharmaceuticals和iOnctura均发表了高影响力论文，证实了各自核心资产的潜力。MoonLake Immunotherapeutics 月湖免疫治疗公司, a clinical-stage biopharmaceutical company focused on developing advanced therapies for inflammatory diseases, announced that its lead asset, sonelokimab, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe palmoplantar pustulosis (PPP), a chronic inflammatory skin disease. ，一家专注于开发炎症性疾病先进疗法的临床阶段生物制药公司，宣布其主要资产 sonelokimab 已获得美国食品药品监督管理局（FDA）快速通道资格，用于治疗中度至重度掌跖脓疱病（PPP），一种慢性炎症性皮肤病。The designation was granted following positive results from the Phase 2 LEDA trial. FDA Fast Track is intended to facilitate the development and expedite the review of new therapies for serious conditions where there is an unmet medical need.. 该指定是在第二阶段LEDA试验取得积极结果后授予的。FDA快速通道旨在促进严重疾病新疗法的开发，并加速对未满足医疗需求的疗法的审查。Sonelokimab (M1095) is an investigational 40 kDa humanized Nanobody® consisting of three heavy-chain-only antibodies covalently linked by flexible glycine-serine spacers, able to inhibit interleukin-17 (IL-17), a major inflammatory driver. Nanobodies® represent a new generation of antibody-derived targeted therapies. Sonelokimab（M1095）是一种研究中的40 kDa人源化纳米抗体®，由三个仅含重链的抗体通过柔性的甘氨酸-丝氨酸间隔区共价连接而成，能够抑制白细胞介素-17（IL-17），这是一种主要的炎症驱动因子。纳米抗体®代表了新一代的抗体衍生靶向疗法。They have several advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations.. 它们相比传统抗体有几个优势，包括体积小、组织穿透力强、抗温度变化、易于制造，以及能够被设计成具有定制靶点组合的多价治疗分子。Two high-impact papers published 两篇高影响力的论文发表Alys Pharmaceuticals 艾丽斯制药公司, which is focused on immuno-dermatology, has announced a recent publication in ，该公司专注于免疫皮肤病学，宣布了最近在某个刊物上的发表。Nature Communications 自然通讯featuring encouraging data from their lead asset ALY-101, a small interfering RNA (siRNA)-lipid conjugate. The paper demonstrates that the siRNA remains durable in the skin for over two months, highlighting its strong therapeutic potential. ALY-101 is currently in Phase 2a clinical trials for the treatment of patchy alopecia areata, a chronic autoimmune disease that causes hair to fall out.. 主打产品ALY-101（一种小干扰RNA（siRNA）-脂质结合物）的鼓舞人心的数据。本文展示了该siRNA在皮肤中能持续两个月以上，突显了其强大的治疗潜力。ALY-101目前正处于治疗斑块型斑秃的2a期临床试验阶段，斑秃是一种导致脱发的慢性自身免疫性疾病。Dedicated to combating neglected and hard-to-treat cancers, 致力于对抗被忽视和难以治疗的癌症，iOnctura 离子肿瘤学is developing new treatments with precision oral small molecules that target cancers in novel ways. The company recently published encouraging results on their lead asset roginolisib, a novel allosteric modulator of PI3Kδ in 正在开发以精确口腔小分子治疗癌症的新方法。该公司最近发布了其主要资产 roginolisib（一种新型的 PI3Kδ 别构调节剂）的鼓舞人心的结果。Molecular Oncology 分子肿瘤学. The paper provides an in‑depth look at the unique biology and differentiated mechanism of roginolisib, reinforcing its potential to deliver meaningful anti‑tumor activity without the immune‑related toxicities traditionally associated with PI3Kδ inhibition. 本文深入探讨了roginolisib的独特生物学特性及其差异化作用机制，进一步证实其在不产生与PI3Kδ抑制相关的免疫毒性的情况下，具有显著抗肿瘤活性的潜力。Roginolisib is now being evaluated across a broad clinical program, including a randomized Phase II study in uveal melanoma (UM), randomized Phase I/II trials in non‑small cell lung cancer (NSCLC) and CLL, and additional Phase I/II studies in myelofibrosis and peripheral T‑cell lymphoma (PTCL). More than 170 patients have been treated so far.. Roginolisib 目前正在广泛的临床项目中进行评估，包括在葡萄膜黑色素瘤 (UM) 中的随机 II 期研究、在非小细胞肺癌 (NSCLC) 和慢性淋巴细胞白血病 (CLL) 中的随机 I/II 期试验，以及在骨髓纤维化和外周 T 细胞淋巴瘤 (PTCL) 中的其他 I/II 期研究。迄今为止，已有超过 170 名患者接受了治疗。(Press release/AJ) （新闻稿/AJ）0 0Comments 评论Back to all news 返回所有新闻 Please 请login 登录or 或sign up 注册to comment. 评论。Commenting guidelines 评论指南 Send 发送

快速通道siRNA

2026-01-09

·PRNewswire

iOnctura CEO to present at the 2026 J.P. Morgan Healthcare Conference

Participation underscores growing excitement around company's momentum and potential in precision oncology GENEVA, AMSTERDAM and CAMBRIDGE, Mass., Jan. 9, 2026 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company developing precision oral small molecules for neglected and hard-to-treat cancers, today announces that its Chief Executive Officer, Catherine Pickering, will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12–15, 2026, in San Francisco, California. Dr. Pickering will present on Thursday, January 15, 2026 at 11:00 PST. The presentation will highlight iOnctura's clinical progress with a focus on its lead program, roginolisib, the first allosteric modulator of PI3Kδ. Recognized as the world's largest and most influential healthcare investment conference, the J.P. Morgan Healthcare Conference is an invite-only event that serves as a vital forum for innovation and capital formation across the pharmaceutical and biotechnology sectors. Participation reflects iOnctura's growing visibility within the global oncology ecosystem and underscores the company's progress towards advancing transformative targeted therapies for patients with cancer. "We are honored to be invited to present at this year's J.P. Morgan Healthcare Conference," said Catherine Pickering, CEO and co-founder of iOnctura. "This recognition reflects the increasing interest in our science-driven approach and the meaningful clinical advances we have achieved with roginolisib. We look forward to sharing our progress and engaging with partners committed to transforming cancer care." Members of the management team will also be available for one-on-one meetings with investors and partners during the conference. For more information contact: Corporate Press Office: [email protected] About iOnctura iOnctura is a clinical-stage precision oncology company combating neglected and hard-to-treat cancers with a pipeline of first-in-class small molecules. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Lead asset, roginolisib, is a non-ATP competitive, allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. Roginolisib is being investigated in multiple randomized Phase II studies in solid and hematological malignancies. iOnctura is headquartered in Amsterdam, The Netherlands with subsidiaries located in Geneva, Switzerland and Cambridge, MA, USA. iOnctura is backed by specialist institutional investors including Syncona, M Ventures, Inkef Capital, EIC Fund, VI Partners, Schroders Capital and XGEN Venture. About roginolisib Roginolisib is a first-in-class, non-ATP competitive, allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. The PI3K signaling pathway is one of the most commonly dysregulated pathways across multiple cancer types. The potential of roginolisib has been validated by positive clinical signals in Phase I in solid tumor and hematological malignancies, including a doubling of overall survival compared to historical controls in rare eye cancer, uveal melanoma. The company has carefully designed its clinical program to allow full development in uveal melanoma, while in parallel validating the program in larger market indications. The Phase II OCULE-01 study in uveal melanoma started in March 2025, the PULMO-01 study in non-small cell lung cancer (NSCLC) started in May 2025 and the HEMA-MED Phase I/II study in myelofibrosis began in November 2025. Logo : SOURCE iOnctura 21% more press release views with Request a Demo

临床2期临床1期

2025-12-04

·PRNewswire

iOnctura initiates Phase I/II trial in patients with myelofibrosis ahead of new non-clinical data at ASH

First patient dosed in Phase I/II HEMA-MED clinical trial (NCT06887803) evaluating the tolerability and efficacy profile of roginolisib (PI3Kδ inhibitor) plus ruxolitinib in myelofibrosis (MF) patients unresponsive to Janus kinase (JAK) inhibitors Dual-target approach: combining PI3Kδ and JAK inhibition addresses complementary disease mechanisms and may overcome unresponsiveness to JAK inhibitors in MF New supporting non-clinical data to be presented at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida: Data from ex-vivo models of MF demonstrate roginolisib monotherapy activity and synergy with JAK inhibition GENEVA, AMSTERDAM and CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today announces it has dosed the first patient in its Phase I/II clinical trial evaluating roginolisib in patients with MF who are no longer responding to JAK inhibition. Further details of the trial will be presented in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida on Sunday, December 7 at 6pm EST. This milestone marks an important step toward addressing the significant unmet medical needs of MF patients who face diminishing therapeutic options, as their disease progresses or becomes resistant to standard-of-care JAK inhibitor treatment. The Phase I/II trial is part of a comprehensive development program evaluating next-generation PI3Kδ inhibitor roginolisib's tolerability and anti-tumor response across a number of solid and hematologic malignancies. "Based on non-clinical data being presented at ASH, we anticipate that targeting both the PI3Kδ and JAK pathways could have a synergistic effect in MF — an approach that has previously eluded older generation PI3Kδ inhibitors because of their unfavorable tolerability profiles." said Dr Michael Lahn, Chief Medical Officer of iOnctura. Overactivation of the PI3K-Akt signaling pathway contributes to the occurrence and progression of cancer[1]. In MF, pathway activation is a well described mechanism of resistance in response to JAK inhibition[2]. Inhibition of this pathway using roginolisib may overcome the lack of response and lead to a beneficial therapeutic effect. Non-clinical evidence in support of this mechanism is being presented at ASH on Monday, December 8, 2025 at 6pm EST. These data demonstrate monotherapy activity of roginolisib against MF cell lines and in vitro models of primary MF cells. Further, roginolisib and JAK inhibition (ruxolitinib or momelotinib) exerts a synergistic anti-cancer effect. These data support the rationale behind the ongoing HEMA-MED clinical trial. Professor Alessandro Vannucchi, Professor of Hematology and Department Head of the Center for Research and Innovation in Myeloproliferative Neoplasms (CRIMM) at the University of Florence, Florence, Italy and Principal Investigator of the HEMA-MED study said: "Myelofibrosis patients often have suboptimal responses to ruxolitinib and/or acquire resistance over time. Roginolisib's intriguing mechanism of action and favorable toxicity profile position it as a compelling partner for ruxolitinib. By combining these agents, we could unlock more durable responses and redefine therapeutic expectations for this challenging rare disease." In addition to the two posters related to MF, trials in progress posters for the ongoing investigations of roginolisib in peripheral T-cell lymphoma and chronic lymphocytic leukemia (CLL) will also be presented at ASH. iOnctura poster presentations at the 67th ASH Annual Meeting in Orlando, Florida, USA: 1. A Vannucchi et al. Trial in progress: Sunday, December 7, 06:00 PM - 08:00 PM EST Abstract 25-4153: A study of roginolisib in combination with ruxolitinib in patients with myelofibrosis who are unresponsive to JAK inhibitors (HEMA-MED) 2. M Balliu et al.: Monday, December 8, 06:00 PM - 08:00 PM EST Abstract 25-7102: The selective PI3Kd inhibitor roginolisib synergizes with ruxolitinib against progenitor cells from naïve and JAK-inhibitor-refractory/resistant patients with myelofibrosis 3. D Sibon et al. Trial in progress: Sunday, December 7, 06:00 PM - 08:00 PM EST Abstract 25-11050: PlatΤform: A multicenter, multi-arm, academic platform trial evaluating novel agents and combinations in relapsed or refractory peripheral T-cell lymphomas 4. J Brown et al. Trial in progress: Sunday, December 7, 06:00 PM - 08:00 PM EST Abstract 25-7765: Roginolisib (IOA-244), an orally bioavailable, selective PI3Kδ inhibitor, in combination with venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) About myelofibrosis (MF) MF is a rare myeloproliferative neoplasm marked by activation and growth of mutated cells in the bone marrow, with approximately 0.5 cases per 100,000 individuals diagnosed globally a year[3]. JAK inhibitors are a key treatment option for MF patients and improve symptoms and quality of life, but approximately half of patients discontinue therapy within three years[4]. Reasons for discontinuation include disease progression, tolerability and adverse events and death resulting from resistance to the JAK therapy[5],[6]. About the HEMA-MED clinical trial The HEMA-MED trial (NCT06887803) is a prospective, multi-center, open-label Phase I/II single arm trial consisting of two parts. Part 1 (Phase 1) will enroll 13 patients to assess the safety of the combination of the PI3Kδ inhibitor roginolisib in combination with the JAK inhibitor ruxolitinib, and Part 2 (Phase 2) will expand to enroll 13 additional patients to further allow the assessment of benefit/risk for all 26 patients. In addition to safety, the secondary endpoints of the HEMA-MED trial include blood biomarker and spleen reduction responses, and improvements of MF related symptoms. Exploratory measures will assess endpoints associated with the mechanism of action (MOA) of roginolisib. About iOnctura iOnctura is a clinical-stage precision oncology company combating neglected and hard-to-treat cancers with a pipeline of first-in-class small molecules. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Lead asset, roginolisib, is a non-ATP competitive, allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. Roginolisib is being investigated in multiple randomized Phase II studies in solid and hematological malignancies. iOnctura is headquartered in Amsterdam, The Netherlands with subsidiaries located in Geneva, Switzerland and Cambridge, MA, USA. iOnctura is backed by specialist institutional investors including Syncona, M Ventures, Inkef Capital, EIC Fund, VI Partners, Schroders Capital and XGEN Venture. About roginolisib Roginolisib is a first-in-class, non-ATP competitive, allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. The PI3K signaling pathway is one of the most commonly dysregulated pathways across multiple cancer types. The potential of roginolisib has been validated by positive clinical signals in Phase I in solid tumor and hematological malignancies, including a doubling of overall survival compared to historical controls in rare eye cancer, uveal melanoma. The company has carefully designed its clinical program to allow full development in uveal melanoma, while in parallel validating the program in larger market indications. The Phase II OCULE-01 study in uveal melanoma started in March 2025, the PULMO-01 study in non-small cell lung cancer (NSCLC) started in May 2025 and the HEMA-MED Phase I/II study in myelofibrosis began in November 2025. For more information contact: Corporate Press Office: [email protected] [1] He et al., 2021 [2] Moyo et al., 2023 [3] Titmarsh et al., 2014 [4] Verstovsek et al., 2015 [5] Kuykendall et al., 2018 [6] Newberry et al., 2017 Logo - SOURCE iOnctura 21% more press release views with Request a Demo

临床2期ASH会议临床1期

100 项与 Roginolisib 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
骨髓纤维化	临床2期	英国	iOnctura SA	2025-11-17
原发性血小板增多症后骨髓纤维化	临床2期	意大利	iOnctura SA	2025-11-17
原发性血小板增多症后骨髓纤维化	临床2期	西班牙	iOnctura SA	2025-11-17
真性红细胞增多症后骨髓纤维化	临床2期	意大利	iOnctura SA	2025-11-17
真性红细胞增多症后骨髓纤维化	临床2期	西班牙	iOnctura SA	2025-11-17
外周T细胞淋巴瘤	临床2期	法国	iOnctura SA	2025-08-20
晚期鳞状非小细胞肺癌	临床2期	比利时	iOnctura SA	2025-04-22
晚期鳞状非小细胞肺癌	临床2期	意大利	iOnctura SA	2025-04-22
晚期鳞状非小细胞肺癌	临床2期	西班牙	iOnctura SA	2025-04-22
转移性非小细胞肺癌	临床2期	比利时	iOnctura SA	2025-04-22

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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


NCT07018752 (PlatΤform, ASH2025)	临床1/2期	外周T细胞淋巴瘤	49	Roginolisib	鏇窪糧淵遞壓顧鹹憲淵(鹹窪膚鏇醖網餘網醖膚) = Golcadomide + Oral Azacitidine: neutropenia (67%, mainly grade 3) and thrombocytopenia (11%). Roginolisib: anemia (19%), thrombocytopenia (16%), and neutropenia (16%), with 1 grade 4 event (thrombocytopenia). 衊窪糧繭憲獵築夢淵鏇 (觸窪構製鹽鏇鹹網顧鑰 )	积极	2025-12-06
NCT06644183 (ASH2025)	临床1/2期	复发性慢性淋巴细胞白血病	28	Roginolisib + Venetoclax + Rituximab	獵鏇簾範繭鬱繭壓顧醖(襯獵選鬱鏇夢鏇廠鹽窪) = 鹹築艱壓繭膚衊觸艱鑰構齋蓋鹹膚鏇願糧廠廠 (簾遞醖選選膚繭範糧餘 )	积极	2025-12-06
NCT04328844 (DIONE-01, ESMO_IO2024) 人工标引	临床1期	葡萄膜黑色素瘤	29	Roginolisib	夢積壓積襯膚艱顧選醖(範範鹹顧網製獵餘願齋) = 鏇願構顧網糧遞簾醖願製壓鬱構齋繭齋鑰襯獵 (壓襯衊鹹壓積壓鹹廠鹽 ) 更多	积极	2024-12-12
NCT04328844 (Roginolisib (IOA-244), ESMO2024)	临床1期	葡萄膜黑色素瘤 CD63 expression on basophils \| blood-based proteins	29	Roginolisib 80 mg QD	醖製襯夢積醖壓鏇蓋顧(鹹願選獵築鬱構築簾鬱) = 鑰夢鬱齋廠網獵窪廠鹽選觸獵構壓蓋夢糧醖願 (艱餘構製艱壓鏇艱壓壓 )	积极	2024-09-14
NCT04328844 (FiH dose escalation study, ICML2023)	临床2期	滤泡性淋巴瘤	8	Roginolisib 80 mg QD	製齋鬱製遞襯壓顧餘淵(憲顧獵艱艱繭鬱襯製簾) = 憲鬱襯選憲衊網積築繭襯獵簾鏇壓鹹齋壓遞繭 (膚廠壓淵齋膚願蓋製夢 ) 更多	积极	2023-06-09
EHA2023	N/A	难治性滤泡性淋巴瘤	8	Roginolisib 20 mg QD	窪壓壓蓋遞窪網構鏇襯(繭壓築夢遞壓憲積顧鑰) = AST/ALT elevation (G3) were observed in 2/8 pts 鏇製構艱網鬱襯艱鏇蓋 (範製鹹簾選鏇網艱願獵 ) 更多	-	2023-06-08
EHA2023	N/A	难治性滤泡性淋巴瘤	8	Roginolisib 80 mg QD		-	2023-06-08
NCT04328844 (DIONE-01, ASCO 12023 \| ASCO 22023) 人工标引	临床1期	葡萄膜黑色素瘤 \| 晚期癌症	24	Roginolisib (Part A: pts with solid tumours and Follicular Lymphoma)	範糧襯齋膚襯衊壓繭築(鏇糧獵窪鑰顧簾遞艱顧) = roginolisib 80 mg QD 觸積淵廠齋鹹齋遞鏇獵 (獵膚壓醖網願鑰糧繭蓋 ) 更多	积极	2023-05-26
NCT04328844 (DIONE-01, ASCO 12023 \| ASCO 22023) 人工标引	临床1期	葡萄膜黑色素瘤 \| 晚期癌症	24	Roginolisib (Part A(dose escalation): UM pts)		积极	2023-05-26
NCT04328844 (ASCO2022) 人工标引	临床1期	晚期癌症	23	IOA-244 (Part A Solid Tumor (completed))	顧網壓網夢膚鏇選蓋鏇(繭糧膚簾範鹽鏇鹽憲糧) = 壓夢鏇網鏇獵遞觸顧廠衊獵淵顧願繭餘衊獵膚 (築鬱夢網遞艱夢衊膚築 )	积极	2022-06-02
NCT04328844 (ASCO2022) 人工标引	临床1期	晚期癌症	23	IOA-244 (Uveal Melanoma Pts (progressed ≥1 line prior therapy))	遞壓遞鹹願鑰鹽糧鏇鬱(蓋積醖醖鑰糧鬱襯選蓋) = 醖範觸觸壓鹹衊窪膚繭構獵遞糧餘餘鬱衊簾網 (窪糧醖顧鏇蓋簾鹹鹽顧 ) 更多	积极	2022-06-02