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 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2025-05-01

申办/合作机构

iOnctura SA

NCT06879717

/ Recruiting临床1/2期

A Phase I/IIa Study of Roginolisib in Combination With Dostarlimab With or Without Docetaxel in Patients With Advanced Non-squamous NSCLC Who Have Progressed on Standard of Care Immune Checkpoint Therapy and Platinum Doublet Chemotherapy or Standard Immunotherapy Without Chemotherapy (PULMO-1)

The goal of this clinical trial is to learn how roginolisib works in combination with dostarlimab with or without docetaxel in adult patients with advanced non small-cell lung cancer. The main questions it aims to answer are:
To compare across the treatment arms the proportion of patients with a reduction in Treg cells To evaluate the safety and tolerability of roginolisib plus dostarlimab, with or without docetaxel

开始日期2025-04-22

申办/合作机构

iOnctura SA

NCT06644183

/ Not yet recruiting临床1/2期IIT

A Phase 1/2, Open Label, Study of Roginolisib (IOA-244), an Orally Bioavailable, Selective PI3Kδ Inhibitor in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) in Combination With Venetoclax and Rituximab

This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
The names of the study drugs involved in this study are:
* Roginolisib (a novel type of PI3-kinase delta inhibitor)
* Venetoclax (a type of B-cell lymphoma 2 inhibitor)
* Rituximab (a type of monoclonal antibody)

开始日期2025-04-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

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

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）

2025-05-08

·PRNewswire

iOnctura commences randomized Phase I/II study in non-small cell lung cancer

First patient dosed in study investigating roginolisib + dostarlimab +/- docetaxel in patients with NSCLC who have progressed on prior immunotherapy/chemo Study will evaluate safety of the combination and explore whether targeting PI3Kδ with immunotherapy may rebalance the immune system to prevent or reverse resistance to current standard immunotherapy/chemo in NSCLC GENEVA and AMSTERDAM, May 8, 2025 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today announces it has dosed the first patient in the randomized Phase I/II study investigating lead asset roginolisib in combination with dostarlimab with or without docetaxel, in patients with advanced non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. Lung cancer is the leading cause of cancer death globally, accounting for approximately 1 in 5 of all cancer deaths[1]. Anti-programmed death-ligand 1 (PD-L1) or anti-programmed cell death protein 1 (PD1) immunotherapy is a standard therapy for NSCLC patients with no actionable mutations in the first or second lines of therapy, with or without chemotherapy. However, treatment is often of limited duration as the cancer cells develop resistance to the treatment. Rebalancing the immune system via PI3Kδ inhibition is thought to re-invigorate anti-tumour immune cells and thus is a promising mechanism to overcome resistance to current immunotherapies[2]. Michele Maio, MD, PhD, Professor of Medical Oncology at the University of Siena and Director of the Center for Immuno-Oncology at the University Hospital of Siena (Italy), Primary Coordinating Investigator of the Phase I/II study said: 'There is a significant lack of treatment options for NSCLC patients who have progressed on immunotherapy and chemotherapy. We will be investigating whether the combination of roginolisib with dostarlimab and +/- chemotherapy can be given safely and may provide a novel treatment option in patients who no longer respond to their current treatment.' Emerging clinical and translational biomarker data supports the hypothesis that combining roginolisib with an anti-PD-L1/PD1 agent, with or without docetaxel, may prevent or reverse drug resistance in NSCLC and may show synergistic anti-tumor immune activity without significant addition of toxicity. Firstly, the combination of anti-PD1 and roginolisib had an anti-tumor effect in vitro [3]. Secondly, ex vivo evaluation of NSCLC samples from patients responding and failing to immunotherapy showed that roginolisib rebalanced the composition of immune cells by inhibiting regulatory T-cells and enhancing CD8+ T cell killing cells3. Finally, roginolisib augmented the cytotoxicity of chemotherapy and immunotherapy3. Dostarlimab is a PD-1-blocking antibody approved in the US in combination with chemotherapy for certain patients with endometrial cancer, as well as a single agent for certain patients with dMMR tumours that have progressed on or following prior treatment. It has also demonstrated clinical activity in combination with chemotherapy in NSCLC[4]. Under a supply agreement with iOnctura, GSK will supply dostarlimab for use in the trial. iOnctura will retain worldwide rights to roginolisib. The Phase I/II open-label, randomized, parallel-arm PULMO-01 study (NCT06879717) will assess roginolisib in combination with dostarlimab, with or without docetaxel. The study will enrol approximately 45 patients who have progressed on standard-of-care immune checkpoint therapy. It will investigate the safety of the combination and the proportion of patients with a reduction in peripheral blood regulatory T cells in each arm. Roginolisib is an allosteric modulator of PI3Kδ, widely recognized as a 'master switch' of cancer. Inhibition of PI3Kδ unleashes a multi-pronged anti-tumor and immune response to combat the tumor[5]. Roginolisib has demonstrated an unprecedented clinical profile in solid and liquid cancers[6], and is currently being investigated in a randomized Phase II clinical trial in uveal melanoma. A separate Phase I/II study in myelofibrosis is being initiated. 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 an 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 BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. 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 an 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 and the Phase I/II PULMO-01 study in NSCLC started in May 2025. Further studies in other malignancies, including myelofibrosis, are being initiated. [1] World Health Organisation, June 2023 [2] Exposito et al., Cancer Res (2023) 83 (15): 2513–2526 [3] Riganti et al., Poster Presentation, EACR 2023 [4] Lim et al., Nature Communications (2023) 14:7301 [5] AACR Volume 3, Issue 4, April 2023, Poster presentation, SITC 2022 [6] Poster presentation, ESMO-IO 2023 SOURCE iOnctura WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期免疫疗法临床结果临床1期AACR会议

2025-03-20

·PRNewswire

iOnctura commences randomized Phase II study in metastatic uveal melanoma

First patient dosed in Phase II OCULE-01 study with roginolisib, an allosteric modulator of PI3Kδ The European Medicines Agency (EMA) has granted Orphan Drug Designation for roginolisib for treatment of uveal melanoma - benefits include 10 years market exclusivity in the European Union GENEVA and AMSTERDAM, March 20, 2025 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today announces it has dosed the first patient in the randomized Phase II OCULE-01 study investigating lead asset roginolisib in patients with metastatic uveal melanoma (UM), a rare cancer of the eye. Roginolisib is an orally dosed small molecule allosteric modulator of PI3Kδ. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. In the Phase I DIONE-01 study roginolisib demonstrated an excellent safety profile and a doubling of overall survival in metastatic uveal melanoma patients compared to historical controls. With few available treatments, eye melanoma is a rapidly growing market which is projected to be worth USD 9.56B by 2032[1]. The Phase II open label, randomized, parallel-arm OCULE-01 study (NCT06717126), has been designed to assess roginolisib as a monotherapy with the primary objective to evaluate overall survival in patients. The study will have multiple sites across Europe and the US, enrolling approximately 85 patients with metastatic UM, who have progressed following at least one prior therapy. The secondary objectives of the Phase II study will assess progression free survival, objective response rate, duration of response, time to response, disease control rate, clinical benefit rate, safety and tolerability, pharmacokinetics, safety, health care utilization and quality of life. Late in 2024, iOnctura also received Organ Drug Designation (ODD) from the European Medicines Agency (EMA) for roginolisib. ODD provides privileged status to drugs that show promise for the treatment of rare diseases in the European Union and qualifies iOnctura for benefits including protocol assistance, market exclusivity and fee reductions. Additionally, in early 2023 the US Food and Drug Administration (FDA) granted ODD for roginolisib in UM. Paul Nathan, Principal Investigator of the Phase II OCULE-01 study said: 'Roginolisib has so far shown impressive tolerability and an interesting median overall survival of 16 months in patients with uveal melanoma who had progressed on prior systemic therapy. With roginolisib's attractive safety profile and the encouraging survival data observed in the first-in-human dose study, we look forward to continuing to investigate the potential of roginolisib in patients with limited therapeutic options.' Catherine Pickering, CEO and Co-Founder of iOnctura added: 'We have achieved our first significant milestone for 2025 by starting one of several planned randomized Phase II studies for roginolisib. We are excited by the potential of roginolisib across a number of indications including uveal melanoma, non-small cell lung cancer and myelofibrosis, and we look forward to early data readouts by the end of the year.' 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 an 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 BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. 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 an 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 and Phase II studies in other cancers, including non-small cell lung cancer and myelofibrosis, are being initiated. [1] Emergen Research, Jan 2024 SOURCE iOnctura WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期孤儿药临床1期临床结果

2024-12-11

·PRNewswire

iOnctura reaches new clinical milestones in uveal melanoma

Completed Phase I DIONE-01 study demonstrates clinical activity and long-term safety of roginolisib, a unique allosteric modulator of PI3Kδ Patients with uveal melanoma showed a doubling of overall survival compared to historical controls Site activation ongoing for randomized Phase II OCULE-01 study in uveal melanoma GENEVA and AMSTERDAM, Dec. 11, 2024 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today provides a clinical update on its lead asset, roginolisib. Results from the completed Phase I DIONE-01 study are due to be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) annual congress tomorrow, 12 December at 12:30 CET (presentation 164P). Allosteric modulator of PI3Kδ, roginolisib, has a unique chemical structure and binding mechanism which makes it highly specific for PI3Kδ, giving it an advantageous pharmacology profile and an unprecedented safety profile compared to previous generations of PI3Kδ inhibitors. Roginolisib is being investigated in solid and hematological malignancies including uveal melanoma (UM), a rare cancer of the eye. Eye melanoma is a rapidly growing market which is projected to be worth USD 9.56B by 2032[1]. The two-part Phase I study DIONE-01, firstly evaluated continuous daily dosing of roginolisib [at 10, 20, 40 and 80 mg] in 24 patients with pretreated solid tumors and follicular lymphoma (FL), and secondly evaluated a dose confirmation cohort in 20 UM patients. Results from DIONE-01 show: Study met its primary objective to determine the safety of the anticipated optimal biologically effective dose (BED): Roginolisib was well tolerated at the recommended Phase II dose (RP2D) of 80mg, with <7% Grade 3/4 treatment-emergent adverse events (TEAEs) considered to be related to roginolisib. TEAEs did not result in immune-related toxicity, or dose-limiting toxicity, in either solid tumor or hematological patients. In contrast to prior PI3Kδ inhibitors, roginolisib dosing did not require dose modifications. Roginolisib is well tolerated over long periods of treatment, up to 4.5 years. Median overall survival (OS) was 16 months for the 29 patients with UM treated with roginolisib, who had previously received a median of two prior therapies. This exceeds the median OS of 7 months observed in historical controls in patients receiving immunotherapies as second line treatment[2]. Median progression free survival (PFS) was 5 months for patients treated with roginolisib versus less than 3 months for historical controls2. Clinical findings validate the mechanism of action of roginolisib: roginolisib reduces immune-suppressive immune cells and chemokines, UM-related tumor clones (ctDNA) and PI3K-related signaling indicating a rebalancing of the immune system. Catherine Pickering, Chief Executive Officer of iOnctura, said: "The Phase I DIONE-01 data highlight the benefits of roginolisib for patients with uveal melanoma and advanced cancers. Roginolisib's unique allosteric binding mechanism has translated into a differentiated beneficial clinical profile, including a doubling of overall survival compared to historical controls in uveal melanoma. We are delighted to announce these data support progression of roginolisib into a randomized Phase II study." Professor Michele Maio, University of Siena and Principal Investigator of the roginolisib studies, added: "Being able to continue to investigate roginolisib in a randomized Phase II study is a positive step to understand more about this already well tolerated molecule. Roginolisib has given prolonged disease stabilization to patients with uveal melanoma who have exhausted all other therapeutic options. So far, these patients have maintained a good quality of life without major limitations. I'm looking forward to seeing what the Phase II trial delivers over the coming months." Activation of trial sites for the Phase II OCULE-01 study (NCT06717126) investigating roginolisib versus investigator's choice in the second-line+ treatment of uveal melanoma is ongoing. About iOnctura iOnctura is a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers with precision oral small molecules that target cancers in novel ways. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Two therapeutic candidates have progressed into mid-stage clinical development: roginolisib is the first allosteric modulator of PI3Kδ; and cambritaxestat is the only autotaxin inhibitor in clinical development to treat cancer. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. iOnctura is backed by specialist institutional investors including Syncona, EIC Fund, M Ventures, Inkef Capital, VI Partners and Schroders Capital. About roginolisib Roginolisib is an allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. The PI3K signaling pathway is one of the most commonly dysregulated pathways in cancer and the precise targeting of the PI3Kδ isoform delivers substantial anti-tumor effects with a low-toxicity profile. Clinical data have demonstrated roginolisib's excellent safety profile and sustained clinical activity in uveal melanoma (UM), a rare eye cancer with few available treatments. Site activation for the randomized Phase II OCULE-01 study in uveal melanoma is ongoing, and Phase II studies in other cancers, including non-small cell lung cancer and myelofibrosis, are in planning. [1] Emergen Research, Jan 2024 [2] Rantala et al., Melanoma Res., 2019 Dec 29(6):561-568 SOURCE iOnctura WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床2期临床结果免疫疗法

100 项与 Roginolisib 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
原发性血小板增多症后骨髓纤维化	临床2期	意大利	iOnctura SA	2025-05-01
原发性血小板增多症后骨髓纤维化	临床2期	西班牙	iOnctura SA	2025-05-01
真性红细胞增多症后骨髓纤维化	临床2期	意大利	iOnctura SA	2025-05-01
真性红细胞增多症后骨髓纤维化	临床2期	西班牙	iOnctura SA	2025-05-01
晚期肺非小细胞鳞癌	临床2期	比利时	iOnctura SA	2025-04-22
晚期肺非小细胞鳞癌	临床2期	意大利	iOnctura SA	2025-04-22
晚期肺非小细胞鳞癌	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
转移性非小细胞肺癌	临床2期	意大利	iOnctura SA	2025-04-22
转移性非小细胞肺癌	临床2期	西班牙	iOnctura SA	2025-04-22

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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


NCT04328844 (DIONE-01, ESMO_IO2024) 人工标引	临床1期	葡萄膜黑色素瘤	29	Roginolisib	艱築願廠繭膚觸鬱鏇鏇(鹹淵餘膚製艱築鏇繭顧) = 觸膚鹽膚構鬱積顧範鏇積築襯鬱範憲積艱衊淵 (製憲夢顧蓋艱鏇餘襯醖 ) 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	膚憲鹹鹽夢壓淵範餘衊(製觸積簾鹹選糧淵願選) = 襯膚鑰鬱淵網製觸壓鏇構齋積構遞鏇鹽憲簾鏇 (餘壓齋積積築廠鬱壓簾 )	积极	2024-09-14
NCT04328844 (ESMO_IO2023)	临床1期	葡萄膜黑色素瘤 \| 霍奇金淋巴瘤 \| 非小细胞肺癌 ... 更多	-	Roginolisib 80 mg	築築淵憲廠網衊製齋衊(繭憲艱鏇鑰鹹廠網築齋) = 憲鹽夢遞顧膚鬱製醖網鬱觸鏇齋鑰襯觸鬱鹽獵 (簾網顧襯糧築醖窪構獵 )	-	2023-12-07
NCT04328844 (FiH dose escalation study, ICML2023)	临床2期	滤泡性淋巴瘤	8	Roginolisib 80 mg QD	齋鑰製餘餘齋觸膚糧鑰(顧選觸鹽築衊鏇顧膚膚) = 顧襯繭築壓蓋鹹襯顧鏇簾糧願製餘夢簾膚遞窪 (製醖壓鏇壓製遞範壓網 ) 更多	积极	2023-06-09
EHA2023	N/A	难治性滤泡性淋巴瘤	8	Roginolisib 20 mg QD	糧衊鹹築壓鬱獵膚範襯(構獵窪製鏇廠齋餘範鹹) = AST/ALT elevation (G3) were observed in 2/8 pts 鏇範蓋鹽糧齋齋鬱願襯 (觸淵襯膚艱觸膚積糧製 ) 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)	夢餘顧鏇遞糧構衊築蓋(顧廠夢鑰觸夢夢夢襯襯) = roginolisib 80 mg QD 鑰網遞簾繭蓋鬱顧獵窪 (網願範淵窪蓋積鑰簾選 ) 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))	膚齋淵窪醖齋鬱衊淵願(淵壓築鹹選製廠襯獵積) = 鏇蓋夢網願醖糧廠夢齋鹽選範構觸糧鑰衊築獵 (遞顧構鬱鹹廠鹽醖獵製 )	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))	鏇構範鬱觸鹽窪艱鏇淵(憲獵繭觸網構衊顧窪製) = 鬱鏇艱觸齋簾願衊襯製繭積蓋壓醖獵齋壓膚積 (鹽壓鏇遞齋膚製廠構鹹 ) 更多	积极	2022-06-02