A Phase 2, randomised, open label, multicentre study of an intraperitoneal a-emitting radionuclide therapy (Radspherin®) in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are homologous recombination proficient and scheduled to undergo neoadjuvant chemotherapy and interval debulking surgery

开始日期2024-10-01

申办/合作机构

Oncoinvent ASA

NCT06504147

/ Recruiting临床2期

A Phase 2, Randomised, Open Label, Multicentre Study of an Intraperitoneal Α-emitting Radionuclide Therapy (Radspherin®) in Patients with Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, with Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery

This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.

开始日期2024-06-15

申办/合作机构

Oncoinvent ASA

NCT03732768

/ Active, not recruiting临床1期

A Phase 1 Study to Evaluate the Dose, Safety and Tolerability of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Platinum Sensitive Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis Following CRS

RAD-18-001 is a First-In-Man, Dose Escalation study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first).
In the expansion cohort the subject will receive the recommended dose. The expansion cohort will be conducted at 4 sites. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first).

开始日期2020-06-08

申办/合作机构

Oncoinvent ASA

100 项与 Radspherin 相关的临床结果

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100 项与 Radspherin 相关的转化医学

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100 项与 Radspherin 相关的专利（医药）

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项与 Radspherin 相关的文献（医药）

2024-11-01·Journal of Surgical Oncology

Eighteen‐Months Safety and Efficacy Following Intraperitoneal Treatment With ²²⁴Radium‐Labeled Microparticles After CRS‐HIPEC in Patients With Peritoneal Metastasis From Colorectal Cancer

Article

作者: Mariathasan, A. M. ; Rashid, G. ; Spasojevic, M. ; Larsen, R. H. ; Sørensen, O. ; Gjertsen, T. J. ; Bruland, Ø. S. ; Lundstrøm, N. ; Larsen, S. G. ; Graf, W. ; Aksnes, A.‐K. ; Revheim, M.‐E.

ABSTRACTBackground and ObjectivesPeritoneal metastasis from colorectal cancer carries a high risk for relapse after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS‐HIPEC). A novel alpha‐emitting radiopharmaceutical (Radspherin) has been designed to deliver short‐range radiation to micrometastases and free‐floating tumor cells.MethodsA Phase 1/2a study evaluated the safety, tolerability, and signal of efficacy of escalating doses of Radspherin injected intraperitoneally after CRS‐HIPEC.ResultsEleven patients received 1−4 MBq (Group 1) whereas 12 patients received 7 MBq; nine patients single dose/three patients split‐dose (Group 2). Median age was 66.5 and 61.5 years, and median peritoneal cancer index 6 and 7, respectively. One hundred and seventy‐eight adverse events were reported, only seven were deemed related to Radspherin. Thirteen serious adverse events (SAEs) were reported in eight patients and no SAEs were related to Radspherin. At 18‐months, none of the 12 patients receiving 7 MBq experienced peritoneal recurrences, however four had non‐peritoneal recurrences. Across both groups (n = 22), 41% had recurrent disease, only 14% of them in the peritoneum.ConclusionsRadspherin was well tolerated. At 18 months, median disease‐free survival has not been reached, and none of the patients receiving the recommended dose (7 MBq) had peritoneal recurrences. The results are encouraging and warrant further clinical evaluation.

2023-01-01·Frontiers in medicine

First experience with ²²⁴Radium-labeled microparticles (Radspherin®) after CRS-HIPEC for peritoneal metastasis in colorectal cancer (a phase 1 study).

Article

作者: Selboe, Silje ; Larsen, Stein Gunnar ; Bruland, Øyvind Sverre ; Revheim, Mona-Elisabeth ; Holtermann, Anne ; Graf, Wilhelm ; Mariathasan, Anthony Burton ; Spasojevic, Milan ; Sørensen, Olaf ; Lundstrøm, Nadja ; Goscinski, Mariusz Adam

BackgroundPeritoneal metastasis (PM) from colorectal cancer carries a dismal prognosis despite extensive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). With a median time to recurrence of 11-12 months, there is a need for novel therapies. Radspherin® consists of the α-emitting radionuclide radium-224 (²²⁴Ra), which has a half-life of 3.6 days and is adsorbed to a suspension of biodegradable calcium carbonate microparticles that are designed to give short-range radiation to the serosal peritoneal surface linings, killing free-floating and/or tumor cell clusters that remain after CRS-HIPEC.MethodsA first-in-human phase 1 study (EudraCT 2018-002803-33) was conducted at two specialized CRS-HIPEC centers. Radspherin® was administered intraperitoneally 2 days after CRS-HIPEC. Dose escalation at increasing activity dose levels of 1-2-4-7-MBq, a split-dose repeated injection, and expansion cohorts were used to evaluate the safety and tolerability of Radspherin®. The aim was to explore the recommended dose and biodistribution using gamma-camera imaging. The results from the planned safety interim analysis after the completion of the dose-limiting toxicity (DLT) period of 30 days are presented.ResultsTwenty-three patients were enrolled: 14 in the dose escalation cohort, three in the repeated cohort, and six in the expansion cohort. Of the 23 enrolled patients, seven were men and 16 were women with a median age of 64 years (28-78). Twelve patients had synchronous PM stage IV and 11 patients had metachronous PM [primary stage II; (6) and stage III; (5)], with a disease-free interval of 15 months (3-30). The peritoneal cancer index was median 7 (3-19), operation time was 395 min (194-515), and hospital stay was 12 days (7-37). A total of 68 grade 2 adverse events were reported for 17 patients during the first 30 days; most were considered related to CRS and/or HIPEC. Only six of the TEAEs were evaluated as related to Radspherin®. One TEAE, anastomotic leakage, was reported as grade 3. Accordion ≥3 grade events occurred in a total of four of the 23 patients: reoperation due to anastomotic leaks (two) and drained abscesses (two). No DLT was documented at the 7 MBq dose level that was then defined as the recommended dose. The biodistribution of Radspherin® showed a relatively even peritoneal distribution.ConclusionAll dose levels of Radspherin® were well tolerated, and DLT was not reached. No deaths occurred, and no serious adverse events were considered related to Radspherin®.Clinical Trial Registration: Clinicaltrials.gov, NCT03732781.

2023-01-01·Technology in Cancer Research & Treatment

Effect of Intraperitoneal ²²⁴Radium-Labelled Microparticles on Compartmentalized Inflammation After Cytoreductive Surgery and Hypertherm Intraperitoneal Chemotherapy

Article

作者: Schjalm, Camilla ; Thorgersen, Ebbe Billmann ; Bruland, Øyvind Sverre ; Mollnes, Tom Eirik ; Larsen, Stein Gunnar ; Asvall, Jørund ; McAdam, Karin Ekholt

Despite extensive treatment with surgery and chemotherapy many patients with peritoneal metastases from colorectal cancer experience intraperitoneal disease relapse. The α-emitting 224radium-labelled microparticle radionuclide therapeutic Radspherin® is being explored as a novel treatment option for these patients. Radspherin® is specially designed to give local radiation to the surface of the peritoneal cavity and potentially kill remaining attached micrometastases as well as free-floating cancer cells, thus preventing future relapse. The effect of Radspherin® on the immune system is not known. Systemic and local inflammatory responses were analyzed in plasma, intraperitoneal fluid and urine collected prospectively as part of a phase 1 dose-escalation study of intraperitoneal instillation of the α-emitting therapeutic radiopharmaceutical Radspherin®, at baseline and the first 7 postoperative days from nine patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. All patients additionally received intraperitoneal instillation of Radspherin® on postoperative day 2. Complement activation products C3bc and the terminal complement complex were analyzed using enzyme-linked immunosorbent assay. Cytokines ( n = 27), including interleukins, chemokines, interferons and growth factors, were analyzed using multiplex technique. The time course and magnitude of the postoperative cytokine response after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy displayed a modest systemic response in plasma, in contrast to a substantial local intraperitoneal response. After administration of Radspherin®, a significant increase ( P < 0.05) in TNF and MIP-1β was observed in both plasma and peritoneal fluid, whereas IL-9 increased only in plasma and IFNγ and IL1-RA only in peritoneal fluid. Only minor changes were seen for the majority of the inflammatory markers after Radspherin® administration. Our study showed a predominately local rather than systemic inflammatory response to cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Radspherin® had overall modest impact on the inflammation.

项与 Radspherin 相关的新闻（医药）

2025-05-04

·药明康德

疾病控制率超90%的抗癌多肽偶联药物；癌症复发率降低4倍的放射性疗法…… | 一周盘点

本期看点1. 多肽偶联药物AVA6000的1期临床试验结果积极，在唾液腺癌患者中，≥250 mg/m²剂量水平的AVA6000治疗的疾病控制率达到91%。2. 放射性疗法Radspherin的1/2期临床试验18个月随访结果公布，在铂敏感复发性卵巢癌合并腹膜癌转移患者中，手术后接受Radspherin治疗的患者18个月后复发率为10%。而在类似人群中，接受最佳标准治疗的患者在同一随访时点预计复发率约为40%。AVA6000：公布1期临床试验结果Avacta Therapeutics公司日前公布了其主打在研多肽偶联药物AVA6000的1期临床试验积极数据。AVA6000是一种在肿瘤微环境中特异性激活的多柔比星（doxorubicin）前药，旨在减少传统化疗的全身性副作用。在1a期剂量递增研究中，无论是每三周一次（Q3W）还是每两周一次（Q2W）的给药方案，AVA6000均显示出良好的耐受性。即使剂量升高至每三周385 mg/m²，也未达到最大耐受剂量（MTD）。在唾液腺癌患者（n=11）中，接受≥250 mg/m²剂量水平的AVA6000治疗后，多位患者获得确认缓解，疾病控制率达到91%。中位无进展生存期（PFS）尚未达到，当前中位随访时间已超过25周。AVA6000是Avacta研发管线中的首个多肽偶联药物，由多柔比星与Avacta专有的pre|CISION多肽偶联而成，该多肽可在肿瘤微环境中由成纤维细胞激活蛋白-α（FAP）特异性切割。FAP在大多数实体瘤中，与健康组织相比表达水平显著升高。Avacta的多肽偶联药物利用这一特征在肿瘤微环境中特异性释放活性药物，从而降低系统暴露和毒性，为患者提供更好的治疗效果。CHS-114：公布1期临床试验结果Coherus BioSciences公布了其正在进行的1期临床试验的更新数据，该试验旨在评估选择性抗CCR8抗体CHS-114作为单药，以及与toripalimab联用，治疗复发/转移性头颈部鳞状细胞癌（HNSCC）患者的活性，以优化给药方案。数据显示，一例经过多线治疗且对PD-1抑制剂耐药的患者获得确认部分缓解，同时CCR8阳性调节性T细胞（Treg）减少超过50%、CD8阳性效应T细胞数量增加，与抗肿瘤活性一致，证明了药物的作用机制。这些数据支持继续评估CHS-114与包括toripalimab在内的其他疗法联用，并支持推进该研究第3部分的患者招募与开展，以进一步评估CHS-114与toripalimab在HNSCC中的疗效。CHS-114是一种去岩藻糖化的CCR8单克隆抗体，能优先杀伤肿瘤微环境中的CCR8阳性Treg，同时保留正常组织中的CD8阳性效应T细胞和Treg。Radspherin：公布1期临床试验18个月随访结果Oncoinvent日前公布了其1期临床试验RAD-18-001的18个月随访结果。该试验在铂敏感复发性卵巢癌合并腹膜癌转移患者中评估放射性疗法Radspherin的效果，该试验于2023年底完成患者招募，目前患者正接受长期随访。在本试验中，10例患者接受了单次腹腔内Radspherin给药。Oncoinvent在2024年11月公布的12个月数据中，10例患者中仅1例出现腹膜复发。18个月随访时，未见新增复发病例，即迄今为止仅10%的患者出现复发。而在类似人群中，接受最佳标准治疗的患者在同一随访时点预计约有40%的复发率。Radspherin是一种在研放射性药物，旨在局部治疗已扩散至体腔的癌症。它由数十亿个含放射性同位素镭-224的碳酸钙微粒组成。其作用机制是镭-224衰变发射的α粒子，这是一种高效能的电离辐射形式。Radspherin用于治疗卵巢癌和结直肠癌引起的腹膜癌转移，在外科切除所有可见肿瘤后，通过腹腔内给药。DT-168：公布1期临床试验积极数据Design Therapeutics公司日前公布了在研药物DT-168在健康志愿者中开展的1期单次及多次递增剂量（SAD/MAD）试验的积极数据。DT-168是一种新型GeneTAC小分子药物，制剂为滴眼液，旨在选择性靶向并降低导致角膜内皮细胞功能障碍的突变TCF4基因的表达，从而治疗Fuchs角膜内皮营养不良（FECD）。这项试验旨在评估DT-168滴眼液的安全性、耐受性和系统药代动力学（PK）。试验结果显示，DT-168滴眼液在所有受试者中均耐受良好。未观察到严重不良事件，也无眼部相关不良事件（AEs），亦无因不良事件导致的停药。所有观察到的不良事件均被研究者判定为与DT-168无关。PK分析结果表明，在所有时间点和所有剂量组中，受试者的系统性暴露均低于定量检测的下限。基于上述发现，Design公司计划开展DT-168的2期生物标志物临床试验，评估其在FECD患者中的安全性、耐受性及角膜内皮生物标志物表现。参考资料：[1] Bayer Initiates Phase I Study Targeting GPC3 With Actinium-225 Radiopharmaceutical in Patients With Advanced Hepatocellular Carcinoma. Retrieved April 29, 2025, from https://www.businesswire.com/news/home/20250429877323/en/Bayer-Initiates-Phase-I-Study-Targeting-GPC3-With-Actinium-225-Radiopharmaceutical-in-Patients-With-Advanced-Hepatocellular-Carcinoma[2] Coherus Presents Promising Early Clinical Data from Phase 1 Dose Expansion Study of CHS-114 in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma at AACR 2025. Retrieved April 29, 2025, from https://www.globenewswire.com/news-release/2025/04/28/3069362/33333/en/Coherus-Presents-Promising-Early-Clinical-Data-from-Phase-1-Dose-Expansion-Study-of-CHS-114-in-Patients-with-Recurrent-Metastatic-Head-and-Neck-Squamous-Cell-Carcinoma-at-AACR-2025.html[3] BlackfinBio Announces FDA Clearance to Initiate Phase 1/2 Clinical Trial for Novel AAV Gene Therapy BFB-101 to Treat the Rare Neurological Disease Hereditary Spastic Paraplegia, Type 47 (SPG47). Retrieved April 29, 2025, from https://www.globenewswire.com/news-release/2025/04/28/3068935/0/en/BlackfinBio-Announces-FDA-Clearance-to-Initiate-Phase-1-2-Clinical-Trial-for-Novel-AAV-Gene-Therapy-BFB-101-to-Treat-the-Rare-Neurological-Disease-Hereditary-Spastic-Paraplegia-Typ.html[4] Oncoinvent Reports updated 18-Month Data from Phase 1 Ovarian Cancer Trial with Radspherin®: No new recurrences Demonstrate Continued Promise of Preventing Disease Progression. Retrieved April 29, 2025, from https://www.prnewswire.com/news-releases/oncoinvent-reports-updated-18-month-data-from-phase-1-ovarian-cancer-trial-with-radspherin-no-new-recurrences-demonstrate-continued-promise-of-preventing-disease-progression-302439415.html[5] Therini Bio Announces Positive Phase 1a Trial Results Evaluating THN391 for Neurodegenerative Diseases. Retrieved April 30, 2025, from https://www.globenewswire.com/news-release/2025/04/29/3070399/0/en/Therini-Bio-Announces-Positive-Phase-1a-Trial-Results-Evaluating-THN391-for-Neurodegenerative-Diseases.html[6] Design Therapeutics Announces Favorable Phase 1 Data for DT-168 Supporting Advancement into Phase 2 Biomarker Trial for Patients with Fuchs Endothelial Corneal Dystrophy. Retrieved May 1, 2025, from https://www.globenewswire.com/news-release/2025/05/01/3072316/0/en/Design-Therapeutics-Announces-Favorable-Phase-1-Data-for-DT-168-Supporting-Advancement-into-Phase-2-Biomarker-Trial-for-Patients-with-Fuchs-Endothelial-Corneal-Dystrophy.html[7] Nouscom Presents Positive Final Results from Completed Phase Ib/II Study of Neoantigen Immunotherapy NOUS-209 at AACR 2025, Demonstrating a Highly Potent and Durable Immune Response in Lynch Syndrome Carriers. Retrieved May 1, 2025, from https://www.globenewswire.com/news-release/2025/04/29/3070727/0/en/Nouscom-Presents-Positive-Final-Results-from-Completed-Phase-Ib-II-Study-of-Neoantigen-Immunotherapy-NOUS-209-at-AACR-2025-Demonstrating-a-Highly-Potent-and-Durable-Immune-Response.html[8] Avacta Therapeutics Presents Data from Lead pre|CISION® Candidate FAP-Dox (AVA6000) at the 2025 AACR Annual Meeting. Retrieved May 2, 2025, from https://avacta.com/avacta-therapeutics-presents-data-from-lead-precision-candidate-fap-dox-ava6000-at-the-2025-aacr-annual-meeting/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2

临床结果临床1期放射疗法临床2期

2025-04-28

·PRNewswire

Oncoinvent Reports updated 18-Month Data from Phase 1 Ovarian Cancer Trial with Radspherin®: No new recurrences Demonstrate Continued Promise of Preventing Disease Progression

OSLO, Norway, April 28, 2025 /PRNewswire/ -- Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, today announced the 18-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin® in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis. The trial was closed for recruitment at the end of 2023 and patients are currently in long-term follow-up. In this trial, 10 patients received a single intraperitoneal dose of 7 MBq Radspherin®. Oncoinvent reported 12-month data in November 2024, where only 1 out of the 10 receiving the selected dose had peritoneal recurrence. At the 18-month follow-up, no further patient had experienced recurrence. i.e., only 10% of patients treated have so far had a recurrence. In similar populations, receiving best standard of care, it is expected that approximately 40% of patients would have had disease recurrence at this time point[1],[2],[3]. "Ovarian cancer's characteristic peritoneal metastasis lead to frequent recurrences despite a comprehensive treatment approach," commented Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "I am proud to be part of a study program exploring whether Radspherin® may become a novel therapy that can prevent disease progression, offering hope for a better and longer life for my patients." "These compelling results underscore Radspherin®'s potential to significantly reduce peritoneal recurrence in ovarian cancer patients," said Øystein Soug, CEO of Oncoinvent. "The data not only reinforce our confidence in Radspherin® but also support its advancement in Phase 2 trials, including the ongoing randomized controlled Phase 2 trial assessing progression-free survival in patients with peritoneal metastasis from ovarian cancer." To discuss these promising clinical results, provide an update on operations, and discuss the ongoing Phase 2 trial, Oncoinvent has decided to move up its Quarterly Update from the previously announced May 27 to April 30 at 11:00 CEST. About Oncoinvent Oncoinvent is a clinical-stage biotechnology company developing novel radiopharmaceutical therapies against cancer. The lead product candidate, Radspherin®, uses the alpha-emitting radionuclide radium-224, directly targeting micro-metastases post-surgery, harnessing the benefits of modern radiopharmaceuticals without the complexities of biological targeting. Oncoinvent is investigating the safety and efficacy of Radspherin® in a clinical development program in two indications. Currently one Phase 1 trial, one Phase 1/2a trial and one randomized Phase 2 trial are ongoing in the US, UK and Europe. Preliminary clinical efficacy data are highly encouraging, and no serious toxicity or safety concerns have been reported to date. The Oncoinvent team consists of approx. 30 employees and runs a state-of-the-art manufacturing facility to produce drug products for clinical trials in Nydalen, Oslo. Oncoinvent is listed on the Euronext Growth Oslo. About Radspherin Radspherin® is an investigational radiopharmaceutical designed for the local treatment of cancer that has spread to body cavities. It consists of billions of calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation. Radspherin® is investigated in ongoing clinical studies to treat peritoneal carcinomatoses from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors. Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Oncoinvent's plans, estimates, or expectations will be achieved. These forward-looking statements represent Oncoinvent's expectations as of the date of this press release, and Oncoinvent disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. For further information, please contact: Øystein Soug, Chief Executive Officer Email: [email protected] Tore Kvam, Chief Financial Officer Email: [email protected] [1] Coleman et al. N Engl J Med. 2019 Nov 14;381(20):1929-1939 [2]Harter et al. N Engl J Med. 2021 Dec 2;385(23):2123-2131 [3] Shi et al. Lancet Oncol. 2021 Apr;22(4):439-449 This information was brought to you by Cision The following files are available for download: 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期临床结果临床1期

2024-12-04

·Business Wire

Oncoinvent Announces Agreement with ARTBIO to Collaborate on Radiopharma Laboratory Facilities

OSLO, Norway--( BUSINESS WIRE )--Oncoinvent ASA, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced that it has entered into an agreement with ARTBIO, a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies. As part of the agreement, ARTBIO will rent space and equipment, acquire access to some of Oncoinvent’s radioprotection expertise and analytical services, and purchase select R&D equipment. The agreement between Oncoinvent and ARTBIO shows a joint commitment to maximizing resource utilization and operational efficiency in a field which is constrained by a limited supply of these specialized facilities worldwide. “We are excited to partner with ARTBIO on the combined exploitation of our radiopharmaceutical laboratory facilities and analytical services,” said Oystein Soug, Chief Executive Officer of Oncoinvent. “Our state-of-the-art laboratory and equipment represent years of expertise and significant investment in radiopharmaceutical development, making them invaluable resources. This agreement allows us to optimize our facility usage, leveraging our advanced capabilities and capacity.” “Oncoinvent has built up significant expertise in the area of alpha based radiopharmaceuticals R&D and production, offering a considerable opportunity for joint laboratory facility utilization,” said Emanuele Ostuni, Chief Executive Officer of ARTBIO. “We see this partnership as a key collaboration that further strengthens the greater Oslo radiopharmaceutical hub.” About Oncoinvent Oncoinvent ASA is a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers. The technology platform is focused on the use of alpha-emitting radionuclides to deliver powerful radiation directly to cancer cells. The Company’s lead product candidate, Radspherin ® , is being advanced through clinical development by a team with experience from all stages of radiopharmaceutical development. Internal manufacturing and supply chain capabilities have been established, which now have the capacity to supply Radspherin ® for multi-center phase 2 clinical studies. Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Oncoinvent’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Oncoinvent’s expectations as of the date of this press release, and Oncoinvent disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers.

临床2期放射疗法

100 项与 Radspherin 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
卵巢癌	临床2期	比利时	Oncoinvent ASA	2024-06-15
卵巢癌	临床2期	美国	Oncoinvent ASA	2024-06-15
卵巢癌	临床2期	西班牙	Oncoinvent ASA	2024-06-15
卵巢癌	临床2期	英国	Oncoinvent ASA	2024-06-15
卵巢癌	临床2期	挪威	Oncoinvent ASA	2024-06-15
结直肠癌	临床2期	瑞典	Oncoinvent ASA	2020-05-27
结直肠癌	临床2期	挪威	Oncoinvent ASA	2020-05-27
腹膜癌	临床2期	瑞典	Oncoinvent ASA	2020-05-27
铂敏感性原发性腹膜癌	临床1期	西班牙	Oncoinvent ASA	2020-06-08
铂敏感性原发性腹膜癌	临床1期	比利时	Oncoinvent ASA	2020-06-08

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临床结果

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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


NCT03732768 (RAD-18-001, PRNewswire) 人工标引	临床1期	铂敏感性卵巢癌 \| 腹膜癌	10	Radspherin® 7 MBq	(顧願網餘鏇膚壓繭鹹構) = 鬱壓糧鑰艱淵廠膚衊選顧鏇範鬱蓋顧築餘襯築 (鏇築艱鹽廠遞蓋構構餘 )	积极	2025-04-28
NCT03732768 (RAD-18-001, PRNewswire) 人工标引	临床1期	铂敏感性卵巢癌 \| 腹膜癌	10	standard of care (External comparison)	(顧願網餘鏇膚壓繭鹹構) = 蓋網襯鏇鹹膚窪憲鹹鹹顧鏇範鬱蓋顧築餘襯築 (鏇築艱鹽廠遞蓋構構餘 )	积极	2025-04-28
NCT03732781 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	肿瘤转移	23	Radspherin	(窪簾膚範簾鏇願蓋廠淵) = 顧壓鹽夢鏇網獵範網餘壓糧窪膚積壓遞鹽壓範 (製糧憲築繭醖鹽願鹽獵 ) 更多	积极	2023-05-31
NCT03732768 (RAD-18-001, Company_Website) 人工标引	临床1期	卵巢癌	-	Radspherin	糧築窪憲範鹽獵糧製簾(簾夢範廠鹹鹽鹹醖衊壓) = Radspherin® has demonstrated attractive biodistribution, favorable tolerability and potential signals of efficacy. 觸衊製繭願鏇憲餘糧簾 (鏇餘遞選繭鬱鑰範窪觸 )	积极	2023-02-10
NCT03732781 (2018-002803-33, ASCO2022) 人工标引	临床1期	结直肠癌	23	radspherin	(鹹構艱壓壓淵獵衊醖製) = 網構築蓋製餘觸鑰積顧構鑰鬱蓋構構製壓廠糧 (淵齋齋窪醖選憲構襯齋 ) 更多	积极	2022-06-02