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

Start Date01 Oct 2024

Sponsor / Collaborator-

NCT06504147 / RecruitingPhase 2

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.

Start Date15 Jun 2024

Sponsor / Collaborator

Oncoinvent AS

NCT03732768 / Active, not recruitingPhase 1

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).

Start Date08 Jun 2020

Sponsor / Collaborator

Oncoinvent AS

100 Clinical Results associated with Radspherin

100 Translational Medicine associated with Radspherin

100 Patents (Medical) associated with Radspherin

Literatures (Medical) associated with Radspherin

01 Jan 2023·Frontiers in medicine

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

Article

Author: 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.

01 Jan 2023·Technology in Cancer Research & Treatment

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

Article

Author: 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.

01 Mar 2020·International Journal of Radiation Oncology*Biology*PhysicsQ2 · MEDICINE

Initial Safety and Tumor Control Results From a “First-in-Human” Multicenter Prospective Trial Evaluating a Novel Alpha-Emitting Radionuclide for the Treatment of Locally Advanced Recurrent Squamous Cell Carcinomas of the Skin and Head and Neck

Q2 · MEDICINE

Article

Author: L. Deutsch ; A. Mizrachi ; S.R. Bellia ; R. Ben-Hur ; G. Feliciani ; Y. Keisari ; A. Popovtzer ; L. Arazi ; I. Kelson ; A. Sarnelli ; E. Rosenfeld

PURPOSEOur purpose was to report the feasibility and safety of diffusing alpha-emitter radiation therapy (DaRT), which entails the interstitial implantation of a novel alpha-emitting brachytherapy source, for the treatment of locally advanced and recurrent squamous cancers of the skin and head and neck.METHODS AND MATERIALSThis prospective first-in-human, multicenter clinical study evaluated 31 lesions in 28 patients. The primary objective was to determine the feasibility and safety of this approach, and the secondary objectives were to evaluate the initial tumor response and local progression-free survival. Eligibility criteria included all patients with biopsy-proven squamous cancers of the skin and head and neck with either primary tumors or recurrent/previously treated disease by either surgery or prior external beam radiation therapy; 13 of 31 lesions (42%) had received prior radiation therapy. Toxicity was evaluated according to the Common Terminology Criteria for Adverse Events version 4.03. Tumor response was assessed at 30 to 45 days at a follow-up visit using the Response Evaluation Criteria in Solid Tumors, version 1.1. Median follow-up time was 6.7 months.RESULTSAcute toxicity included mostly local pain and erythema at the implantation site followed by swelling and mild skin ulceration. For pain and grade 2 skin ulcerations, 90% of patients had resolution within 3 to 5 weeks. Complete response to the Ra-224 DaRT treatment was observed in 22 lesions (22/28; 78.6%); 6 lesions (6/28, 21.4%) manifested a partial response (>30% tumor reduction). Among the 22 lesions with a complete response, 5 (22%) developed a subsequent local relapse at the site of DaRT implantation at a median time of 4.9 months (range, 2.43-5.52 months). The 1-year local progression-free survival probability at the implanted site was 44% overall (confidence interval [CI], 20.3%-64.3%) and 60% (95% CI, 28.61%-81.35%) for complete responders. Overall survival rates at 12 months post-DaRT implantation were 75% (95% CI, 46.14%-89.99%) among all patients and 93% (95% CI, 59.08%-98.96%) among complete responders.CONCLUSIONSAlpha-emitter brachytherapy using DaRT achieved significant tumor responses without grade 3 or higher toxicities observed. Longer follow-up observations and larger studies are underway to validate these findings.

News (Medical) associated with Radspherin

11 Nov 2024

·www.businesswire.com

Oncoinvent Announces Promising Interim Results for Radspherin® as a Potential Treatment for Peritoneal Carcinomatoses

OSLO, Norway--( BUSINESS WIRE )--Oncoinvent ASA, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced an interim data readout of the Phase 1/2a studies of Radspherin® for the treatment of peritoneal carcinomatoses. The studies were closed for recruitment at the end of 2023, and patients are currently in long-term follow-up. The readout confirmed the previously published results on efficacy and adds further confidence in the ongoing randomized controlled Phase 2 clinical trial for Radspherin® in patients with ovarian cancer. In the first interim readout from the Phase 1 study in ovarian cancer, only 1 patient out of the 10 receiving the selected dose (10%) had peritoneal recurrence at the 12-month interim readout, compared to an expected recurrence rate of 25% in similar populations [1-3]. Correspondingly, in the second intermediate readout of the colorectal cancer study, only 3 of 20 patients (15%) receiving the selected dose of 7 MBq had peritoneal recurrence after the full 18 months follow-up period. With current standard therapy, the expected peritoneal recurrence rate is approximately 50% after 18 months [4]. 36 patients with colorectal cancer have received the selected dose, with results from the final 16 patients still pending full follow-up. “We are excited to announce the interim results of our Phase1/2a studies of Radspherin®, confirming a positive efficacy signal and demonstrating Radspherin’s® ability to enable local control in the peritoneum, thus ensuring patients remain in remission after surgery,” said Oystein Soug, Chief Executive Officer of Oncoinvent. “These positive results increase confidence in the further development of Radspherin® as an effective treatment option for patients suffering from peritoneal carcinomatoses, a condition that is notoriously difficult to treat effectively with systemic therapy.” “Patients with ovarian cancer often have peritoneal carcinomatoses already at diagnosis, giving them higher recurrence rate and worse prognosis - so an effective treatment targeted specifically at these carcinomatoses could reduce recurrence and prolong survival,” says Yun Wang, MD PhD, Department of Gynecologic Oncology, The Norwegian Radium Hospital, Oslo University Hospital, principal investigator in the RAD-18-001 study. 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. About the RAD-18-001 and RAD-18-002 study Two early phase studies with Radspherin® in patients with peritoneal carcinomatoses have completed recruitment at the end of 2023 with 68 patients treated. One study in patients with peritoneal carcinomatoses from platinum sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma (RAD-18-001, n=21, phase 1) scheduled for secondary cytoreduction, and one in patients with peritoneal carcinomatoses from colorectal cancer (RAD-18-002, n=47, phase 1/2a) scheduled for cytoreduction and HIPEC. The two studies were designed to evaluate the dose, safety and tolerability, dosimetry, and signal of efficacy of Radspherin®. 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. References [1] Coleman, R. L., Spirtos, N. M., Enserro, D., Herzog, T. J., Sabbatini, P., Armstrong, D. K., ... & Mannel, R. S. (2019). Secondary surgical cytoreduction for recurrent ovarian cancer. New England Journal of Medicine , 381 (20), 1929-1939. [2] Harter, P., Sehouli, J., Vergote, I., Ferron, G., Reuss, A., Meier, W., ... & Du Bois, A. (2021). Randomized trial of cytoreductive surgery for relapsed ovarian cancer. New England Journal of Medicine , 385 (23), 2123-2131. [3] Shi, T., Zhu, J., Feng, Y., Tu, D., Zhang, Y., Zhang, P., ... & Zang, R. (2021). Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. The Lancet Oncology , 22 (4), 439-449. [4] Quénet, F., Elias, D., Roca, L., Goéré, D., Ghouti, L., Pocard, M., ... & Patrick, R. A. T. (2021). Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. The Lancet Oncology , 22 (2), 256-266.

Clinical ResultPhase 2Phase 3ASCOPhase 1

01 Nov 2024

·www.businesswire.com

Oncoinvent Announces Publication of 18-Month Safety and Efficacy Data from the Phase 1/2a Study of Radspherin® in Colorectal Cancer

OSLO, Norway--( BUSINESS WIRE )--Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced the publication of data from the Phase 1/2a study of Radspherin® in colorectal cancer patients in the peer-reviewed Journal of Surgical Oncology . The results, previously presented at the 2023 Peritoneal Surface Oncology Group International (PSOGI) Congress in Venice, show encouraging 18 months safety and efficacy data from the 23 patients enrolled in the Phase 1 part of the RAD-18-002 study in colorectal cancer patients. “We are pleased to see our data published in such a well-recognized scientific journal,” commented Professor Emeritus Oyvind Bruland, MD, PhD, senior author on the manuscript, co-founder and member of Oncoinvent’s scientific advisory board. "The data in the publication highlights the potential of Radspherin® in treating patients with peritoneal metastases from colorectal cancer, a condition for which there is an urgent unmet need for novel treatment options." “Patients with liver and lung metastases benefit considerably from several other new treatment options, but not those with peritoneal metastases,” commented Stein G. Larsen, MD, PhD, principal investigator of the study and chief gastrosurgeon, the Norwegian Radium Hospital, Oslo University Hospital. The publication concludes that Radspherin® was well tolerated following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). At 18 months, none of the patients receiving the recommended dose (7 MBq) had peritoneal recurrences. Radspherin® also showed a promising signal of efficacy warranting further clinical evaluation. Results from 24 more patients treated with Radspherin® in the RAD-18-002 study are pending. The Journal of Surgical Oncology publication is available online at: https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/full/10.1002/jso.27897 About the RAD-18-002 Study RAD-18-002 is a Phase 1/2a open-label study designed to select the clinical dose, and evaluate the safety, tolerability, and signal of efficacy of intraperitoneally administered Radspherin® in patients with peritoneal metastases from colorectal cancer scheduled for cytoreduction and HIPEC. The study was closed for recruitment at the end of 2023. 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 metastases from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors. About Oncoinvent Oncoinvent AS 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 carefully composed 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. For additional information, please visit www.oncoinvent.com . 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.

Clinical ResultRadiation TherapyASCOPhase 2

28 Oct 2024

·www.businesswire.com

Oncoinvent to Present at JonesTrading Virtual Radiopharma Day

OSLO, Norway--( BUSINESS WIRE )--Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced that members of management will participate in a virtual panel discussion at the JonesTrading Virtual Radiopharma Day on Tuesday, October 29, 2024 at 2:35 p.m. ET. About Oncoinvent Oncoinvent AS 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 carefully composed 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. For additional information, please visit www.oncoinvent.com . 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.

Radiation TherapyPhase 2

100 Deals associated with Radspherin

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Indication	Highest Phase	Country/Location	Organization	Date
Endometrioid intraepithelial neoplasia	Phase 2	NO	Oncoinvent AS	15 Jun 2024
Endometrioid intraepithelial neoplasia	Phase 2	BE	Oncoinvent AS	15 Jun 2024
Ovarian Cancer	Phase 2	ES	Oncoinvent AS	15 Jun 2024
Ovarian Cancer	Phase 2	GB	Oncoinvent AS	15 Jun 2024
Ovarian Cancer	Phase 2	US	Oncoinvent AS	15 Jun 2024
Ovarian Cancer	Phase 2	NO	Oncoinvent AS	15 Jun 2024
Ovarian Cancer	Phase 2	BE	Oncoinvent AS	15 Jun 2024
Colorectal Cancer	Phase 2	SE	Oncoinvent AS	27 May 2020
Colorectal Cancer	Phase 2	NO	Oncoinvent AS	27 May 2020
Peritoneal Neoplasms	Phase 2	SE	Oncoinvent AS	27 May 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03732781 (ASCO2023) Manual	Phase 1/2	Neoplasm Metastasis	23	Radspherin	(fetvumeppw) = npyozoslyd xxtcchwcco (uoljuhxdjj ) View more	Positive	31 May 2023
NCT03732781 (2018-002803-33, ASCO2022) Manual	Phase 1	Colorectal Cancer	23	radspherin	(ukafjpgwua) = ycbsokseqe cegpsvhyif (hpybqhscuo ) View more	Positive	02 Jun 2022

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