This is an open-label whole-body PET/CT study for investigating the value of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in patients with Tumor-induced osteomalacia.

Start Date15 Mar 2020

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT03773133 / TerminatedPhase 1/2

A Multicentre, Open-Label Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)

This study consists of two phases. The phase I study is designed to investigate the safety and tolerability of Satoreotide tetraxetan following fractionated i.v. administrations in pre-treated subjects with locally advanced or metastatic cancers expressing sstr2 as identified by Satoreotide trizoxetan Positron Emission Tomography (PET/CT) scans. This phase will encompass both radioactivity escalation and peptide mass dose evaluation. Phase II will assess the efficacy of Satoreotide tetraxetan in subjects in selected indications, in a basket design.

Start Date14 May 2019

Sponsor / Collaborator

Ipsen SA

100 Clinical Results associated with Gallium-68 satoreotide

100 Translational Medicine associated with Gallium-68 satoreotide

100 Patents (Medical) associated with Gallium-68 satoreotide

Literatures (Medical) associated with Gallium-68 satoreotide

01 Oct 2023·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

⁶⁸Ga-SSO-120 PET for Initial Staging of Small Cell Lung Cancer Patients: A Single-Center Retrospective Study.

Article

Author: Schuler, Martin ; Oezkan, Filiz ; Hautzel, Hubertus ; Darwiche, Kaid ; Stuschke, Martin ; Nader, Michael ; Wienker, Johannes ; Hamacher, Rainer ; Wiesweg, Marcel ; Herrmann, Ken ; Sraieb, Miriam ; Sandach, Patrick ; Eberhardt, Wilfried E E ; Metzenmacher, Martin ; Umutlu, Lale ; Fendler, Wolfgang P ; Kersting, David ; Bölükbas, Servet

PET imaging using the somatostatin receptor 2 (SSTR2) antagonist satoreotide trizoxetan (SSO-120, previously OPS-202) could offer accurate tumor detection and screening for SSTR2-antagonist radionuclide therapy in patients with SSTR2-expressing small cell lung cancer (SCLC). The aim of this single-center study was to investigate tumor uptake and detection rates of ⁶⁸Ga-SSO-120 in comparison to ¹⁸F-FDG PET in the initial staging of SCLC patients. Methods: Patients with newly diagnosed SCLC who underwent additional whole-body ⁶⁸Ga-SSO-120 PET/CT during the initial diagnostic workup were retrospectively included. The mean administered activity was 139 MBq, and the mean uptake time was 60 min. Gold-standard staging ¹⁸F-FDG PET/CT was evaluated if available within 2 wk before or after ⁶⁸Ga-SSO-120 PET if morphologic differences in CT images were absent. ⁶⁸Ga-SSO-120- or ¹⁸F-FDG-positive lesions were reported in 7 anatomic regions (primary tumor, thoracic lymph node metastases, and distant metastases including pleural, contralateral pulmonary, liver, bone, and other) according to the TNM classification for lung cancer (eighth edition). Consensus TNM staging (derived from CT, endobronchial ultrasound-guided transbronchial needle aspiration, PET, and brain MRI) by a clinical tumor board served as the reference standard. Results: Thirty-one patients were included, 12 with limited and 19 with extensive disease according to the Veterans Administration Lung Study Group classification. ⁶⁸Ga-SSO-120-positive tumor was detected in all patients (100%) and in 90 of the 217 evaluated regions (41.5%). Thirteen patients (42.0%) had intense average ⁶⁸Ga-SSO-120 uptake (region-based mean SUV_max ≥ 10); 28 patients (90.3%) had average ⁶⁸Ga-SSO-120 uptake greater than liver uptake (region-based mean peak tumor-to-liver ratio > 1). In 25 patients with evaluable ¹⁸F-FDG PET, primary tumor, thoracic lymph node metastases, and distant metastases were detected in 100%, 92%, and 64%, respectively, of all investigated patients by ⁶⁸Ga-SSO-120 and in 100%, 92%, and 56%, respectively, by ¹⁸F-FDG PET. ⁶⁸Ga-SSO-120 PET detected additional contralateral lymph node, liver, and brain metastases in 1, 1, and 2 patients, respectively (no histopathology available), and ¹⁸F-FDG PET detected additional contralateral lymph node metastases in 3 patients (1 confirmed, 1 systematic endobronchial ultrasound-guided transbronchial needle aspiration-negative, and 1 without available histopathology). None of these differences altered Veterans Administration Lung Study Group staging. The region-based monotonic correlation between ⁶⁸Ga-SSO-120 and ¹⁸F-FDG uptake was low (Spearman ρ = 0.26-0.33). Conclusion: ⁶⁸Ga-SSO-120 PET offers high diagnostic precision with comparable detection rates and additional complementary information to the gold standard, ¹⁸F-FDG PET. Consistent uptake in most patients warrants exploration of SSTR2-directed radionuclide therapy.

01 Mar 2022·Journal of nuclear medicine : official publication, Society of Nuclear MedicineQ1 · MEDICINE

A Randomized, Factorial Phase II Study to Determine the Optimal Dosing Regimen for ⁶⁸Ga-Satoreotide Trizoxetan as an Imaging Agent in Patients with Gastroenteropancreatic Neuroendocrine Tumors

Q1 · MEDICINE

Article

Author: Miller, Colin G ; Czernin, Johannes ; Iversen, Peter ; Kjaer, Andreas ; Bahri, Shadfar ; Carlsen, Esben A ; Maffey-Steffan, Johanna ; Knigge, Ulrich ; Virgolini, Irene ; Loft, Mathias ; Grønbæk, Henning ; Powell, Christine ; McEwan, Sandy ; Rohban, Thomas

⁶⁸Ga-satoreotide trizoxetan is a novel somatostatin receptor antagonist associated with high sensitivity and reproducibility in neuroendocrine tumor (NET) detection and localization. However, the optimal peptide mass and radioactivity ranges for ⁶⁸Ga-satoreotide trizoxetan have not yet been established. We therefore aimed to determine its optimal dosing regimen in patients with metastatic gastroenteropancreatic NETs in a prospective, randomized, 2 × 3 factorial, multicenter phase II study. Methods: Patients received ⁶⁸Ga-satoreotide trizoxetan at a peptide mass of 5-20 µg on day 1 of the study and of 30-45 µg on days 16-22, at 1 of 3 ⁶⁸Ga radioactivity ranges (40-80, 100-140, or 160-200 MBq). Whole-body PET/CT imaging was performed 50-70 min after each injection. The primary endpoint was the detection rate of NET lesions imaged by ⁶⁸Ga-satoreotide trizoxetan relative to contrast-enhanced CT (for each of the 6 peptide mass and radioactivity range combinations). Results: Twenty-four patients were evaluated in the per-protocol analysis. The median number of lesions detected by ⁶⁸Ga-satoreotide trizoxetan PET/CT or PET alone was at least twice as high as the number detected by contrast-enhanced CT across the 6 studied peptide mass and radioactivity range combinations. There were no differences between the 2 peptide mass ranges or between the 3 radioactivity ranges in the number of identified lesions. However, a trend toward a lower relative lesion count was noted in the liver for the 40- to 80-MBq range. No relationship was observed between the radioactivity range per patient's body weight (MBq/kg) and the number of lesions detected by ⁶⁸Ga-satoreotide trizoxetan. The median diagnostic sensitivity of ⁶⁸Ga-satoreotide trizoxetan PET/CT, based on the number of lesions per patient, ranged from 85% to 87% across the different peptide mass and radioactivity ranges. Almost all reported adverse events were mild and self-limiting. Conclusion: A radioactivity of 100-200 MBq with a peptide mass of up to 50 µg was confirmed as the optimal dosing regimen for ⁶⁸Ga-satoreotide trizoxetan to be used in future phase III studies.

01 Dec 2021·EJNMMI researchQ3 · MEDICINE

A novel read methodology to evaluate the optimal dose of 68Ga-satoreotide trizoxetan as a PET imaging agent in patients with gastroenteropancreatic neuroendocrine tumours: a phase II clinical trial

Q3 · MEDICINE

ArticleOA

Author: Virgolini, Irene ; Grønbæk, Henning ; Bahri, Shadfar ; Svirydenka, Hanna ; Kjaer, Andreas ; Iversen, Peter ; McEwan, Sandy ; Miller, Colin G ; Terve, Pierre ; Rohban, Thomas

Abstract:

Background:

68Ga-satoreotide trizoxetan is a novel somatostatin receptor antagonist exhibiting higher tumour-to-background ratios and sensitivity compared to 68Ga-DOTATOC. This randomised, 2 × 3 factorial, phase II study aimed to confirm the optimal peptide mass and radioactivity ranges for 68Ga-satoreotide trizoxetan, using binary visual reading. To that end, 24 patients with metastatic gastroenteropancreatic neuroendocrine tumours received 5–20 µg of 68Ga-satoreotide trizoxetan on day 1 of the study and 30–45 µg on day 16–22, with one of three gallium-68 radioactivity ranges (40–80, 100–140, or 160–200 MBq) per visit. Two 68Ga-satoreotide trizoxetan PET/CT scans were acquired from each patient post-injection, and were scored by experienced independent blinded readers using a binary system (0 for non-optimal image quality and 1 for optimal image quality). For each patient pair of 68Ga-satoreotide trizoxetan scans, one or both images could score 1.

Results:

Total image quality score for 68Ga-satoreotide trizoxetan PET scans was lower in the 40–80 MBq radioactivity range (56.3%) compared to 100–140 MBq (90.6%) and 160–200 MBq (81.3%). Both qualitative and semi-quantitative analysis showed that peptide mass (5–20 or 30–45 µg) did not influence 68Ga-satoreotide trizoxetan imaging. There was only one reading where readers diverged on scoring; one reader preferred one image because of higher lesion conspicuity, and the other reader preferred the alternative image because of the ability to identify more lesions.

Conclusions:

Binary visual reading, which was associated with a low inter-reader variability, has further supported that the optimal administered radioactivity of 68Ga-satoreotide trizoxetan was 100–200 MBq with a peptide mass up to 50 µg.Trial registration ClinicalTrials.gov, NCT03220217. Registered 18 July 2017, https://clinicaltrials.gov/ct2/show/NCT03220217

News (Medical) associated with Gallium-68 satoreotide

07 Sep 2023

·www.prnewswire.com

Ariceum Therapeutics doses first patient with its first-in-class targeted radiopharmaceutical drug satoreotide in its Phase Ib study in small cell lung cancer

Ariceum develops satoreotide its first and best-in-class somatostatin receptor 2 antagonist in extensive stage small cell lung cancer Phase Ib study design will be presented at the European Association of Nuclear Medicine Congress 2023 (EANM 2023) in Vienna, Austria on 10th September 2023 BERLIN, Sept. 7, 2023 /PRNewswire/ -- Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, is pleased to announce that the first patient has been dosed with its first-in-class lead molecule, satoreotide, targeting extensive stage small cell lung cancer (ES-SCLC), at the Murdoch University Health Center in Perth, Australia. Ariceum has successfully initiated its multicentre, open label Phase Ib study which will investigate the safety and tolerability of the 'theranostic pair' of somatostatin receptor antagonist 68Ga-Satoreotide Trizoxetan (SSO120) and 177Lu-satoreotide tetraxetan (SSO110) in patients with ES-SCLC. The main objective of the study is to establish a recommended Phase 2 dose and schedule. 'Theranostics' is the approach of using two paired drugs – the first, a diagnostic agent to identify cells which exhibit a particular biomarker; and the second, a therapeutic drug, to act on those cells. Both the diagnostic agent and therapeutic drug contain Ariceum's proprietary peptide satoreotide, a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SST2), a cell surface protein often overexpressed in certain cancers including small cell lung cancer (SCLC). The study, entitled LuSato-1 study, includes patients with ES-SCLC who will each receive an infusion containing the diagnostic imaging agent, somatostatin receptor antagonist before undergoing a positron emission tomography (PET) scan. This will determine if a patient's tumours express the SST2. Patients identified with confirmed SST2 expression will receive escalating doses of satoreotide, in addition to the immunotherapy atezolizumab, a PD-L1 checkpoint inhibitor, during the maintenance phase of their treatment until a recommended phase 2 dose can be defined. Additional patients may be enrolled in an expansion cohort. Further details on the study can be found on Australian Clinical Trials, under identifier Ariceum SSO11O-01. Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "The initiation of this Phase Ib study is an important milestone reached by the Company in close collaboration with our partners in Australia and Europe. We believe that our lead targeted systemic radiopharmaceutical product satoreotide has the potential to demonstrate positive results in patients with extensive stage small cell lung cancer. Theranostics holds great hope as a highly targeted form of cancer therapy, using a 'search and destroy' approach to seek out tumours while sparing healthy tissue." Germo Gericke, Chief Medical Officer of Ariceum Therapeutics, said: "Although immune checkpoint blockade has improved the treatment of ES-SCLC, disease recurrence often occurs early in the maintenance phase. Adding targeted radiotherapy with satoreotide to immune checkpoint blockade in the maintenance setting holds the promise to improve the therapeutic effect of the maintenance therapy." An Abstract on the LuSato-1 study will be presented at the European Association of Nuclear Medicine Congress 2023 (EANM 2023) in Vienna, Austria, on 10th September 2023. Presentation details below. Abstract OP-230 Top Rated Oral Presentations (TROP) Session: Oncology & Theranostics Committee Session: 606 - Neuroendocrine Tumours Treatment Abstract title: A phase I theranostic study evaluating the safety and tolerability of 177Lu-satoreotide tetraxetan with 68Ga-satoreotide trizoxetan companion imaging in participants with extensive-stage small-cell lung cancer (ES-SCLC) on atezolizumab maintenance therapy Authors: L. Emmett, J. Cardaci, K. O'Byrne, S. Arulananda, A. Prawira, B. Pais, M. Crumbaker, N. Lenzo Date & Time: 10 September, 4:45-6:15pm CEST Notes to Editors About Ariceum Therapeutics Ariceum Therapeutics (Ariceum) is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of 'Marie Curie' whose discovery of radium and polonium have been huge contributions to finding treatments for cancer. Ariceum's lead targeted systemic radiopharmaceutical product, 177Lu-satoreotide tetraxetan ("satoreotide"), is an antagonist of the somatostatin type 2 (SST2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), all of which have few treatment options and poor prognosis. Satoreotide is being developed as a 'theranostic' pair for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum Therapeutics, launched in 2021, acquired all rights from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Australia, United Kingdom, United States of America and Switzerland and activities currently across the globe. Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and Earlybird Venture Capital. For further information, please visit SOURCE Ariceum Therapeutics

Phase 1OligonucleotideAcquisition

08 Sep 2021

·www.globenewswire.com

Japanese Prostate Cancer Imaging Study Completes Enrolment

MELBOURNE, Australia and KYOTO, Japan, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the last patient has been imaged in a Phase I clinical study of Telix’s investigational prostate cancer imaging product TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11 injection) in collaboration with Kanazawa University. This study, which reached target enrolment of ten patients, is the first clinical evaluation of a Gallium-68-labeled prostate cancer diagnostic imaging agent in Japan. The objective is to obtain safety data in a representative Japanese patient population and to confirm that the targeting and biodistribution of TLX591-CDx in Japanese patients are consistent with international experience. Subject to positive outcomes, clinical data obtained from this study will facilitate development planning with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and potentially other Asian regulators. Professor Atsushi Mizokami from the Department of Integrative Cancer Therapy and Urology, Kanazawa University, Graduate School of Medical Science said, “I am pleased that we have successfully completed enrolment of the first Japanese clinical study of 68Ga-PSMA-11 for men with advanced prostate cancer, despite severe ongoing disruption caused by the COVID-19 pandemic. This state-of-the-art PET imaging agent is currently under regulatory review in 17 countries worldwide and we are excited to play our role in bringing this important new diagnostic tool to market in Japan as efficiently as possible.” Shintaro Nishimura, President of Telix Pharmaceuticals Japan, added, “We are grateful to Professor Mizokami and his colleagues for their efforts in recruiting this trial in a timely fashion, as well as study participants for their commitment to delivering innovative benefits to Japanese men living with prostate cancer. I believe that this will become a cornerstone moment for future prostate cancer theranostics in Japan and the Asia-Pacific region and provides a pathway for Telix to engage with regulators for approval of our lead product, in Japan.” About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit and follow Telix on Twitter (@TelixPharma) and LinkedIn. Telix’s lead investigational product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,1 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).2 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union3 and Canada.4 None of Telix’s products have received a marketing authorisation in any jurisdiction. Telix Media Contact Dr. Stewart HolmstromTelix Pharmaceuticals LimitedDirector Corporate CommunicationsEmail: stewart.holmstrom@telixpharma.com 1 ASX disclosure 24/11/20.2 ASX disclosure 14/04/21.3 ASX disclosure 1/05/20.4 ASX disclosure 16/12/20.

100 Deals associated with Gallium-68 satoreotide

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Small Cell Lung Cancer	Phase 2	US	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	AT	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	BE	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	FR	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	DE	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	CH	Ipsen SA	14 May 2019
Small Cell Lung Cancer	Phase 2	GB	Ipsen SA	14 May 2019
Breast Cancer	Phase 2	AT	Ipsen SA	22 Oct 2018
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 2	US	Ipsen SA	26 Sep 2017
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 2	AT	Ipsen SA	26 Sep 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04689893 (Pubmed) Manual	Phase 1	Oncogenic Osteomalacia	19	68Ga-DOTA-TATE	asalsikthy(smzpwriqte) = rbkbkwspov tttktulscc (pfozmzakjg )	Positive	24 Feb 2022
				Gallium-68 satoreotide	asalsikthy(smzpwriqte) = yxryhsjxlw tttktulscc (pfozmzakjg )
NCT03220217 (Pubmed \| J Nucl Med) Manual	Phase 2	Neuroendocrine Tumors	24	Gallium-68 satoreotide trizoxetan	owurqrlvyk(ewrzvanieq) = Gallium-68 satoreotide trizoxetan PET/CT or PET alone was at least twice as high as the number detected by contrast-enhanced CT cvxzmyjpxx (bgdpczawpb )	Positive	02 Jul 2021
				contrast-enhanced CT
NCT03697551 (CTgov)	Phase 2	Breast Cancer	4	68Ga-Satoreotide Trizoxetan	uyrzyrbizp(wabnqbjten) = zxlknbxvlw lcagfvbobu (xzrahgyilr, cxsjnduzwu - wftydbrcdg) View more	-	07 Sep 2020
NCT02162446 (CTgov)	Phase 1/2	SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	12	OPS202 peptide+68Ga-OPS202+68Ga (All Participants)	oqxwldceep(zlqfrefjnk) = pwsswjawbj kyvgeooitg (keyxugigkx, brugpssvxy - aronyakvgk) View more	-	02 Oct 2019
				IP (ITT Population (Pre-dose))	feqdcecnkk(igxvzlvjcm) = cwipuvhuqp nmcoyuexuk (zepekuaqlj, juwnonmycu - yrwccqcrmn) View more

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