What is Satoreotide?
It’s an agonist treatment. i.e. a ‘next generation’ radioligand for Peptide receptor radionuclide therapy (PRRT) or more specifically the radiopharmaceutical that binds to both activated and inactivated somatostatin receptors which are upregulated on these tumours. There is far higher binding via this mechanism than standard octreotate. The technical name of the radiopharmaceutical is Satoreotide tetraxetan lutetium-177 (author’s note, I’m guessing but it could be a variant of Lanreotide).
Somatostatin type 2 (SST2) receptor is overexpressed in many around 80% of NETs, some NEC and in certain hard-to-treat cancers such as small cell lung cancer (SCLC) and neuroblastoma, an aggressive, rare type of cancer that occurs mainly in young children.
It was once named JR11 when owned by Ipsen (see history below).
The term ‘antagonist’ is important and note that most PRRT in use is ‘agonist’. The differences are quite technical but hopefully, I explained them below.
Update 11th November 2025 – Ariceum Therapeutics Doses First Patient in SANTANA-225 Phase 1/2 Clinical Trial of 225Ac-SSO110 in Patients with Extensive-Stage Small Cell Lung Cancer or Merkel Cell Carcinoma. Click here to read more. Worth noting that the use of 225Ac means it is now an alpha-emitter PRRT.
Update 6th February 2025. U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy. Click here to read more.
Update 14th January 2025. FDA Clears Ariceum Therapeutics’ 225Ac-Satoreotide Phase I/II Clinical Study in Patients with Small Cell Lung Cancer or Merkel Cell Carcinoma. Click here to read more.
History
This drug was once owned by Ipsen when it was known as JR11 or OPS 201, but they decided to sell it off. In Jun 2022, Ariceum Therapeutics (Ariceum), a private biotech company developing a radiopharmaceutical product for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, announced the successful investment source of EURO 25 million. The proceeds from the financing will enable Ariceum to further develop its lead asset and proprietary peptide derivative, satoreotide. Ipsen remains a shareholder in the company.
It was interesting to note in the JR11 trial that Satoreotide can be used as a ‘theranostic’ for both the diagnosis and treatment of tumours expressing the SST2 receptor. There is evidence of the existence of a Ga68 PET using Satoreotide, known as 68Ga-Satoreotide Trizoxetan (SSO120). The data looked favourable against regular G68 Dotatate – click here.
What’s the difference ‘agonist’ and ‘antagonist’?
Conventional beta PRRT (e.g. Lutathera, Lu177 Dotatate) is based on a somatostatin receptor ‘agonist’ approach, whereas 177Lu Satoreotide is a receptor ‘antagonist’. The differences are quite technical but in the most layman terms, the antagonist has the capability of attaching (binding) to more receptors, including those in a ‘resting’ or ‘inactive’ state, spends more time on the tumor than agonist-based therapies. The result is a higher number of receptor binding sites and greater tumor uptake. In addition, it is said to show an improved tumor-to-kidney dose ratio compared to the agonist 177Lu-DOTA-TATE.
This would also be reflected in the theranostic use of the drug in Ga68 imaging (i.e. Ga68 Satoreotide).
Trial Summary (Ariceum)
The existence of the record in my normal source (Clinical Trials dot Gov) is confusing as the original Ipsen trial is there marked as terminated but has been updated in 2023. That said, the clinical trial output in 2023 still quotes the original trial number so it may be that it remains out of date in terms of the usual criteria listed in such documents. I will keep my eye on it being updated.
This announcement from the new owner confirms a new trial is underway managed by the new owners.
This citation below will give you the more detail about the above clinical trial activity.
Wild, D., Grønbæk, H., Navalkissoor, S. et al. A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours. Eur J Nucl Med Mol Imaging (2023). https://doi.org/10.1007/s00259-023-06383-1
This document also confirms a separate clinical trial for SCLC (technically a form of Lung Neuroendocrine Carcinoma) which is normally treated by Lung MDTs.
I’m still looking for an update on the new clinical trial managed by Ariceum but for information purposes only until I confirm, the original trial locations (or which are showing now) are Australia (Melbourne and Perth), Austria (Vienna), Canada (CHU de Quebec), Denmark (Aarhus), Switzerland (Basel), UK (Royal Free London), France (Nantes and Toulouse), MD Anderson Texas USA. There is also mention of a site in USA carried out a similar trial at MSK New York where the sponsors reported “In this trial of heavily treated NETs, preliminary data are promising for the use of 177Lu-satoreotide tetraxetan. Additional studies are ongoing to determine optimal therapeutic dose/schedule” – results of the MSK trial were posted here. However, see updates above 6th Feb 25 and 14 Jan 25.
Why is this trial important?
Around 20% of NET patients have no or inefficient somatostatin receptors. This type of treatment could open up more access to PRRT for those with insufficient/inefficient receptors.
Read more of the history here
- Original Ipsen clinical trial (information only) – Study Details | Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs | ClinicalTrials.gov
- New trial info – https://clinicaltrials.gov/study/NCT05017662
- Trial update of the Ariceum sponsored activity in NETs – Wild, D., Grønbæk, H., Navalkissoor, S. et al. A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours. Eur J Nucl Med Mol Imaging (2023). https://doi.org/10.1007/s00259-023-06383-1
- Company announcement on NET trial – Ariceum Therapeutics’ targeted radiopharmaceutical 177Lu-satoreotide exhibits promising clinical response and good tolerability profile in patients with advanced neuroendocrine tumours – Ariceum Therapeutics (ariceum-therapeutics.com)
See also this more modern antagonist product aimed at regular NET
Disclaimer
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
Finally
Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
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Has anyone tried this. What’s it like?
I think there is 1 or maybe 2 people in my private patient group
How would this compare to mibg therapy?
much more modern tech. mibg mainly for pheochromoctyoma/paraganglioma ?
Wow, haven’t even had the one this is going to supercede yet! Thanks for the info Ronny.