ITM Isotope Technologies Munich SE (ITM), today announced that the first patient has been treated in its second pivotal phase III clinical trial, COMPOSE (NCT04919226), evaluating the company’s lead radiopharmaceutical candidate, ITM-11 (n.c.a. 177Lu-edotreotide), for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is a Targeted Radionuclide Therapeutic consisting of the high-quality radioisotope no-carrier-added lutetium-177 (n.c.a. 177Lu) fused with a somatostatin analogue to specifically target somatostatin receptor-positive (SSTR+) GEP-NETs. While COMPOSE is evaluating ITM-11 for the treatment of well-differentiated high grade 2 and grade 3 GEP-NETs, the radiopharmaceutical is also being investigated in ITM’s ongoing pivotal phase III trial, COMPETE (NCT03049189), in patients with grade 1 and 2 GEP-NETs. GEP-NETs can occur in the pancreas or in other parts of the gastrointestinal tract. Due to their frequent asymptomatic and progressive nature, GEP‑NETs often present late with advanced disease requiring innovative therapeutic measures. The trial design of COMPOSE was recently presented at the 2022 ASCO Gastrointestinal Cancers Symposium (ASCO-GI).
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) – (COMPOSE) is a new trial commencing September 2021.
Brief Summary of the COMPOSE trial: This is an Open-label, Multicentre Study. Its purpose is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. So this trial is focused on more aggressive tumours, which is great news.
The clinical trials document is here. (not fully populated yet as at 25th Sep 2021).
Read about on the ITM website – click here
I’ve written about this product before. It’s a synthetic, low-energy beta-emitting isotope of Lutetium 177 (a radioactive component already used within an approved product called Lutathera). Attaching the radiopharmaceutical Solucin® it’s administered as an intravenous infusion, specifically targeting and destroying the tumor cells with ionizing radiation, i.e. it works in exactly the same way as conventional PRRT. Read more by clicking this link plus news of an existing trial in Phase 3 – Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs
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.
Inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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