NCT04997317

Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide

Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-Satoreotide (PROMENADE-Study)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic intestinal neuroendocrine tumours and is currently used in advanced, recurrent or progressive meningiomas with promising results. In this study, the therapeutic index of a standard and newly developed radiolabelled somatostatin antagonist will be evaluated and compared in PRRT. In a second step, safety and efficacy of the latter will be assessed.

Detailed description

The somatostatin receptor subtype 2 (sstr2) has been identifies as a peptide hormone receptor that is highly expressed in 70 - 100% of meningiomas representing an attractive target for so called "theranostic" applications combining molecular imaging and targeted radionuclide therapy with radiolabelled somatostatin analogues.The newly developed radiolabelled somatostatin antagonist 177Lu-DOTA-JR11 has been shown to exert a high binding affinity to sstr2 suggesting a higher efficacy in the treatment of advanced meningiomas than the currently available somatostatin analogues (e.g. 177Lu-DOTATOC, 177Lu-DOTATATE).Therefore, the hypothesis has been postulated that 177LuDOTA-JR11 has an improved therapeutic index (tumour-to-dose limiting organ dose ratios) compared to 177Lu-DOTATOC, and that it can be safely used for PRRT in patients with advanced, recurrent or progressive meningiomas. The aim of this 2-step Phase 0 / Phase I/II study is to a) evaluate in the same meningioma patients the therapeutic index (tumour-to-dose limiting organ dose ratios) of 177Lu-DOTA-JR11 in comparison to 177Lu-DOTATOC and b) based on the previous results, to evaluate safety and preliminary efficacy of PRRT with 177Lu-DOTA-JR11.

Conditions

• Meningioma

Interventions

Type	Name	Description
DRUG	177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over)	177Lu-DOTA-JR11 has three main components, namely the somatostatin analogue JR11, the chemical chelator group DOTA and the beta emitter 177Lutetium (177Lu). In the Phase 0 part of the study 177Lu-DOTA-JR11 will be administered once intravenously. The activity of the first 2 cycles will be capped at 4.5 GBq (range: 4.2-4.6 GBq).
DRUG	177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4	177Lu-DOTATOC is a therapeutic medicinal product and has 3 main components (a) 177Lutetium (177Lu), a beta-emitting radionuclide with a half-life of 6.64 days; (b) DOTA, a chemical chelator group; and (c) TOC (= \[Tyr\]3-octreotide) an agonistic somatostatin analogue which binds to sstr2 and sstr5 receptors. In the Phase 0 part of the study 177Lu-DOTATOC will be administered once intravenously. The activity of the first 2 cycles will be capped at 4.5 GBq (range: 4.2-4.6 GBq). The remaining 2 cycles will be performed with an activity of 7.4 GBq 177Lu-DOTATOC (total number of cycles = 4).
DRUG	177Lu-DOTA-JR11 (Phase I/II)	In the phase I/II part of the study: 3 cycles of 177Lu-DOTA-JR11 will be administered with an activity of 4.5-7.4 GBq. Two additional 177Lu-DOTA-JR11 treatment cycles can be performed if clinically indicated

Timeline

• Start date: 2021-04-21
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-08-09
• Last updated: 2025-04-13

Locations

1 site across 1 country: Switzerland