NCT04997317: PROMENADE

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

Recruiting now Phase 1, PHASE2 Last updated 13 April 2025

What this trial tests

Phase 1, PHASE2 trial testing 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over) in Meningioma in 18 participants. Currently enrolling.

Timeline

21 April 2021

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	University Hospital, Basel, Switzerland
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	21 April 2021
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Switzerland

Drugs / interventions tested

• 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over) — full drug profile →
• 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4 — full drug profile →
• 177Lu-DOTA-JR11 (Phase I/II) — full drug profile →

Conditions studied

• Meningioma — all drugs for Meningioma →

Sponsor

University Hospital, Basel, Switzerland

Who can join

18 and older, any sex, with Meningioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intracranial meningiomas: an update of the 2021 World Health Organization classifications and review of management with a focus on radiation therapy.
   Yarabarla V, Mylarapu A, Han TJ, McGovern SL, et al · · 2023 · cited 31× · PMID 37675219 · DOI 10.3389/fonc.2023.1137849
2. The Role of Pharmacotherapy in Treatment of Meningioma: A Systematic Review.
   Shahbandi A, Shah DS, Hadley CC, Patel AJ. · · 2023 · cited 21× · PMID 36672431 · DOI 10.3390/cancers15020483
3. Radiolabeled Somatostatin Receptor Antagonist Versus Agonist for Peptide Receptor Radionuclide Therapy in Patients with Therapy-Resistant Meningioma: PROMENADE Phase 0 Study.
   Eigler C, McDougall L, Bauman A, Bernhardt P, et al · · 2024 · cited 20× · PMID 38423782 · DOI 10.2967/jnumed.123.266817
4. Hormone therapies in meningioma-where are we?
   Miyagishima DF, Moliterno J, Claus E, Günel M. · · 2023 · cited 17× · PMID 36418843 · DOI 10.1007/s11060-022-04187-1
5. Radioligand therapies in meningioma: Evidence and future directions.
   Mair MJ, Tabouret E, Johnson DR, Sulman EP, et al · · 2024 · cited 15× · PMID 38702966 · DOI 10.1093/neuonc/noae069
6. Current clinical application of lutetium‑177 in solid tumors (Review).
   Niu T, Fan M, Lin B, Gao F, et al · · 2024 · cited 13× · PMID 38596660 · DOI 10.3892/etm.2024.12514
7. The Current Role of Peptide Receptor Radionuclide Therapy in Meningiomas.
   Fodi CK, Schittenhelm J, Honegger J, Castaneda-Vega SG, et al · · 2022 · cited 12× · PMID 35566491 · DOI 10.3390/jcm11092364
8. Targeted radioligand therapy: physics and biology, internal dosimetry and other practical aspects during <sup>177</sup>Lu/<sup>225</sup>Ac treatment in neuroendocrine tumors and metastatic prostate cancer.
   Dadgar H, Pashazadeh A, Norouzbeigi N, Assadi M, et al · · 2025 · cited 10× · PMID 40225563 · DOI 10.7150/thno.107963