SOMther (lutetium-177 DOTA satoreotide)

P1, N=70, Active, not recruiting, Ariceum Therapeutics Australia Pty Ltd | Recruiting --> Active, not recruiting

In this article, we review both preclinical and clinical data evaluating the efficacy and safety of [¹⁷⁷Lu]Lu-satoreotide tetraxetan in the treatment of neuroendocrine tumors. We also provide a brief overview of other SSTR antagonists currently under investigation.

P1/2, N=50, Recruiting, Ariceum Therapeutics GmbH

P1/2, N=18, Recruiting, University Hospital, Basel, Switzerland | Phase classification: P1 --> P1/2 | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026

[177Lu]Lu-satoreotide tetraxetan showed a favourable dosimetry profile, with high and prolonged tumour uptake, supporting its acceptable safety profile and promising efficacy.

[Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing.

P1, N=70, Recruiting, Ariceum Therapeutics Australia Pty Ltd | Initiation date: Jun 2000 --> Jun 2023

P1/2, N=40, Terminated, Ipsen | Trial completion date: Jan 2023 --> Feb 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2023 --> Feb 2022; Terminated (Due to small number of ongoing patients. Patients ongoing at time of termination could choose to join study D-FR-01072-004 for long term follow-up.

Whereas most of [Lu]Lu-OPS201 remained at the cell surface, [Lu]Lu-DOTA-TATE was almost completely internalised inside the cell. The present data identified distinct differences between [Lu]Lu-OPS201 and [Lu]Lu-DOTA-TATE regarding the recognition of receptor binding sites (higher for [Lu]Lu-OPS201) and their kinetics (faster association and slower dissociation of [Lu]Lu-OPS201) that explain, to a great extent, the improved therapeutic efficacy of [Lu]Lu-OPS201 compared to [Lu]Lu-DOTA-TATE.

These preliminary data, reporting an acceptable safety profile and a high DCR, are promising and support a potential role for 177Lu-satoreotide tetraxetan in treating advanced NETs.

P1/2, N=40, Active, not recruiting, Ipsen | Trial completion date: May 2022 --> Jan 2023 | Trial primary completion date: May 2022 --> Jan 2023

P1, N=18, Recruiting, University Hospital, Basel, Switzerland