Peptide Receptor Radionuclide Therapy (PRRT) with a Somatostatin Receptor (SSTR) Antagonist in Patients with SSTR-Positive, Progressive Neuroendocrine Tumours (NETs): A Phase I/II Open-Label Trial to Evaluate the Safety and Preliminary Efficacy of 177Lu-O

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Introduction: PRRT with radiolabelled SSTR agonists is highly effective and has become an integral part of NET treatment. Tumour uptake and tumour-to-tissue dose ratios may be higher with radiolabelled SSTR antagonists than agonists. DOTA-JR11 (OPS201) is a very promising next-generation SSTR2-selective antagonist.

Aim(s): This phase I/II, international, single-arm, open-label study will evaluate 177Lu-OPS201 as PRRT in 45 adults with unresectable, SSTR-positive, progressive gastroenteropancreatic-NETs, lung NETs, phaeochromocytomas and paragangliomas.

Materials and methods: Phase A: 6 patients receive 3 cycles of 177Lu OPS201 at 4.5 GBq over 24 weeks. A further 9 patients receive 3 cycles of 177Lu OPS201 at 4.5 GBq, or an activity not evoking dose-limiting toxicity, dependent on initial safety/dosimetry data. Phase B: 30 patients receive 3 cycles of 177Lu OPS201 at up to 7.4 GBq, dependent on phase A safety/dosimetry data. Tumour response (centrally reviewed [RECIST1.1.]) will be assessed on CT/MRI every 3 months from end of core trial visit for 2 years, or until progressive disease/death.

Conference: 14th Annual ENETSConcerence (2017)

Presenting Author:

Authors: Nicolas G, Baum R, Herrmann K, Lassmann M, Hicks R,

Keywords: PRRT, 177Lu, OPS201,