Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs

Official Title

An International, Multicentre, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumours (NETs)


The purpose of this clinical phase I/II study is to investigate the safety and tolerability of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumours (NETs). Secondary objectives of these study are the assessment of biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201.

Trial Description

Primary Outcome:

  • Safety and Tolerability of 177Lu-OPS201 assessed by number of patients with treatment related adverse events using CTCAE v5.0
Secondary Outcome:
  • Area under the curve (AUC) of 177Lu-OPS201 per cycle in discernible thoracic and abdominal organs, target lesions and blood
  • Maximal uptake (achieved in %) at the target lesions per cycle.
  • Maximal uptake in discernible organs (%) and blood (%/mL) per cycle.
  • Organs receiving the highest absorbed dose (Gy) for each cycle.
  • Specific absorbed dose per organ (achieved in Gy/GBq) for each cycle.
  • Cumulative absorbed organ doses (achieved in Gy).
  • Preliminary therapeutic efficacy of 177Lu-OPS201 assessed by tumour response based on RECIST v1.1
  • Preliminary therapeutic efficacy of 177Lu-OPS201 assessed by monitoring of PFS (based on RECIST v1.1 status)
  • Quality of Life (QoL) questionnaire
  • Terminal half-life of radioactivity concentrations of the radiopharmaceutical in blood
  • PK parameters of OPS201, if OPS201 levels are measurable in plasma and urine.

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Canadian Cancer Society

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