To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)

Inclusion Criteria:

- Pathologically confirmed, well differentiated functioning or non-functioning
metastatic GEP-NET (Grade I and II as per World Health Organisation classification
2010)

- Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour
lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months
prior to screening (Visit 1) and showing minimally two lesions in at least one of the
key organs; these images shall be available to be sent to the imaging core lab
electronically to ascertain quality and admissibility

- Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive

- Adequate bone marrow, liver and renal function

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion Criteria:

- Fewer than five lesions in total and more than 25 lesions/organ detected by the
previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs

- Subject who have received treatment of any somatostatin analogue, including
Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within
24 hours prior to first 68Ga-OPS202 administration

- Prior or planned administration of a radiopharmaceutical within 8 half-lives of the
radionuclide

- Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects
who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or
arthroplasty, or any other objects that might interfere with the PET and/or CT
analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects
unable to lie still for the entire imaging time, e) Subjects weighing greater than 110
kg (243 lb)