A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with advanced solid tumors known to overexpress gastrin-releasing peptide receptor (GRPR).

Solid tumors known to overexpress GRPR and with [68Ga]-NeoB lesion uptake.

Phase I: Incidence and nature of dose limiting toxicities (DLTs)., Phase IIa: - Cohorts A, B, C: Individual clinical responses assessed by Response Evaluation Criteria In Solid Tumors (RECIST v1.1). - Cohort E only: only performed in the US and UK.

Phase I: • Tissue Activity Curves (ACs) generated from the amount of radioactivity in one given tissue at a given moment over the amount of radioactivity present in the blood at that given moment • Time ACs, describing % of the activity amount injected vs. time will be derived • Absorbed radiation doses of [177Lu]-NeoB in critical organs (e.g. kidneys, bone marrow, pancreas), Phase I: • Urinary excretion of [177Lu]-NeoB • Half-life of [177Lu]-NeoB in blood • Residence times of [177Lu]-NeoB in organs and tumor lesions • Individual objective response and Duration of Response (DOR), Phase IIa Cohorts A, B, C: • Absorbed radiation doses of [177Lu]-NeoB in organs and tumor lesions based on TACs • Concentration of [177Lu]-NeoB in blood over time and derived PK parameters • Changes from baseline in EORTC QLQ-C30, Phase IIa Cohort E only: (only performed in the US and UK) • Adverse events, serious adverse events, changes in hematology and chemistry values, vital signs, ECGs • Dose interruptions and modifications, Phase I and IIa: • Adverse events, serious adverse events, changes in hematology and chemistry values, vital signs, ECGs • Dose interruptions and modifications

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Austria, France, Netherlands, Spain