NeoRay - Phase I/IIa trial of [177Lu]-NeoB in advanced solid tumours

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  260368

• Contact name

  Luigi Aloj

• Contact email

  la398@cam.ac.uk

• Sponsor organisation

  Advanced Accelerator Applications

• Eudract number

  2018-004727-37

• Duration of Study in the UK

  2 years, 10 months, 1 days

• Research summary

  This is a Phase I/IIa, first-in-human clinical trial of [177Lu]-NeoB to characterise the safety, distribution and radiation dosimetry and anti-tumour activity of [177Lu]-NeoB in patients with advanced solid tumours and with [68Ga]-NeoB lesion uptake. Participants from the age of 16 years old are expected to enrol across research sites globally, with an overall participation of 15 months.

  This study is divided into 2 parts: Escalation (Phase I), where the optimal dose of [177Lu]-NeoB for treatment of the participants disease without any high risks for their health is determined and Expansion (Phase IIa), where the recommended Phase II dose in an extended number of patients is determined. The participant will only be involved in one phase of the study.

  Within this study there are 2 investigational medicinal products (IMPs), [177Lu]-NeoB, which will be administered during the treatment part of the study, and [68Ga]-NeoB, which will be administered during the selection part of the study.

  The study consists of:
  - Selection (up to 4 weeks)
  - Treatment - Escalation: Phase I
  - Treatment - Expansion: Phase IIa

  The study should only be conducted in participants who may receive potential benefit from the treatment of [177Lu]-NeoB. Therefore, to make sure it is the case, during the selection part, all participants will be administered first with the product [68Ga]-NeoB and the participant will then undergo a PET/CT or PET/MRI. If the scan shows a positive overexpression of Gastrin-Releasing Peptide Receptor (GRPR) in the participants tumour(s), then they will be selected for the treatment with [177Lu]-NeoB.

  The purpose of the study is to establish whether the product NeoB, can be used, without any high risks and safety issues for the participants health, combining selection and treatment of the disease characterised by an overexpression of GRPR, a receptor normally present on some of your body cells.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  19/NE/0133

• Date of REC Opinion

  10 May 2019

• REC opinion

  Favourable Opinion