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Be Part of Research - Trial Details - [177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-NeoB Lesion Uptake

[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-NeoB Lesion Uptake

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this first-in-human (FIH) study of \[177Lu\]-NeoB is to characterize the safety, tolerability, pharmacokinetics (PK) as well as the distribution and radiation dosimetry, and anti-tumor activity of \[177Lu\]-NeoB in patients with advanced solid tumors known to overexpress Gastrin-Releasing Peptide Receptor (GRPR) and with \[68Ga\]-NeoB lesion uptake.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2019 Nov 2025

Publications

"Sundlov A, Sjogreen-Gleisner K. Peptide Receptor Radionuclide Therapy - Prospects for Personalised Treatment. Clin Oncol (R Coll Radiol). 2021 Feb;33(2):92-97. doi: 10.1016/j.clon.2020.10.020. Epub 2020 Nov 12."; "33189510"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : \[177Lu\]-NeoB peptide receptor radionuclide therapy: 370 MBq/mL (10 mCi/mL), solution for infusion

Intervention Arm Group : Phase I: Cohort I;Phase I: Cohort II;Phase I: Cohort III;Phase I: Cohort IV;Phase I: Cohort V;Phase IIa: Cohort A;Phase IIa: Cohort B;Phase IIa: Cohort C;Phase IIa: Cohort D;Phase IIa:Cohort E;

Intervention Type : DRUG
Intervention Description : \[68Ga\]-NeoB radioactive diagnostic agent: 50 µg, kit for radiopharmaceutical preparation

Intervention Arm Group : Phase I: Cohort I;Phase I: Cohort II;Phase I: Cohort III;Phase I: Cohort IV;Phase I: Cohort V;Phase IIa: Cohort A;Phase IIa: Cohort B;Phase IIa: Cohort C;Phase IIa: Cohort D;Phase IIa:Cohort E;

Intervention Type : DRUG
Intervention Description : dose strength 49/51 mg, film-coated tablets for oral use

Intervention Arm Group : Phase IIa:Cohort E;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Addenbroke's hospital
    Cambridge


The study is sponsored by Advanced Accelerator Applications




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Read full details for Trial ID: NCT03872778
Last updated 22 January 2025

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