drugset / Trial / NCT03872778
[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake
Non-randomizedSequentialOpen-labelTreatment
Summary
First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of \[177Lu\]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with \[68Ga\]-NeoB lesion uptake.
Timeline
- Start
- 2019-05-24
- Primary completion
- 2025-01-07
- Completion
- 2025-11-27
Publications
- Taunk NK, Escorcia FE, Lewis JS, Bodei L. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets. Cancer J. 2024 May-Jun 01;30(3):218-223. doi: 10.1097/PPO.0000000000000720.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LCZ696 | Unknown | — | Oral |
| Subject | [177Lu]-NeoB | Peptide | 5.55 g | — |
| Subject | [177Lu]-NeoB | Peptide | 9.25 g | — |
| Subject | [177Lu]-NeoB | Peptide | 11.1 g | — |
| Subject | [68Ga]-NeoB | Diagnostic / imaging agent | — | — |