Table 1.
Nanobody development for preclinical molecular diagnostics (Data sources for clinical trials: https://clinicaltrials.gov/, accessed on 9 August 2022).
| Target | Agent | Title | Clinical Trials: Stage and Status/References |
|---|---|---|---|
| HER2 | 99mTc/188Re | HER2 Expression Detection and Radionuclide Therapy in Breast Cancer Using 99mTc/188Re Labeled Single Domain Antibody | Clinical, NCT04674722 (Early Phase 1) |
| 99mTc-NM-02 | HER2 Expression Detection in Breast Cancer Using 99mTc-NM-02 | Clinical, NCT04040686 (Early Phase 1) | |
| 99mTc-7C12 | Correlation between EGFR-Nbs uptake and tumor burden | [86] | |
| HER3 | 89Zr-MSB0010853 | 89Zr-MSB0010853 monitor Human EGFR3-Specific Tumor Uptake and Biodistribution | [87] |
| PD-L1 | [99mTc]-NM-01 | PD-L1 Expression in Lung Cancer | Clinical, NCT04992715 (Phase 2) |
| AlbudAb | 68Ga-THP-APN09 | PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor | Clinical, NCT05156515 (Not Applicable) |
| 18F-B3, 18F-A12, 64Cu-B3 | PD-L1 for an activated-independent adipocytes biomarker | [88] | |
| 68Ga-NOTA-Nb109 | 68Ga-NOTA-Nb109 monitor cisplatin (CDDP) induced NCLH1299 cells PD-L1 expression | [89] | |
| 89Zr-Df-KN035 | 89Zr-Df-KN035 monitor PD-L1 expression in nude mice bearing LN229 xenografts, and used to evaluate the whole-body biodistribution in non-human primates (NHPs) | [90] | |
| 99mTc-C3, 99mTc-C7, 99mTc-E2, 99mTc-E4 | The nanobody imaging is used assess murine PD-L1 expression in syngeneic tumor models | [91] | |
| 89Zr-GSK3128349 | A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects | Clinical, NCT02829307 (Phase 1) | |
| CD20 | 68Ga-9079 | the Anti-CD20 Nb for targeted radionuclide therapy of human Non-Hodgkin Lymphoma | [92] |
| CD38 | 68Ga-NOTA-Nb1053 | ImmunoPET imaging of multiple myeloma with 68Ga-NOTA-Nb1053 | [93] |
| CD8 | 89Zr-VHH-X118 | Predicting the Response to CTLA-4 Blockade by Longitudinal Noninvasive Monitoring of CD8 T Cells. | [94] |
| 68Ga-NOTA-SNA006 | Human CD8+ T Cells with 68Ga-Labeled Nanobody Diagnostic | [95] | |
| CEA | 99mTc-NbCEA5 | Tumor Targeting of a Humanized, Grafted Nanobody in Mice Using Pinhole SPECT/Micro-CT | [96] |
| PSMA | 111In-JVZ007 | A 111In-Labeled Anti-Nanobody for Prostate Cancer | [97] |
| HGF | 89Zr-1E2, 89Zr-6E10 | Nanobodies Targeting the Hepatocyte Growth Factor | [98] |