Tracers / [18F]DK222

[18F]DK222

Also written as [18F]DK222; [F-18]DK222; DK222
Radionuclide
F-18 t½ 109.7 min
Modality
PET
Production route
Cyclotron liquid target
Stage
Research
Syntheses indexed
2
Receptor expression phenotypingImmune cell and immunotherapy imagingLung cancerMelanoma

What it is

Compound class
—
Target / mechanism
Programmed death-ligand 1 (PD-L1); peptide binder PMID 36627757 / DOI 10.1002/jlcr.4012
Clinical application
PET imaging of PD-L1 expression in cancer and of pharmacodynamic changes during PD-1/PD-L1 immunotherapy (NSCLC, urothelial carcinoma, melanoma models); cGMP radiosynthesis validated for human PET PMID 36627757 / DOI 10.1002/jlcr.4012; PMID 37793856 / DOI 10.1136/jitc-2023-007535
Theranostic pair
—

Regulatory status

FDA
No Drugs@FDA / openFDA drug registry — no approved application found; search: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=DK222
EMA (centralised)
—
Other approvals
—
Brand names
—

Clinical use

Typical injected activity
—
Uptake time
—

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
In-house / custom built
in-house
custom manifoldSPE52.2% ± 3.6%
no
—DK-NODA
CPC Scientific, San Jose, CA
36627757
2023 J Labelled Comp Radiopharm
The vial was then connected to a custom-built solid phase extraction (SPE) module for purification and formulation (see supplemental data). — resulting in a non-decay corrected radiochemical yield of 52.2% ± 3.6%
FASTlab 2
GE HealthCare
vendor cassetteSPE30.0% ± 4.6%
no
—DK-NODA
CPC Scientific, San Jose, CA
36627757
2023 J Labelled Comp Radiopharm
the GE FastLab2 synthesis module using the GE FastLab developer software version 3.2.0.2 — The non-decay corrected yield of [18F]DK222 was 30.0% ± 4.6%

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Quality control Preliminary — inferred from compound class

Ph. Eur. monograph
—
USP monograph
—
AppearancepHRCP HPLCRCP TLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrity
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); organic-phase radiosynthesis assumed from isotope/compound class, no synthesis data confirming it -> GC residual solvents (preliminary); conventional nucleophilic 18F-fluorination assumed from isotope/compound class, no synthesis data confirming K222 use -> Kryptofix test (preliminary)

Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived

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Notes

Target and application not filled - to be taken from the publication.