Phase I clinical study of NMK36: a new PET tracer with the synthetic amino acid analogue anti-[18F]FACBC

Abstract

The findings of this study indicate that NMK36 is well tolerated. NMK36 has favorable characteristics for imaging brain and pelvic tumors, such as low brain uptake, slow urinary excretion, and high in vivo stability.

Anti-3-18F-FACBC (18F-Fluciclovine) PET/CT of Breast Cancer: An Exploratory Study

“…Complete metabolic profile, complete blood count, and urinalysis just before and approximately 1 wk after the 18 F-fluciclovine PET scan were obtained, and no attributable adverse events were noted. Dosimetry and phase 1 safety data have already been reported (15)(16)(17).…”

[14C]Fluciclovine (alias anti-[14C]FACBC) uptake and ASCT2 expression in castration-resistant prostate cancer cells

“…For [15]. A phase I clinical trial of [ 18 F] fluciclovine in Japan demonstrated the favorable pharmacokinetics for PCa detection such as slow excretion in urine and high stability [16]. In several studies, […”

Diagnostic performance and safety of NMK36 (trans-1-amino-3-[18F]fluorocyclobutanecarboxylic acid)-PET/CT in primary prostate cancer: multicenter Phase IIb clinical trial

“…The radiation exposure doses (effective dose) evaluated in the Phase I clinical trial conducted in Japan were the same or lower than those of approved diagnostic radiopharmaceuticals (31). Based on the above results in regard to safety, it was indicated that NMK36 was tolerable clinically and that further assessment of NMK36 is warranted.…”

“…In the Phase I clinical trial conducted in Japan, NMK36 was administered to six healthy adult males, and two mild adverse events developed in two subjects (decreased blood fibrinogen and injection site erythema). Both events were mild and not serious, and the subjects recovered without receiving medical treatment; however, it was concluded that a causal relation with NMK36 could not be ruled out (31). Moreover, two adverse events (somnolence and blood urine present) developed in an early Phase II clinical trial conducted on 10 prostate cancer patients, but the events were mild and non-serious, and the subjects recovered from both events without requiring medical treatment.…”

“…111 In-capromab, 18 F-choline, 11 C-choline, 11 C-acetate and others have been expected its usefulness as a new tracer for prostate cancer (20)(21)(22), but there have also been reports on the inability of these agents to differentiate prostate cancer from benign diseases, such as hyperplasia (23)(24)(25)(26) conducted in Japan. Safety, biodistribution and radiation dosimetry were assessed in the Phase I clinical trial, and it was suggested that NMK36 was tolerated in clinical use (31). The early Phase II clinical trial confirmed that primary lesions, lymph node metastases, bone metastases and lung metastases of prostate cancers were visualized by PET/CT with NMK36.…”