Metastatic Prostate Carcinoma Clinical Trial
Official title:
A Phase I/II, Open-Label, Dose-Escalation and -Expansion, Safety, Pharmacokinetics and Efficacy Study of SHR3680 in Patients With Metastatic Castration-Resistant Prostate Cancer
This study evaluates the tolerability, safety, pharmacokinetics and efficacy of SHR3680 in patients with metastatic castration-resistant prostate cancer (mCPRC). All participants will receive SHR3680.
Androgenic signaling plays a pivotal role in the development of prostate cancer. Androgen
deprivation therapy is the mainstay treatment for this cancer in the metastatic setting, but
the disease eventually develops to castration-resistant prostate cancer (CRPC) mainly due to
the overexpression of androgen receptors (AR) and continued AR activation.
SHR3680 is a novel strong AR antagonist. By competitively binding to AR, SHR3680 inhibits
androgen-mediated translocation of AR to the nucleus, binding of AR to Deoxyribonucleic acid
(DNA), and finally the transcription of AR target genes, thus possibly resulting in a
specific and strong anti-tumor effect on prostate cancer. Unlike first-generation AR
antagonists (e.g. bicalutamide), which undergoes an antagonist-to-agonist switch to stimulate
AR in the setting of AR overexpression in CRPC, SHR3680 is a full antagonist of AR and thus
it is supposed to be more effective for the treatment of CRPC.
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