A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC

Prostate Cancer Clinical Trial

Official title: A Phase I/II,Open-Label,Does-Escalation and -Expansion, Safety,Pharmacokinetics and Efficacy Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of Patients With Metastatic Castration Resistant Prostate Cancer

Status Terminated

Clinical Trial Summary

The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer.

Clinical Trial Description

This is a multicenter, open, non-randomized and dose-escalating and -expansion Phase I/II trial and it studies the tolerance, PK and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer. The Phase I part is a dose-escalating study including Ia (dose-escalation monotherapy) and Ib (dose-escalation combination therapy). Approximately 18-30 patients in Phase Ia will only receive one of five dose levels of orally SHR2554. Approximately 30~48 patients in Phase Ib trial will receive SHR2554 combined with SHR3680, in which 2~3 different dose levels of SHR2554 will be selected based on the result of the Phase Ia. Phase II part is a dose-expansion study. Primary endpoints of the study are dose-limiting tolerance (DLT), maximum-tolerated dose (MTD) and prostate specific antigen (PSA) response rate. ;

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03741712
• Study type: Interventional
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 20, 2018
• Completion date: December 8, 2020