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Clinical Trial Summary

This is a multicenter, dose-escalation phase 1 trial to evaluate the safety and tolerability of SHR3680 given orally to subjects with metastatic castration-resistant prostate cancer (mCRPC) as monotherapy.


Clinical Trial Description

This study consists of 2 phases. In the dose escalation phase, up to 6 dose levels of SHR3680 (40 mg/day, 80 mg/day, 160 mg/day, 240 mg/day, 360 mg/day, 480 mg/day) will be investigated with a sequential "3+3" design (3 or 6 participants in each dose level). There will be a single-dose pharmacokinetic (PK) run-in period (7 days). Following the first dose, participants will enter a 1 week treatment-free period to evaluate safety and single-dose PK. If not dose-limiting toxicities (DLTs) are observed during the 1-week period, SHR3680 administration will resume at the same dose level.

In the expansion phase, up to 12 additional participants will be enrolled at the MTD or recommended phase 2 dose (RP2D). The purpose of the expansion part of the study is to explore the clinical benefits of SHR3680 and to further identify its PK features. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02747342
Study type Interventional
Source Atridia Pty Ltd.
Contact Kathy You, MD, PhD
Phone +61 02 9299 0433
Email kathyyou@atridia.com
Status Recruiting
Phase Phase 1
Start date September 2016
Completion date September 2018

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