NCT02747342

A Phase 1 Trial of SHR3680 With or Without SHR3162 in Prostate Cancer

A Phase 1 Trial of SHR3680 With or Without SHR3162 in Subjects With Metastatic Castration-Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, dose-escalation/expansion phase 1 trial to evaluate the safety, tolerability and efficacy of SHR3680 with or without SHR3162 given orally to subjects with metastatic castration-resistant prostate cancer (mCRPC).

Detailed description

This study consists of 2 Part. In the Part 1 (dose escalation phase), up to 4 dose levels of SHR3680 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 Part 2a (expansion phase), up to 9 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. In Part 2b (combination phase), two dose cohorts of SHR3162 combine with SHR3680 at fixed dose will be investigated.

Conditions

• Neoplasm
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	SHR3680; SHR3162	SHR3680 will be administered orally in dose escalation/expansion phase, SHR3680 will be administered orally at a fixed dose together with SHR3162 in combination phase.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-06-28
• Completion: 2020-06-28
• First posted: 2016-04-21
• Last updated: 2020-07-21

Locations

6 sites across 1 country: Australia