ATRIDIA SHR3680-002 : A Phase 1 Trial of SHR3680 in Subjects With Metastatic Castration-Resistant Prostate Cancer as Monotherapy

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

This phase I trial is testing a new oral drug (SHR3680) in patients with metastatic Castration Resistant Prostate Cancer (mCRPC).
 

This trial is treating patients with Prostate Cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1 Trial of SHR3680 in Subjects With Metastatic Castration-Resistant Prostate Cancer as Monotherapy

Commercial Sponsor

Atridia Pty Ltd.

Summary

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.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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