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NCT05252364 : A Phase 1 Open-Label Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer

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 trying to understand how safe and effective a targeted therapy (HP518) is in people with prostate cancer..
 

This trial is treating patients with metastatic, castration-resistant prostate cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • 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 had certain treatments, surgical procedures or drugs.

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 Open-Label Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer

Commercial Sponsor

Hinova Pharmaceuticals Aus Pty Ltd

Summary

This is an open-label dose escalation and dose expansion study. Part 1 of the study (dose escalation) consists of 6 cohorts. Each cohort will be assigned a different dose level of HP518: either 25mg/d, 50mg/d, 100mg/d, 200mg/d, 300mg/d or 400mg/d. In all cohorts, HP518 will be administered orally, once daily in 28-day cycles. In Part 2 of the study (dose expansion), participants will receive HP518 orally, once daily in 28-day cycles at the highest dosage level with acceptable toxicity (RP2D) based on the data from Part 1 of the study.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Emily Prain
e.prain@alfred.org.au
03 9076 7464

Border Medical Oncology
Albury
Ms Kate Oates
koates@bordermedonc.com.au
02 6064 1499

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Richelle Linklater
PCCTU.MoncA@petermac.org

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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