ARX788 : A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Breast Cancer With Multiple Levels of HER2 Expression

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

Over 18Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | BreastBreast,Stomach,

Trial Overview Read MoreRead more

This phase I trial is trying to determine the optimal dose of ARX788 (a drug that is intraveneously administered) in patients with an advanced HER 2 cancer.
 

This trial is treating patients with advanced HER 2 cancers of the breast and stomach.

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, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Breast Cancer With Multiple Levels of HER2 Expression

Commercial Sponsor

Zhejiang Medicine Co., Ltd.

Summary

This is a 2-part, Phase 1 first in human study with Phase 1a designed to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) in subjects with metastatic breast cancer with a human epidermal growth factor receptor 2 (HER2) test result that is in situ hybridization (ISH) positive (+) or immunohistochemistry (IHC) 3+, and Phase 1b designed to assess anticancer activity and safety in two different metastatic breast cancer cohorts namely, for tumors that test as HER2 ISH+ OR IHC3+, and a second cohort for tumors that test as HER2 ISH- AND IHC 1+ or 2+.

Recruiting Hospitals Read MoreRead more

Monash Medical Centre, Medical Oncology
Clayton
Ms Irina Arzhintar
Irina.Arzhintar@monashhealth.org
03 8572 2018

Not Recruiting Hospitals Read MoreRead more

Recruitment on hold

Epworth Hospital
Richmond
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055

Epworth Freemasons, Medical Oncology
East Melbourne
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055