Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT03255070 : A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Cancers With HER2 Expression

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18-75Age 18-75

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Breast,Stomach and upper gastrointestinal tractBreast,Stomach

Trial Overview Read MoreRead more

This phase I trial is evaluating a new intravenous drug (ARX788) in patients with HER2+ advanced cancers.
 

This trial is treating patients with advanced cancers that are HER2+.

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.

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

Commercial Sponsor

Ambrx, Inc.

Summary

This is a 2-part, Phase 1, open-label study. Phase 1a is designed to determine the recommended Phase 2 dose (RP2D) in subjects with advanced cancer whose HER2 test results are in situ hybridization (ISH) positive or immunohistochemistry (IHC) 3+. The IMP, ARX788, will be administered every 3 weeks or every 4 weeks via IV infusion. Five sequential dose escalation cohorts are planned. Cohort 1 and Cohort 2 will each enroll 3 subjects following a 3+3 design with possible expansion to 6 subjects as determined by the Safety Monitoring Committee based on dose-limiting toxicity assessment and comprehensive reviews of safety, tolerability and PK data. Cohort 3, Cohort 4 and Optional Cohort 5 will enroll 6 subjects each without planned expansion. Phase 1b is designed to investigate the RP2D, from Phase 1a, to assess anticancer activity and safety in 2 advanced breast cancer expansion cohorts: 1) tested tumors HER2 ISH positive or IHC 3+ and 2) tested tumors HER2 ISH negative with IHC 2+.

Recruiting Hospitals Read MoreRead more

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

Monash Health, Medical Oncology
Clayton
Early Phase Research Study Coordinator
earlyphase.oncresearch@monashhealth.org
0474 769 510

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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