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

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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

Monash Medical Centre, Medical Oncology
Clayton
Ms Karen Gillett
Karen.Gillett@monashhealth.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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