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.

NCT05356741 : A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX 818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Breast,Female reproductive organs,Stomach and upper gastrointestinal tract,Urinary systemBladder,Breast,Ovary,Pancreas,Stomach

Trial Overview Read MoreRead more

This phase I study is evaluating how safe and effective a new targeted therapy (AMX 818) is alone, or in combination with immunotherapy (pembrolizumab) in people with HER2+ cancers.
 

This trial is treating patients with locally advanced or metastatic HER2+ cancers, such as breast. bladder, ovarian, pancreatic and stomach cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.
  • 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.

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, First-in-Human Study of the Safety and Pharmacokinetics of AMX 818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Commercial Sponsor

Amunix, a Sanofi Company

Summary

This dose escalation and dose expansion study has four parts. In Part 1 (dose escalation), participants will receive AMX 818 alone, administered via intravenous (IV) infusion. In Part 2 (dose escalation), participants will receive AMX 818 (via IV) in combination with pembrolizumab (via IV). In Part 3 (dose expansion), participants will receive AMX 818 alone, via IV, at the Recommended Phase 2 Dose. In Part 4 (dose expansion), participants will receive AMX 818 (via IV) at the recommended Phase 2 Dose in combination with pembrolizumab (via IV).

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Nathan Reader Wilson
PCCTU.EDD@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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