Study on the Safety and Effects of VIR-5818 Alone and with Pembrolizumab for Advanced HER2-Positive Cancers

Sponsor: Vir Biotechnology, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05356741

Provider View

This clinical trial is testing a new drug, VIR-5818, alone and in combination with pembrolizumab, to see if it is safe and effective for treating advanced cancers that express the HER2 protein.

Patient Parameters

Program Overview

This study is the first to test VIR-5818 in humans. It aims to find out if VIR-5818, used alone or with pembrolizumab, is safe and how it behaves in the body. The study will also look at its initial effects on different types of HER2-positive cancers. The trial is divided into four parts: two parts will test increasing doses of VIR-5818 alone and with pembrolizumab, and two parts will expand on these doses to further evaluate their effects. The study is expected to last about 72 months from start to finish.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Have a life expectancy of at least 12 weeks.
  • Be in good general health, able to carry out normal activities or light work.
  • Have a cancer that tests positive for HER2 and meets specific study criteria.

Exclusion Criteria

  • Have serious heart or lung disease or recent heart problems.
  • Have a history of major autoimmune diseases affecting organs.
  • Have ongoing or recent serious infections.

Locations

FACILITYZIPCITYSTATE
City of Hope National Medical Center91010DuarteCalifornia

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