Recruiting
Phase 1
Phase 2

VIR-5818 & Pembrolizumab

Sponsor:

Vir Biotechnology, Inc.

Code:

NCT05356741

Conditions

Locally Advanced or Metastatic HER2-Expressing Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VIR-5818

pembrolizumab

Study Details

Brief summary:

This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of VIR-5818 (Formerly AMX-818) as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts:

  • Part 1 (dose escalation): Single-agent VIR-5818
  • Part 2 (dose escalation): VIR-5818 plus pembrolizumab
  • Part 3 (dose expansion): Single-agent VIR-5818
  • Part 4 (dose expansion): VIR-5818 plus pembrolizumab

The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 72 months.

Conditions

Locally Advanced or Metastatic HER2-Expressing Cancers

Study ID

NCT05356741

Start date

Apr 13, 2022

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Written informed consent by the participant (or legally acceptable representative if applicable)
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests

Exclusion criteria:

  • Significant cardiopulmonary disease and recent cardiac events
  • History of major organ autoimmune diseases
  • Acute or chronic infections

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Study Design

Enrollment

645 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 (dose escalation)

Participants will receive single-agent VIR-5818

experimental: Part 2 (dose escalation)

Participants will receive VIR-5818 plus pembrolizumab

experimental: Part 3 (dose expansion)

Participants will receive single-agent VIR-5818

experimental: Part 4 (dose expansion

Participants will receive VIR-5818 plus pembrolizumab

Interventions

VIR-5818

Administered as IV infusion

pembrolizumab

Administered as IV infusion

Primary outcome measure

  • Incidence of dose-limiting toxicity - Part 1 and Part 2 [ Time Frame: Up to approximately 21 days (Part 1) and 42 days (Part 2) ]
  • Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)- Parts 1, 2, 3, and 4 [ Time Frame: Up to approximately 55 months ]
  • Objective Response Rate (ORR) - Part 3 and Part 4 [ Time Frame: Up to approximately 55 months ]
  • Duration of Response (DOR) - Part 3 and Part 4 [ Time Frame: Up to approximately 55 months ]

Central Contacts and Locations

Central contacts

Study Inquiry

415-654-5281clinicaltrials@vir.bio

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

More Information

Sponsor

Vir Biotechnology, Inc.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vir Biotechnology, Inc. on 2026-08-19.