To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Vir Biotechnology

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Locally Advanced or Metastatic HER2-Expressing Cancers

Treatments: Drug: pembrolizumab; Drug: VIR-5818

Study type: Interventional

Funder types: Industry

Identifiers

NCT05356741

KEYNOTE-D14 (Other Identifier)

VIR-5818-V101

MK-3475-D14 (Other Identifier)

Details and patient eligibility

About

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 52 months.

Enrollment: 645 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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645 participants in 4 patient groups

Part 1 (dose escalation)

Experimental group

Description:

Participants will receive single-agent VIR-5818

Treatment:

Drug: VIR-5818

Part 2 (dose escalation)

Experimental group

Description:

Participants will receive VIR-5818 plus pembrolizumab

Treatment:

Drug: VIR-5818

Drug: pembrolizumab

Part 3 (dose expansion)

Experimental group

Description:

Participants will receive single-agent VIR-5818

Treatment:

Drug: VIR-5818

Part 4 (dose expansion

Experimental group

Description:

Participants will receive VIR-5818 plus pembrolizumab

Treatment:

Drug: VIR-5818

Drug: pembrolizumab