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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

645 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2027-08-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Locally Advanced or Metastatic HER2-Expressing Cancers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Administered as IV infusion

Interventions

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VIR-5818

Administered as IV infusion

Intervention Type DRUG

pembrolizumab

Administered as IV infusion

Intervention Type DRUG

Other Intervention Names

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KEYTRUDA®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes