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NCT Number: NCT07284797

A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases

The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.

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Key information

Conditions

Healthy Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Idiopathic Inflammatory Myopathies Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Salivary Gland Diseases Scleroderma, Diffuse Scleroderma, Systemic Sjogren's Syndrome Sjögren's Disease Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Systemic Sclerosis Xerostomia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xencor Investigative Site

Melbourne, Australia

Location status: Recruiting

About this study

This is a Phase 1 study to determine the safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD), and immunogenicity of XmAb657 in healthy adult participants and participants with autoimmune diseases.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy participants - Adult participants in good health

Idiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)/American College of Rheumatology (ACR) Classification Criterion for IIM

Systemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR/EULAR Classification Criteria for SSc

Sjogren's Disease participants that meet the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome

All participants - Use of highly effective methods of contraception

Exclusion criteria

  • Major surgery within 12 weeks prior to dosing or planned within the study
  • Recurrent infections or active clinically significant infection
  • Active or untreated latent tuberculosis
  • Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
  • Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease

Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.

Treatment and study plan

XmAb657

Biological

Biological

Primary outcomes

  1. Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Through Week 52

Secondary outcomes

  1. Serum concentration of XmAb657

    Time frame: Through Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Jaime Mertz

CONTACT

[email protected]

Noriko Iikuni, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xencor, Inc.

Industry

Registry information

Official study title

A Phase 1, First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of XmAb657 in Healthy Participants and in Participants With Autoimmune Diseases

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 16, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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