Phase 1 safety test of XmAb657 in healthy adults and people with myositis, scleroderma, or Sjögren's
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
This study will test whether subcutaneous injections of XmAb657 are safe and well tolerated in healthy adults and people with autoimmune diseases such as idiopathic inflammatory myopathies, systemic sclerosis, or primary Sjögren's syndrome.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xencor, Inc. Industry-sponsored |
| Locations | 1 site (Melbourne) |
| Trial ID | NCT07284797 on ClinicalTrials.gov |
What this trial studies
This is an open-label Phase 1 trial that administers XmAb657 subcutaneously to cohorts of healthy adults and adults who meet established classification criteria for idiopathic inflammatory myopathies, systemic sclerosis, or primary Sjögren's syndrome. The study is designed to collect safety and tolerability data and to measure pharmacokinetics, pharmacodynamics, and immunogenicity signals. Standard exclusion criteria apply, including recent major surgery, active or recurrent infections, untreated latent tuberculosis, recent cancer, and uncontrolled major organ disease. The sponsor is Xencor, Inc., and dosing and follow-up occur at the listed investigative site in Melbourne.
Who should consider this trial
Good fit: Ideal candidates are adults in good health for the healthy cohort or adults who meet the 2017 EULAR/ACR criteria for IIM, the 2013 ACR/EULAR criteria for systemic sclerosis, or the 2016 ACR/EULAR criteria for primary Sjögren's and who agree to use effective contraception.
Not a fit: Patients with active or recurrent infections, untreated latent tuberculosis, recent major surgery, recent cancer or lymphoproliferative disease, or uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, XmAb657 could become a new immune-targeting treatment option for people with certain autoimmune diseases that are poorly controlled by current therapies.
How similar studies have performed: Other monoclonal antibody therapies targeting immune pathways have shown benefit in some autoimmune diseases, but XmAb657 itself is an early-stage investigational agent with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Melbourne
- Xencor Investigative Site — Melbourne, Australia (Recruiting)
Study contacts
- Study coordinator: Noriko Iikuni, MD, PhD
- Email: 657-aiinfo@xencor.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.