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XmAb657

Phase 1

Healthy | Monoclonal antibody | Other |Xencor, Inc.|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07284797A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune DiseasesPHASE1 RECRUITING 60 — — Feb 24, 2026Oct 1, 2028May 22, 20261 Australia
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Study Endpoints
Primary Endpoints
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Through Week 52
Secondary Endpoints
Serum concentration of XmAb657
Through Week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALXmAb657 administered SC
Interventions
NameTypeDescription
XmAb657BIOLOGICALBiological
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 Sy...

Countries:Australia
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07284797Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07284797studyFirstPostDate: changed