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XmAb412 Monoclonal Bispecific Antibody

Phase 1

Not Applicable - Healthy Adult Participants | Small molecule | Other |Xencor, Inc.|Last Updated: Aug 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

XmAb412 Monoclonal Bispecific Antibody · 1 trial · 1 indication

Phase 1 1
NCT07713485Study of XmAb412 in Healthy ParticipantsNot Applicable - Healthy Adult Participants
RECRUITING128 Analytics
PHASE1RECRUITING
Study of XmAb412 in Healthy Participants
Not Applicable - Healthy Adult ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb412 in healthy adult participants (Part A and Part B)
Up to 28 weeks

Secondary Endpoints

Serum PK parameters of XmAb412 in healthy adult participants (Part A and Part B)
Up to 28 weeks
Cmax (Maximum concentration of drug)
Up to 28 weeks
Tmax (Time of maximum concentration of drug)
Up to 28 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Active DrugACTIVE_COMPARATORActive XmAb412 to be administered to healthy adult participants.
Part A: PlaceboPLACEBO_COMPARATORPlacebo Comparator to be administered to healthy participants.
Part B: ActiveACTIVE_COMPARATORActive XmAb412 to be administered to healthy participants.
Part B: PlaceboPLACEBO_COMPARATORPlacebo Comparator to be administered to healthy participants.

Interventions

NameTypeDescription
XmAb412 Monoclonal Bispecific AntibodyDRUGMonoclonal Bispecific Antibody
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Age 18-55 years old * Must be in good health with no significant medical history * BMI 18-35 kg/m2 * Contraceptive use consistent with local regulations * Able and willing to provide written informed consent Exclusion Criteria: * Any physical condition that prohibits study c...

Countries:Australia
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Recent Changes (Last 90 Days)

LOWAug 3, 2026NCT07713485lastUpdatePostDate: changed
LOWAug 3, 2026NCT07713485lastUpdatePostDate: changed
LOWJul 20, 2026NCT07713485NEW_TRIAL: changed
LOWJul 20, 2026NCT07713485NEW_TRIAL: changed

Frequently asked questions about XmAb412 Monoclonal Bispecific Antibody

What is XmAb412 used for?

XmAb412 is an investigational monoclonal bispecific antibody being studied in healthy adult participants. It is currently in Phase 1 clinical development, with an active trial evaluating its safety and tolerability. The drug is not approved for any indication and is not being studied in any patient population at this time.

Who makes XmAb412?

XmAb412 is being developed by Xencor, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XNCR. Xencor is conducting a Phase 1 clinical trial of XmAb412 in healthy participants, with the study currently recruiting in Australia.

What phase is XmAb412 in?

XmAb412 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A single Phase 1 trial is currently recruiting healthy adult participants to evaluate the drug, with an enrollment target of 128 participants.

What clinical trials is XmAb412 in?

XmAb412 is being studied in one active clinical trial, identified as NCT07713485, titled "Study of XmAb412 in Healthy Participants." This Phase 1, randomized, double-blind, placebo-controlled trial is recruiting 128 healthy adult participants aged 18 years and older in Australia.

Is XmAb412 a small molecule or a biologic?

XmAb412 is a monoclonal bispecific antibody, which is a biologic drug, not a small molecule. It is being developed by Xencor, Inc. and is currently in Phase 1 clinical testing in healthy volunteers. The drug is investigational and has not been approved for any use.

Is XmAb412 FDA approved?

XmAb412 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial, NCT07713485, is studying the drug in healthy adult participants to assess its safety and tolerability, and it has not yet progressed to later-stage trials or regulatory review.