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XmAb27564

Phase 1

Undisclosed | Small molecule | Other |Xencor, Inc.|Trials Updated: Mar 1, 2023

XmAb27564 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Apr 2021

XmAb27564 target and mechanism

Molecular targetENPP3
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

XmAb27564 clinical trials

XmAb27564 · 1 trial · 1 indication

Phase 1 1
NCT04857866Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy VolunteersSafety in Healthy Volunteers
COMPLETED48 Analytics
PHASE1COMPLETED
Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events, graded by CTCAE Version 5.0
Up to Day 45

Secondary Endpoints

PK: Area Under the Drug Concentration - Time Curve from Zero to the End of Observation
45 Days
PK: Maximum Observed Drug Concentration (Cmax) of XmAb27564 after a single dose
45 Days
PK: Measurement of Cmax
45 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending Dose - XmAb27564 Subcutaneous injection of Dose A, B, C, D, E or FEXPERIMENTAL -
Single Ascending Dose - Placebo Subcutaneous injection of placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
XmAb27564DRUGSingle ascending dose of XmAb27564
PlaceboDRUGSingle dose of placebo
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Total body weight 50.0 to 100.0 kg and body mass index (BMI) 19.0 to 35.0 kg/m2 * In good general health with no clinically significant abnormality identified on medical or laboratory evaluation and no history of any clinically significant disorder, condition, or disease. * A ...

Countries:United States
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Frequently asked questions about XmAb27564

What is XmAb27564?

XmAb27564 is an investigational small molecule developed by Xencor, Inc. that targets ENPP3. It has been studied in a Phase 1 trial in healthy adult volunteers in the United States. Its clinical development remains at the early Phase 1 stage, and it is not an approved medicine.

What does XmAb27564 target?

XmAb27564 targets ENPP3, an enzyme that is the molecular target of this small molecule. By binding ENPP3, the compound is designed to act on that specific target. ENPP3 is the only mechanism-related detail disclosed for this asset, and the specific disease indications being pursued have not been publicly disclosed.

Who makes XmAb27564?

XmAb27564 is developed by Xencor, Inc., a clinical-stage biopharmaceutical company whose common stock trades on Nasdaq under the ticker symbol XNCR. Xencor is the sponsor of the clinical program for XmAb27564, which is built on the company's XmAb engineering platform.

What phase is XmAb27564 in?

XmAb27564 is in Phase 1 clinical development. Its only recorded trial is a completed Phase 1 study in healthy volunteers. The asset is investigational and has not been approved by the FDA for any indication, so it is not available as a marketed therapy.

What clinical trials is XmAb27564 in?

XmAb27564 has been evaluated in one clinical trial, NCT04857866, titled "Safety, Tolerability and PK of a Single Subcutaneous Injection of XmAb27564 in Healthy Volunteers." This completed Phase 1 study enrolled 48 healthy adult participants aged 21 and older in the United States and was randomized, double-blind, and placebo-controlled.