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XmAb14045

Phase 1

Acute Myelogenous Leukemia | Monoclonal antibody | Oncology |Xencor, Inc.|Trials Updated: Mar 8, 2022

XmAb14045 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

XmAb14045 clinical trials

XmAb14045 · 1 trial · 4 indications

Phase 1 1
NCT02730312PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic MalignanciesAcute Myelogenous Leukemia
COMPLETED120 Analytics
PHASE1COMPLETED
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
Acute Myelogenous LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety as determined by the number of participants with treatment-related adverse events
Baseline Day 1 through Day 56

Treatment-related adverse events as assessed by CTCAE v4.03

Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
Baseline Day 1 through Day 56
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XmAb14045EXPERIMENTALBiological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks

Interventions

NameTypeDescription
XmAb14045BIOLOGICALAdministered IV weekly up to 8 weeks, with or without step-up dosing
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Diagnosis of 1 of the following diseases: * Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia) * B-cell ALL * BPDCN * CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor thera...

Countries:United States
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Frequently asked questions about XmAb14045

What is XmAb14045 used for?

XmAb14045 is an investigational monoclonal antibody being studied for Acute Myelogenous Leukemia and other CD123-expressing hematologic malignancies. It was evaluated in a Phase 1 trial that also enrolled patients with B-cell Acute Lymphoblastic Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myeloid Leukemia, and blast crisis.

Who makes XmAb14045?

XmAb14045 is developed by Xencor, Inc., which trades on the Nasdaq under the ticker XNCR. Xencor is the sponsor of the clinical program for this monoclonal antibody.

What phase is XmAb14045 in?

XmAb14045 is in Phase 1 development. Its single clinical trial, NCT02730312, has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is XmAb14045 in?

XmAb14045 was studied in one Phase 1 trial, NCT02730312, titled a Phase 1 study to evaluate safety and tolerability in patients with CD123-expressing hematologic malignancies. The trial enrolled 120 patients in the United States and is now completed.

What does XmAb14045 target?

XmAb14045 targets CD123, an antigen expressed on hematologic malignancies. The Phase 1 trial NCT02730312 specifically enrolled patients with CD123-expressing cancers, including Acute Myelogenous Leukemia.