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XmAb14045

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

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 the treatment of Acute Myelogenous Leukemia (AML). It was evaluated in a Phase 1 clinical trial in patients with CD123-expressing hematologic malignancies, including AML, B-cell acute lymphoblastic leukemia, blastic plasmacytoid dendritic cell neoplasm, and chronic myeloid leukemia in blast crisis.

Who makes XmAb14045?

XmAb14045 is being developed by Xencor, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XNCR. The company sponsored the Phase 1 clinical trial of this investigational antibody for hematologic malignancies.

What phase is XmAb14045 in?

XmAb14045 is in Phase 1 clinical development. The single Phase 1 study evaluating this investigational drug has been completed. It is not approved by the FDA and remains an investigational agent in clinical development for Acute Myelogenous Leukemia and other CD123-expressing hematologic malignancies.

What clinical trials is XmAb14045 in?

XmAb14045 was studied in one clinical trial, registered as NCT02730312. This was a Phase 1 study to evaluate the safety and tolerability of XmAb14045 in patients with CD123-expressing hematologic malignancies. The trial enrolled 120 participants in the United States and has been completed.

What does XmAb14045 target?

XmAb14045 targets CD123, a protein expressed on the surface of certain hematologic malignancies. The Phase 1 trial enrolled patients with CD123-expressing cancers, including Acute Myelogenous Leukemia, B-cell acute lymphoblastic leukemia, blastic plasmacytoid dendritic cell neoplasm, and chronic myeloid leukemia in blast crisis.