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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02730312
Other study ID # XmAb14045-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2016
Est. completion date September 2021

Study information

Verified date March 2022
Source Xencor, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 therapy - Patients with relapsed or refractory disease with no available standard therapy - ECOG performance status 0-2 - Not a candidate for, or refusing treatment with hematopoietic stem cell transplantation - Fertile patients must agree to use effective contraception during and for 4 weeks after the last dose of XmAb14045 - Male patients must agree to use highly effective contraception, and refrain from donating sperm during the treatment period and for at least 4 weeks after the last dose of XmAb14045 - Able and willing to complete the entire study Exclusion Criteria: - Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment. - Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific and bsAbs, immunoconjugates, or chimeric antigen receptor- modified T-cell therapy - Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to malignant bone marrow involvement) - Known uncontrolled central nervous system involvement by malignant disease - Absolute blast count =10,000/mm3 or symptoms of leukostasis - Diagnosis of promyelocytic leukemia - Aspartate aminotransferase or alanine aminotransferase at screening >3.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement - Bilirubin >1.5 x ULN, unless prior diagnosis and documentation of leukemic organ involvement, ongoing hemolysis, or Gilbert's syndrome - Serum creatinine >2.0 x ULN, or estimated creatinine clearance <40mL/min - Active heart failure or New York Heart Association Class III or IV or Objective Assessment C or D - History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures, or completion - Evidence of any active, uncontrolled bacterial, viral, parasitic, or systemic fungal infections within 1 week of first dose of study drug - Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody (unless HCV viral load test by PCR is negative). HBcAb positivity will be allowed if one or more of the following is true: a) HBsAb is present; b) hepatitis B DNA testing is negative and the patient is receiving hepatitis B reactivation prophylaxis with entecavir, tenofovir, or lamivudine - Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit - Patients with substance abuse or other medical or psychiatric conditions that, in the opinion of the Investigator, would confound study interpretation or affect the patient's ability to tolerate or complete the study

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
XmAb14045
Administered IV weekly up to 8 weeks, with or without step-up dosing

Locations

Country Name City State
United States Blood and Marrow Transplant Group of Georgia Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Winship Cancer Institute, Emory University Atlanta Georgia
United States The University of Chicago Medical Center Chicago Illinois
United States Wexner Medical Center at The Ohio State University Columbus Ohio
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Mayo Clinic Jacksonville Jacksonville Florida
United States Swedish Cancer Institute Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Xencor, Inc. ICON Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety as determined by the number of participants with treatment-related adverse events Treatment-related adverse events as assessed by CTCAE v4.03 Baseline Day 1 through Day 56
Primary Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing Baseline Day 1 through Day 56
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