- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02730312
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
March 4, 2022 updated by: Xencor, Inc.
A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic Jacksonville
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Winship Cancer Institute, Emory University
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Atlanta, Georgia, United States, 30342
- Blood and Marrow Transplant Group of Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, United States, 30342
- Northside Hospital
-
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Illinois
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Chicago, Illinois, United States, 60637
- The University of Chicago Medical Center
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Wexner Medical Center at the Ohio State University
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-
Texas
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Houston, Texas, United States, 77030
- The University of Texas MD Anderson Cancer Center
-
-
Washington
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: XmAb14045
Biological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks
|
Administered IV weekly up to 8 weeks, with or without step-up dosing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety as determined by the number of participants with treatment-related adverse events
Time Frame: Baseline Day 1 through Day 56
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Treatment-related adverse events as assessed by CTCAE v4.03
|
Baseline Day 1 through Day 56
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Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
Time Frame: Baseline Day 1 through Day 56
|
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
|
Baseline Day 1 through Day 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Raman Garcha, MD, Xencor, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2016
Primary Completion (ACTUAL)
September 1, 2021
Study Completion (ACTUAL)
September 1, 2021
Study Registration Dates
First Submitted
March 31, 2016
First Submitted That Met QC Criteria
March 31, 2016
First Posted (ESTIMATE)
April 6, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 8, 2022
Last Update Submitted That Met QC Criteria
March 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Neoplastic Processes
- Leukemia, Lymphoid
- Cell Transformation, Neoplastic
- Carcinogenesis
- Hematologic Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Blast Crisis
Other Study ID Numbers
- XmAb14045-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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