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PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02730312
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Xencor, Inc.

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE August 2016
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Safety as determined by the number of participants with treatment-related adverse events [ Time Frame: 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 [ Time Frame: Baseline Day 1 through Day 56 ]
    Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb14045 dosing
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • Number of patients experiencing an adverse event [ Time Frame: Baseline Day 1 up to Day 43 ]
    As assessed by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
  • Percentage of patients experiencing an adverse event [ Time Frame: Baseline Day 1 up to Day 43 ]
    As assessed by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Change History Complete list of historical versions of study NCT02730312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
Official Title  ICMJE A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myelogenous Leukemia
  • B-cell Acute Lymphoblastic Leukemia
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Chronic Myeloid Leukemia, Blast Crisis
Intervention  ICMJE Biological: XmAb14045
Administered IV weekly up to 8 weeks, with or without induction dosing
Study Arms  ICMJE Experimental: XmAb14045
Biological/Vaccine: XmAb14045 Administered IV weekly up to 8 weeks
Intervention: Biological: XmAb14045
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
105
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2016)
60
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 completion of study
  • 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
  • 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
  • Evidence of any active, uncontrolled bacterial, viral, parasitic 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02730312
Other Study ID Numbers  ICMJE XmAb14045-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xencor, Inc.
Study Sponsor  ICMJE Xencor, Inc.
Collaborators  ICMJE Chiltern International Inc.
Investigators  ICMJE
Study Director: Wayne Saville, MD VP, Oncology Clinical Development, Xencor, Inc.
PRS Account Xencor, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP