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Study to Evaluate Safety and Tolerability of XmAb13676 in Patients With CD20-expressing Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT02924402
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Xencor, Inc.

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date August 2020   (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 XmAb13676 dosing [ Time Frame: Baseline Day 1 through Day 56 ]
    Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Baseline Day 1 through Day 56 ]
  • Maximum tolerated (MTD) and/or recommended dose (RD) [ Time Frame: Baseline Day 1 through Day 56 ]
Change History Complete list of historical versions of study NCT02924402 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 Study to Evaluate Safety and Tolerability of XmAb13676 in Patients With CD20-expressing Hematologic Malignancies
Official Title  ICMJE A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 in Patients With CD20-Expressing Hematologic Malignancies
Brief Summary The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb13676 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 Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will enroll two parallel disease groups: patients with non-CLL B cell malignancies and patients with CLL/SLL/Ricter's Transformation.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • B-cell Non-Hodgkins Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Intervention  ICMJE Biological: XmAb13676
Biological
Study Arms  ICMJE
  • Experimental: Non-CLL B Cell Malignancies (Group NHL)
    XmAb13676 administered IV weekly up to 8 weeks
    Intervention: Biological: XmAb13676
  • Experimental: CLL/SLL (Group CLL)
    XmAb13676 administered IV weekly up to 8 weeks
    Intervention: Biological: XmAb13676
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2016)
66
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
65
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to provide written informed consent
  • Diagnosis of either Non-CLL B cell malignancy or CLL/SLL
  • Ineligible for or have exhausted standard therapeutic options
  • Last dose of anti-CD20 antibody therapy must have been >4 weeks before the first dose of XmAb13676
  • 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:

  • Cytotoxic chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or small molecule or investigational agents within 6 elimination half-lives of the first dose of XmAb13676
  • Prior allogeneic stem cell or solid organ transplantation
  • Failure to recover from Grade 3 or 4 toxicity from previous treatment
  • Multiple myeloma/plasma cell leukemia or B cell acute lymphoblastic leukemia
  • Known intolerance to CD20 monoclonal antibody therapy
  • History of primary central nervous system lymphoma or neoplastic central nervous system disease
  • Platelet count < 50 x 10^9/L
  • Absolute neutrophil count < 1.0 x 10^9/L
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at screening > 3x upper limit of normal (ULN)
  • Bilirubin > 1.5 mg/dL
  • Estimated creatinine clearance < 50 mL/min
  • Active/uncontrolled autoimmune disease
  • Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
  • Seizure disorder
  • History of stroke with the past year
  • 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 serious bacterial, viral, parasitic or systemic fungal infections within the 30 days prior to study entry
  • Positive test for human immunodeficiency virus (HIV) or hepatitis C (HCV) antibodies (unless HCV viral load test by PCR is negative)
  • Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy). HBcAb positivity will be allowed if HBsAb is present.
  • 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: David Liebowitz, MD 858-617-6160 ext 260 dliebowitz@xencor.com
Contact: Chelsea Johnson 858-480-3891 ext 159 cjohnson@xencor.com
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02924402
Other Study ID Numbers  ICMJE XmAb13676-01
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 November 2018

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