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

April 9, 2024 updated by: Xencor, Inc.

A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-Expressing Hematologic Malignancies

The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

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 Contact

Study Contact Backup

  • Name: Steve Kye, MD, MPH
  • Phone Number: 858-243-9970
  • Email: skye@xencor.com

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
      • Creteil, France, 94010
        • Hopital Henri Mondor
      • Marseille Cedex 9, France, 13273
        • Institut Paoli Calmette Dpt of Oncology/Hematology
      • Montpellier Cedex 5, France, 34295
        • Chu Montpellier, Hematologie Clinique St. Eloi
      • Nantes, France, 44000
        • CHU de NANTES
      • Nice Cedex, France, 06189
        • Centre Antoine Lacassagne
      • Pessac, France, 33604
        • CHU Haut-Leveque, Service d'Hematologie Clinique et Therapie Cellulaire
      • Pierre-Benite Cedex, France, 69495
        • Centre Hospitalier Lyon-Sud, Service d'Hematologie
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Toulouse, France, 31100
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Villejuif, France, 94805
        • CLCC Institut Gustave Roussy
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Moores UC San Diego Cancer Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center and James Cancer Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Health System, Division of Hematology & Oncology
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and Medical College of Wisconsin

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

Description

Inclusion Criteria:

  • Able to provide written informed consent
  • Diagnosis of either Non-CLL B cell malignancy
  • Ineligible for or have exhausted standard therapeutic options and have relapsed or refractory disease
  • ECOG performance status 0-2
  • Fertile patients must agree to use highly effective contraception during and for 5 months (male patients) and 8 months (female patients) after last dose of XmAb13676
  • Able and willing to complete the entire study

Additional Patient Inclusion Criteria for the DLBCL Cohort (Expansion Phase)

  1. Histologically confirmed diagnosis (specified by 2016 World Health Organization) of DLBCL or transformed low-grade lymphoma with measurable disease
  2. Patient must be refractory or have relapsed after 2 or more standard therapeutic options, at least one of which must have included anti-CD20 antibody therapy.
  3. Not a candidate for or refusing treatment with hematopoietic stem cell transplantation

Additional Patient Inclusion Criteria for the Follicular Lymphoma Cohort (Expansion Phase)

  1. Diagnosis of follicular lymphoma Grades 1-3a
  2. Patient must be ineligible for or have exhausted standard therapeutic options and have had 2 or more prior systemic regimens.

Exclusion Criteria:

  • Cytotoxic chemotherapy, radiotherapy, or immunotherapy including other anti-CD20 antibodies within 4 weeks, or small molecule or investigational agents within 5 elimination half-lives of the first dose of XmAb13676
  • Prior 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 unless prior diagnosis and documentation of ongoing hemolysis or Gilbert's syndrome has been made)
  • Estimated creatinine clearance < 40 mL/min
  • Active/uncontrolled autoimmune disease
  • Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
  • Seizure disorder
  • History of stroke with the past 6 mos prior to study entry
  • 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 or HBV-DNA is negative and patient is receiving Hep B reactivation prophylaxis.
  • Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, and 8 months after the last dose of study drug
  • Positive urine pregnancy test (ie, urine human chorionic gonadotropin) at screening
  • Live viral vaccine within 2 weeks of the first dose of XmAb13676

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-CLL B Cell Malignancies (Group NHL) Part A
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Biological: XmAb13676
Biological
Experimental: CLL/SLL (Group CLL) Part A
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Biological: XmAb13676
Biological
Experimental: Non-CLL B Cell Malignancies (Group NHL) Part B
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Biological: XmAb13676
Biological
Experimental: CLL/SLL (Group CLL) Part B
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Biological: XmAb13676
Biological
Experimental: Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Biological: XmAb13676
Biological
Experimental: Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion
XmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Biological: XmAb13676
Biological

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame: Baseline Day 1 through Day 56
Baseline Day 1 through Day 56
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing
Time Frame: Baseline Day 1 through Day 56
Baseline Day 1 through Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xencor, Inc.

Collaborators

ICON Clinical Research

Investigators

  • Study Director: Chet Bohac, PharmD, MD, MSc, Executive Medical Director, Clinical Development, 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)

October 1, 2016

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimated)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XmAb13676-01

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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