Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

September 26, 2023 updated by: Xencor, Inc.

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: Part A, dose escalation, and Part B, dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC. All eligible subjects will have relapsed or refractory disease after standard therapy.

Study Type

Interventional

Enrollment (Estimated)

95

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

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Department of Medical Oncology and Therapeutics Research, City of Hope
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
    • New York
      • New York, New York, United States, 10032
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute, LLC
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:

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:

  • Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Subjects who have relapsed and refractory ccRCC with evidence of disease progression on standard-of-care therapies
  • ECOG performance status of 0 or 1.
  • All subjects must have adequate tumor sample available (slides or archival FFPE blocks)

Exclusion Criteria:

  • Prior treatment with an investigational anti-ENPP3/CD203c therapy
  • History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
  • Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
  • Failure to recover from any clinically significant toxicity related to previous anticancer treatment
  • Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
  • Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
  • Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
  • Have a known additional malignancy that is progressing or has required active treatment within the past 2 years

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation and Expansion

Dose Escalation (Part A): Part A will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC in subjects with ccRCC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose.

Dose Expansion (Part B): Part B-1 may administer XmAb819 IV, and Part B-2 may administer XmAb819 SC.
Biological: XmAb819
Monoclonal Bispecific Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
Time Frame: 28 days
Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
28 days
Incidence of dose limiting toxicities (DLTs)
Time Frame: 28 days
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Cmax
Time Frame: 56 days
Peak plasma concentration (Cmax)
56 days
Measurement of AUCtau
Time Frame: 56 days
Area under the plasma concentration versus time curve (AUCtau)
56 days
Objective Response rate
Time Frame: 42 days
Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)
42 days
Progression-free survival
Time Frame: 42 days
Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)
42 days
Duration of response
Time Frame: 42 days
Duration of response (RECIST 1.1 assessment of CT/MRI imaging)
42 days

Collaborators and Investigators

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

Sponsor

Xencor, Inc.

Investigators

  • Study Director: Chet Bohac, 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)

June 13, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 20, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XmAb819-01

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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