RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-06-13
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05433142

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Subjects who have relapsed and refractory ccRCC with evidence of disease progression on standard-of-care therapies
  3. * ECOG performance status of 0 or 1.
  4. * All subjects must have adequate tumor sample available (slides or archival FFPE blocks)
  1. * Prior treatment with an investigational anti-ENPP3/CD203c therapy
  2. * History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
  3. * Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
  4. * Failure to recover from any clinically significant toxicity related to previous anticancer treatment
  5. * Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
  6. * 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)
  7. * Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
  8. * Have a known additional malignancy that is progressing or has required active treatment within the past 2 years

Contacts and Locations

Study Contact

Chet Bohac, MD
CONTACT
(626)305-5900
cbohac@xencor.com
Lisa Finnigan
CONTACT
lfinnigan@xencor.com

Principal Investigator

Chet Bohac, MD
STUDY_DIRECTOR
Xencor, Inc.

Study Locations (Sites)

Department of Medical Oncology and Therapeutics Research, City of Hope
Duarte, California, 91010
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering
New York, New York, 10065
United States
Duke University
Durham, North Carolina, 27710
United States
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, 37203
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Xencor, Inc.

  • Chet Bohac, MD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2022-06-13
Study Completion Date2027-03

Study Record Updates

Study Start Date2022-06-13
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • ccRCC
  • RCC
  • Renal Cell Cancer
  • Kidney Cancer

Additional Relevant MeSH Terms

  • Clear Cell Renal Cell Carcinoma