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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

Phase
Phase 1
Sponsor
Xencor, Inc.
Enrollment
95
Timeline
Jun 2022 → Nov 2027
About This Study

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).

Eligibility Criteria

Inclusion Criteria

  • 1Subjects 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.
  • 2Subjects who have relapsed and refractory ccRCC with evidence of disease progression on standard-of-care therapies
  • 3ECOG performance status of 0 or 1.
  • 4All subjects must have adequate tumor sample available (slides or archival FFPE blocks)

Exclusion Criteria

  • 1Prior treatment with an investigational anti-ENPP3/CD203c therapy
  • 2History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
  • 3Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
  • 4Failure to recover from any clinically significant toxicity related to previous anticancer treatment
  • 5Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
  • 6Active 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)
  • 7Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
  • 8Have a known additional malignancy that is progressing or has required active treatment within the past 2 years

Locations

8 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

Department of Medical Oncology and Therapeutics Research, City of Hope

Duarte, California 91010

Recruiting

The University of Chicago Medical Center

Chicago, Illinois 60637

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →