Status:
RECRUITING
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
Lead Sponsor:
Xencor, Inc.
Conditions:
Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 carcinom...
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 XmAb...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05433142
Start Date
June 13 2022
End Date
November 1 2027
Last Update
July 31 2025
Active Locations (8)
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1
Department of Medical Oncology and Therapeutics Research, City of Hope
Duarte, California, United States, 91010
2
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
3
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
4
Columbia University Medical Center
New York, New York, United States, 10032