Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
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
1 other identifier
interventional
307
4 countries
23
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 carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2022
Longer than P75 for phase_1
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2022
CompletedStudy Start
First participant enrolled
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 5, 2026
March 1, 2026
4.6 years
June 13, 2022
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
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)
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 Outcomes (5)
Measurement of Cmax
56 days
Measurement of AUCtau
56 days
Objective Response rate
42 days
Progression-free survival
42 days
Duration of response
42 days
Study Arms (1)
Dose Escalation and Expansion
EXPERIMENTALDose Escalation will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose. Dose Expansion may administer XmAb819 IV, and XmAb819 SC.
Interventions
Eligibility Criteria
You may qualify if:
- 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, pRCC, NSCLC, and CRC 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xencor, Inc.lead
Study Sites (23)
Xencor Investigative Site
Phoenix, Arizona, 85054, United States
Xencor Investigative Site
Duarte, California, 91010, United States
Xencor Investigative Site
Sacramento, California, 95817, United States
Xencor Investigative Site
New Haven, Connecticut, 06520, United States
Xencor Investigative Site
Jacksonville, Florida, 32224, United States
Xencor Investigative Site
Atlanta, Georgia, 30322, United States
Xencor Investigative Site
Chicago, Illinois, 60611, United States
Xencor Investigative Site
Chicago, Illinois, 60637, United States
Xencor Investigative Site
Louisville, Kentucky, 40207, United States
Xencor Investigative Site
Rochester, Minnesota, 55905, United States
Xencor Investigative Site
New Brunswick, New Jersey, 088901, United States
Xencor Investigative Site
New York, New York, 10032, United States
Xencor Investigative Site
New York, New York, 10065, United States
Xencor Investigative Site
Charlotte, North Carolina, 28777, United States
Xencor Investigative Site
Durham, North Carolina, 27710, United States
Xencor Investigative Site
Cincinnati, Ohio, 45267, United States
Xencor Investigative Site
Columbus, Ohio, 43210, United States
Xencor Investigative Site
Oklahoma City, Oklahoma, 73104, United States
Xencor Investigative Site
Nashville, Tennessee, 37203, United States
Xencor Investigative Site
Seattle, Washington, 98109, United States
Xencor Investigative Site
Villejuif, 94805, France
Xencor Investigative Site
Madrid, 28050, Spain
Xencor Investigative Site
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chet Bohac, MD
Xencor, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2022
First Posted
June 27, 2022
Study Start
June 13, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share