Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
NCT ID: NCT05585034
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2022-12-14
2025-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumab
XmAb®808 in combination with pembrolizumab
XmAb®808
Monoclonal bispecific antibody
Keytruda® (pembrolizumab)
Monoclonal antibody
Interventions
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XmAb®808
Monoclonal bispecific antibody
Keytruda® (pembrolizumab)
Monoclonal antibody
Eligibility Criteria
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Inclusion Criteria
* Part B: Histologically confirmed advanced/metastatic castration-resistant prostate cancer that is PD1-naïve; head and neck squamous cell carcinoma that is PD1-naïve or has progressed on prior PD1 therapy; or melanoma that is PD1-naïve or has progressed on prior PD1 therapy
* Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
* Life expectancy \> 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
* Any prior treatment with an investigational agent targeting CD28
* History of a life-threatening adverse event related to prior immunotherapy
* Known active central nervous system involvement by malignant disease. Subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
18 Years
ALL
No
Sponsors
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Xencor, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mira Kistler, MD
Role: STUDY_DIRECTOR
Xencor, Inc.
Locations
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UCLA Hematology/Oncology
Los Angeles, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Columbia University Irvine Medical Center
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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XmAb808-01
Identifier Type: -
Identifier Source: org_study_id
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