Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 7, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Xencor, Inc.
- Interventions being studied
- Biological: XmAb®808; Biological: Keytruda® (pembrolizumab)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- Part A: Histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast cancer, or colorectal cancer that has progressed on standard therapies
- 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 Key
- Subjects currently receiving other anticancer therapies
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Hematology/OncologyLos Angeles, California
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Florida Cancer SpecialistsSarasota, Florida
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- Northwestern Memorial HospitalChicago, Illinois
- Columbia University Irvine Medical CenterNew York, New York
- University of Cincinnati Medical CenterCincinnati, Ohio
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
- Tennessee OncologyNashville, Tennessee
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Huntsman Cancer Institute, University of UtahSalt Lake City, Utah
- Froedtert Hospital & The Medical College of WisconsinMilwaukee, Wisconsin
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 7, 2025. Always confirm current availability with the study team.