Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors
1 other identifier
interventional
60
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2022
Typical duration for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedStudy Start
First participant enrolled
December 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2025
CompletedAugust 7, 2025
August 1, 2025
2.4 years
October 11, 2022
August 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs)
Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
Up to 5 years
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
49 days
Secondary Outcomes (5)
Measurement of Cmax
Through study completion, Up to 5 years
Measurement of AUCtau
Through study completion, Up to 5 years
Objective Response Rate
Through study completion, Up to 5 years
Progression-free Survival
Through study completion, Up to 5 years
Duration of Response
Through study completion, Up to 5 years
Study Arms (1)
Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumab
EXPERIMENTALXmAb®808 in combination with pembrolizumab
Interventions
Monoclonal bispecific antibody
Monoclonal antibody
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xencor, Inc.lead
Study Sites (12)
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Columbia University Irvine Medical Center
New York, New York, 10032, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mira Kistler, MD
Xencor, Inc.
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
October 11, 2022
First Posted
October 18, 2022
Study Start
December 14, 2022
Primary Completion
May 20, 2025
Study Completion
May 20, 2025
Last Updated
August 7, 2025
Record last verified: 2025-08