Trial Title:
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
Condition:
Head and Neck Squamous Cell Carcinoma
Melanoma Excluding Uveal Melanoma
Non-small Cell Lung Cancer, Squamous or Non-squamous
Urothelial Carcinoma
Renal Cell Carcinoma, Clear Cell
Castration-resistant Prostate Cancer
Ovarian Cancer, Epithelial
TNBC - Triple-Negative Breast Cancer
Colorectal Cancer
Conditions: Official terms:
Carcinoma
Melanoma
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Ovarian Epithelial
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
XmAb®808
Description:
Monoclonal bispecific antibody
Arm group label:
Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumab
Intervention type:
Biological
Intervention name:
Keytruda® (pembrolizumab)
Description:
Monoclonal antibody
Arm group label:
Dose Escalation and Expansion XmAb®808 administered in combination with pembrolizumab
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.
Detailed description:
This is a Phase 1, open-label, first-in-human (FIH), multiple-dose, dose escalation study
with cohort expansion at the RD, designed to evaluate the safety and tolerability of
XmAb808 in combination with pembrolizumab. This study will be conducted in 2 parts: Part
A (dose escalation) and Part B (cohort expansion).
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Hematology/Oncology
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute at HealthONE
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
Winship Cancer Institute, Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Irvine Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Cincinnati Medical Center
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Status:
Recruiting
Facility:
Name:
Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Froedtert Hospital & The Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Start date:
December 14, 2022
Completion date:
December 2027
Lead sponsor:
Agency:
Xencor, Inc.
Agency class:
Industry
Source:
Xencor, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05585034
