Clinical trial NCT05585034: Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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).

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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 5 years
measure: Incidence of dose-limiting toxicities (DLTs)
timeFrame: 49 days
Secondary outcomes:
measure: Measurement of Cmax
timeFrame: Through study completion, Up to 5 years
measure: Measurement of AUCtau
timeFrame: Through study completion, Up to 5 years
measure: Objective Response Rate
timeFrame: Through study completion, Up to 5 years
measure: Progression-free Survival
timeFrame: Through study completion, Up to 5 years
measure: Duration of Response
timeFrame: Through study completion, Up to 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: New York
country: United States
facility: Columbia University Irvine Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute, University of Utah
state: Utah
city: Milwaukee
country: United States
facility: Froedtert Hospital & The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Xencor, Inc.
name: Mira Kistler, MD
role: STUDY_DIRECTOR
References: