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Brief Title: 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

INTRODUCTION

  • Org Study ID: XmAb808-01
  • Secondary ID: N/A
  • NCT ID: NCT05585034
  • Sponsor: Xencor, Inc.

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).

  • Overall Status
    Recruiting
  • Start Date
    December 14, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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

ELIGIBILITY

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

OFFICIAL INFORMATION

Name: Ben Thompson, MD PhD

Role: Study Director

Affiliation: Xencor, Inc.

Overall Contact

Name: Ben Thompson, MD PhD, Amber Sarot

Phone: (619) 517-7381, (858) 245-9419

Email: bthompson@xencor.com, asarot@xencor.com

LOCATION

Facility Status Contact
Facility: UCLA Hematology/Oncology
Los Angeles, California 90095
United States 		Status: Recruiting Contact: N/A
Facility: Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States 		Status: Recruiting Contact: N/A
Facility: Florida Cancer Specialists
Sarasota, Florida 34232
United States 		Status: Recruiting Contact: N/A
Facility: Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States 		Status: Recruiting Contact: N/A
Facility: Northwestern Memorial Hospital
Chicago, Illinois 60611
United States 		Status: Recruiting Contact: N/A
Facility: Columbia University Irvine Medical Center
New York, New York 10032
United States 		Status: Recruiting Contact: N/A
Facility: University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States 		Status: Recruiting Contact: N/A
Facility: UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15213
United States 		Status: Recruiting Contact: N/A
Facility: Tennessee Oncology
Nashville, Tennessee 37203
United States 		Status: Recruiting Contact: N/A
Facility: The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States 		Status: Recruiting Contact: N/A
Facility: Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
United States 		Status: Recruiting Contact: N/A
Facility: Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States 		Status: Recruiting Contact: N/A

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