Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors
NCT05585034 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-08-07
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.
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
Interventions
- BIOLOGICAL
-
XmAb®808
Monoclonal bispecific antibody
- BIOLOGICAL
-
Keytruda® (pembrolizumab)
Monoclonal antibody
Sponsors & Collaborators
-
Xencor, Inc.
lead INDUSTRY
Principal Investigators
-
Mira Kistler, MD · Xencor, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-14
- Primary Completion
- 2025-05-20
- Completion
- 2025-05-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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