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Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy
Sponsor: Lyvgen Biopharma Holdings Limited
Summary
LVGN6051 is a humanized monoclonal antibody that specifically binds to CD137, and acts as an agonist against CD137. This first in human study of LVGN6051 is designed to establish the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) as well as the recommended Phase 2 dose(s) (RP2D) of LVGN6051, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Pembrolizumab/MK-3475) in the treatment of advanced or metastatic malignancy.
Official title: An Open Label, First in Human (FIH), Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
276
Start Date
2019-10-31
Completion Date
2025-12-31
Last Updated
2024-10-31
Healthy Volunteers
No
Conditions
Interventions
LVGN6051
IV infusion once every 3 weeks (Q3W).
KEYTRUDA® (pembrolizumab)
IV infusion once every 3 weeks (Q3W).
Locations (7)
University of California Irvine Health
Orange, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Verdi Oncology Research
Lafayette, Indiana, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Nebraska Cancer Specialist
Omaha, Nebraska, United States
NYU Langone Health
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States