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ACTIVE NOT RECRUITING
NCT04130542
PHASE1

Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy

Sponsor: Lyvgen Biopharma Holdings Limited

View on ClinicalTrials.gov

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

BIOLOGICAL

LVGN6051

IV infusion once every 3 weeks (Q3W).

BIOLOGICAL

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