Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy
NCT04130542 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2026-05-19
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.
Conditions
Interventions
- BIOLOGICAL
-
LVGN6051
IV infusion once every 3 weeks (Q3W).
- BIOLOGICAL
-
KEYTRUDA® (pembrolizumab)
IV infusion once every 3 weeks (Q3W).
Sponsors & Collaborators
- collaborator INDUSTRY
-
Lyvgen Biopharma Holdings Limited
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-31
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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