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ACTIVE NOT RECRUITING
NCT04635995
PHASE1

Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy

Sponsor: Lyvgen Biopharma Holdings Limited

View on ClinicalTrials.gov

Summary

LVGN7409 is a humanized monoclonal antibody that specifically binds to CD40, and acts as an agonist against CD40. This first in human study of LVGN7409 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 LVGN7409, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody and/or CD137 agonist in the treatment of advanced or metastatic malignancy.

Official title: An Open Label, First in Human (FIH), Phase 1a/1b Trial of LVGN7409 (CD40 Agonist Antibody) as a Single Agent, in Combination With LVGN3616 (Anti-PD-1 Antibody), and in Combination With LVGN3616 and LVGN6051 (CD137 Agonist Antibody) in Patients With Locally Advanced, Relapsed, Refractory, or Metastatic Malignancy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2020-12-11

Completion Date

2025-12-31

Last Updated

2024-10-31

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

LVGN7409

IV infusion once every 3 weeks (Q3W).

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States