NCT04635995

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Lyvgen Biopharma Holdings Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RDE and RP2D of LVGN7409 as a single agent (monotherapy) and in combination with anti-PD-1 antibody and/or CD137 agonist. The first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of the study is the dose expansion phase (i.e., Phase 1b). During the study, dose interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are not permitted. Intra-patient dose escalations will be allowed for the early dose cohorts (single-patient dose groups) in Phase 1a Part 1. Patients will be considered evaluable for safety and tolerability if they receive at least one dose of LVGN7409 or anti-PD-1 antibody and/or CD137 agonist at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 2 years, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	LVGN7409	IV infusion once every 3 weeks (Q3W).

Timeline

• Start date: 2020-12-11
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-11-19
• Last updated: 2024-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study