NCT04130542

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Lyvgen Biopharma Holdings Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 LVGN6051 as a single agent (monotherapy) and in combination with pembrolizumab (MK-3475). 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 LVGN6051 or pembrolizumab (MK-3475) 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	LVGN6051	IV infusion once every 3 weeks (Q3W).
BIOLOGICAL	KEYTRUDA® (pembrolizumab)	IV infusion once every 3 weeks (Q3W).

Timeline

• Start date: 2019-10-31
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-10-17
• Last updated: 2024-10-31

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study