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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04635995.
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.
Lead OrganizationLyvgen Biopharma Holdings Limited
