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

A Cancer clinical trial begins in United States.

The research company Lyvgen Biopharma Holdings Limited is conducting the clinical trial Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy.

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 CD40 agonist in the treatment of advanced or metastatic malignancy.

It is planned to include 126 participants.

Actual study start date is December 2020. The researchers expect to complete the study by April 2023.

One primary outcome measure is Treatment-emergent adverse events (TEAEs), determination of DLTs and serious AEs (SAEs) of LVGN7409 as monotherapy. Adverse events will be assessed, and severity will be assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

The following population can be recruited into this study:

-Males or females aged ≥ 18 years. - Ability to understand and willingness to sign a written informed consent document. - Patients must have a histologically or cytologically confirmed metastatic or unresectable malignancy. - Estimated life expectancy, in the judgment of the Investigator, of at least 90 days. - Adequate bone marrow, liver, and renal functions - Men and women of childbearing potential must agree to take highly effective contraceptive methods. - Patients should recover from all reversible AEs of previous anticancer therapies to baseline. - Patients infected with the HIV virus will be eligible if the disease is under control of effective therapy.

Among the exclusion criteria are:

- Prior therapy with anti-CD40 therapy. - Receipt of systemic anticancer therapy or radiotherapy within certain period of time. - Prior exposure to immune-therapeutics experienced Grade ≥ 3 drug-related toxicity, or a toxicity requiring discontinuation. - Received a live-virus vaccine within 30 days of the first dose of study drug. - Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody. - History of Grade ≥ 3 immune-related AEs (irAEs). - Prolonged QT syndrome, or clinically significant cardiac condition. - Receiving an immunologically based treatment for any reason. - History or current active or chronic autoimmune disease. - Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites drainage. - Female patients who are pregnant or breastfeeding. - History of hemorrhagic or ischemic stroke within the last 6 months. - Previously received an allogeneic tissue/organ transplant, stem cell or bone marrow transplant or solid organ transplant.

The location of the study and further details can be found here:https://ichgcp.net/clinical-trials-registry/NCT04635995

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