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

NCT04130542

CompletedPhase 1

Sponsor: Lyvgen Biopharma Holdings Limited

Conditions: Cancer

Interventions: LVGN6051, KEYTRUDA® (pembrolizumab)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Receipt of systemic anticancer therapy including investigational agents or devices within 5 half-lives of the first dose of study treatment.
* Previous radiotherapy within 14 days of the first dose of study treatment.
* Known active CNS metastasis and/or carcinomatous meningitis.
* Has received a live-virus vaccine within 30 days.
* Has had a Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody.
* Abnormality of QT interval or syndrome.
* Patients with history of Grade ≥ 3 immune-related AEs (irAEs) or irAE.
* Patients who are receiving an immunologically-based treatment for any reason.
* Treatment with systemic immune-stimulatory agents within 4 weeks prior to the first dose of study drug.
* Active or chronic autoimmune disease that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease.
* Has a clinically significant cardiac condition, including unstable angina, acute myocardial infarction within 6 months.
* Has an active infection requiring intravenous (i.v.) anti-infectives within 14 days before the first dose of study treatment.
* Current evidence or history of interstitial lung disease or active, noninfectious pneumonitis requiring treatment such as oral or intravenous glucocorticoids to assist with management.
* Female patients who are pregnant or breastfeeding.
* Any evidence of severe or uncontrolled systemic disease.
* Any other disease or clinically significant abnormality in laboratory parameters.
* Has previously had a stem cell or bone marrow or solid organ transplant.

Locations (7)

Orange, California, United States
San Francisco, California, United States
Lafayette, Indiana, United States
Baltimore, Maryland, United States
Omaha, Nebraska, United States
New York, New York, United States
Houston, Texas, United States