Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (MK-3475-A31/KEYNOTE-A31) in Advanced or Metastatic Malignancy

  • STATUS
    Recruiting
  • End date
    Mar 28, 2024
  • participants needed
    276
  • sponsor
    Lyvgen Biopharma Holdings Limited
Updated on 16 February 2022
monoclonal antibodies
bone marrow procedure
pembrolizumab
primary cancer

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.

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.

Details
Condition Cancer
Treatment LVGN6051
Clinical Study IdentifierNCT04130542
SponsorLyvgen Biopharma Holdings Limited
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

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
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