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

March 13, 2024 updated by: Lyvgen Biopharma Holdings Limited

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

276

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine Health
        • Contact:
      • San Francisco, California, United States, 94115
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center
        • Contact:
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Recruiting
        • Verdi Oncology Research
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • The Johns Hopkins University
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68130
    • New York
      • New York, New York, United States, 10016
    • Texas
      • Houston, Texas, United States, 77030-3722
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LVGN6051
The dose escalation phase includes 10 dose levels of LVGN6051, and the highest dose is up to 10mg/kg. Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits.
Biological: LVGN6051
IV infusion once every 3 weeks (Q3W).
Other Names:
  • KEYTRUDA® (pembrolizumab)
Biological: KEYTRUDA® (pembrolizumab)
IV infusion once every 3 weeks (Q3W).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/Tolerability
Time Frame: up to 24 months
mEvaluate the safety and tolerability and determine the Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and recommended Phase 2 dose(s) (RP2D) of LVGN6051 administered as a single agent (monotherapy) and in combination with pembrolizumab, in adult patients with advanced malignancy.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lyvgen Biopharma Holdings Limited

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2019

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVGN6051-101
  • MK-3475-A31/KEYNOTE-A31 (Other Identifier: Merck Sharp & Dohme LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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