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

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ClinicalTrials.gov Identifier: NCT04130542
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lyvgen Biopharma Holdings Limited

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Biological: LVGN6051 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, First in Human (FIH), Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Pembrolizumab (MK-3475-A31/KEYNOTE-A31) in Advanced or Metastatic Malignancy
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : February 2022

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).




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130542


Contacts
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Contact: Lynn Jiang, PhD 1-484-686-9652 lynn.jiang@lyvgen.com

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-3722
Contact: Yi-Hsin Hsu, PhD    713-794-3601    YHsu1@mdanderson.org   
Sponsors and Collaborators
Lyvgen Biopharma Holdings Limited
Merck Sharp & Dohme Corp.
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Responsible Party: Lyvgen Biopharma Holdings Limited
ClinicalTrials.gov Identifier: NCT04130542    
Other Study ID Numbers: LVGN6051-101
KEYNOTE-A31 ( Other Identifier: Merck Sharp & Dohme Corp. )
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lyvgen Biopharma Holdings Limited:
Lyvgen
MK-3475
Pembrolizumab
Keytruda
Additional relevant MeSH terms:
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Neoplasms