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

NCT04130542 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: LVGN6051-101MK-3475-A31/KEYNOTE-A31
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 7

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.

Conditions

Cancer

Keywords

Lyvgen; MK-3475; Pembrolizumab; Keytruda

Outcome Measures

Primary Outcomes (1)

• Safety/Tolerability

  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

Study Arms (1)

LVGN6051

EXPERIMENTAL

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; Biological: KEYTRUDA® (pembrolizumab)

Interventions

LVGN6051 BIOLOGICAL

IV infusion once every 3 weeks (Q3W).

LVGN6051

KEYTRUDA® (pembrolizumab) BIOLOGICAL

IV infusion once every 3 weeks (Q3W).

LVGN6051

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lyvgen Biopharma Holdings Limited: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (7)

University of California Irvine Health

Orange, California, 92868, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Verdi Oncology Research

Lafayette, Indiana, 47905, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Nebraska Cancer Specialist

Omaha, Nebraska, 68130, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-3722, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 17, 2019
• Study Start: October 31, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

US (7)