Status:
ACTIVE_NOT_RECRUITING
Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy
Lead Sponsor:
Lyvgen Biopharma Holdings Limited
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 tolerate...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT04130542
Start Date
October 31 2019
End Date
December 31 2025
Last Update
October 31 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Irvine Health
Orange, California, United States, 92868
2
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
3
Verdi Oncology Research
Lafayette, Indiana, United States, 47905
4
The Johns Hopkins University
Baltimore, Maryland, United States, 21205