Status:
COMPLETED
Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy
Lead Sponsor:
Lyvgen Biopharma Holdings Limited
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study of LVGN6051-201 is designed to use a bridging dose escalation to quickly establish the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) as well as the recommended...
Detailed Description
Based on the dose escalation results from the study of LVGN6051-101, a bridging dose escalation (3+3) is used in study of LVGN6051-201. The traditional 3 + 3 dose escalation algorithm to identify the ...
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.
Exclusion
- Receipt of CD137 and or PD-1 antibodies.
- Receipt of systemic anticancer therapy within 5 half-lives 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.
- 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.
- Tested positive of HIV or HBV or HCV.
- Female patients who are pregnant or breastfeeding.
- Any evidence of severe or uncontrolled systemic disease.
- Has previously had a CAR-T therapy, or stem cell or bone marrow or solid organ transplant.
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04694781
Start Date
May 14 2021
End Date
October 31 2023
Last Update
April 19 2024
Active Locations (2)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
2
Shanghai Chest Hospital
Shanghai, China