Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy

• Status: Not yet recruiting
• Trial end date: 2023-07-11
• Target enrollment: 0
• Participant gender: All

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 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) in the treatment of advanced or metastatic malignancy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lyvgen Biopharma Holdings Limited
• Treatments: Pembrolizumab

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.

Exclusion Criteria:

• 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.