Clinical trial · Interventional
Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy
An Open Label, Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Pembrolizumab in Advanced or Metastatic Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LVGN6051 | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Monotherapy Dose Escalation
- description
- LVGN6051 monotherapy dose escalation
- interventionNames
- Drug: LVGN6051
- type
- EXPERIMENTAL
- label
- Monotherapy Dose Expansion
- description
- LVGN6051 dose expansion cohorts
- interventionNames
- Drug: LVGN6051
- type
- EXPERIMENTAL
- label
- Combination therapy dose escalation
- description
- LVGN6051 in combination with anti-PD-1 antibody pembrolizumab dose escalation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available