New antibody combo takes on advanced cancers in first human trial
NCT ID NCT04130542
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested an experimental drug called LVGN6051, which activates immune cells by targeting CD137, both alone and combined with the approved immunotherapy Keytruda. The study involved 105 adults with advanced or metastatic cancers that had spread. The main goal was to find a safe dose and check for side effects, not yet to measure how well it fights cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LVGN6051 (an experimental antibody) and pembrolizumab (Keytruda, an approved immunotherapy)
- What this could lead to
- If successful, this could lead to a new treatment option for people with advanced cancers that have not responded to other therapies.
- What could go wrong
- This is a very early (Phase 1) trial focused on safety and dosing, not on proving effectiveness. Many experimental cancer drugs fail in later stages. Side effects from immune activation could be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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105 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * Patients infected with the HIV virus will be eligible if the disease is under control of effective therapy. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MD Anderson Cancer Center
Houston, Texas, 77030-3722, United States
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NYU Langone Health
New York, New York, 10016, United States
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Nebraska Cancer Specialist
Omaha, Nebraska, 68130, United States
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The Johns Hopkins University
Baltimore, Maryland, 21205, United States
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
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University of California Irvine Health
Orange, California, 92868, United States
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Verdi Oncology Research
Lafayette, Indiana, 47905, United States
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