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New antibody combo takes on advanced cancers in first human trial

NCT ID NCT04130542

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

105 people

The number who actually took part.

Started

Oct 2019

Finished

Dec 2025

Lead sponsor

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

Anyone

Healthy volunteers

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

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

  • MD Anderson Cancer Center

    Houston, Texas, 77030-3722, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Nebraska Cancer Specialist

    Omaha, Nebraska, 68130, United States

  • The Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115, United States

  • University of California Irvine Health

    Orange, California, 92868, United States

  • Verdi Oncology Research

    Lafayette, Indiana, 47905, United States

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