New antibody combo tackles Hard-to-Treat cancers in early trial
NCT ID NCT04635995
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called LVGN7409, which boosts the immune system to fight cancer. It was given alone or with other immune-boosting drugs to 66 adults with advanced cancers that had stopped responding to standard treatments. The main goal was to find the safest dose and check for side effects.
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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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66 people
The number who actually took part.
- Started
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Dec 2020
- 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
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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: * Prior therapy with anti-CD40 therapy. * Receipt of systemic anticancer therapy or radiotherapy within certain period of time. * Prior exposure to immune-therapeutics experienced Grade ≥ 3 drug-related toxicity, or a toxicity requiring discontinuation. * Received a live-virus vaccine within 30 days of the first dose of study drug. * Grade ≥ 3 allergic reaction to treatment with a monoclonal antibody. * History of Grade ≥ 3 immune-related AEs (irAEs). * Prolonged QT syndrome, or clinically significant cardiac condition. * Receiving an immunologically based treatment for any reason. * History or current active or chronic autoimmune disease. * Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites drainage. * Female patients who are pregnant or breastfeeding. * History of hemorrhagic or ischemic stroke within the last 6 months. * Previously received an allogeneic tissue/organ transplant, stem cell or bone marrow transplant 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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