Can a Two-Antibody combo supercharge the immune system against Hard-to-Treat cancers?
NCT ID NCT05040932
First seen Sep 22, 2026 · Last updated Sep 22, 2026
Summary
Researchers are testing an experimental antibody called YH004 in adults with advanced solid tumors or non-Hodgkin lymphoma that has come back or stopped responding to treatment. YH004 is designed to activate immune cells by targeting a protein called 4-1BB. The study gives YH004 alone and in combination with toripalimab, an existing immune-boosting antibody, to find the highest dose people can tolerate and to watch for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- YH004, an experimental antibody that activates immune cells, alone and with toripalimab
- What this could lead to
- If it works, this could point toward a new way to boost the immune system against advanced solid tumors and lymphoma that have resisted other treatments.
- What could go wrong
- This is a very early first-in-human study with only a handful of participants, so most experimental drugs at this stage do not become treatments. Immune-activating drugs can also cause serious side effects, including inflammation in healthy organs.
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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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8 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Jun 2023
- 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 to 80 years
- 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 to 80 years at the time of screening. * Ability to understand and willingness to sign a written informed consent document. * Subjects must have advanced histologically or cytologically confirmed solid tumor or relapsed or refractory Non-Hodgkin lymphoma. * Adequate bone marrow, liver, and renal functions. * Men and women of childbearing potential must agree to take highly effective contraceptive methods. * Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the first dose. Exclusion Criteria: * Receipt of systemic anticancer therapy including investigational agents or devices within 5 half-lives of the first dose of study treatment. * Known active CNS metastasis. * Has received a live-virus vaccine within 28 days. * History of clinically significant sensitivity or allergy to monoclonal antibodies and their excipients or known allergies to antibodies produced from Chinese hamster ovary cells. * Abnormality of QT interval or syndrome. * Patients with history of Grade ≥ 3 immune-related AEs (irAEs) or irAE. * Patients who receive concurrent or prior use of an immunosuppressive agent within 4 weeks of the first dose of study drug. * Previous exposure to anti-CD137 (eg, utomilumab, urelumab) antibodies. . * Active or chronic autoimmune disease that has required systemic treatment in the past 3 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 before the first dose of study treatment. * History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease.. * Female patients who are pregnant or breastfeeding. * Any evidence of severe or uncontrolled systemic disease. * Any condition that the investigator or primary physician believes may not be appropriate for participating the study.
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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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Cabrini Health Limited
Malvern East, 3144, Australia
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Southside Cancer Care Centre, School of Medicine, University of Wollongong
Wollongong, Australia, 2217, Australia
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Westmead Hospital
Sydney, 2145, Australia
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