Can a Two-Antibody combo supercharge the immune system against Hard-to-Treat cancers?

NCT ID NCT05040932

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

8 people

The number who actually took part.

Started

Dec 2021

Finished

Jun 2023

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 to 80 years

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 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

  • Cabrini Health Limited

    Malvern East, 3144, Australia

  • Southside Cancer Care Centre, School of Medicine, University of Wollongong

    Wollongong, Australia, 2217, Australia

  • Westmead Hospital

    Sydney, 2145, Australia

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