CancerPhase 1NCT05040932
Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy
A Phase 1 study testing YH004 in people with Cancer, run by Eucure (Beijing) Biopharma Co., Ltd at 3 sites in Australia.
Trial summary
YH004 is a humanized monoclonal antibody that specifically binds to 4-1BB, and acts as an agonist against 4-1BB. This first in human study of YH004 is designed to establish the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of YH004, both as a single agent (monotherapy) and in combination… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- YH004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesAustralia
- Study dates
- 7 Dec 2021to 16 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Cabrini Health Limited
Malvern East, 3144
Westmead Hospital
Sydney, 2145
Southside Cancer Care Centre, School of Medicine, University of Wollongong
Wollongong, Australia, 2217
About this study
Official title: A First-In-Human, Multicenter, Open-Label, Phase I Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of YH004 As A Single Agent And Combination With Toripalimab In Subjects With Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
YH004 is a humanized monoclonal antibody that specifically binds to 4-1BB, and acts as an agonist against 4-1BB.
This first in human study of YH004 is designed to establish the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of YH004, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Toripalimab) in the treatment of advanced solid tumors and relapsed or refractory non-Hodgkin Lymphoma.
Read the detailed description
This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RP2D of YH004 as a single agent (monotherapy) and in combination with Toripalimab. The first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of the study is the dose expansion phase (i.e., Phase 1b). During the study, dose interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are permitted following protocol guidelines. Intra-patient dose escalations will be allowed for the early dose cohorts (single-patient dose groups) in Phase 1a. Patients will be considered evaluable for safety and tolerability if they receive at least one dose of YH004 or Toripalimab at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 1 year, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression.
- Conditions
- Cancer
- Being tested
- YH004
- Keywords
- Eucure, YH004, anti-4-1BB, Toripalimab, anti-PD-1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH004Drug
IV infusion once every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| YH004 | Experimental | The dose escalation phase includes 7 dose levels of YH004, and the highest dose is up to 10mg/kg. Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 16 cycles if patients receive benefits. Receives: Drug: YH004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs)
Adverse events will be assessed, and severity will be assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Measured: up to 24 months
Maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D)
The MTD and/or RP2D will be determined based on TEAEs
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start7 Dec 2021
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eucure (Beijing) Biopharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rong Chen, Ph.D, Study chair, Eucure (Beijing) Biopharma Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040932
- Sponsor's protocol ID
- YH004002
- Status last verified
- Jan 2025
- First submitted
- 27 Aug 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Multicenter, Open-Label, Phase I Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of YH004 As A Single Agent And Combination With Toripalimab In Subjects With Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05040932
- Acronym / sponsor ID
- YH004002
- Conditions
- Cancer
- Keywords
- Eucure, YH004, anti-4-1BB, Toripalimab, anti-PD-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Eucure (Beijing) Biopharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
YH004 is a humanized monoclonal antibody that specifically binds to 4-1BB, and acts as an agonist against 4-1BB.
This first in human study of YH004 is designed to establish the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of YH004, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Toripalimab) in the treatment of advanced solid tumors and relapsed or refractory non-Hodgkin Lymphoma.
Detailed description
This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RP2D of YH004 as a single agent (monotherapy) and in combination with Toripalimab. The first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of the study is the dose expansion phase (i.e., Phase 1b). During the study, dose interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are permitted following protocol guidelines. Intra-patient dose escalations will be allowed for the early dose cohorts (single-patient dose groups) in Phase 1a. Patients will be considered evaluable for safety and tolerability if they receive at least one dose of YH004 or Toripalimab at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 1 year, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YH004 | Experimental | Drug: YH004The dose escalation phase includes 7 dose levels of YH004, and the highest dose is up to 10mg/kg. Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 16 cycles if patients receive benefits. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YH004IV infusion once every 3 weeks (Q3W). | Drug | YH004 |
Primary outcome
Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs)
Time frame: up to 24 months
Adverse events will be assessed, and severity will be assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D)
Time frame: up to 24 months
The MTD and/or RP2D will be determined based on TEAEs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Chen, Ph.D study chair
Eucure (Beijing) Biopharma Co., Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YH004 in people with Cancer, run by Eucure (Beijing) Biopharma Co., Ltd at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs) (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.