Advanced Solid TumorsPhase 1NCT05564806
Study of YH004 (4-1BB Agonist Antibody) in Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
A Phase 1 study testing YH004 in people with Advanced Solid Tumors and Relapsed Or Refractory Non-Hodgkin Lymphoma, run by Eucure (Beijing) Biopharma Co., Ltd at 2 sites in China.
Trial summary
This is an multicenter, open-label, dose-escalation study of the study drug YH004 . The study is designed to determine the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of YH004 in subjects with advanced solid tumors and relapsed or refractory Non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumors, Relapsed Or Refractory Non-Hodgkin Lymphoma
- 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
- 9 participants
- Where
- 2 sitesChina
- Study dates
- 31 Jan 2023to 11 Mar 2024
- 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
- Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study procedures.
- Patients with histologically or cytologically confirmed advanced solid tumor or relapsed or refractory Non-Hodgkin Lymphoma (including but not limited to inert and transformed type, patients with inert lymphoma must undergo systematic treatment at the time of screening), which has progressed after treatment with standard therapies or intolerant of standard therapies or have no standard of care.
- Subject must have at least one measurable lesion by RECIST 1.1 or per Cheson criteria (Lugano 2014).
- Subjects must be 18 years to 80 years of age at the time of screening.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have life expectancy of at least 12 weeks based on investigator's judgement.
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- Sufficient organ and bone marrow functions before screening or administration.
- Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test at the time of screening.
- Women of reproductive potential who are sexually active must consistently use highly effective contraception/birth control (less than 1% per year) between signing of the informed consent and 90 days after the last administration of the study drug.
Who cannot join
- Previous exposure to an anti-CD137 (e.g., utomilumab, urelumab) antibodies.
- Subjects must not have another active invasive malignancy within 2 years or currently.
- Subjects have received any anticancer therapy or another investigational agent within the longer of 4 weeks or 5 half-lives before the first dose of the study drug.
- Continuance of toxicities due to prior anti-tumor therapy that have not recovered to ≤ Grade 1 per CTCAE 5.0.
- Subjects who have major operations within 4 weeks before the first dose of the study drug, or minor surgery within 2 weeks prior to the first dose.
- Subjects have received any radiotherapy within the longer of 4 weeks before the first dose of the study drug.
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- Subjects with primary CNS malignancy or symptomatic CNS metastasis.
- Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy or treatment discontinuation due to previous immunotherapy.
- Subjects must not receive concurrent or prior use of an immunosuppressive agent within 4 weeks of the first dose of study drug.
- Subjects must not receive any other investigational drug or participated in other clinical studies within 4 weeks before the first dose of study drug.
- Subjects must not have received a live vaccine or attenuated live vaccine within 4 weeks before the first dose of study drug.
- Known allergies to the active ingredient or excipients of the test drug, or history of severe allergic reaction (≥ grade 3) to any other monoclonal antibody or intravenous therapeutic protein preparation drug.
- History of interstitial lung disease or noninfectious pneumonia requiring corticosteroid treatment.
- More than moderate amount of uncontrollable pleural, abdominal or pericardial effusion requiring repeated drainage or with obvious symptoms.
- Subjects must not have an active autoimmune disease, a history of autoimmune disease requiring systemic therapy, or a history of autoimmune disease within 2 years of the first dose of study drug.
- Clinically uncontrolled illness, including but not limited to severe diabetes, uncontrolled hypertension, serious endocrine disorders or other serious diseases requiring systemic treatment such as severe abnormal thyroid function.
- Subjects must not have a history or persistent active virus or tuberculosis infection. Including but not limited to: human immunodeficiency virus (HIV), syphilis, hepatitis C, hepatitis B or active COVID-19 infection; previous or current active pulmonary tuberculosis and other active infectious diseases.
- Severe infections requiring intravenous administration within 7 days before the first dose of study drug.
- Severe cerebro-cardiovascular disease within 6 months of the first dose of study drug, such as cerebrovascular rupture, stroke, myocardial infarction, unstable angina pectoris, congestive heart failure (NYHA grade ≥ II), valvular disease with significant clinical significance, and serious out of control arrhythmia requiring drug treatment (pulmonary hypertension or left ventricular ejection fraction (LVEF) ≤ 50% during screening period).
- QTc > 480 ms at baseline, corrected for heart rate using Frederica's formula.
- Subjects must not have a history of allogeneic bone marrow transplantation or organ transplantation.
- Any known mental illness or disorder, substance abuse history, drug abuse history or alcohol dependence history that would preclude subject from participation.
- Females who are lactating, except for whom agreed to stop lactating during the trial.
- Any condition that the investigator believes may not be appropriate for participating the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Multicenter, Open-Label, Phase I Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of YH004 In Subjects With Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
This is an multicenter, open-label, dose-escalation study of the study drug YH004 . The study is designed to determine the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of YH004 in subjects with advanced solid tumors and relapsed or refractory Non-Hodgkin lymphoma.
- Being tested
- YH004
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH004Drug
All subject will receive YH004 intravenously as single agent every three weeks (Q3W), until intolerable toxicity, disease progression, withdrawal of consent, or Investigator decision, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | All subject will receive YH004 intravenously as single agent every three weeks (Q3W), until intolerable toxicity, disease progression, withdrawal of consent, or Investigator decision, whichever comes first. Receives: Drug: YH004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
The safety profile of YH004 will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0.
Measured: up to 1 year after the last dosing
Maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D)
The MTD and/or RP2D will be determined based on the data of safety and tolerability.
Measured: up to 1 year after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start31 Jan 2023
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Model description
- Clinical trials with a single arm
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eucure (Beijing) Biopharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564806
- Sponsor's protocol ID
- YH004003
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 Multicenter, Open-Label, Phase I Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of YH004 In Subjects With Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05564806
- Acronym / sponsor ID
- YH004003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Eucure (Beijing) Biopharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 4 Oct 2022 (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.
This is an multicenter, open-label, dose-escalation study of the study drug YH004 . The study is designed to determine the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of YH004 in subjects with advanced solid tumors and relapsed or refractory Non-Hodgkin lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trials with a single arm
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Drug: YH004All subject will receive YH004 intravenously as single agent every three weeks (Q3W), until intolerable toxicity, disease progression, withdrawal of consent, or Investigator decision, whichever comes first. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study procedures.
- Patients with histologically or cytologically confirmed advanced solid tumor or relapsed or refractory Non-Hodgkin Lymphoma (including but not limited to inert and transformed type, patients with inert lymphoma must undergo systematic treatment at the time of screening), which has progressed after treatment with standard therapies or intolerant of standard therapies or have no standard of care.
- Subject must have at least one measurable lesion by RECIST 1.1 or per Cheson criteria (Lugano 2014).
- Subjects must be 18 years to 80 years of age at the time of screening.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (24 listed)
- Previous exposure to an anti-CD137 (e.g., utomilumab, urelumab) antibodies.
- Subjects must not have another active invasive malignancy within 2 years or currently.
- Subjects have received any anticancer therapy or another investigational agent within the longer of 4 weeks or 5 half-lives before the first dose of the study drug.
- Continuance of toxicities due to prior anti-tumor therapy that have not recovered to ≤ Grade 1 per CTCAE 5.0.
- Subjects who have major operations within 4 weeks before the first dose of the study drug, or minor surgery within 2 weeks prior to the first dose.
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 |
|---|---|---|
| YH004All subject will receive YH004 intravenously as single agent every three weeks (Q3W), until intolerable toxicity, disease progression, withdrawal of consent, or Investigator decision, whichever comes first. | Drug | Intervention/treatment |
Primary outcome
Adverse events (AEs)
Time frame: up to 1 year after the last dosing
The safety profile of YH004 will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0.
Maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D)
Time frame: up to 1 year after the last dosing
The MTD and/or RP2D will be determined based on the data of safety and tolerability.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Advanced Solid Tumors and Relapsed Or Refractory Non-Hodgkin Lymphoma, run by Eucure (Beijing) Biopharma Co., Ltd at 2 sites in China.
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 9 inclusion and 24 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 2 sites in China. 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?
Adverse events (AEs) (time frame: up to 1 year after the last dosing). 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.