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Trial details imported from ClinicalTrials.gov
Ethics application status
Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy
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
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Treatment: Drugs - YH004
Experimental: YH004 - 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.
Treatment: Drugs: YH004
IV infusion once every 3 weeks (Q3W).
Intervention code 
Comparator / control treatment
Primary outcome 
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
Primary outcome 
Maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) - The MTD and/or RP2D will be determined based on TEAEs
Key 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
- Women of reproductive potential must have negative serum beta human chorionic
gonadotropin (ß -HCG) pregnancy test within 7 days of the first dose.
Both males and females
Can healthy volunteers participate?
Key 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
- 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
- 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.
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
Statistical methods / analysis
Not yet recruiting
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Southside Cancer Care Centre, School of Medicine, University of Wollongong - Wollongong
Recruitment postcode(s) 
Primary sponsor type
Eucure (Beijing) Biopharma Co., Ltd
Ethics application status
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.
Trial related presentations / publications