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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy
Scientific 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
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Study type
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 [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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
Timepoint [1] 0 0
up to 24 months
Primary outcome [2] 0 0
Maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) - The MTD and/or RP2D will be determined based on TEAEs
Timepoint [2] 0 0
up to 24 months

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
contraceptive methods.

- Women of reproductive potential must have negative serum beta human chorionic
gonadotropin (ß -HCG) pregnancy test within 7 days of the first dose.
Minimum age
18 Years
Maximum age
80 Years
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.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Southside Cancer Care Centre, School of Medicine, University of Wollongong - Wollongong
Recruitment postcode(s) [1] 0 0
2217 - Wollongong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Eucure (Beijing) Biopharma Co., Ltd

Ethics approval
Ethics application status

Brief 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 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 website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ryan Wen
Address 0 0
Country 0 0
Phone 0 0
+86 010 85950770
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see