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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05040932




Registration number
NCT05040932
Ethics application status
Date submitted
27/08/2021
Date registered
10/09/2021
Date last updated
10/09/2021

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
YH004002
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Name
Eucure (Beijing) Biopharma Co., Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/show/NCT05040932
Trial related presentations / publications
Public notes

Contacts
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
ryan.wen@eucure.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05040932