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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05040932




Registration number
NCT05040932
Ethics application status
Date submitted
27/08/2021
Date registered
10/09/2021
Date last updated
7/09/2023

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)
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)
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/07/2023
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cabrini Health Limited - Malvern East
Recruitment hospital [2] 0 0
Westmead Hospital - Sydney
Recruitment hospital [3] 0 0
Southside Cancer Care Centre, School of Medicine, University of Wollongong - Wollongong
Recruitment postcode(s) [1] 0 0
3144 - Malvern East
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 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/ct2/show/NCT05040932
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rong Chen, Ph.D
Address 0 0
Eucure (Beijing) Biopharma Co., Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05040932