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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Not applicable
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05040932