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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/NCT05169697
Registration number
NCT05169697
Ethics application status
Date submitted
10/12/2021
Date registered
27/12/2021
Date last updated
13/09/2023
Titles & IDs
Public title
A Study to Assess YH002 in Combination With YH001 in Subjects With Advanced Solid Tumors
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Scientific title
A Multicenter, Open-label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YH002 in Combination With YH001 in Subjects With Advanced Solid Tumors
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Secondary ID [1]
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YH002004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - A:YH002+YH001
Treatment: Drugs - B:YH002+YH001
Treatment: Drugs - YH002+YH001
Experimental: YH002 in combination with YH001 - Dose escalation:A traditional 3+3 dose escalation algorithm will be utilized to identify MTD and/or RP2D Dose expansion:One selected dose after the escalation stage will be expanded to enroll additional 20 subjects. The subjects will be divided into two groups:A and B.
Treatment: Drugs: A:YH002+YH001
YH002 on CnD1,YH001 on CnD8,Q3W
Treatment: Drugs: B:YH002+YH001
YH002 and YH001 on same day,Q3W
Treatment: Drugs: YH002+YH001
A traditional 3+3 dose escalation algorithm
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Determined the maximum tolerated dose (MTD)
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Assessment method [1]
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The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
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Timepoint [1]
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Up to 1 year after the last dosing
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Primary outcome [2]
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Determined the recommended Phase II dose (RP2D)
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Assessment method [2]
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The safety profile of combination treatment will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
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Timepoint [2]
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Up to 1 year after the last dosing
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Eligibility
Key inclusion criteria
To be eligible for study entry patients must satisfy all of the following criteria:
1. Subjects must have the ability to understand and willingness to sign a written
informed consent document.
2. Subjects must have histologically advanced or cytologically confirmed solid tumor and
and must have at least 1 unidimensional measurable lesion by RECIST 1.1.
3. Subjects have progressed on after treatment with at least one standard therapy, or
intolerant of the standard therapy, or no standard therapy accessible to the patients
due to any reason.
4. Subjects must be age 18 to 80 years of age at the time of screening.
5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1.
6. Life expectancy =3 months based on investigator's judgement.
7. Subjects have adequate bone marrow and other organ function at the screening visit.
8. Women of reproductive potential must have negative serum beta human chorionic
gonadotropin (ß -HCG) pregnancy test within 7 days of the first dosing. Women of
reproductive potential are those who have not been post-menopausal for at least 12
months or who have not undergone bilateral tubal occlusion, hysterectomy, or bilateral
salpingectomy.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Subjects who meet any of the following criteria cannot be enrolled:
1. Subjects have another active invasive malignancy within 5 years.
2. Previous exposure to TNFR such as anti-OX40 antibodies.
3. Subjects must not have received any anticancer therapy or another investigational
agent within the shorter of 4 weeks or 5 half-lives before the first dose of the study
treatment(subject to the longer one).
4. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have
not recovered to = Grade 1 per CTCAE 5.0, except alopecia = Grade 2.
5. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
6. Subjects must not have a known or suspected history of an autoimmune disorder,
including but not limited to inflammatory bowel disease, celiac disease, Wegner
syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis,
or autoimmune hepatitis, within 3 years of the first dose of study treatment.
7. Clinically uncontrolled intercurrent illness, including but not limit to an ongoing
active infection, active coagulopathy, uncontrolled diabetes (blood glucose > 250
mg/dl), uncontrolled pleural and peritoneal effusion, psychiatric illness that would
limit compliance with the study requirements and other serious medical illnesses
requiring systemic therapies
8. Subjects must not have active infection of human immunodeficiency virus, hepatitis B,
hepatitis C or Covid-19.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/02/2025
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Actual
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Sample size
Target
44
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Orange Health Services - Orange
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Recruitment hospital [2]
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Macquarie University Hospital - Sydney
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Recruitment hospital [3]
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Peninsula and South Eastern Haematology & Oncology Group - Frankston
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Recruitment hospital [4]
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Cabrini Hospital Malvern - Malvern
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Recruitment postcode(s) [1]
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2800 - Orange
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Recruitment postcode(s) [2]
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2109 - Sydney
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Recruitment postcode(s) [3]
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3199 - Frankston
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Recruitment postcode(s) [4]
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3144 - Malvern
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Henan
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Country [2]
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China
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State/province [2]
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Hubei
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Country [3]
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China
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State/province [3]
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Liaoning
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Country [4]
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China
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State/province [4]
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Shanghai
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Country [5]
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China
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State/province [5]
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Zhejiang
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eucure (Beijing) Biopharma Co., Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A multicenter, open-label, phase I dose escalation study to evaluate the safety,
tolerability, pharmacokinetics and preliminary anti-tumor activity of YH002 in combination
with YH001 in subjects with advanced solid tumors
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05169697
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Hongming Pan
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Address
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Sir Run Run Shaw Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Fangxia Pan
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Address
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Country
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Phone
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+86 01085950770
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05169697
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