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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05176509




Registration number
NCT05176509
Ethics application status
Date submitted
15/12/2021
Date registered
4/01/2022
Date last updated
7/09/2023

Titles & IDs
Public title
A Study to Evaluate the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors
Scientific title
A Multicenter, Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Combination of YH003, YH001 and Pembrolizumab in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
YH003005
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YH003
Treatment: Drugs - YH001
Treatment: Drugs - Pembrolizumab

Experimental: Intervention/treatment -


Treatment: Drugs: YH003
YH003 will be administered intravenously over 60 minutes every 21-day cycle.

Treatment: Drugs: YH001
YH001 will be administered intravenously over 60 minutes every 21-day cycle.

Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered intravenously over 30 minutes every 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events (AEs)
Timepoint [1] 0 0
up to 1 year after the last dosing
Primary outcome [2] 0 0
Maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D)
Timepoint [2] 0 0
up to 1 year after the last dosing

Eligibility
Key inclusion 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.
* 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. Subject must have at least 1 unidimensional measurable disease by RECIST 1.1(Eisenhauer et al., 2009).
* 5. Subjects must be age 18 years or older.
* 6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 7. Life expectancy =3 months based on investigator's judgement.
* 8. Subjects must meet the following laboratory values at the screening
* 9. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (ß -HCG) pregnancy test within 7 days of the first dose of study drugs.
* 10. Women of reproductive potential who are sexually active with a non-sterilized male must consistently use highly effective contraception/birth control between signing of the informed consent and 120 days after the last administration of the study drugs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 1. Subjects have another active invasive malignancy within 5 years
* 2. Subjects must not have received any anticancer therapy or another investigational agent within the longer of 4 weeks or 5 half-lives before the first dose of the study treatment
* 3. Subjects with a history of = Grade 3 immune-related adverse events resulted from previous immunotherapy.
* 4. History of clinically significant sensitivity or allergy to monoclonal antibodies and their excipients or known allergies to antibodies produced from Chinese hamster ovary cells, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to YH003, YH001 or Pembrolizumab.
* 5. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
* 6. History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease.
* 7. Subjects must not have a known or suspected history of an autoimmune disorder
* 8. Clinically uncontrolled intercurrent illness, including active coagulopathy, uncontrolled diabetes, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.
* 9. Has an active infection requiring systemic therapy.
* 10. Severe cardiovascular disease including symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, active coagulopathy, uncontrolled diabetes (blood glucose > 250 mg/dl), uncontrolled peritoneal effusion, cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of arterial thromboembolic event and pulmonary embolism within 3 months of the first dose of investigational agent.
* 11. QTcF> 480 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome.
* 12. Subjects must not have active infection of human immunodeficiency virus (HIV), hepatitis B, hepatitis C or Covid-19.
* 13. Subjects must not have a history of primary immunodeficiency.
* 14. Subjects from endemic area will be specifically screened for tuberculosis. Subjects with active tuberculosis are excluded. Subjects who have received BCG vaccination may have a false positive PPD test. These subjects are eligible if they have a negative Interferon Gamma Release Assay (IGRA).
* 15. Subjects must not receive concurrent or prior use of an immunosuppressive agent within 4 weeks of the first dose
* 16. Major surgery within 4 weeks prior to study entry and Minor surgery within 2 weeks prior to the first dose.
* 17. Subjects must not have received any vaccine within 28 days before the first dose, and subjects, if enrolled, should not receive live vaccines during the study or for 180 days after the last dose.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre, Clinical Trials, Block C, Level 3, 18 Blacktown Road - Blacktown
Recruitment hospital [2] 0 0
"Oncology Clinical Trial Unit St George Private Hospital 1 South Street" - Kogarah
Recruitment hospital [3] 0 0
55 Commercial Rd, Level 2 WBRC - Melbourne
Recruitment hospital [4] 0 0
Level 3, Suite 7, North Building, Frankston Private, 5 Susono Way, Frankston - Prahran
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Prahran

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eucure (Beijing) Biopharma Co., Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Multicenter, Open-Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Combination of YH003, YH001 and Pembrolizumab in Subjects with Advanced Solid Tumors
Trial website
https://clinicaltrials.gov/study/NCT05176509
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
Fangxia Pan
Address 0 0
Country 0 0
Phone 0 0
86 010 85950770-8000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05176509