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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/NCT05212922
Registration number
NCT05212922
Ethics application status
Date submitted
30/11/2021
Date registered
28/01/2022
Date last updated
20/03/2023
Titles & IDs
Public title
A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC
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Scientific title
An Open-Label, Non-Randomized, Multi-center Phase 2 Study of YH001 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) and Hepatocellular Carcinoma (HCC)
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Secondary ID [1]
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YH001004
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Universal Trial Number (UTN)
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Trial acronym
YH001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HCC
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NSCLC Stage IIIB
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NSCLC Stage IV
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - YH001 + Toripalimab
Experimental: YH001 + Toripalimab - This study will include two cohorts of up to 40 subjects each treated with RP2D dose of YH001 in combination with 240 mg Toripalimab to assess the antitumor activity and safety/tolerability.
Treatment: Drugs: YH001 + Toripalimab
YH001 + Toripalimab
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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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ORR
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Assessment method [1]
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Overall Response Rate (ORR) by investigator's assessment according to the RECIST v1.1
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Timepoint [1]
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maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
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Secondary outcome [1]
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safety and tolerability
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Assessment method [1]
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The safety and tolerability will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
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Timepoint [1]
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maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
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Secondary outcome [2]
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OS
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Assessment method [2]
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To assess other antitumor activity of YH001 in combination with Toripalimab
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Timepoint [2]
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maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
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Secondary outcome [3]
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anti-drug antibodies (ADA)
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Assessment method [3]
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Immunogenicity
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Timepoint [3]
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maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
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Secondary outcome [4]
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neutralizing antibodies (NAbs).
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Assessment method [4]
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To assess the immunogenicity of YH001 in combination with Toripalimab
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Timepoint [4]
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maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
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Secondary outcome [5]
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peak concentration (Cmax)
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Assessment method [5]
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To characterize the pharmacokinetic (PK) profiles of YH001 in combination with Toripalimab
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Timepoint [5]
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maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
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Eligibility
Key inclusion criteria
1. Male or female, aged = 18 years;
2. Willing and able to provide signed and dated informed consent prior to any
study-related procedures and willing and able to comply with all study procedures.
3. Target Population
Cohort A:
- Have histologically or cytologically confirmed diagnosis of NSCLC (squamous or
non-squamous)
- Recurrent or unresectable locally advanced (Stage IIIB) or metastatic (Stage IV);
- Naïve to any systemic anti-cancer therapy
- No EGFR mutation or ALK/ ROS1 gene rearrangement
- PD-L1 positive (TPS=1%) NSCLC
Cohort B:
- HCC diagnosis confirmed by or radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B disease not amenable
to locoregional therapy or refractory to locoregional therapy and not amenable to
a curative treatment approach;
- Child-Pugh A liver score within 7 days prior to first dose of study drug;
- Documented objective radiographic progression during or after treatment with
sorafenib/lenvatinib, or intolerant of sorafenib/lenvatinib; or documented
objective radiographic progression during or after treatment with atezolizumab
and bevacizumab, or intolerant of atezolizumab and bevacizumab.
4. At least 1 unidimensional measurable target lesion per RECIST v1.1
5. ECOG performance status score 0 or 1
6. Have life expectancy of at least 12 weeks based on investigator's judgement.
7. Adequate organ and bone marrow function:
8. Women of reproductive potential must have negative serum beta human chorionic
gonadotropin (ß -HCG) pregnancy test within 7 days of the fist dose of YH001.
9. 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 drug.
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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
1. Treatment with any investigational drug within 4 weeks prior to the fist dose of study
drug;
2. Prior anticancer therapy:
- Cohort B: Subjects received sorafenib/lenvatinib within 14 days of first dose of
study medication.
- Prior palliative radiotherapy to bone metastases = 2 weeks prior to the first
dose of YH001 is acceptable.
- It is unacceptable to have wash out less than 2 weeks for herbal therapy approved
for anticancer.
3. Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded.
4. Subjects with a history of = Grade 3 immune-related adverse events resulted from
previous immunotherapy or an AE of any grade that resulted in discontinuation of prior
immunotherapy
5. History of (non-infectious) pneumonitis that required corticosteroids or current
pneumonitis, or history of interstitial lung disease
6. Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone or
equivalent) or other immunosuppressive medications within 21 days before the planned
first dose of study drug or has need to be treated while on trial
7. Allergic to YH001 and Toripalimab or any component of the study drug formulation.
8. Subjects with concomitant active autoimmune disease, history of autoimmune disease
requiring systemic treatment, or history of autoimmune disease within the two years
prior to study entry.
9. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
10. Subjects with severe cardiovascular diseases, e.g. New York Heart Association (NYHA)
Class III or IV heart failure, myocardial infection within 6 months prior to first
dose of YH001, uncontrolled hypertension, unstable angina pectoris or unstable cardiac
arrhythmia.
11. QTcF > 470 ms at baseline; no concomitant medications that would prolong the QT
interval; no family history of long QT syndrome.
12. Viral infection:
- Acute or Chronic active Hepatitis B (HBsAg positive and HBV DNA=2000 IU/mL).
- Chronic HCV infection (HCV antibody positive and HCV RNA detectable).
- Human immunodeficiency virus (HIV) infection as well as COVID-19.
13. 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).
14. Clinically uncontrolled concurrent illnesses, including, but not limited to, active
infection that requires systematic treatment, serious diabetes (fasting blood glucose
> 250 mg/dl), psychiatric illness that would limit compliance with the study
requirements and other serious medical illnesses requiring systemic therapies.
15. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have
not recovered to = Grade 1 per CTCAE v5.0
16. Failure to recover adequately, as judged by the investigator, from prior surgical
procedures; the subjects have had major surgery within 28 days, or minor surgery
within 2 weeks prior to the first dose of YH001.
17. Subjects received any live or attenuated vaccine within 28 days prior to the first
dosing of study drug. For inactivated or attenuated COVID -19 vaccine, follow local
guidelines.
18. Pregnant or breast-feeding females.
19. Any clinically significant abnormality in the laboratory
20. Subjects have another active invasive malignancy within 5 years
21. Cohort B:
- History of esophageal or gastric variceal bleeding within the last 6 months, or
current active gastrointestinal bleeding;
- Large tumor lesion in liver (=60% liver volum), portal vein invasion at the main
portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on
imaging;
- Clinically diagnosed hepatic encephalopathy in the last 6 months
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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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
1/06/2023
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Actual
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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
1/03/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
0
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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University of New South Wales (UNSW) - Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Andrew Love Cancer Centre - Geelong
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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3220 - Geelong
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Recruitment outside Australia
Country [1]
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Armenia
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State/province [1]
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Ohio
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Country [2]
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Austria
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State/province [2]
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New South Wales
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Country [3]
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China
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State/province [3]
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Beijing
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Country [4]
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China
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State/province [4]
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Heilongjiang
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Country [5]
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China
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State/province [5]
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Henan
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Country [6]
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China
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State/province [6]
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Hubei
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Country [7]
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China
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State/province [7]
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Jiangsu
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Country [8]
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China
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State/province [8]
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Jilin
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Country [9]
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China
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State/province [9]
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Shanghai
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Country [10]
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China
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State/province [10]
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Sichuan
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Country [11]
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China
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State/province [11]
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Zhejiang
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Country [12]
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Taiwan
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State/province [12]
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Kaohsiung
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Country [13]
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Taiwan
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State/province [13]
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Taichung
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Country [14]
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Taiwan
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State/province [14]
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Tainan
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Country [15]
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Taiwan
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State/province [15]
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Taipei
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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
This is an Open-label, Non-Randomized, Multi-center Phase 2 study of YH001 in Combination
with Toripalimab,The study is designed to determine the safety ,tolerability and antitumor
activity of YH001 in combination with Toripalimab in subjects with advanced NSCLC and HCC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05212922
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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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Rong Chen, Ph.D
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Address
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Eucure (Beijing) Biopharma Co., Ltd
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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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Address
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05212922
Download to PDF