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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05212922




Registration number
NCT05212922
Ethics application status
Date submitted
30/11/2021
Date registered
28/01/2022

Titles & IDs
Public title
A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC
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)
Secondary ID [1] 0 0
YH001004
Universal Trial Number (UTN)
Trial acronym
YH001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HCC 0 0
NSCLC Stage IIIB 0 0
NSCLC Stage IV 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ORR
Timepoint [1] 0 0
maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
Secondary outcome [1] 0 0
safety and tolerability
Timepoint [1] 0 0
maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
Secondary outcome [2] 0 0
OS
Timepoint [2] 0 0
maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
Secondary outcome [3] 0 0
anti-drug antibodies (ADA)
Timepoint [3] 0 0
maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
Secondary outcome [4] 0 0
neutralizing antibodies (NAbs).
Timepoint [4] 0 0
maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.
Secondary outcome [5] 0 0
peak concentration (Cmax)
Timepoint [5] 0 0
maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Andrew Love Cancer Centre - Geelong
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
Armenia
State/province [1] 0 0
Ohio
Country [2] 0 0
Austria
State/province [2] 0 0
New South Wales
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
China
State/province [4] 0 0
Heilongjiang
Country [5] 0 0
China
State/province [5] 0 0
Henan
Country [6] 0 0
China
State/province [6] 0 0
Hubei
Country [7] 0 0
China
State/province [7] 0 0
Jiangsu
Country [8] 0 0
China
State/province [8] 0 0
Jilin
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
China
State/province [10] 0 0
Sichuan
Country [11] 0 0
China
State/province [11] 0 0
Zhejiang
Country [12] 0 0
Taiwan
State/province [12] 0 0
Kaohsiung
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taichung
Country [14] 0 0
Taiwan
State/province [14] 0 0
Tainan
Country [15] 0 0
Taiwan
State/province [15] 0 0
Taipei

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05212922