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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
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
Secondary ID [1] 0 0
YH002004
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Outcomes
Primary outcome [1] 0 0
Determined the maximum tolerated dose (MTD)
Timepoint [1] 0 0
Up to 1 year after the last dosing
Primary outcome [2] 0 0
Determined the recommended Phase II dose (RP2D)
Timepoint [2] 0 0
Up to 1 year after the last dosing

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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
21/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/02/2025
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Orange Health Services - Orange
Recruitment hospital [2] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [3] 0 0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Recruitment hospital [4] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Henan
Country [2] 0 0
China
State/province [2] 0 0
Hubei
Country [3] 0 0
China
State/province [3] 0 0
Liaoning
Country [4] 0 0
China
State/province [4] 0 0
Shanghai
Country [5] 0 0
China
State/province [5] 0 0
Zhejiang

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, pharmacokinetics and preliminary anti-tumor activity of YH002 in combination
with YH001 in subjects with advanced solid tumors
Trial website
https://clinicaltrials.gov/ct2/show/NCT05169697
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hongming Pan
Address 0 0
Sir Run Run Shaw Hospital
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 01085950770
Fax 0 0
Email 0 0
fangxia.pan@eucure.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05169697