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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03995472




Registration number
NCT03995472
Ethics application status
Date submitted
9/05/2019
Date registered
24/06/2019
Date last updated
28/09/2023

Titles & IDs
Public title
A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors
Scientific title
A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of SHR-1501 in Combination With SHR-1316 in Patients With Advanced Malignancies
Secondary ID [1] 0 0
SHR-1501-I-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-1501
Treatment: Drugs - SHR-1316

Experimental: SHR-1501 and SHR-1316 dose escalation - SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously.

Experimental: SHR-1501 and SHR-1316 dose expansion - SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously.

Experimental: SHR-1501 and SHR-1316 Indication expansion - SHR-1501 given subcutaneously with a recommended dose. SHR-1316 given intravenously.


Treatment: Drugs: SHR-1501
Administered subcutaneously

Treatment: Drugs: SHR-1316
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting toxicity and Maximum tolerated dose
Timepoint [1] 0 0
Approximately 42 Days.
Primary outcome [2] 0 0
Recommended Phase 2 dose (RP2D)
Timepoint [2] 0 0
Approximately 2 years
Primary outcome [3] 0 0
Adverse event/Serious adverse event
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Pharmacokinetic (PK)
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Pharmacokinetic (PK)
Timepoint [2] 0 0
Approximately 2 years
Secondary outcome [3] 0 0
Pharmacokinetic (PK)
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Pharmacokinetic (PK)
Timepoint [4] 0 0
Approximately 2 years
Secondary outcome [5] 0 0
Pharmacokinetic (PK)
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [6] 0 0
Pharmacokinetic (PK)
Timepoint [6] 0 0
Approximately 2 years
Secondary outcome [7] 0 0
Pharmacokinetic (PK)
Timepoint [7] 0 0
Approximately 2 years
Secondary outcome [8] 0 0
Pharmacokinetic (PK)
Timepoint [8] 0 0
Approximately 2 years
Secondary outcome [9] 0 0
Pharmacokinetic (PK)
Timepoint [9] 0 0
Approximately 2 years
Secondary outcome [10] 0 0
Pharmacokinetic (PK)
Timepoint [10] 0 0
Approximately 2 years
Secondary outcome [11] 0 0
Pharmacokinetic (PK)
Timepoint [11] 0 0
Approximately 2 years
Secondary outcome [12] 0 0
Pharmacokinetic (PK)
Timepoint [12] 0 0
Approximately 2 years
Secondary outcome [13] 0 0
Pharmacokinetic (PK)
Timepoint [13] 0 0
Approximately 2 years
Secondary outcome [14] 0 0
Pharmacokinetic (PK)
Timepoint [14] 0 0
Approximately 2 years
Secondary outcome [15] 0 0
Immune related features
Timepoint [15] 0 0
Approximately 2 years
Secondary outcome [16] 0 0
Immune related features
Timepoint [16] 0 0
Approximately 2 years
Secondary outcome [17] 0 0
Immune related features
Timepoint [17] 0 0
Approximately 2 years
Secondary outcome [18] 0 0
Immune related features
Timepoint [18] 0 0
Approximately 2 years
Secondary outcome [19] 0 0
Objective response rate
Timepoint [19] 0 0
Approximately 2 years
Secondary outcome [20] 0 0
Disease control rate
Timepoint [20] 0 0
Approximately 2 years
Secondary outcome [21] 0 0
Duration of response
Timepoint [21] 0 0
Approximately 2 years
Secondary outcome [22] 0 0
progression-free survival
Timepoint [22] 0 0
Approximately 2 years
Secondary outcome [23] 0 0
12 months overall survival
Timepoint [23] 0 0
Approximately 2 years
Secondary outcome [24] 0 0
Durable clinical benefit rate at 6 month
Timepoint [24] 0 0
Approximately 2 years
Secondary outcome [25] 0 0
Immunogenicity
Timepoint [25] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
• All Patients All patients must meet all the following criteria to be eligible to participate:

1. Voluntarily participate in this clinical study, understand the research procedure and be able to sign informed consent in writing;
2. Subjects must be willing and able to follow the research protocol;
3. Aged 18-75 years old when the informed consent form is signed;
4. Have a histologically or cytologically confirmed diagnosis of advanced or metastatic tumor malignancy;
5. Patients' malignancies must be relapsed or refractory to standard treatment, or patients cannot tolerate standard treatment, or patients have actively refused standard therapy;
6. FFPE tumor tissue or unstained slides of tumor sample must be obtained from patients enrolled in the dose expansion or indication expansion stage, both preserved samples collected within 6 months before the first dose (or up to 12 months prior to the first dose) and fresh samples (preferred) are acceptable;
7. Eastern Cooperative Oncology Group ECOG PS score of 0-1;
8. Have a life expectancy of = 12 weeks;
9. Adequate organ function defined according to the protocol, These results should be completed within 14 days prior to the first study treatment:
10. Non-surgically sterilized women of childbearing age or male subjects are required to consent to the use of at least one medically approved contraceptive (eg intrauterine devices, contraceptives or condoms) is performed during the study treatment period and within 3 months of the end of the study treatment period.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with cancerous meningitis (ie meningeal metastasis);
2. Patients with active central nervous system (CNS) metastasis.
3. Spinal cord compression that cannot be radically treated with surgery and/or radiotherapy cannot be enrolled.
4. Patients with double cancer or more serious cancer;
5. Patients with a history of autoimmune diseases;
6. Significant clinical significance in the history of cardiovascular disease;
7. Arterial/venous thrombosis events such as cerebrovascular accidents deep vein thrombosis and pulmonary embolism within 6 months prior to first administration;
8. Have a history of immunodeficiency including HIV infection;
9. Active hepatitis B or hepatitis C patients;
10. Any disease or symptom that is not appropriate for inclusion in this study determined by the investigator.;
11. Patients have undergone major surgery within 28 days prior to the first dose (except for diagnostics);
12. Those who used a live attenuated vaccine within 4 weeks prior to the first dose or expect a live attenuated vaccine during the study period;
13. Those who received other clinical trials within 4 weeks prior to the first study;
14. Those who received systemic immunosuppressive therapy within 2 weeks prior to the first study dose;
15. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
16. A history of severe allergic reactions to other monoclonal antibody/fusion protein drugs;
17. Mental illness, alcohol abuse, drug abuse or substance abuse;
18. Any disease or condition that causes reasonable suspicion to prohibit the use of the study drug or affect the interpretation of the study results or the patient is at high risk of treatment complications (any other disease, metabolic disorder, physical examination results or laboratory tests abnormalities);
19. Pregnant or lactating women or women planning to become pregnant during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/01/2023
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Sydney Southwest Private Hospital - Liverpool
Recruitment hospital [2] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [3] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [4] 0 0
John Flynn Private Hospital - Tugun
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4224 - Tugun
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Guangdong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jiangsu HengRui Medicine Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in combination with SHR-1316 in patients with advanced malignancies and to provide a recommended dose (RP2D) for subsequent clinical studies.
Trial website
https://clinicaltrials.gov/study/NCT03995472
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yilong Wu, MD
Address 0 0
Guangdong General Hospital & Guangdong Academy of Medical Sciences
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03995472