A Study of SHR-1501 in Patients With Advanced Tumors

NCT ID: NCT04025957

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2022-07-31

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in patients with advanced malignancies .

Conditions

Advanced Malignancies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1501 dose escalation

SHR-1501 given subcutaneously

Group Type: EXPERIMENTAL

SHR-1501

Intervention Type: DRUG

Administered subcutaneously

SHR-1501 dose expansion

SHR-1501 given subcutaneously

Group Type: EXPERIMENTAL

SHR-1501

Intervention Type: DRUG

Administered subcutaneously

Interventions

SHR-1501

Administered subcutaneously

Intervention Type: DRUG

Eligibility Criteria

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 18-70 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. Eastern Cooperative Oncology Group ECOG PS score of 0-1;

7. Have a life expectancy of ≥ 12 weeks;

8. Adequate organ function defined according to the protocol, These results should be completed within 14 days prior to the first study treatment:

9. 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.

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 primary cancers;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Huang, MD

Role: STUDY_DIRECTOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer hospital, Chinese academy of medical sciences

Beijing, , China

Countries

China

Other Identifiers

SHR-1501-I-102

Identifier Type: -

Identifier Source: org_study_id