Clinical trial NCT04025957: A Study of SHR-1501 in Patients With Advanced Tumors
Official title: A Phase I Study on Tolerance, Safety and Pharmacokinetics of SHR-1501 in Patients With Advanced Malignancies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: Approximately 2 years
measure: Maximum tolerated dose
timeFrame: Approximately 2 years
measure: Adverse event/Serious adverse event
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Pharmacokinetic (PK)
timeFrame: Approximately 2 years
measure: Immune-related biomarkers
timeFrame: Approximately 2 years
measure: Immune-related biomarkers
timeFrame: Approximately 2 years
measure: Immune-related biomarkers
timeFrame: Approximately 2 years
measure: Immune-related biomarkers
timeFrame: Approximately 2 years
measure: Objective response rate
timeFrame: Approximately 2 years
measure: Disease control rate
timeFrame: Approximately 2 years
measure: Immunogenicity
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer hospital, Chinese academy of medical sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jing Huang, MD
role: STUDY_DIRECTOR
References: