A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors

  • End date
    Jun 24, 2023
  • participants needed
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 24 January 2021


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.

Condition Advanced Malignancies
Treatment SHR-1316, SHR-1501
Clinical Study IdentifierNCT03995472
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on24 January 2021


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Inclusion Criteria

All Patients All patients must meet all the following criteria to be eligible
Voluntarily participate in this clinical study, understand the research procedure and be able to sign informed consent in writing
Subjects must be willing and able to follow the research protocol
Aged 18-75 years old when the informed consent form is signed
Have a histologically or cytologically confirmed diagnosis of advanced or metastatic tumor malignancy
Patients' malignancies must be relapsed or refractory to standard treatment, or patients cannot tolerate standard treatment, or patients have actively refused standard therapy
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
Eastern Cooperative Oncology Group ECOG PS score of 0-1
Have a life expectancy of 12 weeks
Adequate organ function defined according to the protocol, These results should be completed within 14 days prior to the first study treatment
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

Patients with cancerous meningitis (ie meningeal metastasis)
Patients with active central nervous system (CNS) metastasis
Spinal cord compression that cannot be radically treated with surgery and/or radiotherapy cannot be enrolled
Patients with double cancer or more serious cancer
Patients with a history of autoimmune diseases
Significant clinical significance in the history of cardiovascular disease
Arterial/venous thrombosis events such as cerebrovascular accidents deep vein thrombosis and pulmonary embolism within 6 months prior to first administration
Have a history of immunodeficiency including HIV infection
Active hepatitis B or hepatitis C patients
Any disease or symptom that is not appropriate for inclusion in this study determined by the investigator
Patients have undergone major surgery within 28 days prior to the first dose (except for diagnostics)
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
Those who received other clinical trials within 4 weeks prior to the first study
Those who received systemic immunosuppressive therapy within 2 weeks prior to the first study dose
Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
A history of severe allergic reactions to other monoclonal antibody/fusion protein drugs
Mental illness, alcohol abuse, drug abuse or substance abuse
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)
Pregnant or lactating women or women planning to become pregnant during the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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