For Healthcare Professionals

Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors

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About the study

This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

EXCLUSION CRITERIA

  • Subjects must meet all the following criteria to be eligible for enrollment into the study:
    1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
    2. Male or female aged ≥18 years at the time of signing the ICF;
    3. Histopathologically or cytologically documented advanced or metastatic malignancies and failed or intolerable to previous standard therapy, has no available standard of care therapy or refused standard therapy;
    4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 (Appendix 2);
    5. Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration.

    Subjects who meet any of the following criteria will be excluded from the study:

    1. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
    2. Patients with tumor-related pain that cannot be controlled as determined by the investigator.
    3. Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment
    4. History of autoimmune diseases, except for Type 1 diabetes (blood glucose can be controlled by insulin therapy)
    5. History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment.
    6. Known history of serious allergic reactions to the investigational product or its main ingredients;
    7. History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition

    Advanced Malignant Tumors

    Age (in years)

    18+

    Phase

    Phase 1

    Participants needed

    50

    Est. Completion Date

    Sep 30, 2025

    Treatment type

    Interventional


    Sponsor

    Atridia Pty Ltd.

    ClinicalTrials.gov identifier

    NCT05082545

    Study number

    SHR-2002-102

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