Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors
About the study
This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
EXCLUSION CRITERIA
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Male or female aged ≥18 years at the time of signing the ICF;
- 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;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 (Appendix 2);
- 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:
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Patients with tumor-related pain that cannot be controlled as determined by the investigator.
- Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment
- History of autoimmune diseases, except for Type 1 diabetes (blood glucose can be controlled by insulin therapy)
- History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment.
- Known history of serious allergic reactions to the investigational product or its main ingredients;
- History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
Study Locations
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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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