A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection in Combination With SHR-1316 in Patients With Advanced Malignant Tumors

SHR-2002-102

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

2021-11-23

2025-07-01

2025-09-01

Active (not recruiting)

Early phase I

50

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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-02-28