Advanced Malignant Tumors
Conditions
Brief summary
This is Phase 1 study FIH to check Dose Escalation, Dose expansion and Indication expansion. This study is AUSTRALIA only study.
Interventions
Cohort study
Sponsors
Study design
Eligibility
Inclusion 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Screening up to study completion, an average of 2 years | Number of subjects with adverse events (AEs) |
| Number of participants experiencing Dose-Limiting Toxicities (DLTs) | Up to 42 days | According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK of SHR-2002 + SHR-1316 | Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years | To check Maximum concentration (Cmax) |
| Immunogenicity of SHR-2002 + SHR-1316 | Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years | ADA of SHR-2002 + SHR-1316 |
Countries
Australia