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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atridia Pty Ltd.

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;