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

Study Overview
=================
Brief Summary
-----------------
This is Phase 1 study FIH to check Dose Escalation, Dose expansion and Indication expansion. This study is AUSTRALIA only study.

Official Title
-----------------
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

Conditions
-----------------
Advanced Malignant Tumors

Intervention / Treatment
-----------------
* Drug: SHR-2002 and SHR-1316


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects must meet all the following criteria to be eligible for enrollment into the study: 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation:SHR-2002+SHR-1316<br>SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316 | Drug: SHR-2002 and SHR-1316<br>* Cohort study<br>|
| Experimental: Dose expansion stage: SHR-2002+SHR-1316<br>Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part. | Drug: SHR-2002 and SHR-1316<br>* Cohort study<br>|
| Experimental: Indication expansion stage：SHR-2002+SHR-1316<br>Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part. | Drug: SHR-2002 and SHR-1316<br>* Cohort study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of subjects with adverse events (AEs) | Screening up to study completion, an average of 2 years | 
| Number of participants experiencing Dose-Limiting Toxicities (DLTs) | According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) | Up to 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of SHR-2002 + SHR-1316 | To check Maximum concentration (Cmax) | Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years | 
| PK of SHR-2002 + SHR-1316 | To check AUC last | Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years | 
| Immunogenicity of SHR-2002 + SHR-1316 | ADA of SHR-2002 + SHR-1316 | Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years |