A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients

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

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients. To explore the reasonable dosage of SHR-2002 injection monotherapy and dosage regimen of combination therapy for advanced malignant tumors of patients.

Inclusion Criteria:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
3. Histopathologically or cytologically documented advanced or metastatic malignancies;
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Life expectancy ≥12 weeks;
6. Adequate organ functions as defined;
7. 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; Female of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding.

Exclusion Criteria:

1. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
2. Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
3. Patients with tumor-related pain that cannot be controlled as determined by the investigator;
4. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
5. Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
6. Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment;
7. Patients who have received >30 Gy of radical radiotherapy within 28 days before the first dose of study treatment;
8. Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy;
9. Use of live attenuated vaccines within 28 days before the first dose of the study treatment;
10. Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment;
11. Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
12. History of autoimmune diseases;
13. History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment;
14. History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment;
15. Evidence or history of arterial/venous thrombosis within 3 months before the first dose;
16. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
17. Known history of serious allergic reactions to the investigational product or its main ingredients;
18. History of immunodeficiency;
19. Presence of active hepatitis B or active hepatitis C;
20. Severe infections within 4 weeks prior to the first study treatment;
21. Evidence or history of active pulmonary tuberculosis within 1 year before study entry;
22. any other conditions that are not suitable for participation in the study in the investigator's opinion.