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

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Criteria

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.