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

NCT ID: NCT05198817

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2023-06-30

Brief 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.

Conditions

Advanced Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Group

Group Type: EXPERIMENTAL

SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection

Intervention Type: DRUG

Firstly Dose Escalation and Dose Expansion of SHR-2002 injection monotherapy should be conducted. After RP2D and MTD of the SHR-2002 injection monotherapy were confirmed, Dose Escalation, Dose Expansion and Efficacy Expansion of SHR-2002 injection in combination with other anti-cancer treatment would be completed, including Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection.

Interventions

SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection

Firstly Dose Escalation and Dose Expansion of SHR-2002 injection monotherapy should be conducted. After RP2D and MTD of the SHR-2002 injection monotherapy were confirmed, Dose Escalation, Dose Expansion and Efficacy Expansion of SHR-2002 injection in combination with other anti-cancer treatment would be completed, including Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan Science and Technology University First Affiliated Hospital

Luoyang, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Linyi Cancer Hospital

Linyi, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

SHR-2002-I-101

Identifier Type: -

Identifier Source: org_study_id