Phase I Study of SHR-2022 Injection in the Treatment of Patients With Advanced Malignant Tumors

NCT ID: NCT06131216

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2026-12-31

Brief Summary

To evaluate the safety and tolerability of SHR-2022 in patients with advanced malignancies and to determine MTD or MAD versus RP2D

Conditions

Advanced Malignant Cancer

Study Design

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

Study Groups

SHR-2022 Injection

Group Type: EXPERIMENTAL

SHR-2022 Injection

Intervention Type: DRUG

SHR-2022 Injection is administered by intravenous (IV) infusion

Interventions

SHR-2022 Injection

SHR-2022 Injection is administered by intravenous (IV) infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up

2. Age 18-80 years old (including both ends), both male and female

3. Subjects with advanced or metastatic malignant tumors confirmed by pathological tissue or cytology, and who have failed previous standard treatments, are intolerant to standard treatments, or have no standard treatments

4. Have measurable lesions

5. ECOG PS score: 0-1

6. Have a life expectancy of at least 3 months

7. The functional level of the major organs must meet the requirements

8. Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating

Exclusion Criteria

1. Central nervous system metastasis or meningeal metastasis with clinical symptoms

2. Spinal cord compression that has not been treated radically by surgery and/or radiotherapy

3. Patients with uncontrolled tumor-related pain as judged by the investigator

4. A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator

5. Systemic antitumor therapy was administered within 28 days prior to treatment in the first study

6. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period

7. Received within 28 days prior to the first investigational dose Non-radical chest radiation therapy of 30Gy received within 24 weeks prior to initial dosing. Patients receiving 30Gy of chest radiation therapy, and those receiving palliative radiation ≤30Gy within 14 days prior to the first dose

8. The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤1

9. Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment

10. Systemic immunosuppressive therapy was administered within 14 days prior to the first study

11. Accompanied by interstitial pneumonia or interstitial lung disease

12. Patients with a history of autoimmune disease

13. The first study studied patients with clinically significant bleeding symptoms or bleeding tendency within 3 months before medication

14. The first study was conducted in subjects with severe cardiovascular and cerebrovascular disease within 6 months prior to medication

15. Arterial/venous thrombosis events occurred within 3 months prior to initial administration

16. The first study studied any other malignancy within 5 years prior to medication

17. A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients

18. Have a history of immune deficiency or organ transplantation, and have active hepatitis B or C

19. Severe infection within 4 weeks prior to the first dose

20. Patients with active pulmonary tuberculosis within 1 year prior to enrollment were found by history or CT examination

21. The presence of other serious physical or mental illness, known alcohol or drug dependence, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yanbo Liu

Role: CONTACT

yanbo.liu@hengrui.com

0518-82342973

Zhenqun Lu

Role: CONTACT

zhenqun.lu@hengrui.com

0518-82342973

Other Identifiers

SHR-2022-I-101

Identifier Type: -

Identifier Source: org_study_id