A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Age 18 to 75 years old (inclusive), Female or male

2. Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology

3. Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;

4. At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)

5. ECOG performance score of 0-1;

6. Expected survival time ≥ 12 weeks;

7. Adequate bone marrow and organ function

8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Subjects with active central nervous system (CNS) metastases.

2. Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.

3. Subjects with uncontrolled tumor-related pain

4. Clinically uncontrollable third space fluid

5. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;

6. Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;

7. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;

8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;

9. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function

10. Serious cardiovascular disease

11. Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases

12. Presence of severe infection within 4 weeks prior to first dose of study drug

13. Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug

14. Arterial/venous thrombotic events within 3 months prior to the first study dose

15. History of immunodeficiency, including a positive HIV test

16. Presence of active hepatitis B or C;

17. History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.

18. Known history of alcohol or drug dependence or addiction;

19. Persons with mental disorders or poor compliance;