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

NCT ID: NCT06092268

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets

Group Type: EXPERIMENTAL

SHR-A2009 for injection ； Almonertinib Mesilate Tablets

Intervention Type: DRUG

Phase IB: SHR-A2009 will be administered intravenously，Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB.

Phase II: 2 dose cohorts will be selected and it's randomization.

Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection

Group Type: EXPERIMENTAL

SHR-A2009 for injection；Adebrelimab Injection

Intervention Type: DRUG

Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB.

Phase II: RPD2 will be selected to evaluate preliminary efficacy.

Interventions

SHR-A2009 for injection ； Almonertinib Mesilate Tablets

Phase IB: SHR-A2009 will be administered intravenously，Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB.

Phase II: 2 dose cohorts will be selected and it's randomization.

Intervention Type: DRUG

SHR-A2009 for injection；Adebrelimab Injection

Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB.

Phase II: RPD2 will be selected to evaluate preliminary efficacy.

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

Fei Qiu

Role: CONTACT

fei.qiu@hengrui.com

0518-82342973

Other Identifiers

SHR-A2009-201

Identifier Type: -

Identifier Source: org_study_id