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

Advanced Solid Tumors Clinical Trial

Official title:

A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06092268
• Other study ID #: SHR-A2009-201
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Fei Qiu
• Phone: 0518-82342973
• Email: fei.qiu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity (DLT) (phase IB)		21 days after the first dose was administered to each subject.
Primary	Objective Response Rate (ORR) (phase II).		2 years
Secondary	PK parameter: toxin-binding antibody of SHR-A2009		through study completion, an average of 2 years
Secondary	PK parameter: total antibody of SHR-A2009		through study completion, an average of 2 years
Secondary	PK parameter: free toxin of SHR-A2009		through study completion, an average of 2 years
Secondary	Plasma concentration of Adebrelimab		through study completion, an average of 2 years
Secondary	Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)		through study completion, an average of 2 years
Secondary	Duration of response(DoR )		One year after the last subject was enrolled in the group
Secondary	Progression Free Survival(PFS)		2 years after the last subject was enrolled in the group
Secondary	Objective response rate		2 years after the last subject was enrolled in the group
Secondary	overall survival (OS) (phase IB)		3 years after the last subject was enrolled in the group
Secondary	Incidence of AEs(Phase II (efficacy expansion phase))		from Day1 to 90 days after last dose
Secondary	Incidence of SAEs(Phase II (efficacy expansion phase))		from Day1 to 90 days after last dose