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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-A2009 for injection；Adebrelimab Injection; Drug: SHR-A2009 for injection ； Almonertinib Mesilate Tablets

• Registration Number: NCT06092268
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection	SHR-A2009 for injection；Adebrelimab Injection	-
Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets	SHR-A2009 for injection ； Almonertinib Mesilate Tablets	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) (phase II).	2 years
Incidence of dose-limiting toxicity (DLT) (phase IB)	21 days after the first dose was administered to each subject.

Secondary Outcome Measures

Name	Time	Method
PK parameter: toxin-binding antibody of SHR-A2009	through study completion, an average of 2 years
PK parameter: free toxin of SHR-A2009	through study completion, an average of 2 years
Plasma concentration of Adebrelimab	through study completion, an average of 2 years
Duration of response(DoR )	One year after the last subject was enrolled in the group
Progression Free Survival(PFS)	2 years after the last subject was enrolled in the group
Objective response rate	2 years after the last subject was enrolled in the group
overall survival (OS) (phase IB)	3 years after the last subject was enrolled in the group
Incidence of AEs（Phase II (efficacy expansion phase)）	from Day1 to 90 days after last dose
Incidence of SAEs（Phase II (efficacy expansion phase)）	from Day1 to 90 days after last dose
PK parameter: total antibody of SHR-A2009	through study completion, an average of 2 years
Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)	through study completion, an average of 2 years