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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: SHR-A2009 for injection ； Almonertinib Mesilate Tablets; Drug: SHR-A2009 for injection；Adebrelimab Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06092268

SHR-A2009-201

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

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

Experimental group

Treatment:

Drug: SHR-A2009 for injection ； Almonertinib Mesilate Tablets

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

Experimental group

Treatment:

Drug: SHR-A2009 for injection；Adebrelimab Injection