> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ib-ii-clinical-study-of-shr-a2009-for-injection-in-e73dd6ec-6f77-4658-a954-6f0f76131427 > Record changed: 2026-11-04 # A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors NCT06092268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) Participants 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) Lead sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) Start date 2023-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Short title** A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Dates **Completion date** 2025-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **First posted** 2023-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Registry last updated** 2023-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Primary completion date** 2025-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Start date** 2023-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Size and sites **Participants** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Planned participants** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Lead sponsor** Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Identifiers **Registry ID** NCT06092268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **ClinicalTrials.gov ID** NCT06092268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Outcomes ### Primary outcomes 1. Incidence of dose-limiting toxicity (DLT) (phase IB) Timeframe: 21 days after the first dose was administered to each subject. 2. Objective Response Rate (ORR) (phase II). Timeframe: 2 years ### Secondary outcomes 1. PK parameter: toxin-binding antibody of SHR-A2009 Timeframe: through study completion, an average of 2 years 2. PK parameter: total antibody of SHR-A2009 Timeframe: through study completion, an average of 2 years 3. PK parameter: free toxin of SHR-A2009 Timeframe: through study completion, an average of 2 years 4. Plasma concentration of Adebrelimab Timeframe: through study completion, an average of 2 years 5. Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB) Timeframe: through study completion, an average of 2 years 6. Duration of response(DoR ) Timeframe: One year after the last subject was enrolled in the group 7. Progression Free Survival(PFS) Timeframe: 2 years after the last subject was enrolled in the group 8. Objective response rate Timeframe: 2 years after the last subject was enrolled in the group 9. overall survival (OS) (phase IB) Timeframe: 3 years after the last subject was enrolled in the group 10. Incidence of AEs（Phase II (efficacy expansion phase)） Timeframe: from Day1 to 90 days after last dose 11. Incidence of SAEs（Phase II (efficacy expansion phase)） Timeframe: from Day1 to 90 days after last dose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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; Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06092268) ## Related records ### Drugs (2) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.md) - [Aumolertinib](https://trialight.com/data/asset/aumolertinib-1339ec2f-ba43-4359-aaa7-6a9516518faa.md) ### Lead sponsors (1) - [Suzhou Suncadia Biopharmaceuticals Co., Ltd.](https://trialight.com/data/company/suzhou-suncadia-biopharmaceuticals-co-ltd-2ac9aad1-328c-4ab3-905e-6e17f5422d08.md) ### Targets (2) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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