> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-shr-1826-for-injection-in-combination-with-other-184181f1-f673-4c75-bcb8-069c6f3428c4 > Record changed: 2026-10-13 # A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors NCT06703177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) Participants 876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) Lead sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) Start date 2025-02-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Title and summary **Summary** This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Short title** A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Official title** Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Dates **Completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **First posted** 2024-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Registry last updated** 2025-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Primary completion date** 2026-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Start date** 2025-02-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Size and sites **Participants** 876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Planned participants** 876 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Lead sponsor** Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Identifiers **Registry ID** NCT06703177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **ClinicalTrials.gov ID** NCT06703177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Outcomes ### Primary outcomes 1. RP2D (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 2. AE (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 3. Objective response rate (ORR) (Phase 2) Timeframe: Screening up to study completion, an average of 1 year. ### Secondary outcomes 1. Objective response rate (ORR) (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 2. Disease control rate (DCR) (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 3. Duration of response (DoR) (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 4. Progression-free survival (PFS) (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 5. Overall survival (OS) (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 6. Drug Resistant Antibody (ADA) (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 7. Blood concentration of SHR-1826 (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 8. Blood concentration of free toxin SHR169265 (Phase 1) Timeframe: Screening up to study completion, an average of 1 year. 9. Disease control rate (DCR) (Phase 2) Timeframe: Screening up to study completion, an average of 1 year. 10. Duration of response (DoR) (Phase 2) Timeframe: Screening up to study completion, an average of 1 year. 11. Progression-free survival (PFS) (Phase 2) Timeframe: Screening up to study completion, an average of 1 year. 12. Overall survival (OS) (Phase 2) Timeframe: Screening up to study completion, an average of 1 year. 13. AE (Phase 2) Timeframe: Screening up to study completion, an average of 1 year. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Voluntary participation and written informed consent; 2. 18-75 years older, no gender limitation; 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1; 4. With a life expectancy ≥ 3 months; 5. Pathologically diagnosed advanced solid tumor; 6. Be able to provide fresh or archived tumour tissue; 7. At least one measurable lesion according to RECIST v1.1; 8. Adequate bone marrow reserve and organ function; 9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose. ### Exclusion criteria 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis; 2. Previous or co-existing malignancies; 3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded; 4. Uncontrollable tumor-related pain; 5. Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody; 6. Received systemic antitumor therapy before the first dose; 7. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; 8. For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment; 9. Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment; 10. Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy; 11. A history of interstitial pneumonia/non-infectious pneumonia; 12. Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms; 13. Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing; 14. With poorly controlled or severe cardiovascular disease; 15. Active hepatitis B, hepatitis C; 16. Patients with a history of immunodeficiency; 17. Severe infection 30 days before the first dose. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Sites - Sun Yat-Sen university cancer centerGuangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703177) ## Related records ### Drugs (6) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.md) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Levoleucovorin calcium](https://trialight.com/data/asset/levoleucovorin-calcium-21e918a4-89ff-4c55-aafc-3b4fd0086bc6.md) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.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 (5) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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