> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/ph1b-2-study-of-the-safety-and-efficacy-of-shr-a1811-cc3e7dfc-8a3e-49d8-a55c-c33c31635d1e > Record changed: 2026-11-04 # Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer NCT05671822 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) Participants 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) Lead sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) Start date 2023-03-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Title and summary **Summary** This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients. The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Short title** Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Official title** A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **First posted** 2023-01-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Registry last updated** 2026-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Start date** 2023-03-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Size and sites **Participants** 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Planned participants** 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Lead sponsor** Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Identifiers **Registry ID** NCT05671822 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **ClinicalTrials.gov ID** NCT05671822 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Outcomes ### Primary outcomes 1. Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs) Timeframe: Safety will be assessed for approximately 24 months from informed consent 2. Phase II: Objective Response Rate (ORR)\[ Timeframe: An average of approximately 12 months ### Secondary outcomes 1. ORR（Phase Ib） Timeframe: An average of approximately 12 months 2. DoR（Phase Ib） Timeframe: An average of approximately 18 months 3. PFS（Phase Ib） Timeframe: An average of approximately 18 months 4. OS（Phase Ib） Timeframe: An average of approximately 30 months 5. DoR（Phase II） Timeframe: An average of approximately 18 months 6. PFS（Phase II） Timeframe: An average of approximately 18 months 7. OS（Phase II） Timeframe: An average of approximately 30 months 8. Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II） Timeframe: Safety will be assessed for approximately 24 months from informed consent\] Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Age from 18 to 75, Male and female participants 2. Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction; 3. HER2 expression ; 4. Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients; 5. ECOG 0-1; 6. The expected survival ≥3 months; 7. Sufficient bone marrow and organ functions; ### Exclusion criteria 1. There were ascites, pleural effusion and pericardial effusion that needed to be treated; 2. Major surgery was performed within 4 weeks; 3. Have active autoimmune disease or history of autoimmune disease; 4. Patients with interstitial pneumonia; 5. There was severe infection within 4 weeks before starting the study treatment; 6. Patients with active pulmonary tuberculosis infection history within 1 year before enrollment; 7. Serious cardiovascular and cerebrovascular diseases; 8. Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment; Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Sites - Zhongshan Hospital, FuDan UniversityShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05671822) ## Related records ### Drugs (6) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.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) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Retlirafusp alfa](https://trialight.com/data/asset/retlirafusp-alfa-896e1516-969b-421a-8f63-2b8ae4836dff.md) - [Trastuzumab rezetecan](https://trialight.com/data/asset/trastuzumab-rezetecan-ff208505-42a4-4c94-aaa2-807da0cdd343.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) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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