> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-efficacy-of-shr2554-combined-with-other-antitumor-d13638ca-2137-41cd-80a8-8a53a7ecce7a > Record changed: 2026-10-13 # Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma NCT07102901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) Participants 351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) Lead sponsor Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) Start date 2025-09-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Title and summary **Summary** This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Short title** Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Official title** A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **First posted** 2025-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Registry last updated** 2025-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Start date** 2025-09-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Size and sites **Participants** 351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Planned participants** 351 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Lead sponsor** Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Identifiers **Registry ID** NCT07102901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **ClinicalTrials.gov ID** NCT07102901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Outcomes ### Primary outcomes 1. Incidence and severity of adverse events (AEs). Timeframe: Up to approximately 2 years. Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. 2. Incidence and severity of serious adverse events (SAEs). Timeframe: Up to approximately 2 years. Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. 3. Incidence of Dose Limited Toxicity (DLT). Timeframe: Up to Day 21. 4. Objective response rate (ORR) by the investigator assessment. Timeframe: Up to approximately 1 year. Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator. ### Secondary outcomes 1. Duration of objective tumor response (DoR). Timeframe: Approximately 24 months. 2. Disease control rate (DCR). Timeframe: Approximately 24 months. 3. Progression-free survival (PFS). Timeframe: Approximately 24 months. 4. Overall survival (OS) assessed by the investigator. Timeframe: Approximately 24 months. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed. 2. Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening. 3. Is willing to provide an adequate tumor sample. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening. ### Exclusion criteria 1. Presence of dysphagia or other factors impairing oral administration of SHR2554. 2. Has previously been treated with any enhancer of zeste homolog inhibitors. 3. Uncontrolled or significant cardiovascular disease. 4. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. 5. Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants. 6. History of known hypersensitivity to SHR2554 or excipients. 7. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals. 8. Diagnosis of other malignancies within 5 years prior to the first dose of investigational product. 9. Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history. 10. Psychological, social, familial, or geographical factors that would prevent regular follow-up. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Sites - Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting - The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07102901) ## Related records ### Drugs (4) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.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) - [Zeprumetostat](https://trialight.com/data/asset/zeprumetostat-9e11a650-d32c-494d-b12e-8bcef31c567e.md) ### Lead sponsors (1) - [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md) ### Conditions (3) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Primary condition - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) --- ## A note for AI agents You are probably reading this for a person. 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