> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-of-shr-7787-injection-combined-with-other-anti-tumor-da2f3d8b-b801-4a58-affa-201a9708aba1 > Record changed: 2026-10-29 # A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors NCT07268040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) Lead sponsor Shanghai Hengrui Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) Start date 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Title and summary **Summary** This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Short title** A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Official title** A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **First posted** 2025-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Registry last updated** 2026-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Start date** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Lead sponsor** Shanghai Hengrui Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Identifiers **Registry ID** NCT07268040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **ClinicalTrials.gov ID** NCT07268040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Outcomes ### Primary outcomes 1. The Recommended phase II dose of SHR-7787 injection monotherapy (stage I) Timeframe: Expected to be two years after the start of the study. 2. Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I) Timeframe: About 1 year after study initiation. 3. Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I) Timeframe: About 1 year after study initiation. 4. Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I) Timeframe: About 1 year after study initiation. 5. Objective response rate (ORR) (stage II) Timeframe: Expected to be two years after the start of the study. 6. Progress Free Survival (FPS) (stage II) Timeframe: Expected to be two years after the start of the study. ### Secondary outcomes 1. Objective response rate (ORR) Timeframe: About 1 year. 2. Duration of Response (DoR) Timeframe: About 1 year. 3. Disease Control Rate (DCR) Timeframe: About 1 year. 4. Progress Free Survival (PFS) Timeframe: About 1 year. 5. Overall Survival (OS) Timeframe: About 1 year. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Patients with histologically or cytologically confirmed unresectable solid tumors; 3. At least one measurable lesion was identified per RECIST 1.1; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 5. Adequate organ functions as defined per protocol; 6. Minimum life expectancy of 3 months. ### Exclusion criteria 1. Patients with known active central nervous system (CNS) metastases; 2. History of other malignancy within the past 5 years, with exceptions defined in the protocol; 3. Patients with uncontrolled cancer pain; 4. Patients with serious cardiovascular and/or cerebrovascular diseases; 5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion; 6. Patients with Severe infections within 4 weeks prior to the first dose; 7. Active pulmonary tuberculosis infection; 8. History of immunodeficiency; 9. History of autoimmune diseases; 10. The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1; 11. Pregnant or nursing women, or planned to become pregnant during the study period; 12. Known allergic to any component of investigational drugs. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Sites - Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & TechnologyWuhan, ChinaRecruiting - Shanghai Pulmonary HospitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07268040) ## Related records ### Drugs (5) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Etoposide phosphate](https://trialight.com/data/asset/etoposide-phosphate-97b820e3-fe22-4590-9942-e33299436d3a.md) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) ### Lead sponsors (1) - [Shanghai Hengrui Pharmaceutical Co., Ltd.](https://trialight.com/data/company/shanghai-hengrui-pharmaceutical-co-ltd-99e79134-0170-4beb-ba13-f33c49843c3e.md) ### Targets (2) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) --- ## A note for AI agents You are probably reading this for a person. 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