A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors

Summary

The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.

Eligibility

Inclusion Criteria:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Patients with unresectable recurrent or metastatic solid tumors;
3. There is at least one lesion could be measured;
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Adequate organ functions as defined;
6. Life expectancy ≥3 months.

Exclusion Criteria:

1. Patients with known active central nervous system (CNS) metastases;
2. Subjects who had other malignancy in five years before the first dose;
3. Patients with tumor-related pain that cannot be controlled as determined;
4. Patients with serious cardiovascular and cerebrovascular diseases;
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
6. Patients with Severe infections;
7. History of immunodeficiency;
8. History of autoimmune diseases;
9. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy
10. Active infection;
11. Pregnant or nursing women;
12. Known history of serious allergic reactions to the investigational product or its main ingredients.

Conditions2

Interventions1

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• A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors — Shanghai Hengrui Pharmaceutical Co., Ltd.

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