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Recruiting
NCT06605222
A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors
Conditions: Advanced Solid Tumors
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 201
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Location: Shanghai Pulmonary Hospital Shanghai Shanghai Municipality
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 Criteria
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.
Source: ClinicalTrials.gov (NCT06605222). StuddyBuddy aggregates publicly available trial information.