Status:
RECRUITING
A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 reaso...
Eligibility Criteria
Inclusion
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Patients with unresectable recurrent or metastatic solid tumors;
- There is at least one lesion could be measured;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Adequate organ functions as defined;
- Life expectancy ≥3 months.
Exclusion
- Patients with known active central nervous system (CNS) metastases;
- Subjects who had other malignancy in five years before the first dose;
- Patients with tumor-related pain that cannot be controlled as determined;
- Patients with serious cardiovascular and cerebrovascular diseases;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Patients with Severe infections;
- History of immunodeficiency;
- History of autoimmune diseases;
- Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy
- Active infection;
- Pregnant or nursing women;
- Known history of serious allergic reactions to the investigational product or its main ingredients.
Key Trial Info
Start Date :
October 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT06605222
Start Date
October 4 2024
End Date
November 30 2026
Last Update
October 18 2024
Active Locations (1)
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1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433