A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors
A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors
Shanghai Hengrui Pharmaceutical Co., Ltd.
201 participants
Oct 4, 2024
INTERVENTIONAL
Conditions
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 Criteria6
- 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 Criteria12
- 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.
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Interventions
Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06605222