To hear about similar clinical trials, please enter your email below
Trial Title:
A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors
NCT ID:
NCT06605222
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
SHR-7787 injection monotherapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-7787 injection
Description:
Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be
conducted.
Arm group label:
Single Group: SHR-7787 injection
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Shengxiang Ren
Start date:
October 4, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06605222
