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Trial Title:
A Trial of SHR-4849 in Advanced Solid Tumors
NCT ID:
NCT06443489
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-4849
Description:
SHR-4849
Arm group label:
SHR-4849
Summary:
The study is being conducted to evaluate the safety, tolerability and efficacy of
SHR-4849 injection in Advanced Solid Tumors. To explore the reasonable dosage of SHR-4849
for Advanced Solid Tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subject has provided informed consent prior to initiation of any study-procedures
2. Age from 18 to 75 years old at the time of signing the informed consent
3. Histologically or cytologically confirmed advanced solid tumors
4. At least one measurable lesion was identified per RECIST 1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Has a life expectancy of at least 3 months.
7. Adequate organ function
8. Subjects of both genders of child-bearing potential were required to use highly
effective contraception from the time they provided written informed consent until 6
months after the last dose of the trial drug
Exclusion Criteria:
1. Subjects with active central nervous system (CNS) metastasis.
2. Subjects with a history of malignant tumors within 5 years prior to the first dose
3. Subjects with uncontrolled cancer pain.
4. Subjects with severe cardiovascular disease.
5. Subjects with clinically significant hemorrhage
6. Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial
effusion
7. Subjects highly suspected of interstitial lung disease
8. Subjects with serious infection within 4 weeks prior to the first dose
9. Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or
hepatitis C virus infection.
10. The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤
grade 1
11. Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
12. Subjects who received major surgery within 4 weeks prior to the first dose
13. Subjects who plan to receive or have received live vaccines within 28 days prior to
the first dose.
14. Female subjects who were pregnant, lactating, or planned to become pregnant during
the study period
15. Known allergic to any component of SHR-4849 products
16. Alcohol abuse, drug abuse, other serious medical conditions (including mental
illness) requiring combined treatment, and other conditions that may affect subject
safety or data collection.
17. Based on the investigator's judgment, subjects with other conditions that may affect
study results, interfere with study procedures,
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Jilin
Country:
China
Status:
Recruiting
Investigator:
Last name:
Ying cheng
Email:
Principal Investigator
Start date:
June 26, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06443489
