Status:
RECRUITING
Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions:
Advanced Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
Eligibility Criteria
Inclusion
- Subjects voluntarily join this study, sign the informed consent form, and have good compliance；
- Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
- Histologically or cytologically diagnosed with advanced cancers;
- Subjects with advanced malignancies who have failed standard therapy or lack effective treatment;
- Major organs are functioning well;
- Female and male subjects of childbearing potential should agree to practice contraception during the study and until 6 months after the completion of the study.
Exclusion
- Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;
- Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;
- Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
- Long-term unhealed wounds or fractures
- Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
- A history of psychotropic drug abuse and cannot be abstained, or have a mental disorder;
- Subjects with any severe and/or uncontrolled disease;
- History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
- Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2922 for injection or its excipients;
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06188624
Start Date
February 1 2024
End Date
December 1 2027
Last Update
April 25 2025
Active Locations (17)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
3
The first affiliated hospital of Guangzhou medical university
Guangzhou, Guangdong, China, 510062
4
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081