TQB2922 for injection: TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle
Study summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Dose limiting toxicity (DLT) — During the first treatment cycle (28 days). DLT is defined as toxicities that meet pre-defined severity criteria according to the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 toxicity assessment criteria, and assessed as having a suspected relationship to study drug that occurred.
Maximum tolerated dose (MTD) — During the first treatment cycle (28 days). MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Adverse events (AEs) rate — From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first. The occurrence rate of all AEs during treatment
Adverse events (AEs) severity — From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first. The severity of all AEs occured during treatment
Trial sites (17)
Facility
City
Region
Status
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
The first affiliated hospital of Guangzhou medical university
Guangzhou
Guangdong
Not Yet Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Not Yet Recruiting
Henan Provincine People's Hospital
Zhengzhou
Henan
Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
The Second Xiangya Hospital of Central South University
Changsha
Hunan
Not Yet Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Not Yet Recruiting
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Not Yet Recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian
Liaoming
Not Yet Recruiting
Department of Medical Oncology, The First Hospital of China Medical University
Shenyang
Liaoning
Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
Not Yet Recruiting
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
Not Yet Recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong
Sichuan
Not Yet Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
Yunnan Cancer Hospital
Kunming
Yunnan
Not Yet Recruiting
More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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