Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers
- Conditions
- Advanced Cancer
- Interventions
- Drug: TQB2922 for injection
- Registration Number
- NCT06188624
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Brief Summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB2922 for injection TQB2922 for injection TQB2922 for injection, 28 days as a treatment cycle
- Primary Outcome Measures
Name Time Method 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
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.
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
- Secondary Outcome Measures
Name Time Method Half-life (T1/2) Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. Terminal half-life (T1/2) after administration
Apparent volume of distribution (Vz) Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. The ratio of the amount of TQB2922 in the body to the blood concentration
Minimum concentration (Cmin) Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. Minimum observed concentration (Cmin) of TQB2922
Progression-free survival (PFS) Up to 2 years. The time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.
The area under the curve (AUC) Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. The area under the curve (AUC) of blood concentration-time of TQB2922.
Objective response rate (ORR) Up to 2 years. The percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Immunogenicity of TQB2922 From the time of informed consent to 90 days after the last dose. Immunogenicity of TQB2922 is assessed according to the incidence of anti-drug antibody (ADA).
Apparent plasma clearance (CL) Pre-dose and 5 minutes post-dose on Cycle 1 Day 1, 8, 15, 22 and Cycle 2 Day 1; Pre-dose on Day 15 Cycle 2; 2, 6, 24, 72 hours after dose on Cycle 1 Day 1; 6, 24, 72, 128 hours after dose on Cycle 2 Day 1. Each cycle is 28 days. Apparent plasma clearance of TQB2922.
Duration of response (DOR) Up to 2 years. The time from first documented response to documented disease progression.
Trial Locations
- Locations (17)
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoming, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The first affiliated hospital of Guangzhou medical university
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Henan Provincine People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Department of Medical Oncology, The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China
Affiliated Hospital of North Sichuan Medical College
🇨🇳Nanchong, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China