Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers
- Summary
- This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
- Short title
- Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers
- Official title
- A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2024-01-03
- Registry last updated
- 2025-04-25
- Primary completion date
- 2026-12-01
- Start date
- 2024-02-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06188624
- ClinicalTrials.gov ID
- NCT06188624
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Dose limiting toxicity (DLT)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Half-life (T1/2)
Timeframe: 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
The area under the curve (AUC)
Timeframe: 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.
Apparent plasma clearance (CL)
Timeframe: 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.
Apparent volume of distribution (Vz)
Timeframe: 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)
Timeframe: 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
Objective response rate (ORR)
Timeframe: 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.
Duration of response (DOR)
Timeframe: Up to 2 years.
The time from first documented response to documented disease progression.
Progression-free survival (PFS)
Timeframe: Up to 2 years.
The time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.
Immunogenicity of TQB2922
Timeframe: 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).
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- Chongqing University Cancer HospitalChongqing, ChinaNot yet recruiting
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
- The first affiliated hospital of Guangzhou medical universityGuangzhou, ChinaNot yet recruiting
- Harbin Medical University Cancer HospitalHarbin, ChinaNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaNot yet recruiting
- Henan Provincine People's HospitalZhengzhou, ChinaNot yet recruiting
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNot yet recruiting
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
- Hunan Cancer HospitalChangsha, ChinaNot yet recruiting
- Nanjing Drum Tower HospitalNanjing, ChinaNot yet recruiting
- Affiliated Zhongshan Hospital of Dalian UniversityDalian, ChinaNot yet recruiting
- Department of Medical Oncology, The First Hospital of China Medical UniversityShenyang, ChinaNot yet recruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaNot yet recruiting
- Shanghai Pulmonary HospitalShanghai, ChinaNot yet recruiting
- Affiliated Hospital of North Sichuan Medical CollegeNanchong, ChinaNot yet recruiting
- Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaNot yet recruiting
- Yunnan Cancer HospitalKunming, ChinaNot yet recruiting
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Metastatic malignant neoplasm Primary condition