Advanced CancerPhase 1NCT06188624
Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers
A Phase 1 study testing TQB2922 for injection in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 17 sites in China.
Trial summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- TQB2922 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 17 sitesChina
- Study dates
- 1 Feb 2024to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites, 17 recruiting
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Fang Ma, Doctor, 13975806788, dr_fma@126.com
Pingfei Fang, Doctor, 13517491647, fangpingfei@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yongchang Zhang, Doctor, 13873123436, zhangyongchang@csu.edc.cn
- Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Yi Gong, Doctor, 13228685295, gongyi_95@163.com
- Not yet recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoming, 116001
Ruoyu Wang, Doctor, 15842465751, 357122231@qq.com
Xiang Li, Master, 18018931093, 94207842@qq.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, Doctor, 020-87343458, zhangli@sysucc.org.cn
- Not yet recruiting
The first affiliated hospital of Guangzhou medical university
Guangzhou, Guangdong, 510062
Xicheng Wang, Master, 13902400598, 13902400598@126.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Baogang Liu, Doctor, 13804552752, liubaogang1962@sina.com
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Runxiang Yang, Master, 13888876721, 13888876721@163.com
- Not yet recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Yan Gui, Master, 15882618827, 15882618828@163.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yongsheng Wang, Doctor, 15150580136, 15150580136@163.com
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shengxiang Ren, Doctor, 13816756732, harry_ren@126.com
- Not yet recruiting
Department of Medical Oncology, The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Xiujuan Qu, Doctor, 13604031355, xjqu@cmu.edu.cn
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Peng Chen, Doctor, 18622221220, chenpengdoc@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 7100614
Yu Yao, Doctor, 13572101611, Oncology_yao@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Yanqiu Zhao, Doctor, 13938252350, 13938252350@163.com
- Not yet recruiting
Henan Provincine People's Hospital
Zhengzhou, Henan, 450003
Shundong Cang, Doctor, 13592675836, cangshundong@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Sanxing Guo, Doctor, 18337128112, sanxing134@hotmail.com
About this study
Official title: A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
- Conditions
- Advanced Cancer
- Being tested
- TQB2922 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2922 for injectionDrug
TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| TQB2922 for injection | Experimental | TQB2922 for injection, 28 days as a treatment cycle Receives: Drug: TQB2922 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
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.
Measured: During the first treatment cycle (28 days).
Maximum tolerated dose (MTD)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Measured: During the first treatment cycle (28 days).
Adverse events (AEs) rate
The occurrence rate of all AEs during treatment
Measured: From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
Adverse events (AEs) severity
The severity of all AEs occured during treatment
Measured: From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.
Secondary outcomes (9)
Half-life (T1/2)
Terminal half-life (T1/2) after administration
Measured: 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)
The area under the curve (AUC) of blood concentration-time of TQB2922.
Measured: 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 (CL)
Apparent plasma clearance of TQB2922.
Measured: 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 volume of distribution (Vz)
The ratio of the amount of TQB2922 in the body to the blood concentration
Measured: 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 concentration (Cmin)
Minimum observed concentration (Cmin) of TQB2922
Measured: 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.
Objective response rate (ORR)
The percentage of patients with complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measured: Up to 2 years.
Duration of response (DOR)
The time from first documented response to documented disease progression.
Measured: Up to 2 years.
Progression-free survival (PFS)
The time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.
Measured: Up to 2 years.
Immunogenicity of TQB2922
Immunogenicity of TQB2922 is assessed according to the incidence of anti-drug antibody (ADA).
Measured: From the time of informed consent to 90 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188624
- Sponsor's protocol ID
- TQB2922-I-01
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT06188624
- Acronym / sponsor ID
- TQB2922-I-01
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2922 for injection | Experimental | Drug: TQB2922 for injectionTQB2922 for injection, 28 days as a treatment cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2922 for injectionTQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle | Drug | TQB2922 for injection |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
9 secondary outcomes
Half-life (T1/2)
Time frame: 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)
Time frame: 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 (CL)
Time frame: 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 volume of distribution (Vz)
Time frame: 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 concentration (Cmin)
Time frame: 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.
Objective response rate (ORR)
Time frame: Up to 2 years.
Duration of response (DOR)
Time frame: Up to 2 years.
Progression-free survival (PFS)
Time frame: Up to 2 years.
Immunogenicity of TQB2922
Time frame: From the time of informed consent to 90 days after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2922 for injection in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, Doctor (020-87343458, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: During the first treatment cycle (28 days).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.