Advanced CancersPhase 1NCT07260708

Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

A Phase 1 study testing TQB2922 injection (subcutaneous injection) in people with Advanced Cancers, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Cancers
What is being tested?: TQB2922 injection (subcutaneous injection)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 12 sitesChina
Study dates: 16 Dec 2025to Dec 2029
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 joined this study, signed the informed consent form, and had good compliance；
18-75 yeas old；
Eastern Cooperative Oncology Group Performance Status (ECOG) score: 0-1;
Expected survival of more than 12 weeks；
Histologically or cytologically diagnosed with advanced non-squamous non-small cell lung cancer
Subjects in cohorts 1a/1b/2a/2b need to have received standard treatment or lack effective treatment.

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There must be at least one measurable lesion within the radiotherapy area that can be clearly classified as progressive according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) criteria.
Major organs are functioning well；
Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.

Who cannot join

Current concomitant presence of other malignancies within 5 years prior to the first dose；
At the time of initiating the study of treatment, the adverse reactions caused by previous anti-tumor treatments failed to recover to a CTCAE 5.0 score of grade 1 or below.
Patients who had received major surgical treatment within 4 weeks prior to the first study, had obvious traumatic injuries, or were expected to undergo major surgery during the study treatment period, or had long-term unhealed wounds or fractures.
Hyperactive or venous thrombosis events occurred within 6 months before the first administration;
Major cardiovascular diseases;
Active hepatitis

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Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders.
There was an active infection (≥ Common Terminology Criteria for Adverse Events version 5.0 (CTCAE5.0) score of grade 2) within 2 weeks before the first administration;
Patients with renal failure requiring hemodialysis or peritoneal dialysis;
Patients who have a history of immune deficiency.
Patients who have epilepsy and need treatment;
Evidence of a previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any clinically active interstitial lung disease.
Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first treatment.
Pregnant or lactating women.
There is any serious or uncontrolled systemic disease.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Li Zhang, Doctor contact

020-87343458

zhangli@sysucc.org.cn

City, postcode or hospital

Sites recruiting now only

12 sites in 1 country

China12 sites, 12 recruiting

Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
PingChao Xiang, Master, 13381201858, xpcemail@163.com
Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yongchang Zhang, Doctor, 13873123436, zhangyongchang@csu.edc.cn
Not yet recruiting
West China hospital, Sichuan University
Chengdu, Sichuan, 610041
Jianxin Xue, Doctor, 18982251798, radjianxin@163.com
Li Zheng, Doctor, 18980601950, lzheng2005618@163.com
Not yet recruiting
Chengdu Third People's Hospital
Chengdu, Sichuan, 610100
Yi Yang, Master, 13980013944, cd3yyyy@126.com
Maozhi Liang, Bachelor, 18980601656, maozhi.liang@ebaigcp.com
Not yet recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 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
Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Linlin Wang, Doctor, 13793187739, wanglinlinatjn@163.com
Qi Dang, Master, 15318816098, dangqi123456@126.com
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Longhua Sun, Doctor, 18279110112, sunlonghua012024@163.com
Jinhua Wen, Doctor, 13970823367, wenih8606@163.com
Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yongsheng Wang, Doctor, 15150580136, 15150580136@163.com
Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shengxiang Ren, Doctor, 13816756732, harry_ren@126.com
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Yanqiu Zhao, Doctor, 13938252350, 13938252350@163.com
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Sanxing Guo, Doctor, 18337128112, sanxing134@hotmail.com
Not yet recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate The Safety and Pharmacokinetics of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.

Conditions: Advanced Cancers
Being tested: TQB2922 injection (subcutaneous injection)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TQB2922 injection (subcutaneous injection)Drug
TQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met.

Study groups in NCT07260708
Study group	Role	What they receive
TQB2922 injection (subcutaneous injection)	Experimental	TQB2922 injection (Subcutaneous Injection), 28 days as a treatment cycle Receives: Drug: TQB2922 injection (subcutaneous injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Peak Concentration
Time to Peak Concentration
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Peak concentration
Maximum plasma drug concentration
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
half-life (T1/2)
Terminal half-life (T1/2)
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
The area under the curve (AUC0-∞）
The area under the plasma concentration-time curve extrapolated from the first administration to infinity
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
The area under the curve (AUC0-t)
The area under the plasma concentration-time curve from the time of the first administration to the last quantifiable concentration time point.
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Elimination Rate
Reflects the rate at which a drug disappears from the bloodstream
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Apparent Oral Clearance
The mixed effect reflecting the drug's clearance ability and absorption degree.
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Apparent Volume of Distribution
The mixed effect reflecting the degree of drug distribution and absorption.
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Trough Concentration
The blood drug concentration at the moment before the next administration.
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Accumulation Ratio
The ratio of the drug exposure at a steady state to the drug exposure after the first administration.
Measured: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)

Secondary outcomes (5)

Adverse Events (AE) rate
The occurrence and severity of all AEs
Measured: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first
Objective Response Rate (ORR)
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
Measured: Up to 2 years
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression.
Measured: Up to 3 years
Progression-free survival (PFS)
Defined as the time from the first dose of TQB2922 to the first occurrence of disease progression or death from any cause.
Measured: Up to 3 years
Incidence of anti-drug antibody (ADA)
Incidence of anti-drug antibody (ADA)
Measured: From the time of informed consent signed through 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.

16 Dec 2025Dec 2029

First posted3 Dec 2025
Study start16 Dec 2025
Primary completionDec 2029 (estimated)
Study completionDec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced CancersStudies of the same condition, open and under way.
More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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: 42 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07260708
Sponsor's protocol ID: TQB2922-I-02
Status last verified: Sep 2026
First submitted: 20 Nov 2025
Last updated: 10 Sep 2026
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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study to Evaluate The Safety and Pharmacokinetics of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers
ClinicalTrials.gov ID: NCT07260708
Acronym / sponsor ID: TQB2922-I-02
Conditions: Advanced Cancers
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 42 participants (estimated)
Lead sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Dec 2025 (actual)
Primary completion: Dec 2029 (estimated)
Study completion: Dec 2029 (estimated)
First posted: 3 Dec 2025 (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 clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients 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 injection (subcutaneous injection)	Experimental	Drug: TQB2922 injection (subcutaneous injection)TQB2922 injection (Subcutaneous 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 (9 listed)

Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
18-75 yeas old；
Eastern Cooperative Oncology Group Performance Status (ECOG) score: 0-1;
Expected survival of more than 12 weeks；
Histologically or cytologically diagnosed with advanced non-squamous non-small cell lung cancer

Key exclusion criteria (15 listed)

Current concomitant presence of other malignancies within 5 years prior to the first dose；
At the time of initiating the study of treatment, the adverse reactions caused by previous anti-tumor treatments failed to recover to a CTCAE 5.0 score of grade 1 or below.
Patients who had received major surgical treatment within 4 weeks prior to the first study, had obvious traumatic injuries, or were expected to undergo major surgery during the study treatment period, or had long-term unhealed wounds or fractures.
Hyperactive or venous thrombosis events occurred within 6 months before the first administration;
Major cardiovascular diseases;

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 injection (subcutaneous injection)TQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met.	Drug	TQB2922 injection (subcutaneous injection)

Primary outcome

Time to Peak Concentration
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Time to Peak Concentration
Peak concentration
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Maximum plasma drug concentration
half-life (T1/2)
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Terminal half-life (T1/2)
The area under the curve (AUC0-∞）
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
The area under the plasma concentration-time curve extrapolated from the first administration to infinity
The area under the curve (AUC0-t)
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
The area under the plasma concentration-time curve from the time of the first administration to the last quantifiable concentration time point.
Elimination Rate
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
Reflects the rate at which a drug disappears from the bloodstream
Apparent Oral Clearance
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
The mixed effect reflecting the drug's clearance ability and absorption degree.
Apparent Volume of Distribution
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
The mixed effect reflecting the degree of drug distribution and absorption.
Trough Concentration
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
The blood drug concentration at the moment before the next administration.
Accumulation Ratio
Time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)
The ratio of the drug exposure at a steady state to the drug exposure after the first administration.

5 secondary outcomes

Adverse Events (AE) rate
Time frame: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first
Objective Response Rate (ORR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 3 years
Progression-free survival (PFS)
Time frame: Up to 3 years
Incidence of anti-drug antibody (ADA)
Time frame: From the time of informed consent signed through 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 10 Sep 2026.

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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.

Li Zhang, Doctor contact

020-87343458

zhangli@sysucc.org.cn

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 15 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

Time to Peak Concentration (time frame: Cycle 1 Day 1:predose, 2, 6, 10, 24, 48, 72 hours after infusion, Cycle 1 Day 8, 15, 22:predose; Cycle 2 Day1: predose, 2, 6 h, 10, 24, 48, 72, 168 hours after infusion; Cycle 2 Day 15;Day 1 on Cycle 4, Cycle 6,Cycle 8: predose (each cycle is 28 days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07260708.

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 10 Sep 2026.