Actively Recruiting
A Phase I Clinical Study to Evaluate The Safety and Pharmacokinetics of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2026-04-21
42
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and how the body processes TQB2922, a bispecific antibody given by injection under the skin, in adults with advanced cancers. This Phase I study focuses on patients with advanced non-squamous non-small cell lung cancer who have measurable tumors that are progressing despite prior treatment or lack effective options. The trial is sponsored by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. Participants will receive TQB2922 injections in treatment cycles lasting 28 days. The study includes detailed monitoring of the drug’s levels in the blood at multiple time points during and after dosing across several cycles to understand its behavior in the body. The treatment continues through multiple cycles while patients are observed for side effects and response. Participants will have frequent blood draws and evaluations during the study to measure drug concentration and pharmacokinetics, including peak levels and how long the drug stays in the body. Safety will be monitored by recording adverse events up to 30 days after the last dose. Researchers will also assess cancer response and progression over up to three years. The total study duration may extend with follow-up to observe long-term effects and immune responses to the drug.
CONDITIONS
Brief Title
Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily joined this study, signed the informed consent form, and had good compliance
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 1
- Expected survival of more than 12 weeks
- Histologically or cytologically diagnosed with advanced non-squamous non-small cell lung cancer
- For monotherapy introduction, previous standard treatment received or lack of effective treatment
- At least one measurable lesion within the radiotherapy area classified as progressive by RECIST1.1 criteria
- Major organs functioning well
- Female and male subjects of childbearing potential agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Presence of other malignancies within 5 years prior to the first dose
- Adverse reactions from previous anti-tumor treatments not recovered to grade 1 or below by CTCAE 5.0
- Major surgery within 4 weeks prior to study, traumatic injuries, long-term unhealed wounds or fractures
- Hyperactive or venous thrombosis events within 6 months before first administration
- Major cardiovascular diseases
- Active hepatitis
- History of psychotropic drug abuse or mental disorders
- Active infection of grade 2 or higher within 2 weeks before first administration
- Renal failure requiring dialysis
- History of immune deficiency
- Epilepsy requiring treatment
- Previous or active interstitial lung disease or radiation pneumonitis requiring steroid treatment
- Participation in other anti-tumor clinical trials within 4 weeks before first treatment
- Pregnant or lactating women
- Any serious or uncontrolled systemic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive TQB2922 injection (subcutaneous injection) in 28-day treatment cycles to evaluate safety and pharmacokinetics.
Multiple visits during each 28-day cycle for dosing and pharmacokinetic assessments
Duration - Up to 3 years
Participants are monitored for adverse events and long-term outcomes for up to 3 years after treatment completion.
Visits scheduled periodically for up to 3 years after treatment ends
Trial Site Locations
Total: 11 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
4
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Not Yet Recruiting
5
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
6
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
7
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
Actively Recruiting
8
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
9
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
10
West China hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
11
Chengdu Third People's Hospital
Chengdu, Sichuan, China, 610100
Not Yet Recruiting
Research Team
L
Li Zhang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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