Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Phase
Phase 1
Started
2025-12-16
Last updated
2026-09-10
Condition(s) studied
Advanced Cancers
Investigational drug(s) / intervention(s)
TQB2922 injection (subcutaneous injection)
TQB2922 injection (subcutaneous injection): TQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met.
Study summary
This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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
* 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.
Primary outcome measure(s)
Time to Peak Concentration — 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 — 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) — 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-∞） — 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) — 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 — 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 — 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 — 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 — 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 — 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.
Trial sites (12)
Facility
City
Region
Status
Peking University Shougang Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Not Yet Recruiting
Nanjing Drum Tower Hospital
Nanjing
Jiangsu
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian
Liaoning
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
Recruiting
West China hospital, Sichuan University
Chengdu
Sichuan
Not Yet Recruiting
Chengdu Third People's Hospital
Chengdu
Sichuan
Not Yet Recruiting
More Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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