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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancers
• Intervention / Treatment: Drug: TQB2922 injection (subcutaneous injection)

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Zhang, Doctor; Phone Number: 020-87343458; Email: zhangli@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Li Zhang, Doctor; Phone Number: 020-87343458; Email: zhangli@sysucc.org
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Yanqiu Zhao, Doctor; Phone Number: 13938252350; Email: 13938252350@163.com
    • Zhengzhou, Henan, China, 450052
      • Not yet recruiting
      • the First Affiliated Hospital of Zhengzhou University
      • Contact: Sanxing Guo, Doctor; Phone Number: 18337128112; Email: sanxing134@hotmail.com
  • Hunan
    • Changsha, Hunan, China, 410013
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Contact: Yongchang Zhang, Doctor; Phone Number: 13873123436; Email: zhangyongchang@csu.edc.cn
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Yongsheng Wang, Doctor; Phone Number: 15150580136; Email: 15150580136@163.com
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Longhua Sun, Doctor; Phone Number: 18279110112; Email: sunlonghua012024@163.com
      • Contact: Jinhua Wen, Doctor; Phone Number: 13970823367; Email: wenih8606@163.com
  • Liaoning
    • Dalian, Liaoning, China, 116001
      • Recruiting
      • Affiliated Zhongshan Hospital of Dalian University
      • Contact: Ruoyu Wang, Doctor; Phone Number: 15842465751; Email: 357122231@qq.com
      • Contact: Xiang Li, Master; Phone Number: 18018931093; Email: 94207842@qq.com
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
      • Contact: Linlin Wang, Doctor; Phone Number: 13793187739; Email: wanglinlinatjn@163.com
      • Contact: Qi Dang, Master; Phone Number: 15318816098; Email: dangqi123456@126.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Shengxiang Ren, Doctor; Phone Number: 13816756732; Email: harry_ren@126.com
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Not yet recruiting
      • West China Hospital, Sichuan University
      • Contact: Jianxin Xue, Doctor; Phone Number: 18982251798; Email: radjianxin@163.com
      • Contact: Li Zheng, Doctor; Phone Number: 18980601950; Email: lzheng2005618@163.com
    • Chengdu, Sichuan, China, 610100
      • Not yet recruiting
      • Chengdu Third People's Hospital
      • Contact: Yi Yang, Master; Phone Number: 13980013944; Email: cd3yyyy@126.com
      • Contact: Maozhi Liang, Bachelor; Phone Number: 18980601656; Email: maozhi.liang@ebaigcp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 the monotherapy introduction stage 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB2922 injection (subcutaneous injection); TQB2922 injection (Subcutaneous Injection), 28 days as a treatment cycle	Drug: TQB2922 injection (subcutaneous injection); TQB2922 is a bispecific antibody against Epidermal Growth Factor Receptor (EGFR)/c-Met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Peak Concentration	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)
Peak concentration	Maximum plasma drug 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)
half-life (T1/2)	Terminal 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)
The area under the curve (AUC0-∞）	The area under the plasma concentration-time curve extrapolated from the first administration to infinity	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.	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	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.	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.	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AE) rate	The occurrence and severity of all AEs	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	Up to 2 years
Duration of Response (DOR)	Defined as the time from first documented response to documented disease progression.	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.	Up to 3 years
Incidence of anti-drug antibody (ADA)	Incidence of anti-drug antibody (ADA)	From the time of informed consent signed through 90 days after the last dose.

Collaborators and Investigators

• Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections; Injections, Subcutaneous
• Other Study ID Numbers: TQB2922-I-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No