Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: TQB2922 for injection

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 1

Contacts and Locations

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

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Not yet recruiting
      • Chongqing University Cancer Hospital
      • Contact: Yi Gong, Doctor; Phone Number: 13228685295; Email: gongyi_95@163.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Li Zhang, Doctor; Phone Number: 020-87343458; Email: zhangli@sysucc.org.cn
    • Guangzhou, Guangdong, China, 510062
      • Not yet recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Xicheng Wang, Master; Phone Number: 13902400598; Email: 13902400598@126.com
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Not yet recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Baogang Liu, Doctor; Phone Number: 13804552752; Email: liubaogang1962@sina.com
  • Henan
    • 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
    • Zhengzhou, Henan, China, 450003
      • Not yet recruiting
      • Henan Cancer Hospital
      • Contact: Yanqiu Zhao, Doctor; Phone Number: 13938252350; Email: 13938252350@163.com
    • Zhengzhou, Henan, China, 450003
      • Not yet recruiting
      • Henan Provincine People's Hospital
      • Contact: Shundong Cang, Doctor; Phone Number: 13592675836; Email: cangshundong@163.com
  • Hunan
    • Changsha, Hunan, China, 410013
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Contact: Yongchang Zhang, Doctor; Phone Number: 13873123436; Email: zhangyongchang@csu.edc.cn
    • Changsha, Hunan, China, 410011
      • Not yet recruiting
      • The second Xiangya hospital of central south university
      • Contact: Fang Ma, Doctor; Phone Number: 13975806788; Email: dr_fma@126.com
      • Contact: Pingfei Fang, Doctor; Phone Number: 13517491647; Email: fangpingfei@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Not yet recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Yongsheng Wang, Doctor; Phone Number: 15150580136; Email: 15150580136@163.com
  • Liaoming
    • Dalian, Liaoming, China, 116001
      • Not yet 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
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Not yet recruiting
      • Department of Medical Oncology, The First Hospital of China Medical University
      • Contact: Xiujuan Qu, Doctor; Phone Number: 13604031355; Email: xjqu@cmu.edu.cn
  • Shaanxi
    • Xi'an, Shaanxi, China, 7100614
      • Not yet recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Yu Yao, Doctor; Phone Number: 13572101611; Email: Oncology_yao@163.com
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Not yet recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Shengxiang Ren, Doctor; Phone Number: 13816756732; Email: harry_ren@126.com
  • Sichuan
    • Nanchong, Sichuan, China, 637000
      • Not yet recruiting
      • Affiliated Hospital of North Sichuan Medical College
      • Contact: Yan Gui, Master; Phone Number: 15882618827; Email: 15882618828@163.com
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Not yet recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Peng Chen, Doctor; Phone Number: 18622221220; Email: chenpengdoc@126.com
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Not yet recruiting
      • Yunnan Cancer Hospital
      • Contact: Runxiang Yang, Master; Phone Number: 13888876721; Email: 13888876721@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

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 for injection; TQB2922 for injection, 28 days as a treatment cycle	Drug: TQB2922 for injection; TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During the first treatment cycle (28 days).
Adverse events (AEs) rate	The occurrence rate of all AEs during treatment	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	From date of the first dose until 30 days after last dose or start with new anti-tumor treatment, whichever comes first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Half-life (T1/2)	Terminal half-life (T1/2) after administration	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.	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.	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	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	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.	Up to 2 years.
Duration of response (DOR)	The time from first documented response to documented disease progression.	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.	Up to 2 years.
Immunogenicity of TQB2922	Immunogenicity of TQB2922 is assessed according to the incidence of anti-drug antibody (ADA).	From the time of informed consent to 90 days after the last dose.

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB2922-I-01

Drug and device information, study documents

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