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

NCT ID: NCT07260708

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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Conditions

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Advanced Cancers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB2922 injection (subcutaneous injection)

TQB2922 injection (Subcutaneous Injection), 28 days as a treatment cycle

Group Type EXPERIMENTAL

TQB2922 injection (subcutaneous injection)

Intervention Type DRUG

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

Interventions

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TQB2922 injection (subcutaneous injection)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status NOT_YET_RECRUITING

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Site Status NOT_YET_RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

West China hospital, Sichuan University

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

Chengdu Third People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Zhang, Doctor

Role: CONTACT

Phone: 020-87343458

Email: [email protected]

Facility Contacts

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Li Zhang, Doctor

Role: primary

Yanqiu Zhao, Doctor

Role: primary

Sanxing Guo, Doctor

Role: primary

Yongchang Zhang, Doctor

Role: primary

Yongsheng Wang, Doctor

Role: primary

Longhua Sun, Doctor

Role: primary

Jinhua Wen, Doctor

Role: backup

Ruoyu Wang, Doctor

Role: primary

Xiang Li, Master

Role: backup

Linlin Wang, Doctor

Role: primary

Qi Dang, Master

Role: backup

Shengxiang Ren, Doctor

Role: primary

Jianxin Xue, Doctor

Role: primary

Li Zheng, Doctor

Role: backup

Yi Yang, Master

Role: primary

Maozhi Liang, Bachelor

Role: backup

Other Identifiers

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TQB2922-I-02

Identifier Type: -

Identifier Source: org_study_id