RecruitingPhase 1NCT06188624

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


Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Enrollment

150 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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.

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Interventions

DRUGTQB2922 for injection

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


Locations(17)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The first affiliated hospital of Guangzhou medical university

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincine People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoming, China

Department of Medical Oncology, The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

View Full Details on ClinicalTrials.gov

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NCT06188624


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