Evaluating TQB2922 injection for patients with advanced cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I clinical trial aims to assess the safety, tolerability, and efficacy of TQB2922, an injectable treatment, in patients diagnosed with advanced cancers. Participants will include adults aged 18-75 who have advanced malignancies and have either failed standard therapies or lack effective treatment options. The study will monitor the participants' responses to the treatment while ensuring that major organ functions are stable. The trial will also require participants to comply with contraception guidelines during and after the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Not yet recruiting
• The first affiliated hospital of Guangzhou medical university
  Guangzhou, Guangdong, China Not yet recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Not yet recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Not yet recruiting
• Henan Provincine People's Hospital
  Zhengzhou, Henan, China Not yet recruiting

Study contacts

• Study coordinator: Li Zhang, Doctor
• Email: zhangli@sysucc.org.cn
• Phone: 020-87343458

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.