Evaluating TQB2922 injection for patients with advanced cancers

A Phase I Clinical Study of TQB2922 for Injection in Patients With Advanced Cancers

This study is testing a new injectable treatment called TQB2922 to see if it can help adults with advanced cancers who have run out of other options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 17 sites (Chongqing, Chongqing Municipality and 16 other locations)
• Trial ID: NCT06188624 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced cancers who have not responded to standard therapies.

Not a fit: Patients with unresolved toxicity from previous treatments or those with other malignancies within the last two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers who have limited alternatives.

How similar studies have performed: While this approach is novel, similar studies evaluating new cancer treatments have shown promise in the past.

Eligibility criteria

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 this trial is running

Chongqing, Chongqing Municipality and 16 other locations

• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (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)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Affiliated Zhongshan Hospital of Dalian University — Dalian, Liaoming, China (Not_yet_recruiting)
• Department of Medical Oncology, The First Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Affiliated Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Yunnan Cancer Hospital — Kunming, Yunnan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Li Zhang, Doctor

Conditions Advanced Cancer