TQB2922 subcutaneous treatment for advanced cancers

A Phase I Clinical Study to Evaluate The Safety and Pharmacokinetics of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

This Phase I test will try a new injectable drug, TQB2922, to see if it's safe and how the body handles it in adults with advanced non-squamous non-small cell lung cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 11 sites (Guangzhou, Guangdong and 10 other locations)
• Trial ID: NCT07260708 on ClinicalTrials.gov

What this trial studies

TQB2922 is being given by subcutaneous injection to adults with advanced non-squamous non-small cell lung cancer in a Phase I dose-finding and pharmacokinetics study. The main goals are to determine safety, tolerability, and how the drug is processed by the body, and to identify appropriate dosing. Eligible participants must have ECOG 0–1, expected survival over 12 weeks, a measurable progressive lesion within a prior radiotherapy area per RECIST 1.1, and have received standard treatment or lack effective options. The trial is enrolling at three cancer centers in China and requires regular clinic visits for dosing and follow-up.

Who should consider this trial

Good fit: Adults 18–75 years old with advanced non-squamous non-small cell lung cancer, ECOG 0–1, expected survival >12 weeks, at least one measurable progressive lesion per RECIST1.1, and who have received or lack effective standard treatment are the intended candidates.

Not a fit: Patients with poor organ function, ECOG >1, recent other malignancies, squamous histology, pregnancy, or inability to comply with site visits or contraception requirements are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, TQB2922 could offer a new subcutaneous treatment option for patients with advanced non-squamous NSCLC who have limited standard therapies available.

How similar studies have performed: Other Phase I trials of subcutaneous targeted or immune-modulating cancer agents have sometimes shown acceptable safety and advanced to later phases, but outcomes vary and TQB2922 remains experimental.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong and 10 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Affiliated Zhongshan Hospital of Dalian University — Dalian, Liaoning, China (Recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• West China hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Chengdu Third People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Li Zhang, Doctor

Conditions Advanced Cancers