A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors

Trial Title: A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors

NCT ID: NCT06649656

Condition: Advanced Cancers

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TQB2252 injection
Description: TQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg (20ml) penpulimab per bottle.
Arm group label: TQB2252 injection

Summary: This study is a multicenter, single arm, and open design Phase I clinical trial aimed at evaluating the safety, Pharmacokinetics (PK) characteristics, immunogenicity, and preliminary efficacy of TQB2252 injection in subjects with advanced malignant tumors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance; - 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form); - Electrocorticogram (ECOG) score ranges from 0 to 1 points; - Expected survival is greater than 12 weeks； - Confirmed to have at least one measurable lesion according to RECIST 1.1 (solid tumor) or Lugano 2014 (lymphoma) criteria； - Late stage malignant tumor subjects who have failed standard treatment or lack effective treatment； - Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study; Men should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study period. Exclusion Criteria: - Has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication; - There are multiple factors that affect diseases related to intravenous injection and venous blood collection; - The adverse reactions of previous anti-tumor treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score of ≤ 1; - Individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication; - Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first administration; - An arterial/venous thrombotic event occurred within 6 months prior to the first administration; - Active viral hepatitis with poor control; - Active syphilis infected individuals in need of treatment; - History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia; - Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; - Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy due to a history of hepatic encephalopathy; - Previously experienced grade 3 or higher adverse reactions related to immunotherapy; - Suffering from significant cardiovascular disease; - Active or uncontrolled severe infections; - Patients with renal failure requiring hemodialysis or peritoneal dialysis; - History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases; - Individuals with epilepsy who require treatment; - Previously received treatment with similar anti-lag3 drugs.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Guangdong provincial people's hospital

Address:
City: Guangzhou
Zip: 519041
Country: China

Contact:
Last name: Xing Zhang, Doctor

Phone: 13610223691
Email: zhangxing@sysucc.org.cn

Start date: November 2024

Completion date: December 2026

Lead sponsor:
Agency: Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.
Agency class: Industry

Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06649656