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

Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Cancers

Treatments: Drug: TQB2252 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06649656

TQB2252-I-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

TQB2252 injection

Experimental group

Description:

This product is administered via intravenous infusion, with recommended doses of 600mg TQB2223 monoclonal antibody and 200mg penpulimab injection, administered once every 3 weeks.

Treatment:

Drug: TQB2252 injection