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

Launched by CHIA TAI TIANQING PHARMACEUTICAL (GUANGZHOU) CO., LTD. · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TQB2252 injection for people with advanced cancers. The main goals are to see if this treatment is safe, how it works in the body, and whether it helps fight cancer. The trial will include participants who are between 18 and 75 years old and have been diagnosed with late-stage cancers that have not responded to standard treatments. To take part, individuals must have at least one measurable tumor and be able to provide informed consent, which means they agree to participate in the study after understanding what it involves.

Participants can expect to receive the TQB2252 injection and will be closely monitored for any side effects and how their bodies react to the treatment. It's important to note that certain individuals, such as those with other active cancers, serious infections, or certain health conditions, will not be eligible to join. This trial is not yet recruiting participants, but it aims to gather important information that could help develop new options for treating advanced cancers in the future.

Gender

ALL

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.