TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers

Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2223 Injection Combined With Penpulimab Injection in Subjects With Advanced Cancers

TQB2223 is a recombinant, fully humanized antibody that binds lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and effectiveness of TQB2223 injection in combination with Penpulimab in subjects with advanced cancers.

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
• Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥3 months;
• Histologically or cytologically confirmed malignancies;
• Subjects with advanced malignant tumors who failed standard treatment or lacked effective treatment;
• Patient has at least one evaluable lesion assessed by RECIST 1.1;
• The main organs function is well;
• Male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures during study period until at least 6 months after the last dose of study drug.

Exclusion Criteria:

• Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years;
• History of uncontrolled intercurrent illness;
• Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
• Prior treatment targeting LAG-3;
• Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.