TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Criteria

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.