TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers

CTTQ

Status and phase

Enrolling

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: TQB2223 injection+ Penpulimab Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05894421

TQB2223-I-01

Details and patient eligibility

About

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.

Enrollment

92 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.