Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers

CTTQ

Status and phase

Enrolling

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: TQB2922 for injection

Study type

Interventional

Funder types

Industry

Identifiers

TQB2922-I-01

Details and patient eligibility

About

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB2922 for injection in subjects with advanced cancers

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects voluntarily join this study, sign the informed consent form, and have good compliance；
Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
Histologically or cytologically diagnosed with advanced cancers;
Subjects with advanced malignancies who have failed standard therapy or lack effective treatment;
Major organs are functioning well;
Female and male subjects of childbearing potential should agree to practice contraception during the study and until 6 months after the completion of the study.

Exclusion criteria

Current concomitant or ever presented with other malignancies within 2 years prior to the first dose;
Unresolved toxicity of Grade 1 or above according to CTCAE due to any prior anti-tumor therapy;
Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
Long-term unhealed wounds or fractures
Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
A history of psychotropic drug abuse and cannot be abstained, or have a mental disorder;
Subjects with any severe and/or uncontrolled disease;
History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2922 for injection or its excipients;
According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.