Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Status and phase

Enrolling

Phase 1

Conditions

Advanced Cancers

Treatments

Drug: TQB2922 injection (subcutaneous injection)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07260708

TQB2922-I-02

Details and patient eligibility

About

This is a Phase I clinical study aimed at evaluating the safety and pharmacokinetics of TQB2922 subcutaneous injection in patients with advanced cancers.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
18-75 yeas old；
Eastern Cooperative Oncology Group Performance Status (ECOG) score: 0-1;
Expected survival of more than 12 weeks；
Histologically or cytologically diagnosed with advanced non-squamous non-small cell lung cancer
Subjects in the monotherapy introduction stage need to have received standard treatment or lack effective treatment.
There must be at least one measurable lesion within the radiotherapy area that can be clearly classified as progressive according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1) criteria.
Major organs are functioning well；
Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.

Exclusion criteria

Current concomitant presence of other malignancies within 5 years prior to the first dose；
At the time of initiating the study of treatment, the adverse reactions caused by previous anti-tumor treatments failed to recover to a CTCAE 5.0 score of grade 1 or below.
Patients who had received major surgical treatment within 4 weeks prior to the first study, had obvious traumatic injuries, or were expected to undergo major surgery during the study treatment period, or had long-term unhealed wounds or fractures.
Hyperactive or venous thrombosis events occurred within 6 months before the first administration;
Major cardiovascular diseases;
Active hepatitis
Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders.
There was an active infection (≥ Common Terminology Criteria for Adverse Events version 5.0 (CTCAE5.0) score of grade 2) within 2 weeks before the first administration;
Patients with renal failure requiring hemodialysis or peritoneal dialysis;
Patients who have a history of immune deficiency.
Patients who have epilepsy and need treatment;
Evidence of a previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any clinically active interstitial lung disease.
Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first treatment.
Pregnant or lactating women.
There is any serious or uncontrolled systemic disease.