Clinical Trial of TQB2922 for Injection in Patients With Advanced Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB2922 for injection

TQB2922 for injection, 28 days as a treatment cycle

Group Type EXPERIMENTAL

TQB2922 for injection

Intervention Type DRUG

TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle

Interventions

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TQB2922 for injection

TQB2922 for injection is administrated to patients with advanced cancers, 28 days as a treatment cycle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No