Clinical Trial of TQB3002 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

2024-12-09

Study Completion Date

2026-10-31

Brief Summary

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This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 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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TQB3002 Tablets

TQB3002 Tablets, 28 days as a treatment cycle

Group Type EXPERIMENTAL

TQB3002 Tablets

Intervention Type DRUG

TQB3002 is a fourth-generation small molecule Epidermal growth factor receptor (EGFR) inhibitor, which inhibits relevant tyrosine kinase activity and intracellular phosphorylation process by competitively binding to Adenosine triphosphate (ATP) site of intracellular tyrosine kinase binding domain, thereby inhibiting EGFR downstream signaling, ultimately achieving the purpose of inhibiting tumor growth.

Interventions

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TQB3002 Tablets

TQB3002 is a fourth-generation small molecule Epidermal growth factor receptor (EGFR) inhibitor, which inhibits relevant tyrosine kinase activity and intracellular phosphorylation process by competitively binding to Adenosine triphosphate (ATP) site of intracellular tyrosine kinase binding domain, thereby inhibiting EGFR downstream signaling, ultimately achieving the purpose of inhibiting tumor growth.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
* Age: ≥ 18 years old; 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 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；
* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy
* Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks 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
* Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy
* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder
* Subjects with any severe and/or uncontrolled disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING