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NCT Number: NCT06662760

Clinical Trial of TQB3002 in Patients With Advanced Cancers

This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TQB3002 Tablets

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.

Primary outcomes

  1. Dose Limiting Toxicity (DLT)

    Time frame: During the first 28 days

    DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28days) of treatment.

  2. Maximum tolerated dose (MTD)

    Time frame: During the first 28 days

    MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

Secondary outcomes

  1. Half-life (T1/2)

    Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    Terminal half-life (T1/2)

  2. The area under the curve (AUC)

    Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    The area under the curve (AUC) of serum concentration of TQB3002

  3. Apparent Plasma Clearance (CL)

    Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    Apparent plasma clearance of TQB3002

  4. Apparent volume of distribution (Vz)

    Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    The ratio of the amount of TQB3002 in the body to the blood concentration

  5. Minimum concentration (Cmin)

    Time frame: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration

    Minimum observed concentration (Cmin) of TQB3002

Study contacts

Contact information is provided by the study sponsor or research team.

Qing Zhou, Doctor

CONTACT

[email protected]

020-83827812

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 29, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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