Clinical Trial of TQB3002 in Patients With Advanced Cancers

NCT06662760 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TQB3002-I-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  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.

  During the first 28 days

• Maximum tolerated dose (MTD)

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

  During the first 28 days

Secondary Outcomes (5)

• Half-life (T1/2)

  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)

  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 (CL)

  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 volume of distribution (Vz)

  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 concentration (Cmin)

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

Study Arms (1)

TQB3002 Tablets

EXPERIMENTAL

TQB3002 Tablets, 28 days as a treatment cycle

Drug: TQB3002 Tablets

Interventions

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.

TQB3002 Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (11)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, 518117, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330038, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710004, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610040, China

NOT YET RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, 621099, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

NOT YET RECRUITING

Central Study Contacts

Qing Zhou, Doctor

CONTACT

020-83827812; zhouqing@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: December 9, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-09

Locations

CN (11)