Advanced CancerPhase 1NCT06662760
Clinical Trial of TQB3002 in Patients With Advanced Cancers
A Phase 1 study testing TQB3002 Tablets in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites in China.
Trial summary
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- TQB3002 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesChina
- Study dates
- 9 Dec 2024to Oct 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610040
Juan Li, Doctor, 13570431657
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510180
Qing Zhou, Doctor, 020-83827812, zhouqing@gdph.org.cn
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Runxiang Yang, Master, 13888876721, 13888876721@163.com
- Not yet recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621099
Yu Zhang, Doctor, 15228700888, 543703371@qq.com
- Not yet recruiting
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330038
Longhua Sun, Doctor, 18279110112, 48570887@qq.com
Jinhua Wen, Doctor, 13970823367, wenjh8606@163.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Renhua Guo, Master, 13585145540, guorenhua@csco.ac.cn
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Shengxiang Ren, Doctor, 13816756732, harry_ren@126.com
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518117
Shi Jin, Doctor, 13796600916, 13796600916@126.com
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004
Hui Guo, Doctor, 13572824106, guohuihappy97@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710061
Yu Yao, Doctor, 13572101611, Oncology_yao@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Yanqiu Zhao, Doctor, 13938252350, 13938252350@163.com
About this study
Official title: A Phase I Clinical Study 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
- Conditions
- Advanced Cancer
- Being tested
- TQB3002 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3002 TabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TQB3002 Tablets | Experimental | TQB3002 Tablets, 28 days as a treatment cycle Receives: Drug: TQB3002 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the first 28 days
Secondary outcomes (5)
Half-life (T1/2)
Terminal half-life (T1/2)
Measured: 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)
The area under the curve (AUC) of serum concentration of TQB3002
Measured: 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)
Apparent plasma clearance of TQB3002
Measured: 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)
The ratio of the amount of TQB3002 in the body to the blood concentration
Measured: 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)
Minimum observed concentration (Cmin) of TQB3002
Measured: Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start9 Dec 2024
- Primary completionNov 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662760
- Sponsor's protocol ID
- TQB3002-I-01
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No