Testing TQB3002 in patients with advanced cancers
A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers
This study is testing a new pill called TQB3002 to see if it can help people with advanced cancers that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Locations | 11 sites (Guangzhou, Guangdong and 10 other locations) |
| Trial ID | NCT06662760 on ClinicalTrials.gov |
What this trial studies
This Phase I clinical trial evaluates the safety, tolerability, and efficacy of TQB3002 tablets in patients diagnosed with advanced cancers. Participants must have advanced malignancies that have not responded to standard therapies or for which no effective treatment options are available. The study aims to determine how well TQB3002 can be tolerated and its potential effectiveness in this patient population. Eligible participants are those aged 18-75 with a good performance status and expected survival of more than three months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced cancers that have failed standard therapies.
Not a fit: Patients with unresolved toxicity from prior treatments or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers who have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for advanced cancers have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong and 10 other locations
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, Guangdong, China (Not_yet_recruiting)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
- The First Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Not_yet_recruiting)
- The First Affiliated Hospital of Xi'an Jiao Tong University — Xi’an, Shanxi, China (Not_yet_recruiting)
- Sichuan Cancer Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
- Mianyang Central Hospital — Mianyang, Sichuan, China (Not_yet_recruiting)
- Yunnan Cancer Hospital — Kunming, Yunnan, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Qing Zhou, Doctor
- Email: zhouqing@gdph.org.cn
- Phone: 020-83827812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.