Testing TQB3107 tablets in patients with advanced cancers
A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors
This study is testing TQB3107 tablets to see if they are safe and effective for people with advanced cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06413953 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and tolerability of TQB3107 tablets, a protein inhibitor designed to induce apoptosis and inhibit tumor cell proliferation, in patients with advanced malignancies. The study aims to identify dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for future phases. Participants will be closely monitored to assess the drug's effects and overall safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced malignant tumors that have no standard treatment options or have progressed after prior therapies.
Not a fit: Patients with hematologic malignancies involving the central nervous system or those who have received recent anti-cancer therapies 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 that have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies targeting advanced cancers with protein inhibitors have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); Score 0\~1 point, estimated survival ≥ 3 months； * Malignant tumors with no standard treatment regimen or disease progression or intolerance after prior standard therapy； * The major organs are functioning well； * Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception throughout the study and for 6 months after the study ends; * Subjects voluntarily participated in this study, signing the informed consent form and demonstrating good compliance. Exclusion Criteria: * Hematologic malignancy has or is suspected to involve the central nervous system, or primary central nervous system lymphoma; * Received any anti-cancer therapy such as major surgery, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to the first dose; * Combined with severe or not well-controlled diseases, which the investigator judges to be at greater risk of entering this study； * Those with a history of drug addiction or substance abuse； * Based on the investigator's judgement, subjects with concomitant diseases that pose a significant risk to their safety or compromise the study's completion, or subjects deemed unsuitable for enrollment due to other reasons, will be excluded.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Cen — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: ZhiMing Li, Doctor
- Email: lzmsysu@163.com
- Phone: 13719189172
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.