Actively Recruiting
Phase I Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2024-07-03
140
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of TQB3107 tablets in adults with advanced malignant tumors who have no standard treatment options or whose disease has progressed despite prior therapies. This Phase I clinical study aims to identify the dose-limiting toxicities, maximum tolerated dose, and recommended dose for further studies. TQB3107 is a protein inhibitor designed to stop tumor cell growth and trigger cancer cell death. Participants will receive TQB3107 tablets in one of two dosing schedules: either once daily for five days each week with two days off during a 28-day cycle, or once daily every day for the full 28-day cycle. An initial single fasting dose will be given followed by a 7-day observation period. The study will monitor participants during multiple cycles to assess safety and appropriate dosing. Throughout the study, participants will have regular evaluations including blood tests to measure how the drug is processed in the body and to monitor tumor response. Researchers will track toxicities and overall tolerability primarily during the first treatment cycle and continue assessments up to 24 months. Additional outcomes include objective tumor response, disease control, progression-free survival, and overall survival. Participants will be closely observed for adverse effects and treatment impact over the study duration.
CONDITIONS
Brief Title
A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at consent with a performance score of 0 to 1 and estimated survival of at least 3 months
- Diagnosis of malignant tumors with no standard treatment or disease progression/intolerance after prior therapy
- Good functioning of major organs
- Negative pregnancy test within 7 days before first dose, non-lactating, and agreement to use contraception during and for 6 months after study
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Hematologic malignancy involving or suspected in the central nervous system or primary CNS lymphoma
- Received anti-cancer therapy (surgery, chemotherapy, radiotherapy, immunotherapy, targeted therapy) within 4 weeks before first dose
- Severe or uncontrolled diseases posing increased risk as judged by investigator
- History of drug addiction or substance abuse
- Other concomitant diseases or conditions deemed by investigator to pose safety risks or affect study completion or suitability for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive TQB3107 tablets as a protein inhibitor to inhibit tumor cell proliferation and induce apoptosis. The medication is administered in 28-day cycles with either 5 consecutive days per week followed by 2 days off or daily dosing for 28 days per cycle.
Visits for dosing and assessments occur according to the dosing schedule with multiple visits during each cycle
Duration - Up to 24 months
Participants are monitored for safety and treatment outcomes including tumor response and survival for up to 24 months after starting treatment.
Periodic visits up to 24 months
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Cen
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Z
ZhiMing Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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