A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors
A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
140 participants
Jun 27, 2024
INTERVENTIONAL
Conditions
Summary
TQB3107 is a protein inhibitor that induces apoptosis and inhibits the proliferation of various tumor cells. This clinical study aims to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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.
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Interventions
TQB3107 tablets is protein inhibitor that inhibit tumor cell proliferation, and induce apoptosis, thereby exerting anti-tumor effects.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06413953