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

TQB3107 is an target inhibitor that binds to target to induce apoptosis and inhibits the proliferation of a variety of tumor cells. This is a clinical study to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).

Inclusion Criteria:

• 18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); Score 0~1 point, estimated survival ≥ 3 months；
• Advanced malignant tumor；
• 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；
• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.