A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TQB3107, which is designed to help fight advanced cancers by stopping tumor cells from growing and encouraging them to die. The main goal of the study is to find out how safe the TQB3107 tablets are, what the best dose is, and any side effects that might occur. The trial is currently recruiting participants, and they want to include adults aged 18 to 75 who have certain types of malignant tumors that do not have standard treatment options or have not responded to previous therapies.

To be eligible for this study, participants should be in generally good health, with functioning major organs, and should not have had other cancer treatments like chemotherapy or surgery in the four weeks before starting the trial. Women must have a negative pregnancy test and agree to use contraception during the study. If you join the trial, you will receive the TQB3107 tablets and be monitored closely for any side effects or health changes. It's important to know that this is an early-stage study, so the results will help determine if TQB3107 is safe and effective for further testing.

Gender

ALL

Eligibility 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.