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A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06413953•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Sun Yat-sen University Cancer Cen

Guangzhou, Guangdong, China

Key Dates

Start Date

June 27, 2024

Primary Completion Date

June 1, 2025

Completion Date

December 1, 2026

Last Updated

July 3, 2024

Enrollment

140

ESTIMATED participants

Conditions

Advanced Cancers

Interventions

TQB3107 Tablets

DRUG

Contacts

ZhiMing Li, Doctor

CONTACT

13719189172 lzmsysu@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

Inclusion Criteria

Exclusion Criteria

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