A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

NCT ID: NCT06413953

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2026-12-31

Brief 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).

Conditions

Advanced Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3107 tablets

Dosing regimen 1 (20/28): 28 days per cycle (4 weeks), the medication is administered once daily for 5 consecutive days per week, followed by a 2-day break. The initial dose is a single fasting dose of C0, with a subsequent 7-day observation period.

Dosing regimen 2 (28/28): 28 days per cycle, the medication is administered once daily for the entire 28-day period, all other dosing requirements are consistent with Regimen 1.

Group Type: EXPERIMENTAL

TQB3107 Tablets

Intervention Type: DRUG

TQB3107 tablets is protein inhibitor that inhibit tumor cell proliferation, and induce apoptosis, thereby exerting anti-tumor effects.

Interventions

TQB3107 Tablets

TQB3107 tablets is protein inhibitor that inhibit tumor cell proliferation, and induce apoptosis, thereby exerting anti-tumor effects.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Cen

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

ZhiMing Li, Doctor

Role: CONTACT

lzmsysu@163.com

13719189172

Facility Contacts

ZhiMing Li, Doctor

Role: primary

lzmsysu@163.com

13719189172

Other Identifiers

TQB3107-I-01

Identifier Type: -

Identifier Source: org_study_id