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Trial Title:
A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors
NCT ID:
NCT06413953
Condition:
Advanced Cancers
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3107 Tablets
Description:
TQB3107 tablets is protein inhibitor that inhibit tumor cell proliferation, and induce
apoptosis, thereby exerting anti-tumor effects.
Arm group label:
TQB3107 tablets
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Cen
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
ZhiMing Li, Doctor
Phone:
13719189172
Email:
lzmsysu@163.com
Start date:
June 27, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06413953
