NCT06413953 A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors
| NCT ID | NCT06413953 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Condition | Advanced Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 140 participants in total. It began in 2024-06-27 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06413953 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06413953 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06413953 currently recruiting?
Yes, NCT06413953 is actively recruiting participants. Contact the research team at lzmsysu@163.com for enrollment information.
Where is the NCT06413953 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06413953 clinical trial?
NCT06413953 is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. The trial plans to enroll 140 participants.
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