Recruiting NCT06413953
A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TQB3107 Tablets.
- Who it may be relevant to
- Registry conditions: Advanced Cancers. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Clinical Study of Tolerability and Pharmacokinetics of TQB3107 Tablets in Patients With Malignant Tumors
Overview
TQB3107 is an target inhibitor that binds to target to induce apoptosis and inhibits the proliferation of a variety of tumor cells. This is a clinical study to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).
Interventions
- Drug TQB3107 Tablets
TQB3107 Tablets is a selective target inhibitor.
Primary outcome measures
- Dose Limiting Toxicity (DLT) [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
- Maximum tolerated dose (MTD) [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
- Phase II Recommended Dose (RP2D) [Time frame: Baseline up to 24 months]
Secondary outcome measures (11)
- Elimination half-life (t1/2) [Time frame: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
- Time to Peak (Tmax) [Time frame: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
- Peak Concentration (Cmax) [Time frame: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
- Area under the plasma concentration-time curve (AUC0-last) [Time frame: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
- Steady-state peak concentration (Css-max) [Time frame: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
- Steady-state trough concentration (Css-min) [Time frame: Cycle 0 Day 1: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 hours. Cycle 1 Day 1, 5, 12: 24 hours post-dose only. Cycle 1 Day 26: pre-dose ≤ 30 minutes; post-dose: 15, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours.]
- Objective Response Rate (ORR) [Time frame: UP to 3 years]
- Disease Control Rate (DCR) [Time frame: UP to 3 years]
- Duration of Response (DOR) [Time frame: UP to 3 years]
- Progression-free survival (PFS) [Time frame: UP to 3 years]
- Overall Survival (OS) [Time frame: UP to 3 years]
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；
- Advanced malignant tumor；
- 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；
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 12 centers
- Sun Yat-sen University Cancer Cen — Guangzhou
- The Fifth Affiliated Hospital Sun Yat-sen University — Zhuhai
- The Affiliated Hospital of Chengde Medical College — Chengde
- Harbin Medical University Cancer Hospital — Harbin
- Hunan Cancer Hospital — Changsha
- The First People's Hospital Of Changzhou — Changzhou
- Shandong Medical And Pharmaceutical University Hospital — Binzhou
- Fudan University Shanghai Cancer Center — Shanghai
- … and 4 more centers
Identifiers
NCT: NCT06413953 · TQB3107-I-01