A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors
ConditionAdvanced Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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；
Trial design
Design model
Single group
Treatments tested in this trial
TQB3107 Tablets
DrugTQB3107 Tablets is a selective target inhibitor.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: TQB3107 tabletsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity (DLT)
DLT refers to toxicities that are associated with the drug and occur from the first medication administration to the end of the first treatment cycle, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria.
Time frame
At the end of Cycle 1 (each cycle is 28 days)2
Maximum tolerated dose (MTD)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Time frame
At the end of Cycle 1 (each cycle is 28 days)3
Phase II Recommended Dose (RP2D)
The recommended dose, determined after initial dose escalation and toxicity assessment, it is used to further evaluate the efficacy and safety of the drug.
Time frame
Baseline up to 24 monthsSecondary outcomes
1
Elimination half-life (t1/2)
The time it takes for the concentration of the drug in the plasma to be reduced by 50%.
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.2
Time to Peak (Tmax)
The time it takes to reach peak concentrations after administration.
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.3
Peak Concentration (Cmax)
Maximum plasma concentration of drug.
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.4
Area under the plasma concentration-time curve (AUC0-last)
The area enclosed by the plasma concentration curve against the timeline.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov