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The sponsor voluntarily withdraw the project.
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This study is divided into two stages: dose escalation and dose extension, including a single dose and a multiple dose clinical study. This is a single-center, open, non randomized, single arm study to the safety and tolerability of TQB3015 tables in patients with advanced malignant cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3015 tablets | Experimental | TQB3015 tables is administered as a single dose or multiple dose, 2-40mg once a day; Oral administration on fast condition, 21 days as a cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3015 tablets | Drug | TQB3015 is a protein inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT will be defined as toxicities that meet pre-defined severity criteria according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity, and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle. | At the end of Cycle 1 (Day 21). |
| Maximum tolerated dose (MTD) | MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. | At the end of Cycle 1 (Day 21). |
| Recommended Phase II Dose (RP2D) | DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3015 tablets in adult patients with Advanced Malignant Cancer. | Baseline up to 24 months |
| Incidence of abnormal clinical laboratory | Incidence of participants with clinical laboratory abnormalities | 30 days after the last administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) | The occurrence of all adverse events (AE). | 30 days after the last administration. |
| Serious adverse events (SAE) | The occurrence of all serious adverse events (SAE). |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant disease and medical history:
Tumor-related symptoms and treatment:
According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
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| 30 days after the last administration. |
| Time to reach maximum (peak) plasma concentration (Tmax) | To characterize the pharmacokinetics of TQB3015 by assessment of time to reach maximum plasma concentration after single and multiple dosing. | Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days. |
| Peak concentration (Cmax) | The maximum observed plasma concentration of study drug. | Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days. |
| Half-life (t1/2) | The time required for half of the drug to be eliminated from the plasma. | Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days. |
| Area under the concentration-time curve from zero to infinity (AUC0-∞) | To characterize the pharmacokinetics of TQB3015 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity. | Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days. |
| Area under the concentration-time curve from zero to last observation (AUC [0-t]) | To characterize the pharmacokinetics of TQB3015 by assessment of area under the plasma concentration time curve from the first dose to a certain time point. | Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days. |
| Apparent clearance (CL/F) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days. |
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution of the TQB3015 in plasma. | Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days. |
| Objective response rate (ORR) | The percentage of patients with complete response (CR) and/or partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks. |