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This is the first-in-human clinical study of TQB3217, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3217 in advanced solid tumors, and to preliminarily explore its efficacy in solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3217Tablets | Experimental | TQB3217 Tablets: Administer once daily, recommended to be taken orally on an empty stomach in the morning at a fixed time, continuously, with each 21-day period as one treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3217Tablets | Drug | TQB3217 Tablets are ubiquitin specific peptidase 1(USP1)-t inhibitor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria. | At the end of Cycle 1 (each cycle is 21 days) |
| Maximum tolerated dose (MTD) | MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. | At the end of Cycle 1 (each cycle is 21 days) |
| Recommended Phase II Dose (RP2D) | DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3217 tablets in adult patients with advanced malignant cancer. | Baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of participant with Adverse events (AEs) and serious adverse events (SAEs) | The incidence and severity of AEs and SAEs, as well as abnormal laboratory test indicators. | 30 days after the last administration |
| Time to Reach the Maximum Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Li, Doctor | Contact | 13801364117 | lb87960440@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100021 | China |
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To characterize the pharmacokinetics of TQB3217 by assessment of time to reach maximum plasma concentration after single and multiple dosing. |
| Single dose day 1: pre-dose, at 0.5, 1, 1.5,2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle) |
| Peak concentration (Cmax) | The maximum observed plasma concentration of TQB3217 tablets. | Single dose day 1: pre-dose, at 0.5, 1, 1.5,2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle) |
| Half-life (t1/2) | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | Single dose day 1: pre-dose, at 0.5, 1, 1.5,2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle) |
| Area under the concentration-time curve (AUC [0-infinity] | To characterize the pharmacokinetics of TQB3217 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity. | Single dose day 1: pre-dose, at 0.5, 1, 1.5,2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle) |
| Area under the concentration-time curve (AUC [0-t] | To characterize the pharmacokinetics of TQB3217 by assessment of area under the plasma concentration time curve from the first dose to a certain time point. | Single dose day 1: pre-dose, at 0.5, 1, 1.5,2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle) |
| Apparent clearance (CL/F) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | Single dose day 1: pre-dose, at 0.5, 1, 1.5,2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle) |
| Apparent Volume of Distribution during the Terminal Phase | Apparent volume of distribution during the Terminal Phase of the TQB3217 in plasma. | Single dose day 1: pre-dose, at 0.5, 1, 1.5,2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle) |
| Objective Response Rate (ORR) | The percentage of complete response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. | Up to 2 years |
| Disease control rate (DCR) | Defined as the proportion of subjects with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). | Up to 2 years |
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression. | Up to 2 years |
| Overall Survival (OS) | the time from start of study treatment to date of death due to any cause. | From start of study treatment up to die ,estimated at two years |