National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
NCT Number: NCT07291050
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100021, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TQB3217 Tablets are ubiquitin specific peptidase 1(USP1)-t inhibitor.
Time frame: At the end of Cycle 1 (each cycle is 21 days)
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.
Time frame: At the end of Cycle 1 (each cycle is 21 days)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Time frame: Baseline up to 24 months
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.
Time frame: 30 days after the last administration
The incidence and severity of AEs and SAEs, as well as abnormal laboratory test indicators.
Time frame: 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)
To characterize the pharmacokinetics of TQB3217 by assessment of time to reach maximum plasma concentration after single and multiple dosing.
Time frame: 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)
The maximum observed plasma concentration of TQB3217 tablets.
Time frame: 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)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time frame: 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)
To characterize the pharmacokinetics of TQB3217 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.
Time frame: 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)
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.
Time frame: 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)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 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 of the TQB3217 in plasma.
Time frame: Up to 2 years
The percentage of complete response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Time frame: Up to 2 years
Defined as the proportion of subjects with Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Time frame: Up to 2 years
Defined as the time from first documented response to documented disease progression.
Time frame: From start of study treatment up to die ,estimated at two years
the time from start of study treatment to date of death due to any cause.
Contact information is provided by the study sponsor or research team.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3217 Tablets in Subjects With Advanced Malignant Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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