A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
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|ClinicalTrials.gov Identifier: NCT04481607|
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor or Hematologic Tumor||Drug: TQB3454||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets|
|Actual Study Start Date :||August 24, 2020|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: TQB3454 tablets
TQB3454 tablets administered orally once. Then TQB3454 tablets administered orally, once daily in 28-day cycle after 7 days of first administration.
TQB3454 tablets is a small molecule oral drug.
- Maximum tolerated dose (MTD) [ Time Frame: Baseline up to 28 days ]MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
- Cmax [ Time Frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose; ]Cmax is the maximum plasma concentration of TQB3454 or metabolite(s).
- Tmax [ Time Frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose; ]To characterize the pharmacokinetics of TQB3454 by assessment of time to reach maximum plasma concentration.
- AUC0-t [ Time Frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose; ]To characterize the pharmacokinetics of TQB3454 by assessment of area under the plasma concentration time curve from zero to infinity.
- Objective response rate (ORR) [ Time Frame: up to 60 weeks ]Percentage of participants achieving complete response (CR) and partial response (PR).
- Progression-free survival (PFS) [ Time Frame: Up to 60 weeks ]PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
- 2-hydroxyglutaric acid [ Time Frame: Hour 0(pre-dose) on single dose; Hour 0(pre-dose) of day1, day8, day15, day28 on multiple dose of first cycle; hour 0(pre-dose) of day15, day28 of second and third cycle; hour 0(pre-dose) of day28 of fourth to eighth cycle.Each cycle is 28 days. ]Correlation between 2-hydroxyglutaric acid and efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481607
|Contact: Lin Shen, Doctorfirstname.lastname@example.org|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100089|
|Contact: Lin Shen, Doctor 010-88196340 email@example.com|
|Principal Investigator: Lin Shen, Doctor|