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TQB3617 is a bromodomain and extra-terminal (BET) inhibitor that can competitively bind to bromodomains (BRDs) with Acetylated lysine(Kac) and block or partially block the role of KAc in subsequent gene transcription and regulation of chromatin structure, thereby playing an anti-tumor role.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3617 | Experimental | 0.1mg, once daily, was used as the initial dose, and the medication stage was divided into single administration and continuous administration stages. The single administration was given once, and the continuous administration stage was entered 7 days after drug withdrawal. The drug was administered continuously until the disease progressed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3617 | Drug | TQB3617 is a BET inhibitor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | The highest dose of a drug or treatment that does not cause unacceptable side effects. | Baseline up to 48 weeks |
| Adverse events (AEs) and serious adverse events (SAEs) | The occurrence of all AEs and SAEs | Baseline up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum (peak) plasma concentration following drug administration(Tmax) | To characterize the pharmacokinetics of TQB3617 by assessment of time to reach maximum plasma concentration after single and multiple dosing | Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojia Wang, Master | Contact | 0571-88122146 | huang_jian22@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Cen | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41151587 | Derived | Zhang Y, Yin Q, Zhao B, Liu F, Li S, Cai J, Fang X, Bai B, Nie M, Zou Q, Ding D, Wang X, Zhu J, Yu D, Wang X, Zhang X, Wang L, Xia Y, Cai Q. TQB3617, a bromodomain and extra-terminal inhibitor, in patients with relapsed or refractory lymphoma: A multicenter, phase 1 trial. Med. 2026 Jan 9;7(1):100893. doi: 10.1016/j.medj.2025.100893. Epub 2025 Oct 27. |
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| Maximum (peak) plasma drug concentration (Cmax) | Cmax is the maximum plasma concentration of TQB3617 or metabolite(s). | Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28. |
| Elimination half-life (to be used in one-or non- compartmental model) (t1/2) | t1/2 is time it takes for the blood concentration of TQB3617 or metabolite(s) to drop by half. | Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours, after oral administration of a single drug delivery. |
| Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) | Maximum (peak) steady-state plasma drug concentration during a dosage interval | Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28. |
| Minimum steady-state plasma drug concentration during a dosage interval (Css-min) | Minimum steady-state plasma drug concentration during a dosage interval | Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28. |
| Concentration at the end of the dosing interval AUCtau,ss | To characterize the pharmacokinetics of TQB3617 by assessment of area the concentration at the end of the administration interval | Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8,12, 24, 48, 72, 96, 120,168 hours after oral administration of a single drug delivery; 30 minutes, 1, 2, 3, 4, 6, 8,12, 24 hours of day 28; 30 minutes before oral administration on day 8, day 15, day 22, day 28. |
| Overall response rate (ORR) | Percentage of participants achieving complete response (CR) and partial response (PR). | up to 96 weeks |
| Progress Free Survival(PFS) | From the start of randomization to the first tumor progression or time of death. | up to 96 weeks |
| Disease control rate(DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 96 weeks |
| Duration of Response (DOR) | The time when the participants first achieved complete or partial remission to disease progression. | up to 96 weeks |
| Overall Survival(OS) | From date of first administration of test drug until the date of death from any cause, | assessed up to 100 months |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 31002 | China |
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