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TQB3909 is an inhibitor targeting B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates caspase 3/7 activity and caspase 3/9 cleavage, and induces apoptosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3909 tablets | Experimental | 200-1000mg of TQB3909 tablets once a day; Oral administration under fast condition, 28 days as a cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3909 tablets | Drug | TQB3909 is an inhibitor targeting BCL-2 protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), 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 (Cycle 1, Day 28) |
| 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 (Cycle 1, Day 28) |
| Recommended Phase II Dose (RP2D) | DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3909 tablets in adult patients with Breast cancers | Baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum (peak)plasma concentration (Tmax) | To characterize the pharmacokinetics of TQB3909 by assessment of time to reach maximum plasma concentration after single and multiple dosing. | before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28. |
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Inclusion Criteria:
Exclusion Criteria:
1. Concomitant disease and medical history:
Tumor-related symptoms and treatment:
Known hypersensitivity to TQB3909, LHRH agonists (e.g., goserelin), or any excipients.
Subjects who have received the vaccine within 28 days prior to the first dose, or are planning to receive the vaccine during the study period.
Has Participated in other clinical trials within 4 weeks before first dose.
According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
female patient aged from 18 to 75 years old, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| Peak concentration (Cmax) | Maximum observed concentration (Cmax) of TQB3909 | before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28. |
| Terminal half-life (T1/2) | Pharmacokinetics parameters to evaluate the half life of TQB3909 (T1/2) | before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28. |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve from the first dose to a certain time point. | before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28. |
| Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) | Cmax,ss is the steady state maximum concentration of TQB3909. | before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28. |
| Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss) | Cmin,ss is the minimum plasma concentration of TQB3909. | before administration at Day 1, Cycle1 Day7,Cycle1 Day14, Cycle1 Day28; 1, 2, 4, 6, 8, 10,24,48, and 72 hours after-dose at Day 1; 1, 2, 4, 6, 8, 10, and 24 hours after-dose at Cycle 1 Day 28. |
| Clinilca Benefit Rate (CBR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | 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. |
| Objective Response Rate (ORR) | Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria | 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. |