Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The trial was divided into two phases: dose escalation and dose expansion. The dosing regimens were single-dose study and continuous dosing study. A single-center, open, non-randomized, single-arm clinical trial design was adopted. Subjects with advanced malignant tumors were selected to take TQB3205 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3205 capsules.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3205 capsules | Experimental | Single or continuous administration, 6-36 mg each time; TQB3205 capsule is taken orally once a day on an empty stomach, and each cycle is 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3205 capsules | Drug | TQB3205 capsule is a targeted protein degrader |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI Common Terminology Criteria for Adverse Events(CTCAE) version6.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle. | At the end of Cycle 1 (each cycle is 21 Days) |
| 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 (each cycle is 21 Days) |
| Recommended Phase II Dose (RP2D) | RP2D describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3205 capsules in adult patients with Advanced Malignant Cancer | Baseline up to 24 months |
| Maximum assessed dose (MAD) | Recommendations made by the investigator and sponsor based on clinical safety, efficacy, Pharmacokinetics (PK), and Pharmacodynamics (PD) data will be considered the highest dose level to complete dose exploration in the absence of an Maximum Tolerated Dose (MTD). | Baseline up to 24 months |
| The occurrence of all adverse events (AEs) | The occurrence of all adverse events (AEs) | From the time the subject receives TQB3205 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years) |
| The occurrence of all serious adverse events (SAEs) | The occurrence of all serious adverse events (SAEs). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The proportion of subjects with best response of Complete response, partial response, Very good partial response, and Minimal response. | From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 3 years |
| Tmax |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihui Hao, Doctor | Contact | 022-23340123-3070 | haojihui@tjmuch.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From the time the subject receives TQB3205 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years) |
| Number of subjects with abnormal incidence of laboratory test indicators | Number of subjects with abnormal incidence and severity of laboratory test indicators . | From the time the subject receives TQB3205 to 28 days after the last dose or until the start of other anti-tumor treatment (whichever occurs first, up to approximately 3 years) |
Time to Reach the Maximum Plasma Concentration |
| Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle) |
| Cmax | Cmax is the maximum plasma concentration of TQB3205. | Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle) |
| Elimination half-life (t1/2) | To evaluate the elimination half-life (t1/2) after oral dose of TQB3205 capsules to subjects. | Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle) |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | To characterize the pharmacokinetics of TQB3205 by assessment of area under the plasma concentration time curve from the first dose to a certain time. | Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is 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 Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle) |
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution of the TQB3205 in plasma. | Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle) |
| Minimum concentration (Cminutes) | Minimum observed concentration (Cminutes) of TQB3205 | Single Day 1: 0.5 hour pre-dose, 1, 2, 3,4, 6, 8, 12,24,48,72,96,144 hours after-dose. Cycle1 Day 1: 0.5 hour pre-dose,1, 2, 3,4, 6, 8, 12,24 hours after-dose. Cycle 1 Day 21: at 30 minutes,1, 2, 3, 4, 6, 8, 12,24 hours after-dose.(21 days is a cycle) |
| Disease Control Rate (DCR) | The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a cancer treatment in clinical trials. | 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 |
| Duration of Response (DOR) | The time from the date of first documentation of a CR or PR or PD to the date of first documentation of tumor progression. | 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 |
| Progression Free Survival (PFS) | The time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. | 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 |
| Overall Survival (OS) | The time from start of study treatment to date of death due to any cause | From the date of first medication use to the date of death from any cause, assessed up to 100 weeks |