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This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB2916 injection in patients with advanced tumors, and to initially evaluate the antitumor efficacy of TQB2916 injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2916 injection | Experimental | 2.5mg/ quaque die (QD) was used as the initial dose, 21 days as a treatment cycle. The drug is administered on the first day of each cycle until the disease progresses or the investigator judges that it is not suitable for subject to continue to take medicine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2916 injection | Drug | TQB2916 injection is a kind of Tumor necrosis factor receptor superfamily member 5 (CD40) agonist, which is a humanized immunoglobulinG2 (IgG2) monoclonal antibody targeting CD40. This product can bind to CD40 on target cells to activate downstream signaling pathways and generate anti-tumor immune responses. At the same time, it can promote the apoptosis of B-cell lymphoma Ramos cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | To evaluate MTD of TQB2916 injection in patients with advanced solid tumors | Baseline up to 52 weeks |
| Dose limited toxicity (DLT) | To evaluate DLT of TQB2916 injection in Chinese adult patients with advanced solid tumors | Baseline up to 52 weeks |
| Recommended Phase II Dose (RP2D) | To evaluate RP2D of TQB2916 injection in Chinese adult patients with advanced solid tumors | Baseline up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) , serious adverse events (SAE) and treatment-related adverse events (TRAE) | The occurrence of all adverse events (AE), serious adverse events (SAE) and treatment-related adverse events (TRAE) | Baseline up to 104 weeks |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Ba, Doctor | Contact | 18622221230 | bayi@tjmuch.com | |
| Huilai Zhang, Doctor | Contact | 18622221228 | zhlwgq@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
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Time to reach maximum (peak) plasma concentration following drug administration
| (-1 to 0 hour) (pre-dose), 0,1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1. |
| Maximum (peak) plasma drug concentration (Cmax) | Cmax is the maximum plasma concentration of TQB2916. | (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1. |
| Elimination half-life (t1/2) | t1/2 is time it takes for the blood concentration of TQB2916 or metabolite(s) to drop by half. | (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1. |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | To characterize the pharmacokinetics of TQB2916 by assessment of area under the plasma concentration time curve from the first dose to infinity. | (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1. |
| Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) | Cmax is the maximum plasma concentration of TQB2916 | (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1. |
| Concentration at the end of the dosing interval AUCtau,ss | To characterize the pharmacokinetics of TQB2916 by assessment of area The concentration at the end of the administration interval | (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1. |
| Minimum steady-state plasma drug concentration during a dosage interval (Css-min) | Cmin is the minimum plasma concentration of TQB2916 | (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1. |
| Progress Free Survival (PFS) | Time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first | 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) | the time from start of study treatment to date of death due to any cause | up to 96 weeks |