All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunoglobulin G

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.

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.

TQB2916 injection

Yi Ba, Doctor

Huilai Zhang, Doctor

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.

Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors

Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors

To evaluate MTD of TQB2916 injection in patients with advanced solid tumors

To evaluate DLT of TQB2916 injection in Chinese adult patients with advanced solid tumors

To evaluate RP2D of TQB2916 injection in Chinese adult patients with advanced solid tumors

The occurrence of all adverse events (AE), serious adverse events (SAE) and treatment-related adverse events (TRAE)

Time to reach maximum (peak) plasma concentration following drug administration

Cmax is the maximum plasma concentration of TQB2916.

t1/2 is time it takes for the blood concentration of TQB2916 or metabolite(s) to drop by half.

To characterize the pharmacokinetics of TQB2916 by assessment of area under the plasma concentration time curve from the first dose to infinity.

Cmax is the maximum plasma concentration of TQB2916

To characterize the pharmacokinetics of TQB2916 by assessment of area The concentration at the end of the administration interval

Cmin is the minimum plasma concentration of TQB2916

Time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first

Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

The time when the participants first achieved complete or partial remission to disease progression.

the time from start of study treatment to date of death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors	NCT05213767	Advanced Tumors	TQB2916 injecti...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors	NCT05213767	Advanced Tumors	TQB2916 injecti...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for tqb2916 injection