All Drugs and Chemicals

Protein Kinase Inhibitors

TQB3912 tablets, 28 days as a treatment cycle.

TQB3912 is a small molecule Phosphorylated protein kinase inhibitor. Activation of the pathway plays an important role in cell survival, proliferation, migration, and differentiation.

TQB3912 tablets

Qiang Wei, Doctor

Quchang Ouyang, Doctor

Ping Feng, Doctor

This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3912 tablets, determine MTD; Phase Ib: Effectiveness exploration period, to expand the safe and effective dose group, and to recommend appropriate dosage and method for subsequent clinical research.

A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3912 Tablets in Subjects With Advanced Malignancies

Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade III hematological toxicity, Neutropenia associated with fever.

MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

From the first drug treatment to the last drug treatment.

Number of patients with adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Number of patients with serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

The proportion of subjects with Complete response (CR), Partial response (PR), or Stable Disease (SD).

The time from the first dose of TQB3912 to the first occurrence of disease progression or death from any cause.

The time from first documented response to documented disease progression.

The time between the date of first administration and the date of death due to any cause.

To characterize the pharmacokinetics of TQB3912 by assessment of time to reach maximum plasma concentration after single and multiple dosing.

Cmax is the maximum plasma concentration of TQB3912 or metabolite(s).

Cmax,ss is the maximum steady-state plasma concentration of TQB3912 or metabolite(s).

To characterize the pharmacokinetics of TQB3912 by assessment of area under the plasma concentration time curve from the first dose to time t.

t1/2 is time it takes for the blood concentration of TQB3912 or metabolite(s) to drop by half.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor	NCT05997342	Advanced Malign...	TQB3912 tablets	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor	NCT05997342	Advanced Malign...	TQB3912 tablets	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for tqb3912 tablets