All Drugs and Chemicals

Estrogens

Take 300mg, 450mg, 600mg, 750mg, 900mg each time, once a day;Oral administration on an empty stomach, 28 days as a cycle. Duration of medication: Continue medication until disease progression or intolerable toxicity occurs.

TQB3915 binds to estrogen receptors through covalent bonds, and blocks intracellular signal transmission by changing the conformation of ERα, thereby inhibiting the growth of tumor cells.

TQB3915 tablets

Yongmei p Yin, Doctor

Shusen Wang, Doctor

Min Yan, Doctor

TQB3915 is a selective estrogen receptor covalent antagonist, by covalently binding to estrogen receptor, by changing the conformation of ERα, blocking intracellular signal transmission, thereby inhibiting the growth of tumor cells.

Phase I Clinical Trial of TQB3915 Tablets in Subjects With Advanced Malignant Solid Tumors

The following adverse events related to the trial drug occurred within 1 treatment cycle (34 days) of the subject's first dose

The MTD was the previous dose at which the following toxicities occurred

To evaluate RP2D of TQB3915 Tablets in patients with advanced malignant tumors

Incidence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)

To characterize the pharmacokinetics of TQB3915 by assessment of time to reach maximum plasma concentration after single dosing

Cmax is the maximum plasma concentration of TQB3915.

t1/2 is time it takes for the blood concentration of TQB3915 to drop by half.

To characterize the pharmacokinetics of TQB3915 by assessment of area under the plasma concentration time curve from the first dose to infinity.

To characterize the pharmacokinetics of TQB3915 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

CL/F is total clearance rate for TQB3915.

Vz/F is the apparent distribution volume of TQB3915.

Css,max is the steady state maximum concentration of TQB3915 .

DF is the volatility coefficient of TQB3915

Css,min is the minimum plasma concentration of TQB3915

Css-av is the mean steady state plasma concentrations of TQB3915

AUC0-τis the area under the steady-state plasma concentration-time curve of TQB3915

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

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

Percentage of subjects who achieved complete remission (CR), partial remission (PR) and stable disease (SD) for at least 24 weeks

The period from the participants first achieving CR or PR to disease progression.

PFS is defined as the time from the first treatment to the first disease progression or death from any cause

OS is defined as the time from the first administration to all-cause death.

Spots Global Cancer Trial Database for tqb3915 tablets