New chemical structure!

Text|Pharmaceutical Mission Hills

On September 8, Kangchen Pharmaceutical issued an announcement stating that its Class 1 new drug KC1036 was in line with the expected research results in the phase 1 clinical study for the treatment of patients with advanced solid tumors.

The data released this time is an open, dose-escalation phase 1 clinical study evaluating the safety, tolerability and pharmacokinetics of KC1036 in the treatment of advanced recurring or metastatic solid tumors (plan number: KC1036-I-01)

The study began on September 4, 2020 to enroll the first subject.

As of the date of this data analysis, in the dose escalation stage, the dose-limiting toxicity (DLT) observation of the third patient in the 80mg dose group has been completed, and no DLT response has been observed; in 13 subjects/5 dose levels, No DLT event was observed, and the trial has successfully entered the second phase of the dose expansion study

In terms of efficacy, 15 subjects completed at least one tumor assessment, of which 2 cases (1 case of lung adenocarcinoma and 1 case of esophageal cancer) had the best effect as partial remission (PR), and 10 cases received The best curative effect of the test subjects was stable disease (SD), 3 subjects were out of the group due to disease progression (PD); the objective response rate (ORR) was 13.

In terms of safety, the more common adverse reactions observed by researchers are abnormal clinical laboratory test indicators, nausea, etc.

The results of the study showed that KC1036 single-drug has good safety and tolerability, and showed outstanding anti-tumor activity in the above-mentioned patients with advanced solid tumors

According to the announcement, although small-molecule targeted drug therapy has made great progress in most advanced tumors (including lung cancer, colorectal cancer, breast cancer, ovarian cancer, etc.

Reference materials:

[1] Announcement on voluntary disclosure of KC1036 clinical trial data.