2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.054 Jun Zhang Abstract

PP01.054 Jun Zhang Abstract

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A phase 1 clinical trial was conducted to evaluate the safety, tolerability, and pharmacokinetics of ICP-723, a novel TRK inhibitor, in patients with advanced solid tumors. The study included seven patients who were administered 8 and 12mg of ICP-723 once daily for 28 days. The primary endpoint of the study was safety and tolerability. <br /><br />The results of the trial showed that ICP-723 was well tolerated by the patients, with no dose-limiting toxicities observed. The most common treatment-related adverse events were constipation, anemia, fall, dysgeusia, and nausea. No grade 3 or higher treatment-related adverse events were reported. <br /><br />The pharmacokinetic data showed that ICP-723 was rapidly absorbed and reached peak concentration within a median time of 1.95 and 1.00 hour(s) for the two dose cohorts, respectively. The half-life of ICP-723 was approximately 20 hours at steady state. The plasma exposures of ICP-723 also increased in a dose-dependent manner. <br /><br />The study included patients with lung, colorectal, sarcoma, and pancreatic cancers, but no patients with TRK or ROS-1 fusions were enrolled. The median age of the patients was 54 years and they had received a median of 3 prior lines of therapy. <br /><br />These results are consistent with the previously reported pharmacokinetic data of ICP-723 in Chinese patients, indicating that the drug may have potential utility in treating solid tumors in diverse populations. The study was funded by InnoCare Pharma and there were no conflicts of interest declared by the authors.

Keywords

phase 1 clinical trial

ICP-723

safety

tolerability

pharmacokinetics

adverse events

plasma exposures

solid tumors

prior lines of therapy

diverse populations