2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.54 (Poster) A Multicenter, Open-Label Phase 1 Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Advanced Solid Tumors

PP01.54 (Poster) A Multicenter, Open-Label Phase 1 Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Advanced Solid Tumors

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A phase 1 clinical trial evaluated the safety and tolerability of ICP-723, a next-generation TRK inhibitor, in advanced solid tumor patients. The trial enrolled 7 patients with various tumor types. No dose-limiting toxicities were observed, and the common treatment-emergent adverse events included constipation, anemia, fall, and nausea. Grade 3 adverse events occurred in 1 patient each, but there were no grade 4 or 5 events. All treatment-related adverse events were grades 1-2, and no grade 3 treatment-related adverse events were reported. There were 4 serious adverse events, but they were not treatment-related. Four patients had adverse events leading to dose interruption, but there were no adverse events leading to dose reduction, treatment withdrawal, or death. <br /><br />The pharmacokinetic analysis showed that plasma exposure to ICP-723 increased dose-dependently. The drug was rapidly absorbed and reached peak concentrations after 1-2 hours. The half-life of ICP-723 was approximately 20 hours at steady state. The pharmacokinetic profile of ICP-723 in US patients was similar to that previously reported in Chinese patients.<br /><br />In conclusion, ICP-723 was well-tolerated in solid tumor patients at doses of 8 mg and 12 mg once daily. There were no severe adverse events or deaths related to the treatment. The drug showed a favorable pharmacokinetic profile, and plasma exposure increased with dose. These findings support the potential use of ICP-723 in treating solid tumors in diverse populations. <br /><br />This study was sponsored and funded by InnoCare Pharma. The authors acknowledge the patients, study centers, investigators, and support staff involved in the trial.

Asset Subtitle

Jun Zhang

Keywords

phase 1 clinical trial

safety and tolerability

ICP-723

next-generation TRK inhibitor

advanced solid tumor patients

dose-limiting toxicities

treatment-emergent adverse events

pharmacokinetic analysis

plasma exposure

InnoCare Pharma