NCT06907043 – A Phase 1/2, Open-Label, Multicenter, Dose-Escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants with Advanced Solid Tumors
This Phase 1/2 trial, sponsored by Eikon Therapeutics, evaluates EIK1004 (also called IMP1707), a CNS penetrant, selective PARP1 inhibitor, given alone in patients with advanced or metastatic solid tumors. Eligible cancer types include endometrioid ovarian cancer, fallopian tube cancer, primary peritoneal cancer, HER2 negative breast cancer, metastatic castration resistant prostate cancer, and metastatic pancreatic ductal adenocarcinoma, in patients who carry deleterious or suspected deleterious mutations in DNA repair genes such as BRCA1, BRCA2, PALB2, RAD51B, RAD51C, or RAD51D. The study has two parts: dose escalation, which identifies the maximum tolerated or maximum administered dose along with a recommended dose for further study, and dose optimization, which continues assessing safety and tolerability at that established dose. Because the drug is designed to cross into the central nervous system, the trial also includes patients with brain metastases.