A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors
Study Title: A Phase I, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LAE118 as Monotherapy and in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors Study Design Overview: This is an open-label, multicenter Phase I clinical trial comprising three cohorts: Cohort A (LAE118 monotherapy), Cohort B (LAE118 plus fulvestrant), and Cohort C (LAE118 plus fulvestrant and palbociclib). Each cohort consists of two stages. Stage I evaluates safety and determines the maximum tolerated dose (MTD) and recommended dose (RD) of LAE118; Stage II assesses the preliminary efficacy of LAE118 at the RD.
Age ≥18 years at the time of signing the informed consent form. [+13]
Prior treatment with a PI3K, AKT, or mTOR inhibitor without clinical benefit ("b... [+24]