Purpose
The purpose of this committee is to facilitate the early phase clinical development of anti-cancer therapies to improve the lives of patients with gynecologic cancers. The focus of this committee is to support the early phase development of novel therapies for gynecologic malignancies and tumor-agnostic approaches to anti-cancer therapy. The goals of this committee include: performing Phase 1 studies to identify the dose/schedule of novel therapies/therapeutic combinations (including chemotherapy, targeted/biologic agents, and immunotherapies) to support further development in Phase 2 and 3 studies; supporting the safety lead-in portion of studies in collaboration with the disease-specific subcommittee; performing pharmacokinetic and pharmacodynamic studies to guide dose/schedule selection and optimization; and, nurturing the progress of early investigators in drug development. The full committee meets 4 times per year with 2 in-person and 2 virtual interim meetings. Study-specific meetings occur on a weekly/bi-weekly basis.