Sponsor: Boundless Bio
Sponsor Study ID: Boundless Bio BBI-355-101
Study Title: An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Oncogene Amplifications
CTO #: 104006
NCT Number: NCT05827614
Phase: I
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Ovary
Study Objectives: To assess the safety, tolerability, and dose-limiting toxicities (DLTs) of BBI-355 as a single agent administered orally at escalating dose levels in adult subjects with locally advanced or metastatic solid tumors with oncogene amplifications. To assess the safety, tolerability, and DLTs ofBBI-355 in combination with each of the following agents: erlotinib, futibatinib, or abemaciclib, at escalating dose levels in adults with locally advanced or metastatic solid tumors with corresponding oncogene amplifications. To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of BBI-355 as a single agent. To determine the MTD and the RP2D of BBI-355 in combination with each of the following agents: erlotinib, futibatinib, or abemaciclib.