Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of BPI-572270 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups, and to further expand the enrollment of more patients to evaluate the efficacy endpoints (ORR/DCR/DOR/TTR).

Inclusion criteria

• Histologically confirmed advanced solid tumor with RAS mutations identified through deoxyribonucleic acid (DNA) sequencing.
• Have received prior standard therapy appropriate for tumor type and stage.
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function.

Exclusion criteria

• Primary central nervous system (CNS) tumors active and untreated brain metastases.
• Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication.
• History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy