A Phase III Study of Oral GFH375 for Adults With Advanced Solid Tumors Having KRAS G12D Mutations

What this Trial Is About

Researchers are evaluating GFH375 in adults with advanced solid tumors that have a KRAS G12D mutation. This open-label, phase III clinical trial aims to explore the safety, tolerability, how the body processes the drug, and early signs of effectiveness in this patient group. Participants will receive GFH375 orally at assigned dose levels and continue treatment until their disease progresses or they experience unacceptable side effects. The study has multiple phases phase Ia focuses on safety and dose-limiting toxicities over 21 days and up to 24 months, phase Ib also monitors safety for up to 24 months, and phase II assesses overall tumor response over 24 months. During the trial, participants will undergo regular assessments including monitoring for adverse events, blood tests for drug levels, and tumor measurements using RECIST 1.1 criteria. The main outcomes measured are the frequency and severity of side effects, dose-limiting toxicities, and tumor response rate. The total participation can last up to 24 months with detailed safety and efficacy evaluations throughout.

A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations