Study of KQB365 Alone and With Other Drugs for Advanced Solid Tumors with KRAS G12C or G12S Mutations Evaluating Safety, Dose, and Effects

What this Trial Is About

Researchers are investigating the safety and effectiveness of KQB365 for treating advanced solid tumor cancers in adults. This study focuses on cancers with specific KRAS G12C or G12S mutations, including colorectal cancer. The trial aims to find the safe dosage of KQB365 alone or combined with cetuximab or KQB198, and to observe how KQB365 affects tumor size and behaves in the body. It is a Phase 1/1b open-label study involving dose escalation and optimization. Participants will receive weekly intravenous infusions of KQB365 either alone, with intravenous cetuximab, or with oral KQB198. The study includes an initial dose escalation phase to determine the recommended Phase 2 dose and evaluates the treatment's effectiveness by measuring tumor response. The treatment and observation period may last up to 35 months, with frequent clinic visits during the first six weeks and weekly visits thereafter. During the study, participants will undergo regular assessments including monitoring for adverse events, dose-limiting toxicities, and tumor measurements using RECIST criteria. Researchers will collect data on safety, tolerability, pharmacokinetics, and efficacy. The schedule involves about nine visits in the first six weeks and weekly visits afterward to closely track treatment effects and patient health throughout the study duration.

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies