A Phase 1/1b Study Evaluating Safety, Tolerability, Pharmacokinetics, and Efficacy of KQB365 Alone and with Cetuximab or KQB198 in Adults With Advanced Solid Tumors Having KRAS G12S or G12C Mutations

What this Trial Is About

Researchers are evaluating the safety and effectiveness of KQB365, alone and in combination with cetuximab or KQB198, in adults with advanced solid tumor cancers that have specific KRAS G12C or G12S mutations. The trial aims to find the safe dose of KQB365, see if it decreases tumor size, and understand how the drug behaves in the body. This study focuses on patients with unresectable or metastatic tumors who have no curative treatment options available. Participants will receive weekly infusions of KQB365 either alone or combined with intravenous cetuximab or oral KQB198. The study includes a dose escalation phase to find the recommended dose, followed by dose expansion phases to evaluate treatment effects. The trial is open-label and non-randomized, with multiple treatment groups receiving different drug combinations to assess safety and response. During the trial, participants will visit the clinic about nine times in the first six weeks and then weekly thereafter. Researchers will monitor adverse events, dose tolerability, tumor response using RECIST criteria, and drug levels in the blood. Outcome measures include the number of side effects, recommended phase 2 dose, objective response rate, survival, and disease control. Monitoring continues for up to 35 months to assess long-term safety and treatment effects.

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