Phase 1 Study to Evaluate Safety and Effectiveness of KQB168 Alone or with Pembrolizumab in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are studying the safety and effectiveness of KQB168, alone or combined with pembrolizumab, in adults with advanced solid tumor cancers that have progressed after immunotherapy. This phase 1 trial aims to find the safe dose of KQB168, see if it reduces tumor size, and understand how the drug behaves in the body. The study is led by Kumquat Biosciences Inc. and focuses on cancers without curative treatment options. Participants will receive oral KQB168 daily either by itself or with intravenous pembrolizumab. The trial involves dose escalation phases for both monotherapy and combination therapy. During the first 8 weeks, participants will visit the clinic about 8 times, followed by visits every 3 weeks thereafter. The study will evaluate treatment safety, tumor responses, and how the drugs are processed over up to 36 months. Throughout the study, participants will undergo regular assessments including monitoring for side effects, tumor measurements using RECIST criteria, and blood tests to check drug levels. Researchers will track adverse events, response rates, duration of response, disease control, progression-free survival, and overall survival. The trial lasts up to 36 months to gather comprehensive safety and efficacy data while supporting ongoing participant care.

A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies