Phase 1 Study of BBO-11818 Alone and With Other Treatments in Adults with Advanced KRAS Mutant Cancers

What this Trial Is About

Researchers are evaluating the safety and early antitumor effects of BBO-11818, a pan-KRAS inhibitor, in adults with locally advanced unresectable or metastatic cancers that have KRAS mutations. This Phase 1, open-label, multi-center trial focuses on solid tumors including non-small cell lung cancer, pancreatic ductal adenocarcinoma, colorectal cancer, and other advanced cancers with specific KRAS mutations. The study aims to understand how BBO-11818 works alone and combined with other cancer treatments. Participants receive BBO-11818 orally, either by itself or with various intravenous treatments such as pembrolizumab, platinum chemotherapy cisplatin or carboplatin, pemetrexed, cetuximab, mFOLFOX6, BBO-10203, mFOLFIRINOX, gemcitabine, and nab-paclitaxel. The trial includes a dose escalation phase to find the recommended dose and a dose expansion phase to further evaluate treatment combinations. Multiple treatment cohorts receive different combinations of these agents. During the study, participants will be monitored for treatment-related side effects, drug levels in the blood, and tumor response using RECIST criteria over approximately five years. Researchers will track safety events, pharmacokinetics, tumor shrinkage, duration of response, progression-free survival, and overall survival. Regular assessments include physical exams, laboratory tests, imaging scans, and evaluation of patient health and life expectancy. The study is designed to gather detailed information about BBO-11818s effects and tolerability in this patient group.

BBO-11818 in Adult Subjects With KRAS Mutant Cancer