Study of BOLD-100 Combined With FOLFOX Chemotherapy for Advanced Gastrointestinal Cancers

What this Trial Is About

Researchers are evaluating BOLD-100, an intravenous ruthenium-based small molecule drug, combined with FOLFOX chemotherapy for advanced gastrointestinal cancers, including colorectal, pancreatic, gastric cancers, and cholangiocarcinoma. This Phase 1b2a study aims to assess safety, tolerability, and anti-tumor activity, focusing on patients who have received limited prior treatment and have specific tumor characteristics. Participants receive BOLD-100 at different dose levels 500 mgm2 or 625 mgm2 combined with standard FOLFOX chemotherapy or FOLFOX alone. The study includes a dose escalation phase to ensure safety, followed by a cohort expansion phase. Some study arms are closed, while others, such as Arm VII for colorectal cancer patients, are actively enrolling with different treatment assignments. During the trial, participants will undergo regular monitoring for adverse events, dose-limiting toxicities, and clinical changes through physical exams, ECGs, lab tests, and performance assessments. Quality of life and neuropathy-related questionnaires will be completed. Researchers will evaluate progression-free survival, overall response, and overall survival, with follow-up continuing for about two weeks after the last treatment to assess these outcomes and collect pharmacokinetic and biomarker data.

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours