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

Official Title

A Phase 1b Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

Summary:

BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.

Trial Description

Primary Outcome:

• Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
• Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;
• Incidence of dose-limiting toxicities (DLT)
• Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results (chemistry, hematology, coagulation, urinalysis), Eastern Cooperative Oncology Group (ECOG) performance status

• Progression Free Survival (PFS); Overall Response Rate (ORR); Overall Survival (OS)
• Standard PK parameters including Cmin
• Baseline GRP78 biomarker levels (Counts/mL)
• Changes in GRP78 biomarker levels during treatment (Counts/mL)
• Standard PK parameters including Cmax
• Standard PK parameters including TSS
• Standard PK parameters including CSS
• Standard PK parameters including Vdss

View this trial on ClinicalTrials.gov