drugset / Trial / NCT04421820

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

NCT04421820

Phase 1/2 Recruiting 220 enrolled Bold Therapeutics, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-08-28
Primary completion
2026-06-01
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BOLD-100 Small molecule 500 mg/m2 Intravenous
Subject BOLD-100 Small molecule 625 mg/m2 Intravenous
Background Leucovorin Small molecule
Background Oxaliplatin Small molecule
Background fluorouracil Small molecule