BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBold Therapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Be 18 years or older.
Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable. (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting.
Have measurable disease according to RECIST v1.1.
Disqualifiers
Neuropathy > grade 2
Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin.
Cerebrovascular accident within the past 6 months before the start of treatment.
History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
Trial design
Treatments tested in this trial
- BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
- BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
Treatment groups
220 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Locations
24Canada
Cross Cancer Institue EdmontonAlberta, Canada
Juravinski Cancer Centre HamiltonOntario, Canada
The Ottawa Hospital Cancer Centre OttawaOntario, Canada
Princess Margaret Cancer Centre TorontoOntario, Canada
Sponsors and collaborators
Bold Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov