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.
Sponsors and collaborators
Source ClinicalTrials.gov