BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours (NCT04421820) | Clinical Trial Compass
RecruitingPhase 1/2
BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
United States, Canada220 participantsStarted 2020-08-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Have an anticipated survival of at least 16 weeks.
✓. Be ambulatory, with an ECOG performance score of 0 or 1.
✓. Have adequate organ function.
✓. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion.
Exclusion criteria
✕. 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.
✕. Any serious medical conditions that might be aggravated by treatment or limit compliance.
What they're measuring
1
Incidence and severity of adverse events ([S]AEs)
Timeframe: Through study completion, approximately 2 weeks after last treatment
2
Incidence of dose-limiting toxicities (DLT)
Timeframe: Screening to 4 weeks after first treatment
3
Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results, ECOG performance status
Timeframe: Through study completion, approximately 2 weeks after last treatment
4
Progression Free Survival (PFS): Arm VII
Timeframe: Through study completion, approximately 2 weeks after last treatment for last patient
5
Overall Response Rate (ORR): Arm VII
Timeframe: Through study completion, approximately 2 weeks after last treatment for last patient
6
Overall Survival (OS): Arm VII
Timeframe: Through study completion, approximately 2 weeks after last treatment for last patient