✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE1
Participants
ALL
Age Range
18 Years+
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 ± Bevacizumab chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase. This study now includes as a treatment intervention the SOC combination FOLFOX ± Bevacizumab, if indicated.
Who Can Join?
Inclusion Criteria: 1. Be 18 years or older. 2. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol. 3. Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX ± Bevacizumab. (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting. 4. Have measurable disease according to RECIST v1.1. 5. Have an anticipated survival of at least 16 weeks. 6. Be ambulatory, with an ECOG performance score of 0 or 1. 7. Have adequate organ function. 8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion. 9. Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF). 10. (ARM VII): BRAF wild-type tumour status. Exclusion Criteria: 1. Neuropathy > grade…
⚠ Always speak to your doctor before applying to any clinical trial.