Tests BOLD-100 with FOLFOX chemotherapy in advanced solid tumours

Trial details

Who runs it

Bold Therapeutics, Inc.

Trial code

NCT04421820EU 2024-517500-11-00

Record updated

28 October 2026

Original description

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.Read full original descriptionShow less

A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy With or Without Bevacizumab in Patients With Advanced Solid Tumours

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.

Inclusion: 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, and are subject to receive FOLFOX ± Bevacizumab. (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; Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF); (ARM VII): BRAF wild-type tumour status.

Exclusion: Previous intolerance to or significant reaction secondary to fluorouracil, oxaliplatin, or bevacizumab; Cerebrovascular accident within the past 6 months before the start of treatment; Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment; Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment; Recent history of weight loss > 10% of current body weight in past 3 months before the start of treatment; Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment; Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD); (ARM VII): Prior exposure to BOLD-100; Any serious medical conditions that might be aggravated by treatment or limit compliance; Any history of serious cardiac illness; Any other known malignancy within 3 years before the start of treatment; Active gastrointestinal tract disease with malabsorption syndrome; Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease; HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent; (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2); Neuropathy > grade 2; History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours; Currently breastfeeding; Dihydropyrimidine Dehydrogenase (DPD) deficiency; (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours.

ClinicalTrials.gov NCT04421820 · EU CTIS 2024-517500-11-00