Comparing 9 approaches for colorectal cancer
Official title: BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours
Interventions
BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone
BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy
Canadian Sites (6)
Cross Cancer Institue
Edmonton, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre Glen Site
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable. (ARMArmOne of the groups in a study, each receiving something different.Read more → VII): Patients must have received only 1 prior line of therapy in the metastatic setting.
- +Be 18 years or older.
- +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 protocolProtocolThe detailed plan a study must follow.Read more →, and sign a REBResearch Ethics Board (REB)The independent committee that must approve a study before it can run.Read more →-approved Informed Consent FormInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (ICF).
- +(ARM VII): BRAF wild-type tumour status.
- +Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
Exclusion
- −History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours.
- −HIV-positive subjects on combination anti-retroviral therapy due to the potential for PKPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → interactions with the study agent.
- −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.
- −Any serious medical conditions that might be aggravated by treatment or limit compliance.
- −Any history of serious cardiac illness.
- −Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment.
- −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.
- −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.
- −Dihydropyrimidine Dehydrogenase (DPD) deficiency
- −Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
- −(ARMArmOne of the groups in a study, each receiving something different.Read more → VII): Prior exposure to BOLD-100
- −(ARM VII): Subjects with microsatellite-high (MSI-H) Tumours
- −(ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
- −Currently breastfeeding
- −Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
What is being given or done in this study: BOLD-100 +/- FOLFOX Chemotherapy (ArmArmOne of the groups in a study, each receiving something different.Read more → VII), BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 9 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 220 people.
The study is currently expected to finish around September 2026.
The main measurement is taken over: Through study completion, approximately 2 weeks after last treatment.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence and severity of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → ([S]AEs) — measured over Through study completion, approximately 2 weeks after last treatment.
Incidence of dose-limiting toxicities (DLT) — measured over ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → to 4 weeks after first treatment.
Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results, ECOG performance status — measured over Through study completion, approximately 2 weeks after last treatment.
Progression Free Survival (PFS): ArmArmOne of the groups in a study, each receiving something different.Read more → VII — measured over Through study completion, approximately 2 weeks after last treatment for last patient.
The study lists 2 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04421820 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)Drug
Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)Drug
BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Through study completion, approximately 2 weeks after last treatment.
The study as a whole is currently expected to finish around 2026-09-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 220 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.