NCT04421820 · Bold Therapeutics, Inc.
BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
What this study is about
BOLD-100 is an given through a vein (IV) 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.
View original scientific 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 chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.
Interventions
DRUG
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
DRUG
BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy
Primary outcome measures
Incidence and severity of adverse events ([S]AEs)
Time frame: Through study completion, approximately 2 weeks after last treatment
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
Incidence of dose-limiting toxicities (DLT)
Time frame: Screening to 4 weeks after first treatment
Dose escalation only.
Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results, ECOG performance status
Time frame: Through study completion, approximately 2 weeks after last treatment
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure
Progression Free Survival (PFS): Arm VII
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
Overall Response Rate (ORR): Arm VII
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
Overall Survival (OS): Arm VII
Time frame: Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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 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.
- 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.
- 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.
- HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
- Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment.
- Currently breastfeeding
- Dihydropyrimidine Dehydrogenase (DPD) deficiency
- Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD)
- (ARM 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)
Where
- Santa Monica, California
- Tampa, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations