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. 2. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol (see Table 12. Acceptable Contraceptive Methods.) 3. Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX as SOC per investigator's judgement. Participants will have received at least one line of chemotherapy in the metastatic setting. Colorectal cancer: Patients must have received at least 1 prior line of therapy prior to enrollment in this study. Pancreatic cancer: Patients must have received at least 1 prior line of therapy. Gastric cancer: Patients who have not received prior treatment may be included in this study. GEJ (gastroesophageal junction) cancer patients are considered eligible to enter this trial. Cholangiocarcinoma: locally advanced or metastatic biliary tract cancer (intra or extrahepatic cholangiocarcinoma or gallbladder can
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