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BOLD-100 + FOLFOX for Advanced Cancers
Study Summary
This trial will test the safety of a new ruthenium-based drug, BOLD-100, when combined with a standard chemotherapy regimen. The drug will be given intravenously, and the trial will first assess safety in a small group of patients before expanding to a larger group.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant and agree to follow the study's birth control requirements.I have not had a stroke in the last 6 months.I have or had brain metastases or tumors in the lining of my brain.My neuropathy is mild or I don't have it.I am 18 years old or older.I do not have any serious health conditions that could worsen with treatment.Any side effects from my previous treatments have mostly gone away.I can take pills by mouth for treatment.I understand and am willing to follow the study's procedures and rules.I can move around and my health is good enough for most activities.My medication doses affecting liver or kidney function have been stable for 30 days.My blood, liver, and kidney functions meet the required levels for the trial.
- Group 1: Part B - Dose Expansion - 1L Gastric Cancer (ARM I)
- Group 2: Part B - Dose Expansion - 2L Gastric Cancer (ARM II)
- Group 3: Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)
- Group 4: Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)
- Group 5: Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)
- Group 6: Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)
- Group 7: Part A - Dose Escalation - Gastric Cancer
- Group 8: Part A - Dose Escalation - Pancreatic Cancer
- Group 9: Part A - Dose Escalation - Colorectal Cancer
- Group 10: Part A - Dose Escalation - Cholangiocarcinoma
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are patients still being enrolled in this clinical trial?
"The latest information available on clinicaltrials.gov suggests that this trial is still open to patients. The listing was first posted on 8/28/2020 and has been edited as recently as 11/7/2022."
Is this trial being overseen by more than one organization?
"Currently, patients are being enrolled at University of California, Los Angeles in Santa Monica, California; Cross Cancer Institue in Edmonton, Alberta; McGill University Health Centre Glen Site in Montréal, Quebec as well as 8 other locations."
What is the total number of people participating in this clinical trial?
"Yes, the information on clinicaltrials.gov indicates that this trial is currently recruiting patients. The study was originally posted on 8/28/2020 and last updated on 11/7/2022. The study is looking for 100 patients across 8 sites."
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