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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants enrolled into Arm VII will complete quality of life questionnaires examining general quality of life and neuropathy associated quality of life parameters."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests BOLD-100, a drug given through a vein, with FOLFOX chemotherapy for advanced cancer of the digestive system. It is for adults whose cancer has spread or cannot be removed with surgery. Researchers will first test doses for safety, then treat a larger group.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old.
- Not be pregnant, and agree to follow the study’s birth control rules.
- Have cancer of the digestive system confirmed by tissue or cell tests. The cancer must have spread or be unable to be removed with surgery.
- Have cancer that can be measured on scans and be expected to live at least 16 weeks.
- Be able to walk and do most daily activities, and have organs that work well enough.
- Take stable doses of any medicines that affect how the liver or kidneys handle drugs.
- Understand your illness and the study, and sign a consent form.
- For study group VII: Have had exactly one prior course of treatment for cancer that has spread, and have a tumor without a BRAF gene change.
Who can't join
- Have nerve damage above grade 2, or have been unable to tolerate fluorouracil or oxaliplatin or had a major reaction to either drug.
- Have had a stroke in the past 6 months, cancer that spread to the brain or spinal cord or their coverings, serious heart disease, or another serious illness that could make treatment unsafe or study participation difficult.
- Have coughed up blood, had bleeding in the brain, or had major bleeding in the digestive system in the past 6 months; or have had another cancer within the past 3 years.
- Have active digestive disease that keeps you from absorbing nutrients, an unhealed wound, broken bone or sore, or poor blood flow in the limbs that causes symptoms. Also excluded: losing more than 10% of your current body weight in the past 3 months.
- Have had radiation, surgery, or another experimental or cancer treatment within 4 weeks before starting treatment, or are currently using another experimental treatment.
- Be breastfeeding, or have HIV and take a combination of HIV medicines that could interact with the study drug.
- Have too little DPD, a protein that helps break down certain drugs, or currently take or have taken drugs that strongly block DPD.
- For study group VII: Have received BOLD-100 before, have a tumor with the MSI-H marker, or receive certain antibody treatments targeting EGFR, VEGF or HER2 for colorectal cancer that has spread.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Be 18 years or older. 2. Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol. 3. 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. 4. Have measurable disease according to RECIST v1.1. 5. Have an anticipated survival of at least 16 weeks. 6. Be ambulatory, with an ECOG performance score of 0 or 1. 7. Have adequate organ function. 8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug excretion. 9. Be fully informed about their illness and the investigational nature of the study protocol, and sign a REB-approved Informed Consent Form (ICF). 10. (ARM VII): BRAF wild-type tumour status. Exclusion Criteria: 1. Neuropathy \> grade 2 2. Previous intolerance to or significant reaction secondary to fluorouracil or oxaliplatin. 3. Cerebrovascular accident within the past 6 months before the start of treatment. 4. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumours. 5. Any serious medical conditions that might be aggravated by treatment or limit compliance. 6. Any history of serious cardiac illness. 7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months before the start of treatment. 8. Any other known malignancy within 3 years before the start of treatment. 9. Active gastrointestinal tract disease with malabsorption syndrome. 10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease. 11. Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment. 12. Recent history of weight loss \> 10% of current body weight in past 3 months before the start of treatment. 13. HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent. 14. Concurrent use of another investigational therapy or anti-cancer therapy within 4 weeks before the start of treatment. 15. Currently breastfeeding 16. Dihydropyrimidine Dehydrogenase (DPD) deficiency 17. Current or prior treatment with potent inhibitors of Dihydropyrimidine Dehydrogenase (DPD) 18. (ARM VII): Prior exposure to BOLD-100 19. (ARM VII): Subjects with microsatellite-high (MSI-H) Tumours 20. (ARM VII): Concurrent monoclonal antibody therapy for mCRC (anti-EGFR, anti-VEGF or anti-HER2)
Study sites (2)
CA
- University of California, Los Angeles · Santa Monica, CA 90095More trials in Santa Monica
FL
- Moffitt Cancer Center · Tampa, FL 33612More trials in Tampa