BOLD-100 combined with FOLFOX for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of BOLD-100, a ruthenium-based small molecule, when used in combination with FOLFOX chemotherapy for patients with advanced solid tumors, including colorectal, pancreatic, gastric cancers, and cholangiocarcinoma. The study consists of a dose escalation phase to assess safety and tolerability, followed by a cohort expansion phase to further evaluate the treatment's efficacy. Participants will have previously received at least one line of chemotherapy and will be monitored for responses to the treatment.

Why it matters

Who can join: the full rules

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, and are subject to receive FOLFOX ± Bevacizumab. (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, oxaliplatin, or bevacizumab.
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)

Where it's running

• Cross Cancer Institue
  Edmonton, Alberta, Canada Recruiting
• Juravinski Cancer Centre
  Hamilton, Ontario, Canada Recruiting
• The Ottawa Hospital Cancer Centre
  Ottawa, Ontario, Canada Recruiting
• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting
• Jewish General Hospital
  Montreal, Quebec, Canada Recruiting
• McGill University Health Centre Glen Site
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Michelle Jones
• Email: clinical@bold-therapeutics.com
• Phone: 604-262-9899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.