A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

Trial ID: NCT04421820

Interventional - Phase 1/2 - Recruiting

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.

Conditions

• Colorectal Cancer
• Pancreatic Cancer
• Gastric Cancers
• Cholangiocarcinoma

Interventions

• BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
• BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

Eligibility

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

• 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)
• 10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
• 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.
• 11. Treatment with radiation therapy or surgery within 4 weeks prior to starting treatment.

Sponsor

Bold Therapeutics, Inc.

Source: ClinicalTrials.gov

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